A New Zealand doctor has been running innovative drug trials
that have given selected patients like Sarah the chance of a new life.
But for the rest of the estimated 50,000 New Zealanders living with Hep
C, there's still a long wait ahead for these drugs to be approved and
then publicly funded.
For Sarah, it was like "walking around in a marshmallow", a permanent hangover even though she had given up drinking 15 years earlier. She lived with it even before the disease was identified by science. After 40 years suffering from Hepatitis C, a blood-borne disease that attacks the liver, earlier this month she was finally accepted on to a clinical trial for a new wonder-drug that promises to cure her. "I burst into tears when they told me," she says. "I felt so happy, so lucky. It was like I had won Lotto."
This morning, Sarah hopes she will awake in an Auckland hospital bed to be told she finally has the all clear. All it took was eating two slices of toast and taking three small white pills at 11.30am each morning for a few weeks .
These new drugs – painless, fast-acting, 95 per cent successful and,
it seems, free of side-effects – are, say Ed Gane, Auckland University
professor of medicine, "a dramatic change, a paradigm shift".
He's been trialling versions of them for major drug companies for the past five years, and those trials have given selected patients like Sarah the chance of a new life. But for the rest of the estimated 50,000 New Zealanders living with Hep C, there's still a long wait ahead for these drugs to be approved and then publicly funded.
For those who can't wait, there's a man in Tasmania, factories in India and China, and a tiptoe across the lines of legality to try and rid yourself of a disease that many carriers simply don't know they have – until their health has taken a very definite turn for the worse.
CONQUERING THE DISEASE
In the history of mankind, only one disease has been conquered by the combined forces of science.
Smallpox, which first emerged in about 10,000 BC, claimed victims including Louis XV of France, Jules Leotard (inventor of his namesake garment) and Ramses V, Pharoah of Egypt, and about 500 million others in the course of the 20th century. In 1979, a group of scientists worldwide were able to declare it eradicated.
If, in about 20 years time, we are able to add Hepatitis C to that list, among the foot-soldiers who brought about that triumph will be Gane, a tousled, cheerful doctor who heads the National Liver Centre at Auckland's Greenlane Hospital, whose part in the research about Hep C has contributed hugely, leading many cutting-edge trials. "It has been a privilege for me to be involved in clinical research in a field of medicine which has witnessed such a rapid evolution in management from an incurable disease, to something that can be eradicated within our lifetime," Gane says.
Gane says global eradication within our lifetime is a realistic
possibility, "and there is certainly no reason why you couldn't
eliminate Hep C from within one country". Georgia, Iceland and now
Australia are all embarked on elimination programmes. Because there are
only around 500 to 900 new cases a year in New Zealand, it's a realistic
proposal for us too.
Hepatitis C, one of five lettered strains of the disease, eventually causes liver failure or liver cancer. It's blood borne, and can be contracted in several ways but mostly these days, it's through the sharing of needles. Many of the New Zealand cases date back to a more liberal, pre-AIDS era – the average age of a Kiwi sufferer is 48. Many don't know they have it, and those who do rarely want to draw attention to it.
Only about one per cent of the infected population begin treatment each year. This, admits Gane, is because the existing regimen is hardly appealing: based on a drug called Interferon, it requires a daily injection for a year, causes depression, weight loss, rashes, poor concentration, irritability, is unsuited to those over 60 and has a success rate of just 50 per cent. The ageing cohort of sufferers also raises the prospect that most eventually won't be able to take Interferon, even if they chose to.
Rob, 50, an Auckland tradie, tried Interferon 13 years ago. He describes it as "shite" and says he would never have agreed to try it if he'd known the low success rates and how painful the side effects were.
For Rob, Hepatitis C was a torture he'd learned to live with. Typically, he had suffered for years without knowing, although he always felt there was something wrong with his health. He's certain he picked it up from experimenting with drugs in his teens – and many of his friends from that time have also been diagnosed. He's been waiting ever since for something better, always worrying his health would deteriorate beyond repair: "Of course, you worry about it," he says. "It's a cloud that hangs over your head all the time."
Earlier this month, he was told he was finally free of Hepatitis C after completing one of Gane's clinical trials. "I'm euphoric," he says. "I've very, very lucky, so fortunate to be put on one of these trials. I've been waiting a while: I'd go and see Ed Gane, and every year he would say the silver bullet is coming. Now it's happened. When they said I could go on the trial I thought 'is it really my turn?' I was still sceptical ... but it is a silver bullet, it's phenomenal. I can't describe it. It's a complete game changer."
Rob was told his course of treatment would have cost him $90,000 if he'd had to pay for it. He'd begun looking at a website run by Tasmanian man Greg Jefferys, who imports cheap generics from India and China, when he received news he'd been selected for the trial. He immediately cut short a planned European holiday to ensure he was available. "I had these two little pots of pills and I was looking at them thinking, jeez, not many people can afford these. I couldn't."
BEHIND THE PACK
Other countries appear to be moving faster than New Zealand to make these drugs widely available: Australia has just agreed a public-funding deal for its patients. In New Zealand, MedSafe – who decide if drugs are fit for use – have approved two early-generation drugs. Pharmac, who decide whether they will pay for them, have yet to rule. One aspect is clearly the prices charged by the big pharmaceutical companies.
