tag:blogger.com,1999:blog-67065541708005086712024-03-05T07:03:52.977-08:00Online Indian Health and Pharmacy NewsOnline Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.comBlogger4148125tag:blogger.com,1999:blog-6706554170800508671.post-65272765273698295892016-09-02T11:33:00.001-07:002016-09-02T11:33:08.291-07:00Study Explores Marijuana Use and Fibrosis in Women with HIV and Hepatitis C <div dir="ltr" style="text-align: left;" trbidi="on">
A study in women coinfected with hepatitis C and HIV found that use of marijuana was not associated with progression to advanced liver fibrosis.<br /><br />University researchers studied long-term effects of tetrahydrocannabinol (THC) from marijuana on fibrosis progression in women enrolled in the Women’s Interagency HIV Study. Results were published recently in the Oxford Journal of Clinical Infectious Diseases.<br /><br />The hepatitis C virus (HCV) is a blood-borne disease that, left unchecked, can lead to fibrosis, cirrhosis, liver cancer, or the need for a liver transplant. The authors note that marijuana use has been associated with progression of liver fibrosis in retrospective analyses of patients with chronic hepatitis C and that other studies on the impact of THC use and liver fibrosis progression have reported conflicting results.<br /><br />“Currently, marijuana has been legalized for medicinal and/or recreational use in 23 US states, as well as the District of Columbia, and its use in HIV/HCV-coinfected patients is common,” the authors stated in the article. “Given that it is becoming more widely available and more regularly consumed, it is critical to assess its clinical effects, including any negative impact of THC use on liver fibrosis progression.”<br /><br />In this longitudinal analysis, researchers measured marijuana and alcohol use, quantifying it as average exposure per week. Liver fibrosis was categorized according to FIB-4 scores, as none, moderate or significant.<br /><br />The study followed women who were coinfected with hepatitis C and HIV for an average of 11 years. Out of 575 women, 25% reported less than weekly THC use, 12% reported weekly use and 7% said that they used daily; just over half reported no THC use at all.<br /><br />There were not many women who were heavy users of THC, but the study’s long follow-up period and study size enabled researchers to conclude that occasional THC is unlikely to contribute to fibrosis progression, according to the article.<br /><br />“We found no evidence that THC accelerated fibrosis progression in women with HIV-HCV coinfection,” lead author Erin Kelly, MD, assistant professor at the University of Ottawa in Canada, said in an email. “Importantly, daily users were less prevalent in this cohort, therefore our results should not be extrapolated to this group.”<br /><br />The possibility of underreported THC and alcohol use by the women in the study was noted as a limitation. In addition, liver biopsy was not conducted and fibrosis stage was instead determined using non-invasive tests.<br /><br />Much like findings from other published studies, predictors of progression of significant fibrosis involving women in the WIHS study included the presence of baseline fibrosis, as well as entry CD4 count and HCV RNA level and ongoing alcohol consumption, according to the article.<br /><br />“Fibrosis progression was associated with poor HIV control and alcohol use,” the authors concluded. “Clinicians should therefore counsel patients on limiting or excluding alcohol intake, in addition to optimizing medical treatment for HIV and HCV, as these factors are more important than THC use in modulating liver disease,” they advised. - See more at: http://www.hcplive.com/medical-news/study-explores-marijuana-use-and-fibrosis-in-women-with-hiv-and-hepatitis-c#sthash.i3jsMf1w.dpuf<div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">
A
study in women coinfected with hepatitis C and HIV found that use of
marijuana was not associated with progression to advanced liver
fibrosis.<br />
<br />
University researchers studied long-term effects of
tetrahydrocannabinol (THC) from marijuana on fibrosis progression in
women enrolled in the Women’s Interagency HIV Study. <a href="http://cid.oxfordjournals.org/content/63/4/512.abstract" target="_blank">Results were published recently</a> in the <em>Oxford Journal of Clinical Infectious Diseases.</em><br />
<br />
The hepatitis C virus (HCV) is a blood-borne disease that, left
unchecked, can lead to fibrosis, cirrhosis, liver cancer, or the need
for a liver transplant. The authors note that marijuana use has been
associated with progression of liver fibrosis in retrospective analyses
of patients with chronic hepatitis C and that other studies on the
impact of THC use and liver fibrosis progression have reported
conflicting results.<br />
<br />
“Currently, marijuana has been legalized for medicinal and/or
recreational use in 23 US states, as well as the District of Columbia,
and its use in HIV/HCV-coinfected patients is common,” the authors
stated in the article. “Given that it is becoming more widely available
and more regularly consumed, it is critical to assess its clinical
effects, including any negative impact of THC use on liver fibrosis
progression.”<br />
<br />
In this longitudinal analysis, researchers measured marijuana and
alcohol use, quantifying it as average exposure per week. Liver fibrosis
was categorized according to FIB-4 scores, as none, moderate or
significant.<br />
<br />
The study followed women who were coinfected with hepatitis C and HIV
for an average of 11 years. Out of 575 women, 25% reported less than
weekly THC use, 12% reported weekly use and 7% said that they used
daily; just over half reported no THC use at all.<br />
<br />
There were not many women who were heavy users of THC, but the study’s
long follow-up period and study size enabled researchers to conclude
that occasional THC is unlikely to contribute to fibrosis progression,
according to the article.<br />
<br />
“We found no evidence that THC accelerated fibrosis progression in
women with HIV-HCV coinfection,” lead author Erin Kelly, MD, assistant
professor at the University of Ottawa in Canada, said in an email.
“Importantly, daily users were less prevalent in this cohort, therefore
our results should not be extrapolated to this group.”<br />
<br />
The possibility of underreported THC and alcohol use by the women in
the study was noted as a limitation. In addition, liver biopsy was not
conducted and fibrosis stage was instead determined using non-invasive
tests.<br />
<br />
Much like findings from other published studies, predictors of
progression of significant fibrosis involving women in the WIHS study
included the presence of baseline fibrosis, as well as entry CD4 count
and HCV RNA level and ongoing alcohol consumption, according to the
article.<br />
<br />
“Fibrosis progression was associated with poor HIV control and alcohol
use,” the authors concluded. “Clinicians should therefore counsel
patients on limiting or excluding alcohol intake, in addition to
optimizing medical treatment for HIV and HCV, as these factors are more
important than THC use in modulating liver disease,” they advised. - See
more at:
http://www.hcplive.com/medical-news/study-explores-marijuana-use-and-fibrosis-in-women-with-hiv-and-hepatitis-c#sthash.i3jsMf1w.dpuf</div>
</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-73761274135891116222016-09-02T11:31:00.001-07:002022-12-30T13:27:04.730-08:00Gilead to get attorney fees in hepatitis C patent fight with Merck<div dir="ltr" style="text-align: left;" trbidi="on">
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Aug
11 (Reuters) - Gilead Sciences Inc is entitled to receive the attorney
fees it incurred related to hepatitis C patent litigation with drugmaker
Merck & Co Inc, a U.S. district judge has ruled.</div><div class="canvas-text Mb(1.0em) Mb(0)--sm Mt(0.8em)--sm canvas-atom" data-reactid=".24w1lzv6jpa.$0.0.0.1.2.0.2.0.0.$Col1-0-ContentCanvas-Proxy.$Col1-0-ContentCanvas.0.4.0:$0" data-type="text" style="letter-spacing: 0.01em;"><br /></div>
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In
June, <a href="https://sunnypharma.info">Gilead</a> was freed from paying up $200 million in damages for
infringing two Merck patents related to Gilead's blockbuster drugs
<a href="https://sunnypharma.info/sovaldi-cost" target="_blank">Sovaldi</a> and <a href="https://medsholidays.com" target="_blank">Harvoni</a>, after a U.S. judge found a pattern of misconduct by
Merck including lying under oath and other unethical practices.</div><div class="canvas-text Mb(1.0em) Mb(0)--sm Mt(0.8em)--sm canvas-atom" data-reactid=".24w1lzv6jpa.$0.0.0.1.2.0.2.0.0.$Col1-0-ContentCanvas-Proxy.$Col1-0-ContentCanvas.0.4.0:$1" data-type="text" style="letter-spacing: 0.01em;"><br /></div>
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In
a filing on Thursday, U.S. District Judge Beth Labson Freeman said that
Gilead was entitled to relief from the fees it incurred while defending
the case.</div><div class="canvas-text Mb(1.0em) Mb(0)--sm Mt(0.8em)--sm canvas-atom" data-reactid=".24w1lzv6jpa.$0.0.0.1.2.0.2.0.0.$Col1-0-ContentCanvas-Proxy.$Col1-0-ContentCanvas.0.4.0:$2" data-type="text" style="letter-spacing: 0.01em;"><br /></div>
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Merck
is trying to catch up to Gilead, which dominates the market on a new
generation of hepatitis C drugs that can cure well over 90 percent of
patients with the liver disease.</div><div class="canvas-text Mb(1.0em) Mb(0)--sm Mt(0.8em)--sm canvas-atom" data-reactid=".24w1lzv6jpa.$0.0.0.1.2.0.2.0.0.$Col1-0-ContentCanvas-Proxy.$Col1-0-ContentCanvas.0.4.0:$3" data-type="text" style="letter-spacing: 0.01em;"><br /></div>
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The
case dates back to 2013 when Gilead and Merck sued each other, claiming
ownership of laboratory work underlying sofosbuvir, the active
ingredient in Gilead's drugs.</div>
</div>
<div id="tango-element-highlighter" style="--tango-highlighter-background-color: transparent; --tango-highlighter-color: #FF7442;"></div>Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-11997913373972392432016-09-02T07:12:00.002-07:002016-09-02T07:12:44.632-07:00Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) Is Gearing Up For Interim HCV Release Next Month<div dir="ltr" style="text-align: left;" trbidi="on">
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) just reported that it is set to release its latest data from a lead HCV combo trial at the European Association for the Study of the Liver (EASL) Special Conference in September. The trial is a real hot focus in the space right now, with the company’s triple regimen therapy being touted as the next big step in once daily oral maintenance in the condition. We’ve got about a month before the data hits, and chances are we will see plenty of speculative volume ahead of the release. With this in mind, and as we head into the closing month of the quarter, here’s a look at the drug/s in question, and what to keep an eye out for when the data hits press.<br /><br />So, the drugs. Achillion has developed a triple regimen of three different HPV compounds, odalasvir, AL-335 and simeprevir. The first of these is a compound that Achillion has developed, while the other two are compounds developed by Johnson & Johnson (NYSE:JNJ)’s Janssen subsidiary. Simeprevir is already approved and branded as Olysio, while AL-335 is still investigational. All three of the compounds inhibit a different protease – with each protease being responsible for a different element of viral replication in HCV. The three protease targets are NS5A, NS3, and NS5B. Olysio has already been demonstrated to be effective in this indication. The hope is, however, that by combining the three compounds and administering them as a triple regimen, the treatment can produce what is called a sustained virologic response when taken once daily orally across a comparatively short dosage timeframe (in this instance, around 12 weeks). This short dosing twelve-week regimen is something of a holy grail in HCV treatment, and if these two can get the treatment to market, it could be a real breakthrough for both as far as bringing a first in class candidate to commercialization is concerned.<br /><br />The World Health Organization estimates that around 4% of the global population has HCV – somewhere in the region of 170 million individuals. In the US, estimates put this number at around 4 million individuals. There are six different genotypes, and this has proved problematic by way of making it difficult to standardize a therapy in a population. At the moment, big Pharma Gilead Sciences, Inc. (NASDAQ:GILD) dominates the space, but if Achillion and Janssen can get this triple regimen approved, it would be able to target multiple genotypes, and as such, could pick up a decent share of the market from Gilead.<br /><br />So, what are we looking for in the upcoming data?<br /><br />Well, the trial is split into four different groups, two of which will receive all three drugs, one for six weeks and one for eight weeks, and the other two of which will receive just AL-335 and odalasvir, again, one group for six weeks and one group for eight weeks. The primary endpoint is the percentage of chronic HCV infected subjects who achieve sustained virologic response 12 weeks after the end of treatment, with this response defined as hepatitis C virus (HCV) ribonucleic acid (RNA)<lower limit of quantification (LLOQ =15 IU/mL, detectable or undetectable). This is a pretty standard definition, and we want to see a good portion of patients hit it to consider the endpoint as hit when topline comes out. From this interim data, we will probably see data that relates to SVR at dose completion, since the trial only kicked off a couple months ago. This doesn’t mean we won’t get any insight into efficacy, however. Specifically, we’re looking for a sustained virological response in as many patients as possible, interim. We would consider anything above 50% as statistically significant, and we would also like to see an improvement in the numbers between the two drug regimens and the three drug regimen, as this would support Achilion’s hypothesis.<br /><br />When should we be watching for the presentation?<br /><br />The company is set to report the data at the above mentioned conference at the end of September, with September 23 touted as the day to keep an eye on.</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-10941407252502959932016-09-02T07:11:00.000-07:002016-09-02T07:11:30.212-07:00Medicare drug spending spike shows need for generics <div dir="ltr" style="text-align: left;" trbidi="on">
An exclusive Associated Press report, which found that Medicare’s spending on certain drugs soared by 85% in two years, emphasizes the government’s need for increasing the use of generics.<br /><br />The AP report said that Medicare’s spending on high-cost “catastrophic” protection drugs jumped from $27.7 billion in 2013 to $51.3 billion in 2015, primarily due to rising brand-drug costs. AP’s data includes costs to taxpayers, insurers, and beneficiaries, as compiled by Medicare's Office of the Actuary.<br /><br />The soaring costs were led by hepatitis C drugs Harvoni and Sovaldi (Gilead Sciences). The two drugs accounted for nearly $7.5 billion of Medicare’s catastrophic drug costs in 2015, up from around $3.5 billion in 2014. Other drugs that skyrocketed in price included Gleevec (Novartis) for leukemia and Revlimid (Celgene) for cancer.<br /><br />“These findings underscore a growing need to make sure that generic drugs are available to hold down public program spending, while increasing patient access to more affordable medicines,” said Chip Davis, president and CEO of the Generic Pharmaceutical Association (GPhA).<br /><br />In fact, generic medicines saved the U.S. health system $254 billion in 2014, with $33 billion of these savings accrued to Medicare, according to GPhA’s annual Generic Drug Savings in the U.S. report.<br /><br />And, without generic drugs, Medicare spending would nearly double, according to Davis. “Increasing access to generic drugs for Medicare enrollees translates to significant savings for the program, taxpayers, and patients, and particularly the 12 million Medicare low-income subsidy (LIS) beneficiaries,” he said. The nonpartisan Medicare Payment Advisory Commission (MedPAC) estimates that changing LIS policies to improve generic utilization for this group could save more than $18 billion over 10 years.<br /><br />One way to realize these savings is for Congress to lower the LIS copay for generic drugs, an effort that can encourage enrollees to choose generic when the option is available, according to Davis.<br /><br /> Meanwhile, one senator is investigating whether Medicare's prescription drug benefit is vulnerable to manipulation by pharmaceutical companies. After the AP report was published, Sen. Charles Grassley (R-Iowa) asked whether Medicare’s prescription program is being handled correctly in a letter to the agency. "Do you believe there is potential for exploitation of the catastrophic benefit as it is currently framed?" Grassley asked.<br /><br />Plus, the Congressional Medicare Payment Advisory Commission recently warned that spending on the prescription program is rising at an "unsustainable" rate, singling out specialty drugs covered under Medicare's catastrophic protection.<br /><br />GPhA suggests several additional measures for increasing access to generics and reducing Medicare drug spending. Policymakers should ensure that “a fully-resourced [FDA] can address the backlog of more than 3,100 generic drug applications and shorten FDA median generic drug approval timelines,” Davis said.<br /><br />Davis is also urging Congress to repeal Section 602 of the Bipartisan Budget Act of 2015. “The Medicaid rebate increase for generic drugs in the budget deal is bad for Medicaid and its beneficiaries, bad for taxpayers, and it should be immediately repealed,” he said.<br /><br />Davis is also urging Congress to pass the bipartisan CREATES Act, the FAST Generics Act, to curb some brand-drug company abuses of FDA safety programs such as Risk Evaluation and Mitigation Strategies (REMS). This would result in an estimated savings of $2.4 billion to $3.2 billion over 10 years, he said.<br /><br />Finally, Davis believes Congress should work closely with industry and regulatory partners to ensure that the framework for biosimilar drugs expands and expedites patient access. Savings to the U.S. healthcare system from biosimilars are projected to reach between $57 and $110 billion from 2015 through 2020, according to the IMS Institute for Healthcare Informatics.</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-4891809835247195732016-09-02T07:08:00.000-07:002016-09-02T07:08:22.767-07:00 Community pharmacy helps diagnose people with hepatitis C infection, study shows<div dir="ltr" style="text-align: left;" trbidi="on">
Pilot project involved community pharmacists in the Isle of Wight testing at-risk adults for hepatitis C virus, hepatitis B, HIV and syphilis.<br /><br />Winners of the 2015 Care Awards Audience Choice Awards. From left, Ryan Buchanan, Pembe Hassan-Hicks and Kevin Noble<br /><br />Source: Simon Wright Photography / The Pharmaceutical Journal<br /><br />A project looking at the role of community pharmacy in identifying people with hepatitis was the 2015 Pharmaceutical Care Awards Audience Choice Awards winners. From left, Ryan Buchanan, Pembe Hassan-Hicks and Kevin Noble<br /><br />Community pharmacists have the potential to identify people with undiagnosed hepatitis C infection, according to research published in Clinical Pharmacist[1] (online, 5 August 2016). <br /><br />In 22 pharmacies on the Isle of Wight, community pharmacists were trained to offer dry blood spot tests to anyone attending needle exchange and opiate substitution therapy. People were also encouraged to self-refer for the service by a publicity campaign. <br /><br />The pilot project performed tests on 88 at-risk adults for hepatitis C virus (HCV), hepatitis B (HBV), HIV and syphilis over a nine-month period from September 2014 to May 2015. <br /><br />The researchers found that 39 of the 88 adults were drug users. Of these, 17 users had not accessed the island’s drug support centre – the recovery integrated service – and were also less likely to have had a previous test compared with those who were registered with mainstream drug support services (77% versus 41%, P=0.04). <br /><br />“The provision of pharmacy-based testing more than trebled the number of tests for HCV undertaken in community open access settings during the pilot period and provides additional capacity for testing in the future,” the researchers say.<br /><br />“Pharmacy-based testing has the potential to reach at-risk individuals who are not tested for HCV elsewhere. When combined with integrated specialist referral, it has the potential to reduce the burden of undiagnosed HCV and engage new diagnoses directly with specialist care.”<br /><br />Individuals who had a positive test for HBV surface antigen or HCV RNA were given a point-of-diagnosis consultation with a member of the specialist hepatology team in the pharmacy at an arranged date, which involved further tests and examinations.<br /><br />People were referred for liver imaging and HCV treatment as necessary; adults with positive tests for HIV and syphilis were referred to the local sexual health service.<br /><br />During the same time period, the recovery integrated service performed similar dry blood tests on 34 patients, of whom 85% had a history of injecting drugs and 56% had been tested previously. <br /><br />Some 7% of tests carried out in the pharmacy and 9% of those carried out at the island’s recovery integrated service were positive for HCV RNA. <br /><br />The average age of people screened by the pharmacist was 40 years and 54% of those screened were men. Around 18% (16 people) of tested individuals presented as a result of a publicity campaign while the remainder were recruited directly by pharmacists. <br /><br />“We have demonstrated that pharmacies are able to reach patients with more diverse risk factors, who are not engaged with, and are therefore less likely to have been tested at, other services,” the researchers say. “This may be because of the inherently non-stigmatising nature of community pharmacies and the co-provision of a range of other services, such as routine prescriptions and needle exchange. <br /><br />The pilot, they say, also illustrates successful collaboration between pharmacists and hepatologists to provide “readily accessible, community services for patients with HCV and thereby secure patient engagement at the beginning of their care pathway”. Researchers believe that if the pilot was rolled out it would have the potential to identify many patients with HCV across the UK. <br /><br />Rachel Halford, deputy chief executive of charity The Hepatitis C Trust, welcomes the report. “It adds to the evidence that community pharmacies could be playing a key role in finding the 100,000 people thought to be living unknowingly with hepatitis C in the UK and ensuring those newly diagnosed are on the path to treatment,” she says. <br /><br />“The proposed cut to community pharmacy funding is concerning, it will likely limit the impact pharmacists would be able to play in the UK’s commitment to the elimination of this disease as a threat to public health.” <br /><br />Kevin Noble, a community pharmacist who was involved in the study, says an NHS culture change is needed to allow the model to reach its potential nationally. <br /><br />“The idea [behind this service] isn’t rocket science. Community pharmacists are running needle exchange services already and needle exchange users are a primary risk of HCV,” he says. <br /><br />Ryan Buchanan, hepatology research fellow at the University of Southampton who was also involved in the project, says community pharmacy was “a really nice environment to work in and was much better from the perspective of the patient”. <br /><br />“The only downside was that only two of the pharmacies had beds in the treatment rooms so potentially examinations were quite limited,” says Buchanan. “But these pharmacists have a fantastic relationship with these patients who are really quite chaotic. The pharmacists are well known to them and have their confidence and trust.” </div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-8794094814215675122016-09-02T07:07:00.000-07:002016-09-02T07:07:21.993-07:00 Merck not only loses hep C case against Gilead, it gets stuck with the bill<div dir="ltr" style="text-align: left;" trbidi="on">
Merck & Co. was sitting pretty earlier this year after winning a legal dispute over sofosbuvir, the active ingredient in Gilead's multibillion-dollar babies Sovaldi and Harvoni. But all of that turned around when a judge threw out the victory and snatched back the $200 million Merck had been awarded. Now, to add insult to injury, Merck has been handed a $200 million bill for Gilead’s legal fees.<br /><br />In a filing on Thursday, U.S. District Judge Beth Labson Freeman said that Gilead was entitled to relief from the fees it incurred while defending the case, Reuters reports.<br /><br />Merck had won the case in March, but then in June, Labson Freeman reversed the decision, saying she found “a pervasive pattern of misconduct” by Merck ($MRK) in the patent fight. A retired Merck scientist and lawyer “intentionally fabricated testimony” about early discoveries that led to the development of next-generation hepatitis C drugs, including Gilead’s blockbuster duo, Harvoni and Sovaldi, the ruling states. And Merck supported the “bad faith conduct,” the judge said.<br /><br />Merck, which has trailed Gilead in the lucrative hep C market, had hoped to capture a piece of Gilead’s enormous revenue stream from Harvoni and Sovaldi. The earlier jury verdict delivered only a $200 million award but also opened the way for Merck to pursue royalties from the two blockbuster drugs’ ongoing sales. Merck’s rival hep C cocktail, Zepatier, recently won FDA approval, but Gilead’s meds have an enormous head start in the market, with more than $23 billion in combined sales since their launches.<br /><br />Merck said earlier that it intended to appeal, saying the judge’s ruling “does not reflect the facts of the case.”</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-6338366942315480022016-09-02T07:06:00.000-07:002016-09-02T07:06:36.690-07:00 A Cure For Hepatitis C: Bringing Medication Within Reach For All<div dir="ltr" style="text-align: left;" trbidi="on">
Here's the promise: There is a cure, a complete cure in a short 12 weeks, for hepatitis C virus (HCV), which the Centers for Disease Control and Prevention estimates afflicts between 2.7 and 3.9 million Americans, and which is a leading cause of liver cancer and other devastating health complications. This new class of HCV drugs, which are much easier on the human body and virtually free of side effects, attacks the virus directly and can reduce the viral load to zero when taken correctly.<br /><br />As with so many things in healthcare, this promise comes with challenges. First, the price tag can be steep--nearly $100,000 for a full 12-week course. But weigh this against the down-the-line medical and lost-productivity costs, not to mention human toll, associated with hepatitis C (HCV) infection, which can cause chronic liver infection, cirrhosis, cancer and the need for a liver transplant. In 2014, there were nearly 20,000 deaths in the U.S. with HCV infection as an underlying or contributing cause.<br /><br />And, although treatment often comes in the form of a single pill taken once a day--simple, right?--people's lives are complicated. Medicine is only as effective as an individual's ability to take it properly, and Americans in general have a poor record here. Nearly three out of four people in the U.S. report that they do not always take their medication as directed. If the HCV regimen is started and abandoned, a great deal of money is being wasted--something the healthcare industry can ill afford.<br /><br /><br />For those suffering from HCV infection, many obstacles can stand in the way of taking medications as directed. What if you don't have stable housing and have nowhere to store the pills? What if you are elderly, asthmatic, live in a fourth-floor walk-up and cannot get to the pharmacy to fill your prescription? What if the medication interacts poorly with the HIV medication that is sustaining your life? Or, what if, fearing stigma of a disease often contracted by sharing needles, you secret the medication away and fail to refill it?<br /><br />Collaborating Towards a Cure<br /><br />Here's a question: How can we ensure that if we use such a costly medicine to treat people with HCV infection, including some of society's most vulnerable, they will follow the regimen day in and day out--and emerge disease-free? A novel partnership in New York City, where an estimated 150,000 people have HCV infection, is aiming to find out and provide a blueprint for others.<br /><br />The effort, called Project INSPIRE* NYC, is funded by an almost $10 million Health Care Innovation Award from the Centers for Medicare & Medicaid Services (CMS). It focuses on collaboration, integrated care and care coordination that is so crucial for a population often burdened with other chronic illnesses and medications, and living without a strong social or family safety net. Now in the second year of a three-year HCIA award, the project reaches out to patients at risk for HCV infection in the Bronx and Manhattan, using an integrated model of care in which primary care providers collaborate with specialized care coordinators, and peer navigators to enroll people with HCV infection, then educate and guide them through the treatment process.<br /><br />This government-provider-payer collaboration is a terrific example of what needs to be done to sustain comprehensive and effective care for a vulnerable population. The New York City Department of Health and Mental Hygiene developed this project to target communities with the highest prevalence of HCV infection. The Health Department is working in partnership with Montefiore and the Mount Sinai Health System, which administer the treatments and provide care coordination, to implement the project. Partners also include two not-for-profit health insurance companies--including my organization, VNSNY CHOICE Health Plans, through its SelectHealth Special Needs Plan--which cover the cost of treatment, recognizing that the true value of the treatment lies not just in delivering the medication but in ensuring that it is taken appropriately.<br /><br />Those covered by our plan, SelectHealth, are Medicaid-eligible New Yorkers with HIV, and, while they are used to being compliant with therapy regimens, they are often living in vulnerable circumstances and can be overwhelmed by adding another medicine to their already long list. "Our Medicaid population includes a sizeable number of people with psychosocial challenges that make it difficult to stick to a three-month medication protocol," explains Dr. Jay Dobkin, SelectHealth's Medical Director.<br /><br />SelectHealth has already had over 400 of its members successfully complete treatment with new HCV drugs. These successes are made possible by care coordination and other supportive services, as is being demonstrated by Project INSPIRE. Our Pharmacy Services program actively encourages robust communication among the patient, care provider and the patient's dispensing pharmacy to ensure that prescriptions are being filled and refilled in a timely manner and that contraindications (including with certain HIV and OTC medications) are observed. For homebound patients, we encourage and monitor home delivery. We have fielded questions from patients accustomed to older HCV therapies that had to be refrigerated, on how to store new meds (answer: at room temperature). And, we recognize the need for patient education, including for patients who have tried older, injectable medications, and fear that regimen's same tremendous commitment and wide array of difficult-to-manage side effects.<br /><br />Creating a Sustainable Model<br /><br />Project INSPIRE offers a model that is right for the times in this era of value-based purchasing in healthcare--focusing the financial equation on health outcomes rather than individual encounters. The cure's $100,000 price tag, then, must be justified by the outcomes determined and achieved by Project INSPIRE. That includes making sure each person who begins the treatment completes it, , and carefully studying the costs offset by achieving a complete cure--including the considerable costs of liver transplants and treatments for liver cancer and end-stage liver failure.<br /><br />"Paying for medical and pharmacy costs is a good investment in the long-term health of our members--and also a Medicaid requirement," says Eli Camhi, Vice President & General Manager of SelectHealth. "We're modeling a new way of reimbursing that pays not only for the medication, but also helps the patient with medication adherence and provides the care coordination services needed to support this vulnerable population. The HCIA dollars get you off the ground and allow evaluation of the intervention, but when the award funding goes away, CMS doesn't want to see the initiative end. They want to know that there's a financial commitment through understanding what this partnership has learned, in order to make sure that the model can be sustained."<br /><br />Eli notes that if the project's positive early reports hold up, it can lead the way on a model that may eventually be adopted across the country. CMS could recommend that Medicare and Medicaid plans cover the cost of care coordination for patients undergoing treatment for HCV infection.<br /><br />"We know the new treatments work," he notes. "Our goal is to be sure our members complete the treatment and get cured."</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-5456970984091230442016-09-02T07:04:00.000-07:002016-09-02T07:04:32.502-07:00 What Analyst Set Lower Earnings Estimate: Gilead Sciences, Inc. (NASDAQ:GILD) , CorMedix Inc (NYSEMKT:CRMD)<div dir="ltr" style="text-align: left;" trbidi="on">
Gilead Sciences, Inc. (NASDAQ:GILD) negotiated 8.45 million shares against it an average volume of 10.18 million shares. The stock concluded the recent trade at $79.57 with upbeat trend move of +0.85%. The company has total market value of 105.01B. The company has got a 52-week exceptional price of $117.70 and reached a 52-week lowest of the share price at $77.92. The daily trading range was observed between a day’s low price of $78.80 to a day’s high price of $79.98.<br /><br />This Quarter Earnings Per Share Estimates:<br /><br />According to FactSet data, Analysts estimated the EPS for This Quarter. These Analysts measured the Higher, Lower and Mean Estimated EPS for this stock. Mean Earnings Per Share (EPS) forecast is set at $2.88 by these analysts. Higher EPS estimate that can be reached in this quarter is determined at $3.11 and lower forecasted EPS is placed at $2.63. The mean EPS is calculated keeping in view the consensus of 22 Analysts. Coefficient Variance is noted at 4.84.<br /><br />Next Quarter Earnings Per Share Estimates:<br /><br />Different Analysts projected the EPS Estimate for Next Quarter. These Analysts measured the Maximum, Minimum and Mean EPS forecasts for this stock, according to FactSet. Mean EPS forecast of 22 analysts for Next Quarter is set at $2.81. Maximum EPS estimate that expected in next quarter is noted at $3.07 and minimum forecasted EPS is calculated at $2.55. Coefficient Variance is measured at 5.15.<br /><br />Gilead Sciences Inc.’s (GILD) stock price showed weak performance of -0.25% in last seven days, switched down -7.21% in last thirty days and it fell -30.26% in last one year. It has 1328.48 million of outstanding shares and its shares float measured at 1323.66.<br /><br />CorMedix Inc (NYSEMKT:CRMD) closed with gain of +24.82% to $1.76. Recent traded volume was 1.64 million shares versus to it an average volume of 333.56 thousand shares. The company market cap of 65.45M. The stock’s day range was recorded between a low of $1.42 and a high $1.83. The one year high of the company is $4.54 and the one year low is $1.15.<br /><br />After the last closing session, the bid price was seen at 1.80. The bid price represents the higher price that a buyer or buyers are willing to pay for a security. The ask price was registered at 1.83. The ask price indicates the lower price that a seller or sellers are willing to receive for the security.<br /><br />This Quarter Earnings Per Share Estimates:<br /><br />According to FactSet data, Analysts estimated the EPS for This Quarter. These Analysts measured the Higher, Lower and Mean Estimated EPS for this stock. Mean Earnings Per Share (EPS) forecast is set at $-0.15 by these analysts. Higher EPS estimate that can be reached in this quarter is determined at $-0.14 and lower forecasted EPS is placed at $-0.18. The mean EPS is calculated keeping in view the consensus of 3 Analysts. Coefficient Variance is noted at -15.06.<br /><br />Next Quarter Earnings Per Share Estimates:<br /><br />Different Analysts projected the EPS Estimate for Next Quarter. These Analysts measured the Maximum, Minimum and Mean EPS forecasts for this stock, according to FactSet. Mean EPS forecast of 3 analysts for Next Quarter is set at $-0.17. Maximum EPS estimate that expected in next quarter is noted at $-0.15 and minimum forecasted EPS is calculated at $-0.21. Coefficient Variance is measured at -20.38.<br /><br />CorMedix, Inc.’s (CRMD) price volatility for a month noted as 8.15% however its price volatility for a week documented as 11.82%. The corporation holds 36.01 million outstanding shares and its 35.46 million shares were floated in the market. The stock established a positive trend of 14.29% in last week and indicated rise of 4.76% in previous month.</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-54073865207038536012016-09-02T07:03:00.003-07:002016-09-02T07:03:46.778-07:00 Global Nonstructural Protein 4B (NS4B) Pipeline Review, H1 2016 - Gilead Sciences, GSK, Inovio, Johnson & Johnson & Merck & Co - Research and Markets <div dir="ltr" style="text-align: left;" trbidi="on">
This report provides comprehensive information on the therapeutic development for Nonstructural Protein 4B NS4B, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Nonstructural Protein 4B NS4B and special features on late-stage and discontinued projects.<br /><br />The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.<br /><br />Key Topics Covered:<br /><br /> Introduction<br /> Nonstructural Protein 4B NS4B Overview<br /> Therapeutics Development<br /> Pipeline Products for Nonstructural Protein 4B NS4B - Overview<br /> Pipeline Products for Nonstructural Protein 4B NS4B - Comparative Analysis<br /> Nonstructural Protein 4B NS4B - Therapeutics under Development by Companies<br /> Nonstructural Protein 4B NS4B - Therapeutics under Investigation by Universities/Institutes<br /> Nonstructural Protein 4B NS4B Products Glance<br /> Late Stage Products<br /> Clinical Stage Products<br /> Early Stage Products<br /> Nonstructural Protein 4B NS4B - Products under Development by Companies<br /> Nonstructural Protein 4B NS4B - Products under Investigation by Universities/Institutes<br /> Nonstructural Protein 4B NS4B - Companies Involved in Therapeutics Development<br /></div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-78643714177217275202016-09-02T07:03:00.000-07:002016-09-02T07:03:05.740-07:00IRS is urged to investigate Gilead for ‘dodging’ US taxes<div dir="ltr" style="text-align: left;" trbidi="on">
An advocacy group is urging the US Internal Revenue Service and the US Treasury Department to investigate Gilead Sciences for allegedly shifting billions of dollars of income offshore in order to avoid paying taxes. The request from Americans for Tax Fairness comes one month after the group released a report accusing the drug maker of dodging $10 billion in taxes.<br /><br />The move also comes shortly after the federal government went to court to force Facebook to respond to summonses in connection to an investigation into whether the firm shifted certain property rights to an Irish subsidiary. The social media site may owe anywhere from $3 billion to $5 billion in back taxes, and the advocacy group maintained that Gilead is worthy of the same scrutiny.<br /><br />Gilead is using “a similar highly aggressive use of transfer pricing,” a maneuver that involves shifting properties between entities, “to avoid US taxes and benefit from substantially reduced tax rates. We urge the administration to bring the full force of your enforcement capabilities against Gilead to collect the tax dollars that rightfully belong to the American people,” the group wrote the federal agencies in a letter Wednesday.<br /><br />In its report, the advocacy group analyzed Gilead’s financial filings and determined that by transferring certain key assets to Ireland, the company was able to take advantage of tax laws that allowed some US sales to be shifted overseas and yield a significantly lower tax rate. Those overseas profits, meanwhile, mushroomed to $28.5 billion, while Gilead was able to escape nearly $10 billion in US taxes.<br />Gilead <br />Read More<br />Gilead avoided nearly $10 billion in taxes last year thanks to tax dodges<br /><br />“The facts suggest that Gilead may be declaring its offshore profits in Ireland, a tax haven, because the key hepatitis C drug, Sovaldi, from which Gilead derives most of its profits has been domiciled there since 2013, even though the patent is registered in the United States, and the bulk of Gilead’s hepatitis C drug sales is in the United States,” the letter to the IRS and the Treasury Department stated.<br /><br />As the advocacy group noted in its recent report, three years ago, a Gilead executive told analysts the patent had been domiciled in Ireland, which would allow the US corporate tax rate to “decline over time.” As ATF noted, Gilead’s worldwide effective tax rate has since plummeted by 40 percent — falling to 16.4 percent last year from 27.3 percent in 2013.<br /><br />In its letter, ATF also urged the agencies to investigate before the European Commission pursues enforcement actions that would force European nations to collect higher taxes from US companies that are sheltering profits there. If that were to happen, these other countries would collect money that “rightfully belongs to US taxpayers.”<br />Subscribe to our Pharmalot newsletter<br /><br />As we noted previously, there has been controversy about US companies that exploit loopholes to avoid paying taxes. Drug makers, in particular, have been singled out for attempting to acquire rivals based overseas to enjoy lower tax rates. The Treasury Department recently issued new rules to thwart such deals, known as tax inversions, prompting Pfizer to scuttle a plan to acquire Allergan.<br /><br />Whether the IRS will take action is unclear. An IRS spokesman wrote us that “federal privacy law prohibits the IRS from commenting on specific taxpayers.”</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-51242095188971418952016-09-02T07:01:00.003-07:002016-09-02T07:01:36.519-07:00 Gilead Draws Buyers as Prospect of Business Divide Rises, Jim Cramer Says<div dir="ltr" style="text-align: left;" trbidi="on">
Stock quotes in this article: abbv, celg, amgn, biib, gild<br />A note from RBC Capital Thursday on Gilead Sciences (GILD) , which some are calling a "trial balloon," got a lot of chatter and, judging by the pickup in some of the drugmaker's call volume Thursday, the chatter may not be idle.<br /><br />RBC Capital suggested the drugmaker would be better off cutting its businesses right down the middle, and shares are likely to jump by as much as about 40% if management makes the cut, analysts with RBC Capital said in an investment note.<br />This article has been updated on Thursday, August 18, to reflect commentary from Jim Cramer on recent increases in volume on Gilead call options. <br /><br />Is Gilead Sciences (GILD) going to take the knife to itself?<br /><br />A recent note from RBC Capital on Gilead, which some are calling a "trial balloon," got a lot of chatter and -- judging by the pickup in recent call-option purchases, particularly with September and October expiration periods -- the chatter may not be idle. RBC Capital suggested the drugmaker would be better off cutting its businesses right down the middle, saying that shares could jump by as much as 40% if management makes the cut.<br /><br />Real Money's Jim Cramer says that Gilead's call volume on Thursday, particularly for call options with a September strike price, is "way too big to ignore," noting that demand appears to be accelerating on Gilead's buyside.<br /><br />The analysts said there is "trapped value" in Gilead's current combination of hepatitis C virus (HCV) and human immunodeficiency virus (HIV) treatments, noting the HCV businesses are less transparent while dealing with mounting competition. The treatments are facing an environment of price erosion and eurozone uncertainties, added the analysts, led by Michael Yee.<br /><br />But if Gilead divides itself -- and the HIV treatment businesses are set loose, RBC Capital says, a separate HCV treatment business would likely begin trading at roughly $40 to $50 a share, while the HIV treatment businesses would hit the market at $50 to $60 per share. And with Gilead closing at $79.57 Thursday, the bifurcated company would be worth 13% to 38% more.<br /><br />The Foster City, Calif.-based drugmaker has long been pressured by its HCV businesses, with shares down 32% over the past 12 months, but RBC Capital says the separated business could better compete with Biogen (BIIB) , Amgen (AMGN) , Celgene (CELG) and AbbVie (ABBV) . (Biogen stock is held in Jim Cramer's Action Alerts PLUS charitable trust.<br /><br />The big question is whether management finds such a procedure urgent, the analysts added. After speaking with management, Yee said that will likely depend on whether there is continued underperformance -- for example, additional periods of lowered guidance -- or if a like-minded activist surfaces.<br /><br />"HIV and HCV are two distinct businesses that each make up about 50% of the company currently, yet they should have different valuations and distinct investor bases, in our view," Yee added. "Accordingly, we believe the combined entity of Gilead trading at 7x 2016 price-to-earnings may present long-term value, because HCV headwinds are 'over-penalizing' a healthy HIV franchise, which should trade at a minimum of 12 to 15x." <br /><br />Get an email alert each time I write an article for Real Money. Click the "+Follow" next to my byline to this article.<br /></div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-46296515053569410222016-09-02T07:01:00.000-07:002016-09-02T07:01:10.221-07:00 A cure at what cost? More states easing restrictions on Hepatitis C treatments <div dir="ltr" style="text-align: left;" trbidi="on">
<br /><br />For years, Valerie Green just wasn't feeling right. She was in a constant state of fatigue but couldn't figure out what was going on. Neither could doctors. That was until a specialist ran a series of blood tests last year, and one came back positive for Hepatitis C. <br /><br />"I was fairly shocked because I wasn't that knowledgeable about the disease. Everyone knows it's not a good thing, it effects your liver," Green recalled. "It was pretty scary."<br /><br />What happened next put Green in the middle of a controversial, and now shifting, landscape when it comes to coverage of Hepatitis C treatment. In Delaware, that's meant experiencing some of the most restrictive rules in the country to, as of this summer, some of the most lenient.<br /><br />New treatments offer new hope<br /><br />Green, who's 56 and lives in Millville Del., isn't exactly sure how she contracted the virus. Hepatitis C (HCV) is mainly spread through blood to blood contact. These days, the most common mode of transmission is through sharing needles or other equipment used for injecting drugs. For baby boomers, especially, many may have also been exposed before the virus was screened out of the blood supply, beginning in 1992. Green thinks she got infected from a blood transfusion 30 years ago, when she gave birth to her son.<br /><br />But the idea that someone like Green could have lived with the virus for decades and not know it isn't all that surprising. Hepatitis C is often referred to as a "silent" disease because most people who are chronically infected don't actually show symptoms (about a quarter of those infected naturally clear the virus). Over time, HCV can damage the liver and result in serious long-term health problems.<br /><br />It's the leading cause of liver cancer and liver transplants in the United States. In 2014, the Centers for Disease Control and Prevention reported that nearly 20,000 people died from HCV complications, surpassing the number of deaths from 60 other infectious diseases, including HIV, combined.<br /><br />After getting over that initial shock of the diagnosis and the stigma often associated with the disease, Green was relieved to finally pin down the actual problem.<br /><br />"I was like, 'Wow, I really am sick, I knew it. I knew something was wrong.' It was validation," she remembered thinking. "Now the next step was, let's get it fixed."<br /><br />Green had good reason to be optimistic.<br /><br />Two and a half years ago, new drugs entered the market that completely transformed the treatment landscape for Hepatitis C. These direct-acting antivirals boast greater than 90 percent cure rates and minimal side effects for the most common types of HCV. And because earlier treatments were less effective and came with serious side effects, many providers and patients had held off on treatment, period, until these new drugs became available.<br /><br />Green has Medicaid in Delaware. After receiving her Hepatitis C diagnosis, her doctor submitted the paperwork required to get these new medications. But Green's excitement only lasted two weeks.<br /><br />"That's when my first denial came back," she recalled. "That was based on, I don't meet their recommendations of not being sick enough."<br /><br />A cure with a catch<br /><br />The new Hepatitis C drugs have come with a big catch: the price tag. It's difficult to know the exact cost — public and private payers negotiate private agreements with drug companies — but one of the main drugs, Sofosbuvir (the brand name is Sovaldi), has been listed at $1,000 a pill before discounts. It's taken once a day for up to three months, often in combination with other drugs, making the cost of a cure upwards of $100,000. <br /><br />"It would not be feasible, financially, for us to treat everybody in our membership who has the diagnosis," said Stephen Groff, Medicaid director for the state of Delaware. "It would have broken the budget quite frankly. This is a situation where we had high cost, high volume — it's just not a good combination."<br /><br />Medicaid officials elsewhere have echoed that sentiment.<br /><br />While other cancer drugs might be even more expensive, the scope and scale of Hepatitis C has put state Medicaid programs, in particular, in an ethical and fiscal bind. More than 100 million people worldwide are chronically infected with Hepatitis C, including an estimated 2.7 to 3.9 million people in the United States. Studies have found the prevalence is higher among Medicaid populations.<br /><br />Delaware is a small state, but Groff estimates that upwards of 2,000 residents with Medicaid coverage have been diagnosed with Hepatitis C. Last year, the state spent more than $13.5 million to treat 141 people who were chronically infected, representing six percent of the state's total drug spend for the year.<br /><br />In nearby Pennsylvania, 1,889 people with Medicaid received treatment in 2015, costing about $145 million, or about seven percent of the state's total annual drug spend, according to the Medicaid office.<br /><br />To determine who qualifies for the treatment, Pennsylvania, Delaware and other states require prior authorization. They base this on a Metavir system, or fibrosis scale, to prioritize treating patients with the most severe liver damage. A score of zero to one indicates minimal fibrosis, while four signals cirrhosis, or severe scarring and decline in liver function.<br /><br />States limiting treatment amid budget concerns<br /><br />Delaware limited eligibility to those with a score of four on that scale.<br /><br />"We felt like we needed to get this drug out to individuals who we knew had an immediate need for a drug," said Groff.<br /><br />That response didn't sit well with patients like Green, who applied again for the drugs and was again denied. While she experienced other symptoms that she attributed to her disease, like fatigue and nausea, her liver was healthy. She applied for several grants from outside organizations, but one that she really needed required a big co-pay from her primary insurer, Medicaid, which wasn't going to happen.<br /><br />"Why make me wait? It's rationing, pure and simple in my mind," she said, referring to the Medicaid denial. "You know day in and day out that your liver is progressively getting worse and worse and worse and worse, and it's not going to get better until you have this drug to eradicate this virus. And you have an official saying, you're not sick enough, you can't have the medication. So it's extremely frustrating."<br /><br />An analysis of pharmacy prescription data in Delaware, Pennsylvania, New Jersey and Maryland through April of 2015 found that people with medicaid were much more likely turned down for coverage of these new Hepatitis C drugs compared to Medicare or other private insurers. Medicaid rejections neared 50 percent.<br /><br />Hepatitis C typically progresses slowly, but critics of such policies contend that making someone with Medicaid wait until they get sicker to qualify for a cure spells discrimination.<br /><br />"Instead of state Medicaid programs embracing the idea that now we have a cure for the number one communicable disease killer in the U.S., we saw many programs implement unprecedented restrictions on access to treatment," said Robert Greenwald, director of the Center for Health Policy & Innovation at Harvard Law School.<br /><br />Greenwald argues Medicaid covers a poorer, more vulnerable population that's being unduly denied treatment. He's been tracking Medicaid policies, and last year, he found that three quarters of states limited one of the main drugs, Sovaldi, to people with advanced liver disease.<br /><br />"If we had a cure for Alzheimer's or cancer or M.S. at $30,000, we would not be in the same situation we're currently in," he said. "People would be storming the White House and legislators, demanding access to a cure. We as a nation should try to figure out how to meet those costs. It's myopic to think about pharmacy line items."<br /><br />He draws a comparison to HIV.<br /><br />"We consider it a tremendous victory that we have transformed HIV and we pay about $15,000 a year for the rest of a person's life," he said. "For HCV, the treatment is about $30,000 - that's proprietary info, it's hard to know the exact price that public and private insurers pay - but at $30,000, we can now cure a person."<br /><br />If someone's cured, they can't transmit the virus, either.<br /><br />Drug companies, which set the price, have long argued that it's worth the value: these drugs represent a one-time treatment that cures someone of a disease, and with that, curbs the need for costly liver transplants down the road. Plus, it costs a lot of money to develop the drugs.<br /><br />Another study out last year also makes the case for the cost effectiveness of the new drugs, but concludes that more resources would be needed to treat patients.<br /><br />Beyond Hepatitis C, mounting prescription drug costs have prompted national and international debates over drug costs. In general, it's on the rise. Both Republican and Democratic presidential candidates have addressed this in their platforms.<br /><br />Changing Landscape<br /><br />Since the initial wave of these new drugs entered the market in late 2013, the scientific, political and economic environment has been shifting. That, and several lawsuits, has spurred some states and private insurers to rethink their policies.<br /><br />A year ago, Pennsylvania Medicaid's fee-for-service program eased its restrictions on Hepatitis C treatment, making those with "less severe" liver disease eligible. The state also removed a rule that a patient has to be drug or alcohol free for six months before qualifying for treatment. Patients coinfected with HIV are automatically eligible.<br /><br />In recent months, Florida and New York expanded access to the drugs through their medicaid programs. Massachusetts lifted its restrictions this month.<br /><br />Last March, the Department of Veterans Affairs announced it would treat all veterans with Hepatitis C, regardless of their liver disease status. It's been reported that several private insurers, including UnitedHealthcare and some Blue Shield plans, have started covering treatment for people who fall into any stage of the liver disease.<br /><br />So why the changes?<br /><br />For one, new medical guidelines have affirmed the new drugs' effectiveness and recommend early treatment.<br /><br />In response, Medicare has eased its restrictions.<br /><br />Last November, the federal government reminded states of their obligation to provide treatment that meets certain medical standards.<br /><br />More drugs have entered the market, adding more competition. Health officials have also been pushing drug manufacturers to lower their rates and offer more rebates.<br /><br />Several lawsuits have challenged state policies and the drug manufacturers' prices.<br /><br />A class action lawsuit (one that Greenwald's center has been involved in) in Washington state resulted in a federal district judge ordering Medicaid to drop its restrictions on HCV treatments, ruling that the previous policy was not consistent with Medicaid requirements that treatments be covered based on medical needs.<br /><br />The state attorney general in Massachusetts had also threatened to sue one of the manufacturers, Gilead Sciences, over drug prices and has since secured more rebates.<br /><br />In Pennsylvania, a Medicaid spokesperson attributed the changes in its policy last year to updates in national and international treatment guidelines, evaluation of more clinical trials, and infectious disease specialist recommendations.<br /><br />In May, the state's pharmacy committee also backed removing all liver disease restrictions for treatment. The state is currently reviewing what additional funds would be available if such a policy is implemented and how the additional costs would be absorbed in the budget.<br /><br />"We have not made any final decisions yet," said Ted Dallas, Pennsylvania's Secretary of Human Services.<br /><br />All in all, about a dozen states have either eliminated or reduced their restrictions in the last year, according to Greenwald, who's continuing to research state Medicaid policies.<br /><br />"There's a movement. It's happening. It's slowly happening," he said. "It should be happening faster, given changes in drug pricing."<br /><br />The pendulum swings in Delaware<br /><br />Back in Delaware, the state lowered its eligibility to a fibrosis scale level of three in April. It also loosened some of its other qualifying criteria.<br /><br />Then last month, the state set in motion a policy that would phase out any liver damage criteria. By January of 2017, eligibility will drop to a fibrosis score of two, and then to zero by January of 2018. In the meantime, those who demonstrate treatment is "medically necessary," regardless of a fibrosis score, will qualify for treatment.<br /><br />"I would say this is always where we wanted to go and where we knew we were going and we're just happy we're getting there a little faster," said Groff, adding that he's hoping that people don't file in at once to get treated.<br /><br />Groff estimates they'll treat between 600 and 700 people in the coming year, with the state spending as much as $40 million. He thinks drug rebates from manufacturers and federal Medicaid matching funds will offset a lot of the added cost.<br /><br />"The landscape has changed significantly over the last three years," he said, adding that initially, the state faced too many unknowns. Now more evidence for the drugs have come out, along with more drug options. "The cost of the drugs themselves has come down considerably now that we have competition in the marketplace. The manufacturers are also willing to negotiate supplemental rebates with states. So that substantial reduction in costs is making it more feasible for us to have open access."<br /><br />Doctors like Bill Mazur welcome the updates. He's an infectious disease doctor with the state prison system and with Christiana Health Care system. Since the new drugs came out, Hepatitis C has turned into his primary focus.<br /><br />"The conversations with patients sometimes were a little uncomfortable because I couldn't inform them how long their wait would be," said Dr. Mazur.<br /><br />Now he has an answer for patients with Medicaid.<br /><br />Looking ahead, Mazur does worry about whether the health system has the capacity, whether there are enough of him to treat everyone who's infected.<br /><br />Kelly McNelis, a clinical pharmacy specialist at Christiana Care Health System's community program and colleague of Mazur's, estimates that since the policy change, they've started three newly eligible people a week on the treatment.<br /><br />"It's been lovely," said McNelis, "It was so disappointing to have to tell someone you know you're healthy now, we'd like to treat you now, but we have to wait until you get a little sicker before we can treat you."<br /><br />As for Valerie Green, who was diagnosed with Hepatitis C last year and denied treatment, she's optimistic she'll be approved for treatment this time around. She had been preparing a lawsuit with Greenwald's group, but they've tabled it. She recently re-applied for treatment.<br /><br />"I was very excited," she said. "Hopefully, I'll feel great, and I won't have these symptoms any longer and I can get back to leading a normal life."<br /><br />For her, that includes working again, raising awareness about the disease and the resources that are available to get tested and treated, and taking part in one of her favorate pastimes...walking on the beach.<br /><br /><br /></div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-7250838091787690452016-09-02T06:55:00.001-07:002016-09-02T06:55:23.282-07:00Pharmalot, Pharmalittle: Valeant under criminal investigation for defrauding insurers<div dir="ltr" style="text-align: left;" trbidi="on">
Good morning, everyone, and how are you today? We are doing reasonably well, thank you, given an especially busy week. But this is to be expected in a busy world, yes? So please join us as we cope by quaffing yet another cup of stimulation. Remember, a prescription is not required. Meanwhile, here are some tidbits to help you along. We hope you have a smashing day and do drop us a line when something fascinating occurs …<br /><br />Federal prosecutors are pursuing a criminal investigation into whether Valeant Pharmaceuticals defrauded insurers by hiding its relationship with Philidor Rx Services, a pharmacy that was used to boost prescriptions of its medicines, the Wall Street Journal reports. At issue is whether insurers thought Philidor was neutral rather actively promoting Valeant drugs. Valeant had acquired an option to buy Philidor, but did not disclose that for many months and only acknowledged the relationship after this report.<br /><br />In its quest to win customers in India, some Abbott Laboratories managers instructed employees to pursue sales at virtually any cost, the New York Times reports. But this was allegedly done in violation of Indian law, professional medical standards, and the company’s own ethics guidelines. Last month, Ashish Awasthi, 35, was found dead on a railway track and a note recovered from him blamed the company and pressure to hit sales targets for his death.<br /><br />The US Department of Veterans Affairs is extending coverage of new antiviral treatments to all veterans with hepatitis C, regardless of the stage of their illness and whether they contracted these infections during military service, according to the Journal of the American Medical Association. The agency is starting therapy for 1,100 patients a week — double from a year ago — and hopes to increase that to 2,000 patients a week by the end of this year.<br /><br />The US Food and Drug Administration agreed to review a Marathon Pharmaceuticals treatment for Duchenne muscular dystrophy, the Chicago Tribune tells us. Known as deflazacort, the drug is already available outside the US, where it has been approved for other uses. But because the steroid does not have FDA approval, the medication is not widely available here.<br /><br />Tax breaks for drug makers: Allergan will use over $58 million in incentives from a New Jersey state agency to consolidate its current operations and develop a new US headquarters at a facility in Madison by the end of 2017, NJBiz writes. Separately, Pfizer has won the first part of its request for a tax break on a planned $145 million expansion of its manufacturing plant in Portage, Mich., according to MLive.<br /><br />AstraZeneca has invested another $140 million in Moderna Therapeutics, raising its stake to 9 percent in the company, which is developing drugs based on a molecule known as messenger RNA, Reuters says.<br /><br />Clinical trial volunteers in India complained to the National Human Rights Commission that some clinical research organizations violated certain regulations and exploited participants, PharmaBiz tells us.<br /><br />A former partner at the Hunton & Williams law firm and his investment adviser were criminally charged with participating in an insider-trading scheme ahead of a Pfizer deal, the Wall Street Journal writes.<br /><br />After two rejections, the FDA finally approved Heron Therapeutics’s long-acting injection for preventing chemotherapy-induced nausea, Reuters reports.<br /><br />PharmaTech recalled more drugs made at a Florida plant that was linked an outbreak of B. cepacia last month, according to InPharma Technologist.<br /><br />The National Health Service in England launched a 45-day public consultation on a proposed clinical commissioning policy for the PrEP HIV treatment, PharmaTimes writes.<br /><br />Australia’s Therapeutic Goods Administration approved changes to labels for prescription and nonprescription medicines so they align with international practices, Regulatory Focus informs us.<br /></div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-1090817015963621152016-09-02T06:54:00.000-07:002016-09-02T06:54:37.198-07:00Billion Dollar Blunder: On the 1-Year Anniversary of a New Class of Cholesterol Medicines, Study Finds Actual Cost of New Drugs Is Billions Less than Predicted <div dir="ltr" style="text-align: left;" trbidi="on">
BEVERLY HILLS, Calif., Aug. 11, 2016 /PRNewswire/ -- Concerns about rising drug costs continue to grab headlines, but a new analysis suggests that health care organizations looking for ways to manage these costs may be relying on seriously flawed numbers that routinely overestimate cost growth.<br /><br />The Partnership for Health Analytics Research (PHAR, LLC), a leading health services research consultancy, announced today that predictions of health care costs made prior to the introduction of new drugs are often dramatically overestimated. These overestimates may, in turn, cause health insurers to make access to drugs more difficult for patients than may be clinically appropriate. <br /><br />In one example, the Institute for Clinical and Economic Review (ICER) predicted the one-year cost of the two PCSK9 inhibitors, a new class of injectable treatments for patients with high cholesterol who are at high risk of CV events, would be $7.2 billion. Based on the initial quarters of reported sales, the actual number will be closer to $83 million, or 1.2% of the prediction, an overestimate of $7.1 billion. As Dr. Michael S. Broder, MD, President of PHAR notes: "Overestimating drug costs by so much cannot lead to good decision making. In fact, it is likely that patients feel the negative effects of such predictions in the form of early access restrictions and higher copayments." <br /><br />The overall study examined publicly released predictions for the cost of 14 drugs launched in a variety of indications since 2012. In addition to the two cholesterol lowering drugs, PHAR studied three drugs to treat various forms of cancer; three for hepatitis C; two for obesity management; and one each for cystic fibrosis, heart failure, psoriasis, and diabetes.<br /><br />The researchers found 24 published predictions for the 14 drugs and compared them to actual sales. On average, predictions were 11 times higher than actual sales. That is, for every $11 of predicted cost there was only $1 of actual cost to the healthcare system.<br /><br />In other examples, PricewaterhouseCoopers and Bloomberg both predicted the drug cost to the healthcare system for Viekira Pak, for hepatitis C, and Opdivo, for metastatic melanoma skin cancer. Their predictions for Viekira Pak were over $2.9 billion; actual first year sales were 28% of the prediction. Similarly, the predicted cost of Opdivo was $1.7 billion; actual sales were 48% of predicted. Underestimates were less common —Cosentyx, originally approved for psoriasis, was predicted to cost $120 million in the first year after launch; actual sales were more than twice that. Taken together, these findings raise concern about the usefulness of pre-launch predictions for payers, patients, and prescribers.<br /><br />The study findings are consistent with other recent research. A prominent physician predicted in the New England Journal of Medicine that the PCSK9 inhibitor class alone would raise annual health care premiums by $124 per person. Yet, a report by the advisory company Avalere Health showed that all prescription drugs accounted for only a $3.29 average increase in per member per month premiums.<br /><br />The results of the current study were submitted for presentation at the Association of Managed Care Pharmacy's (AMCP) upcoming NEXUS conference.<br /><br />Dr. Broder summarized the significance of this research, saying, "Drug usage predictions are used to inform pharmacy policy. Our goal in pointing out these discrepancies is to help improve predictions and decision making. Ideally, payers and policymakers would be able to use them as planning tools. In their current form, I'm afraid these predictions are so far off that they may just be scaring people into making bad decisions about limiting access to new drugs." </div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-55972520478932467292016-09-02T06:53:00.000-07:002016-09-02T06:53:36.730-07:00Dems v. GOP on New Drugs<div dir="ltr" style="text-align: left;" trbidi="on">
As a leader in the Republican Party for the past 40 years, I’ve been involved in the development of 10 party platforms. Party platforms are important because they are more than a list of policies. Instead, they are a statement of the very different world views that explain those policies.<br /><br />This year’s Democratic and Republican Party platforms provide a useful example of differing world views on an issue that will dramatically impact the health and well-being of every U.S. citizen: biomedical research.<br /><br />The GOP platform praises the promise of biomedical research, saying it is “the consequence of marrying significant investment, both public and private, with the world’s best talent.” The Democratic platform says “We recognize the critical importance of a fully funded National Institutes of Health to accelerate the pace of medical progress.”<br /><br />Notice that the Democratic platform fails to “recognize” the vital importance of private funding. EvaluatePharma estimates the private sector will invest $144 billion this year in biomedical research. That’s more than four times as much as the National Institutes of Health’s $32.3 billion a year in grants and in-house research.<br /><br />This blind spot in the Democratic Party’s understanding of what it takes to achieve medical breakthroughs explains why their platform can simultaneously call for accelerating the pace of medical progress while proposing destructive policies that would reduce the amount of money available for the research and development of new cures.<br />Related Articles<br /><br /> Time to Sequester Insipid Federal Research<br /> Private Money Pays Off For Medicine<br /> The People vs. Martin Shkreli<br /><br />The Democrats’ platform calls for de facto price controls in the form of importing prescription drugs from other countries and allowing Medicare to negotiate directly with drug manufacturers. Artificial price-control mechanisms like these try to reduce costs today at the expense of continued innovation.<br /><br />Democrats ignore the fact that while new medicines and treatments may start off being relatively expensive, they invariably reduce in price over time, increasing their value to society. Meanwhile, the higher revenue generated from the first few years of availability is reinvested into research for the next round of breakthroughs. This is the recurring cycle of innovation that creates lower-price and more-effective medications.<br /><br />Consider statins, a cholesterol-lowering medication. Since statins were introduced in the late 1980s, prices have dropped precipitously. One study published in HealthAffairs in 2012 estimated that the use of statins between 1987 and 2008 generated $1.25 trillion in economic value from the years of life saved for those taking the medicine. During that time about $200 billion was spent on statin drugs, meaning that the use of these medications resulted in a net benefit to society of $947 billion. That is a roughly 4:1 benefit-to-cost ratio.<br /><br />The Democratic platform also chastises drug companies for the high cost of some new, breakthrough drugs. However, it fails to account for their value relative to their cost.<br /><br />For instance, while new breakthrough treatments that can cure hepatitis C in a few weeks have large price tags, they save even more money—not to mention suffering—by avoiding the continued hospitalizations and liver treatments associated with the disease. They are also dropping in cost due to competition as more treatments become available. According to Steve Miller, chief medical officer of Express Scripts, the cost of hepatitis C drugs is now lower in the U.S. than in Europe.<br /><br />Instead of calling for artificial price controls that would reduce medical innovation by choking off the resources needed to develop new cures and treatments, the Republican Party’s platform takes a different approach to lowering drug costs.<br /><br />It recognizes that it is becoming more expensive each year to bring lifesaving new cures to market. This is because drug developers are unable to take advantage of new technology and up-to-date approaches to doing their research and, especially, their clinical trials. A recent study in the Journal of Health Economics estimated it costs an average of $2.6 billion to bring a FDA-approved medication to market.<br /><br />Moreover, an analysis published in January 2015 in the Journal of the American Medical Association showed that drug manufacturers have shifted resources from early-stage research to lengthy, expensive clinical trials. This kind of resource shift will lead to fewer breakthroughs and fewer cures.<br /><br />Biomedical research is one of the few areas where there is little doubt that investment pays for itself. Any policies that reduce resources—public or private—available to invest in research and development are akin to killing the proverbial goose that lays the golden egg. As Bill Gates, the world’s top philanthropist when it comes to delivering medicines to the poor, has said, “The drug companies are turning out miracles, and we need their R&D budgets to stay strong. They need to see the opportunity.”<br /><br />Of the two parties’ platforms, only the Republican Party recognizes the vital role that private research plays in the development of new drugs, and takes an appropriate approach to lowering the cost of prescription drugs that will preserve the research base necessary for medical innovation. This is an approach that will save lives and save money.<br /><br />Mr. Gingrich is a former speaker of the House of Representatives. He is an adviser to the Biotechnology Innovation Organization, a Washington, D.C.-based trade group. </div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-55586434526168193292016-09-02T06:52:00.001-07:002016-09-02T06:52:46.962-07:00As Out-of-Pocket Costs Rise, Hepatitis C Drug Adherence Drops <div dir="ltr" style="text-align: left;" trbidi="on">
The high price tag of hepatitis C virus (HCV) drugs has caused widespread criticism, and raises the issue of how much insured members should contribute as a cost share.<br /><br />Although most manufacturers offer coupons to help reduce members’ cost share, little information was known on the extent HCV drug coupons are used, or about the potential impact on initial medication adherence.<br /><br />Currently, pharmaceutical manufacturer coupons for HCV drugs have become available to help lower member cost to $5 per prescription fill to a maximum of 25% of the catalog price for a 12-week treatment regimen, according to a study published in The American Journal of Managed Care.<br /><br />This offer is valid for 6 months from the time of a patient’s first redemption. The researchers wanted to describe the rates of sofosbuvir (Sovaldi) initial medication adherence as a function of the insurer-required out-of-pocket cost, and to determine how manufacturer coupons may affect the insurer-required member cost.<br /><br />For the observational cross-sectional analysis, researchers used administrative pharmacy claims data from 13 million commercially insured members from 14 different plans to identify those who were newly initiating HCV therapy with Sovaldi between January and September 2014. Members who were eligible for the study were required to be continuously enrolled for 90 days after the first Sovaldi transaction.<br /><br />For a sensitivity analysis, members had to have 180 days of continuous enrollment after the first transaction. Members were categorized as either Sovaldi initial adherence or as abandoning therapy.<br /><br />Participants were placed into cost-share groups based on the amount of insurer-required cost share from their index Sovaldi claim. They also examined severity of illness and total drug costs for non-Sovaldi pharmacy claims in 2014.<br /><br />The goal was to evaluate the association between insurer-required member cost and initial medication adherence. In a sub-analysis, the study evaluated Sovaldi index claims with available coupon data to determine how coupon use impacted insurer-required member cost.<br /><br />Researchers identified 3991 members who had met all of the study’s criteria. A majority of the members (67.3%) had an insurer-required cost share of less than $250 for their index Sovaldi claim. Only 201 members (5%) were exposed to a member cost of more than $10,000.<br /><br />The results of the study showed that overall, the index of Sovaldi abandonment rate was 7.4%. In the $0 to <$50-member cost group, Sovaldi abandonment started at 3.8%, and stayed below 8% up to the $5000 to <$10,000 cost group. In the member cost group of $10,000 or more, 52.7% abandoned Sovaldi therapy.<br /><br />In the logistic regression model, there was an association between member cost and abandonment that started at $2500 to <$5000 (OR, 1.9; 95% CI, 1.01 – 3.43; P= .0393). The average member Sovaldi index claim cost was $1349 before the coupon was used and $28 after.<br /><br />The average member sofosbuvir index claim cost was $1349 before a coupon was applied, and $28 after. Overall, coupons offset the member amounts paid by 98%, and coupons amounted to $771,593 of the $787,860 total member cost.<br /><br />Authors noted that there were several limitations to the study such as: not analyzing member characteristics like health literacy, treatment preferences, or prior treatment failures; the assumption that members who abandoned therapy did so only because of their insurer-required Sovaldi member cost share, and did not include additional factors; data availability and study design; using only commercially insured populations; and limiting the impact of Sovaldi coupons on member cost share to only members who filled their initial Sovaldi claim at a specialty pharmacy.<br /><br />The findings revealed that when a manufacturer coupon was used for Sovaldi, it dramatically decreased a member’s cost share by an average of $1321, and in turn, lowered the member’s true amount paid for their initial Sovaldi prescription to an average of $28.<br /><br />Researchers believe that the coupons for HCV therapy could potentially help in the prevention of initial therapy abandonment, since the results of the study showed that an insurer-required member cost share more than $2500 was associated with higher rates of Sovaldi abandonment.<br /><br />However, researchers stated that coupons for non-preferred drugs could result in higher premiums because of the loss of formulary management capabilities, which is needed in order to keep premiums low.<br /><br /></div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-59813426061235412562016-09-02T06:50:00.003-07:002016-09-02T06:50:46.763-07:00Toronto Community Hepatitis C Program meets people where they’re at<div dir="ltr" style="text-align: left;" trbidi="on">
The Toronto Community Hepatitis C Program (TCHCP) is a health care program based on harm reduction principles. It brings together professionals from various disciplines to provide hep C support and treatment to people living with chronic hepatitis C (hep C) in Toronto.<br /><br />The TCHCP is anchored by a series of hep C education and support groups that have built a community of peers with similar experiences and easy access to hep C treatment and general medical care.<br /><br />In this issue of Promising Practices, EENet’s Matt Hollingshead profiles the TCHCP’s approach to helping individuals with hep C access treatment and support. Promising Practices profiles innovative practices and initiatives from around Ontario.</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-70798690467228853812016-09-02T06:50:00.000-07:002016-09-02T06:50:07.854-07:00Isolation as a strategy for controlling the transmission of hepatitis C virus (HCV) infection in haemodialysis units<div dir="ltr" style="text-align: left;" trbidi="on">
Abstract<br />Background<br /><br />The hepatitis C virus (HCV) infection affects about 2% of the world's population and can cause chronic liver infection and persistent long-term sequelae such as cirrhosis and liver cancer.<br /><br />The prevalence of HCV infection among people on haemodialysis is often higher than the general population. The virus is easily transmitted parenterally, and blood transfusions have previously played a significant role in transmission; however, erythropoietin therapy has reduced the need for transfusions, and coupled with improved screening of donated blood, has significantly decreased transmission by transfusion. Although control of hospital-acquired infection has improved with the advent of biosafety measures, stopping HCV transmission in haemodialysis units remains challenging.<br /><br />Isolating people infected with HCV involves physical separation from others to limit direct or indirect transmission and includes a number of strategies during dialysis. The evidence for isolating people infected with HCV during haemodialysis is sparse with some inconsistencies.<br />Objectives<br /><br />To evaluate the benefits and harms of isolation of HCV-infected patients during haemodialysis on the transmission of HCV to other patients.<br />Search methods<br /><br />We searched the Cochrane Kidney and Transplant Specialised Register to 26 November 2015 through contact with the Information Specialist using search terms relevant to this review. We also searched the Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to 2015), Web of Science Conference Proceedings Citation Index-Science (CPCI-S, 1990 to 2015), ProQuest Dissertations & Theses Database (1990 to 2015), and Open Grey (1990 to 2015).<br />Selection criteria<br /><br />We included randomised controlled trials (RCTs), quasi-RCTs and cluster RCTs evaluating the clinical benefits and harms of isolating HCV-infected patients during haemodialysis on the transmission of HCV to other patients. We considered incidence of dialysis-acquired HCV infection, all-cause mortality, and adverse effects associated with isolation as the primary outcomes.<br />Data collection and analysis<br /><br />Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) or standardised mean difference (SMD) and 95% CI for continuous outcomes.<br />Main results<br /><br />Only one study, which included 12 centres was identified: four centres used dedicated haemodialysis machines for HCV-infected patients and eight centres used non-dedicated machines. The total number of patients enrolled was 593. One centre was excluded after randomisation. Random sequence generation was not described and allocation concealment was not performed. Participants and personnel were not blinded and blinding of outcome assessors was not reported. Only 74.5% of the patients were followed for 9 months; and 47.3% were followed for an additional 9 months. The authors only reported one outcome, measuring the difference in the incidence of HCV in both groups. The authors did not consider the exposure time, to determine the adjusted rate of seroconversion risk/patient-year.<br /><br />The study reported that the incidence of HCV infection during the first follow-up period (9 months) was 1.6% in the dedicated group, and 4.7% in the non-dedicated one (446 patients analysed out of 593 randomised; RR 0.34, 95% CI 0.11 to 1.07). During the second follow-up period (18 months) the incidence was 1.3% in the dedicated group and 5.8% in the control (281 patients analysed out of 593 randomised; RR 0.22, 95% CI 0.05 to 1.02). Therefore, we found no differences in terms of the number of participants developing HCV infection when comparing the dedicated group with the usual care. Moreover, the evidence was of very low quality, which means that we have very little confidence in the effect estimate.<br />Authors' conclusions<br /><br />The benefits and harms of isolation of HCV-infected patients during haemodialysis on the transmission of HCV to other patients are uncertain. Evidence from one short-duration cluster-randomised study with a high risk of bias did not find differences in terms of the number of participants developing HCV infection when comparing the use of dedicated haemodialysis machines for HCV infected patients with the use of non-dedicated machines.<br /><br /> EnglishCroatian<br /><br />Plain language summary<br /><br />Isolation as a strategy for controlling the transmission of hepatitis C virus (HCV) infection in haemodialysis units<br /><br />What is the issue?<br /><br />The hepatitis C virus (HCV) is easily transmitted intravenously, such as blood transfusions and the use of haemodialysis. It can cause a persistent infection and chronic liver disease. The frequency of HCV is higher among people on haemodialysis than the general population; and is associated with increased risk of death from heart disease and liver. We wanted to find out if the isolation of people with HCV during haemodialysis (using a different room, machines or dedicated staff, a specific shift) was effective in limiting the direct or indirect transmission of the virus to non-infected patients.<br /><br />What did we do?<br /><br />We conducted an extensive literature search to November 26, 2015, but only found one study looking at isolation as a strategy for controlling the transmission of HCV infection.<br /><br />What did we find?<br /><br />This one study included 12 centres (593 patients). Four centres assigned HCV-infected patients to a dedicated haemodialysis machine and eight centres did not. This study reported the incidence of HCV in haemodialysis patients decreased with the use of dedicated machines; however it was not possible to determine the benefits and harms associated with isolation, cost, or mortality from the disease.<br /><br />Conclusions<br /><br />There is insufficient evidence, but additional studies would help clarify the role of isolation to reduce the transmission of HCV in haemodialysis patients.</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-9078292582475106482016-09-02T06:47:00.002-07:002016-09-02T06:47:53.605-07:00Molecular and Dynamic Mechanism Underlying Drug Resistance in Genotype 3 Hepatitis C NS3/4A Protease<div dir="ltr" style="text-align: left;" trbidi="on">
Abstract<br /><br />Hepatitis C virus (HCV), affecting an estimated 150 million people worldwide, is the leading cause of viral hepatitis, cirrhosis and hepatocellular carcinoma. HCV is genetically diverse with six genotypes (GTs) and multiple subtypes of different global distribution and prevalence. Recent development of direct-acting antivirals against HCV including NS3/4A protease inhibitors (PIs) has greatly improved treatment outcomes for GT-1. However, all current PIs exhibit significantly lower potency against GT-3. Lack of structural data on GT-3 protease has limited our ability to understand PI failure in GT-3. In this study the molecular basis for reduced potency of current inhibitors to GT-3 NS3/4A protease is elucidated with structure determination, molecular dynamics simulations and inhibition assays. A chimeric GT-1a3a NS3/4A protease amenable to crystallization was engineered to fully recapitulate decreased sensitivity of GT-3 protease to PIs. High-resolution crystal structures of this GT-1a3a bound to 3 PIs, asunaprevir, danoprevir and vaniprevir, had only subtle differences relative to GT-1 despite orders of magnitude loss in affinity. In con-trast, hydrogen-bonding interactions within and with the protease active site, and dynamic fluctuations of the PIs were drastically altered. The correlation between loss of intermolecular dynamics and inhibitor potency suggest a drug resistance mechanism where polymorphisms (or mutations) at the drug target confer resistance through altering the inter-molecular dynamics of the protein–inhibitor complex.<br /></div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-48631811314702660132016-09-02T06:46:00.000-07:002016-09-02T06:46:43.954-07:00Achillion Pharma (ACHN) Announces Presentation of Odalasvir, AL-335 and Simeprevir Phase 2b Data<div dir="ltr" style="text-align: left;" trbidi="on">
Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN) announced that interim results from an ongoing phase 2a clinical trial, being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to evaluate all-oral combination regimens, containing odalasvir, AL-335 and simeprevir, were accepted for presentation at the EASL – American Association for the Study of Liver Diseases (AASLD) Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, being hosted in Paris, France on September 23 – 24, 2016.<br /><br />The eposter, entitled “Short duration treatment with AL-335 and odalasvir (ODV), with or without simeprevir (SMV), in treatment naïve patients with hepatitis C virus (HCV) genotype (GT) 1 infection,” will be presented on Friday, September 23, 2016.<br /><br />This phase 2a study aims to establish the safety, pharmacokinetics and efficacy of doublet and triplet regimens, consisting of odalasvir and AL-335 with or without simeprevir, in treatment naïve patients with genotype 1 HCV infection for treatment durations of eight weeks or less. Further information about this study can be found at www.clinicaltrials.gov. Study identifier: NCT02569710.<br /><br />About HCV<br /><br />The hepatitis C virus (HCV) is one of the most common causes of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including approximately 5 million people in the United States. Three-quarters of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Despite available treatments, there remains a significant unmet need for many patients infected with HCV.</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-29503715862742706952016-09-02T06:45:00.000-07:002016-09-02T06:45:07.167-07:00Private needle exchange program opens in Beckley<div dir="ltr" style="text-align: left;" trbidi="on">
BECKLEY — Dr. Ayne Amjad moved back to Beckley from Pittsburgh six years ago and watched rates of hepatitis B and C rise at her practice, until the majority of her patients had been diagnosed, and she waited.<br /><br />She spoke to them about their guilt and embarrassment over contracting the diseases, and the resulting depression, and she waited.<br /><br />Amjad, a Beckley native, watched as people lost their jobs, destroyed relationships, and died as opiate use grew in Southern West Virginia, ground zero for the country’s opiate epidemic, and she waited.<br /><br />“I get tired of waiting for something to change,” she said.<br /><br />Big cities in the United States started implementing needle exchange programs in the late 1980s and early 1990s. They rapidly grew in popularity from the mid-1990s to the early 2000s.<br /><br />West Virginia — where hepatitis B and C are rampant — started to catch up recently.<br /><br />The Cabell-Huntington Health Department launched a program in September 2015. The Kanawha-Charleston Health Department launched a program in December 2015. West Virginia Health Right launched one in Morgantown in October 2015, and the Wheeling-Ohio County Board of Health began a county-operated program in October of 2015.<br /><br />Amjad, who practices internal medicine in Beckley, opened a needle exchange program at the two Beckley Pharmacy locations on Wednesday, in cooperation with Ali Sherwani, the owner of the pharmacy.<br /><br />Amjad says that the role really should have fallen to the Beckley-Raleigh Health Department, but she said it didn’t appear they planned to open a program anytime soon.<br /><br />“Who am I?” said Amjad, who ran a write-in campaign for Beckley mayor earlier this year. “I’m just someone who lives here.”<br /><br />The U.S. Centers for Disease Control and Prevention has reported that Raleigh County is one of the counties viewed as most at risk for a hepatitis C or HIV outbreak in the country. And multiple studies have shown that needle exchange programs are associated with a decrease in the prevalence of HIV and hepatitis C, according to the CDC.<br /><br />In June, the CDC released a list of the 220 counties in the country most at risk for hepatitis C or HIV outbreaks, in large part due to needle sharing among drug users. Ten West Virginia counties, most in Southern West Virginia — Boone, Fayette, Hancock, Logan, McDowell, Mingo, Monroe, Morgan, Raleigh and Wyoming — were in the nation’s top 50.<br /><br />During pharmacy hours at 455 Stanaford Road and 105 Anwar Fatima Lane, intravenous drug users can walk in, without making an appointment, and drop off used needles in a box at the pharmacy, in exchange for two clean needles, Amjad’s business card, and fliers with information about hepatitis C and the purpose of the program. They are simply asked to fill out a brief survey on their frequency of drug use, their age, and whether they want help.<br /><br />Amjad, who is paying for the program, would have no problem with the health department taking the lead on the project. But she also has no problem continuing to run it herself, either. She noted there are grants out there, if she needs them, and other physicians who are willing to help.<br /><br />Candace Hurd, director of nursing for the health department, said they had been in the “beginning stages of discussion” on starting a needle exchange, and wouldn’t say whether they would consider taking the lead, saying that was a question for the county’s board of health.<br /><br />About 10 people had taken advantage of the program as of early afternoon Thursday.<br /><br />The program doesn’t collect names, but that didn’t stop one man from sending in his wife while he waited in the car. A woman there on Thursday afternoon said she was there for her sister.<br /><br />A post on Facebook about the program drew about 1,000 comments, mostly negative. One person even wrote that the place should be bombed.<br /><br />The main argument among people opposed to needle exchange programs is that they “enable” users.<br /><br />They imagine that if the programs don’t exist, maybe people will stop.<br /><br />One former user at the pharmacy on Thursday explained the logic flaw behind that assumption.<br /><br />People with addiction problems aren’t generally thinking about their long-term futures.<br /><br />“You’re looking for that big rush,” he said. “That pain-free rush.”<br /><br />During his worse days, the man, who said he would go by his middle name Allen, was buying used needles.<br /><br />Allen was in Beckley to visit a suboxone clinic. He was an intravenous drug user for 13 years, after a toothache and a car wreck turned into an opiate addiction.<br /><br />Allen, who said his wife is diagnosed with both HIV and hepatitis C due to intravenous drug use, could think of at least seven friends who died from diseases contracted through sharing needles. He believed the diagnosis was MRSA.<br /><br />“If they would have opened a needle exchange years ago, I cannot tell you how many lives it would have saved,” he said.<br /></div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-85045408434373723712016-09-02T06:43:00.004-07:002016-09-02T06:43:59.384-07:00As Out-of-Pocket Costs Rise, Hepatitis C Drug Adherence Drops <div dir="ltr" style="text-align: left;" trbidi="on">
The high price tag of hepatitis C virus (HCV) drugs has caused widespread criticism, and raises the issue of how much insured members should contribute as a cost share.<br /><br />Although most manufacturers offer coupons to help reduce members’ cost share, little information was known on the extent HCV drug coupons are used, or about the potential impact on initial medication adherence.<br /><br />Currently, pharmaceutical manufacturer coupons for HCV drugs have become available to help lower member cost to $5 per prescription fill to a maximum of 25% of the catalog price for a 12-week treatment regimen, according to a study published in The American Journal of Managed Care.<br /><br />This offer is valid for 6 months from the time of a patient’s first redemption. The researchers wanted to describe the rates of sofosbuvir (Sovaldi) initial medication adherence as a function of the insurer-required out-of-pocket cost, and to determine how manufacturer coupons may affect the insurer-required member cost.<br /><br />For the observational cross-sectional analysis, researchers used administrative pharmacy claims data from 13 million commercially insured members from 14 different plans to identify those who were newly initiating HCV therapy with Sovaldi between January and September 2014. Members who were eligible for the study were required to be continuously enrolled for 90 days after the first Sovaldi transaction.<br /><br />For a sensitivity analysis, members had to have 180 days of continuous enrollment after the first transaction. Members were categorized as either Sovaldi initial adherence or as abandoning therapy.<br /><br />Participants were placed into cost-share groups based on the amount of insurer-required cost share from their index Sovaldi claim. They also examined severity of illness and total drug costs for non-Sovaldi pharmacy claims in 2014.<br /><br />The goal was to evaluate the association between insurer-required member cost and initial medication adherence. In a sub-analysis, the study evaluated Sovaldi index claims with available coupon data to determine how coupon use impacted insurer-required member cost.<br /><br />Researchers identified 3991 members who had met all of the study’s criteria. A majority of the members (67.3%) had an insurer-required cost share of less than $250 for their index Sovaldi claim. Only 201 members (5%) were exposed to a member cost of more than $10,000.<br /><br />The results of the study showed that overall, the index of Sovaldi abandonment rate was 7.4%. In the $0 to <$50-member cost group, Sovaldi abandonment started at 3.8%, and stayed below 8% up to the $5000 to <$10,000 cost group. In the member cost group of $10,000 or more, 52.7% abandoned Sovaldi therapy.<br /><br />In the logistic regression model, there was an association between member cost and abandonment that started at $2500 to <$5000 (OR, 1.9; 95% CI, 1.01 – 3.43; P= .0393). The average member Sovaldi index claim cost was $1349 before the coupon was used and $28 after.<br /><br />The average member sofosbuvir index claim cost was $1349 before a coupon was applied, and $28 after. Overall, coupons offset the member amounts paid by 98%, and coupons amounted to $771,593 of the $787,860 total member cost.<br /><br />Authors noted that there were several limitations to the study such as: not analyzing member characteristics like health literacy, treatment preferences, or prior treatment failures; the assumption that members who abandoned therapy did so only because of their insurer-required Sovaldi member cost share, and did not include additional factors; data availability and study design; using only commercially insured populations; and limiting the impact of Sovaldi coupons on member cost share to only members who filled their initial Sovaldi claim at a specialty pharmacy.<br /><br />The findings revealed that when a manufacturer coupon was used for Sovaldi, it dramatically decreased a member’s cost share by an average of $1321, and in turn, lowered the member’s true amount paid for their initial Sovaldi prescription to an average of $28.<br /><br />Researchers believe that the coupons for HCV therapy could potentially help in the prevention of initial therapy abandonment, since the results of the study showed that an insurer-required member cost share more than $2500 was associated with higher rates of Sovaldi abandonment.<br /><br />However, researchers stated that coupons for non-preferred drugs could result in higher premiums because of the loss of formulary management capabilities, which is needed in order to keep premiums low. </div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-39320067014733613182016-09-02T06:43:00.000-07:002016-09-02T06:43:01.959-07:00Class Must Amend Hepatitis C Cure Lawsuit <div dir="ltr" style="text-align: left;" trbidi="on">
SAN FRANCISCO (CN) — Patients must amend their class action accusing Blue Shield of California of unjustly denying coverage for Harvoni, a revolutionary, and expensive, cure for hepatitis C, a federal judge said Wednesday.<br /> Lead plaintiff Aram Homampour sued Blue Shield of California in October 2015 for refusing to cover Harvoni, a one-a-day pill that can cure hepatitis C in as little as eight weeks with little to no harmful side effects.<br /> Although Blue Shield has twice changed its policies to expand coverage of the drug since the lawsuit was filed, Homampour says the company "hedged its bets" on delaying coverage to increase profits.<br /> At a cost of $99,000, the 12-week treatment approved by the FDA in 2014 was shown to cure hepatitis C in 95 to 99 percent of patients during clinical trials.<br /> During a Wednesday hearing, U.S. District Judge William Orrick said he was inclined to dismiss claims for injunctive relief because the insurer has changed its policies to expand coverage of the drug.<br /> But Orrick found it too early to dismiss claims for recovery of ill-gotten profits Blue Shield allegedly obtained by denying coverage in the past.<br /> "I think it's premature to foreclose it," Orrick said.<br /> Blue Shield attorney John LeBlanc argued that the plaintiffs cannot sue one of two named defendants — Blue Shield Life and Health Insurance Co. — because the actual insurer is California Physicians Service dba Blue Shield of California, an HMO benefit plan.<br /> "They are totally separate companies," LeBlanc said. "One's a health plan covered by the Health and Safety Code. The other is an insurance company covered by the Insurance Code."<br /> But plaintiffs' attorney Timothy Rozelle said his clients have shown a clear connection between the two corporate entities because they shared the same guidelines and process "to categorically deny" coverage for Harvoni.<br /> LeBlanc claimed that a January ruling from the U.S. Supreme Court, Montanile v. Board of Trustees of the Nat'l Elevator Industry Health Benefit Plan, prohibits the plaintiffs from masking their claim for damages as a claim for equitable relief.<br /> "That might be a strong argument on summary judgment," Orrick replied. "I'm not sure this is the time to foreclose plaintiffs' claim. I understand what you're arguing, but I think it's a little early."<br /> Lead plaintiff Marina Sheynberg filed a similar class action against Anthem Blue Cross and its affiliated insurance companies in the same court in July 2015.</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-18440883803880977212016-09-02T06:42:00.000-07:002016-09-02T06:42:25.631-07:00What Medicaid’s Hepatitis C Crisis Means for Medicare Part D<div dir="ltr" style="text-align: left;" trbidi="on">
Three million Americans suffer from Hepatitis C. The liver disease killed nearly 20,000 Americans in 2014 – officially claiming more American lives than any other infectious disease. One may wonder why this condition destroys so many lives, given that Hepatitis C is a curable illness.<br /><br />Part of the answer comes down to the type of health care many Hepatitis C sufferers receive. Of the 3 million Americans affected by this disease, a full third of them are Medicaid eligible. Medicaid recipients frequently face major difficulties in accessing primary care and health care screenings, which are essential to detecting Hepatitis C (it can often be asymptomatic) and treating the patient before major liver damage has been done.<br /><br />The other key obstacle facing Medicaid recipients currently struggling with Hepatitis C is access to effective treatment once a diagnosis has been received. Recently, the National Association of Medicaid Directors (NAMD), an association which represents state directors of Medicaid programs across the country, called on Congress to address the strain that the cost of Hepatitis C treatment is placing on the nation’s largest health insurer.<br /><br />Among the many difficulties specifically expressed, NAMD points out that the current rebate system used to set drug prices in the Medicaid program makes it difficult, if not impossible, to negotiate lower rates for Hepatitis C medications while maintaining a steady supply to meet patient needs. This is because the existing rebate program sets very strict and inflexible guidelines for the pricing of prescription medications under Medicaid.<br /><br />As a possible solution, NAMD suggests that this program could be changed to “enable states to effectively utilize market forces to [reduce treatment costs] on their own.” If this suggestion sounds familiar to some, it could be due to the fact that similar negotiating power was one of the selling points for another government-run health care program: Medicare Part D.<br /><br />Part D, a Medicare prescription drug program, went into effect in 2006. The goal of the program was to increase seniors’ access to a wider variety of prescription medications, while utilizing the market forces of competition to control the costs of the program. The program works by allowing administrators to negotiate prices directly with drug companies, rather than relying on a strict rebate formula like Medicaid.<br /><br />The program is far from perfect, but it deserves credit for costing 45 percent less than projected, resulting in the federal government spending $349 billion less than originally anticipated.<br /><br />Further savings have been realized through increased access to medication, as well. Seniors have been able to manage chronic conditions more affordably through medications, saving the expense of costlier medical interventions. Better access to medication through Part D has saved Medicare $1.5 billion per year.<br /><br />That’s why some look to Part D as a possible model for improving medication pricing and access in the Medicaid Program. The most effective way to allow Medicaid administrators to pursue pricing strategies that work best for each individual program’s unique needs would be to block grant Medicaid in its entirety.<br /><br />In a strange coincidence, however, as Medicaid Directors look to Part D as a model for bringing down prices while increasing access to medication, the Obama administration has been looking to the Medicaid Drug Rebate Program as a possible drug pricing model to replace the more flexible negotiating power of Medicare Part D.<br /><br />Many opponents of this idea have already noted that the plan is not likely to decrease the overall cost of Medicare, and will almost certainly erode access to critically-needed medications for Medicare recipients. Yet the administration has remained steadfast in its requests for Medicaid-style rebates to be introduced to the program.<br /><br />As Congress considers whether to grant the administration’s request to interfere with Part D drug pricing, it should pay attention to Medicaid’s Hepatitis C woes. The future of countless Americans entering their golden years — Americans who will need access to medications currently being developed for conditions such as Alzheimer’s and Parkinson’s — will be deeply affected by their decision.</div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0tag:blogger.com,1999:blog-6706554170800508671.post-44875685756493151502016-09-02T06:41:00.000-07:002016-09-02T06:41:41.981-07:00Why You Might Want to Screen More Patients for Hepatitis C<div dir="ltr" style="text-align: left;" trbidi="on">
Hello. I'm Andrew Kaunitz, professor and associate chair of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine. Today I'd like to discuss screening women of reproductive age for hepatitis C.<br /><br />In late July, the Centers for Disease Control and Prevention (CDC) published in its Morbidity and Mortality Weekly Report that the prevalence of hepatitis C virus (HCV) is increasing among US women of reproductive age.[1] Chronic infections occur in at least three quarters of those infected with HCV, and several million men and women in the United States have chronic hepatitis, representing a leading cause of liver-related morbidity and mortality.[2]<br /><br />Current and past injection-drug use represents the most common risk factor for HCV. Although effective treatment is now available, these medications are new, very expensive, and may not be accessible to those who are most in need. Furthermore, ongoing high-risk behavior can result in repeat infection.<br /><br />The CDC report suggests that the increasing prevalence of injection-drug use among young adults likely explains the higher prevalence of HCV among women of reproductive age, and points out that the number of infants born to infected mothers is increasing dramatically. Vertical HCV transmission (ie, maternal infection that is passed to the infant) occurs in almost 6% of children born to women who are infected with only HCV. Transmission is substantially more likely with high HCV viral loads or concomitant HIV infection. Unfortunately, no intervention to prevent vertical HCV transmission is currently recommended.<br /><br />HCV screening involves testing for antibodies, with viral detection tests used to confirm the presence of infection when antibody screens are positive. Clinicians should note that antibody testing is associated with a substantial false-positive rate. Currently, the American Congress of Obstetricians and Gynecologists recommends that pregnant women with risk factors be screened for HCV. However, the CDC suggests that clinicians also assess nonpregnant women of childbearing age for HCV risk factors and screen accordingly.<br /><br />What are the health benefits of identifying HCV infection in nonpregnant women? Those who are found to harbor HCV can be encouraged to use highly effective contraceptives such as an IUD or implant, referred for rehabilitative treatment to eliminate high-risk behavior, and referred for treatment of HCV. Once the infection is eradicated, women could pursue pregnancy if they so choose. Accordingly, in order for screening nonpregnant women to be effective in preventing subsequent vertical HCV transmission, a number of hurdles will have to be cleared.<br /><br />I would like to thank Dr Anna Wald, an infectious diseases expert at the University of Washington, for her valuable input in preparing these comments. Thank you for taking the time to view this video. I am Andrew Kaunitz. </div>
Online Indian Pharmacyhttp://www.blogger.com/profile/13285533624738134106noreply@blogger.com0