For now, that leaves room for Jefferys, who says he's exporting one or two complete treatments a week to New Zealand of generic Indian copies of the drugs, costing $AU1,850 for a 12-week course covering all genotypes. Jefferys was successfully treated for his own Hep C in India, and had his story covered in the Australian media, prompting others to ask him how they could get help. He began importing direct from India, creating his own Dallas Buyers' Club which he calls the FixHepC Buyers Club, for Hep C patients. He asked people to get blood tests at the 14-day mark – and says some returned tests showing the virus was gone, prompting doctors to start supporting him.
A further story on his own case then a piece on ABC television only increased business. "That created an explosion of interest: five months after my return from India, there were thousands of Australians treating their Hep C with Indian generics and it was very very easy to get a prescription and almost all hospitals and most specialists would monitor treatments."
Jefferys says getting the word out in the media is the catalyst to the process. "The only thing preventing the eradication of Hep C in Australia is the will to do so by our government," wrote Jefferys in his blog last year, which is highly critical of the prices charged by the drug companies for their Hep C drugs. From March 1, Australia have said they will make these drugs available to all Hep C patients.
Gane is cautious about this self-medicating, explaining that the various strains of Hepatitis C (there are six genotypes) means prescribing these new drugs is not entirely straightforward and there are question marks about authenticity with some imports, but concedes that he would look after the care of someone who was adamant they would take the imports and urges people to wait for a safe, official dose. "Can they not wait five years?" he asks.
WHAT DO THEY DO?
In layman's terms, the newer drugs have had such an impact because produce molecules which block the enzymes in Hep C – and the newest block three of those enzymes, because AIDS treatment has taught doctors that to block only one gives the virus a chance to develop resistance.
MedSafe has approved two of these drugs, which would cure most people with the predominant version of Hepatitis C - Genotype 1, affecting around 60% of sufferers - but the next generation will be suitable for all six genotypes.
In a statement, Sarah Fitt, the director of operations for Pharmac, said they were "keen to fund new treatments that improve outcomes for patients and are actively looking for ways in which these hepatitis C treatments can be made affordable for New Zealand".
Pharmac were considering four different drugs – with the brand names Sovaldi, Harvoni, Viekira Pak, and Olysio – and said it had advice all were very effective. "Our clinical advisors have therefore given a high priority recommendation for funding for people with hepatitis C at highest risk of progressing to liver transplantation, or at high risk of developing liver cancer."
That stops short of treating all patients and it comes with a caveat: "However, funding would be a substantial commitment of some tens of millions of dollars, which PHARMAC needs to consider carefully against all our other funding options. Any decision to fund a medicine depends on our ability to negotiate the best possible deal within the funding available. Regardless of the level of budget, choices have to be made. PHARMAC's job is to ensure those choices provide better health for New Zealanders, are value for money, and affordable."
At present, a course would cost about $96,000 per patient, on average. Gane says: "Pharmac are working very hard to make an arrangement... we strongly support what Pharmac is trying to do, when you have a limited budget, first of all treat those who can't wait, then increase it to everyone who has liver disease and then increase it to treat everyone." Gane says if we were simply to continue as we are, Hep C deaths would rise 20% a year and treble by 2030.
TIME TO ACT
Sarah will know today just how effective those drugs are. After waiting two years to be accepted on a trial, she consumed only vegetable smoothies for a month, dropping 14kg, to ensure she was passed fit. Gane had to order extra tests after early scares he liver was too damaged to qualify.
She suspects she caught Hep C from a blood transfusion 40 years ago, and may have caught a second mutation from acupuncture at a music festival around the same time but the disease wasn't recognised worldwide until 1988.
She had been a blood donor for years before she was diagnosed. "So I am responsible for heaps of other people getting it but it's not really my fault – I didn't know.
"When I first got it, I didn't know what was wrong with me, and they didn't either: I was treated like a malingerer, told to get on with it ... you feel like crap most of the time."
Fifteen years ago, she quit drinking to protect her failing liver, and later closed her successful business because she couldn't handle the long hours at a computer; she worked in gardening for a while but is now back part-time in a desk-based role thanks to the drugs.
Until he can hand out the wonder drugs, Gane is doing the next best thing: finding everyone who has Hepatitis C in New Zealand. As a result, the Ministry of Health are due to launch a public awareness and targeted testing campaign to find those hidden sufferers.
Another barrier has been the "terrifying concept" of having a liver biopsy done to confirm cirrhosis. But a fibroscan machine can measure liver health non-invasively - the one at Gane's clinic in Auckland has delivered 12,000 tests in the past five years. They now have one in a handy portable form. I succumb to a test: the hand-held device essays a slightly disconcerting thump against my stomach and moments later a little ticket prints out with my result. That machine is now a regular visitor to Mt Eden Prison and to various charities working with drug users.
But the best way to persuade recalcitrant sufferers to come in for diagnosis and treatment would be to give them these new drugs in the comfort of their GP's surgery, Gane says. "That removes so many barriers – a lot of people still feel stigmatised and don't like coming to hospital."
The question is, could it happen any quicker than that? Shouldn't Pharmac be funding it right now?
"Crikey, I'm bound to say that," says long-time sufferer Rob. "I've had this thing for 30 years and I never thought I would get to this point where it wasn't there any more."
One thing that there's no question about is the life-changing qualities of these drugs. Rob says his entire outlook has changed. "I'm looking at things a bit differently: maybe I won't cark it at the end of my fifties. I might kick on a bit."
GANE 'DESERVES A MEDAL'
A cured Craig Hopkins says Gane deserves a medal for his work.
The Christchurch man suffered from Hep C for 30 years, contracting it at 18 during a back yard tattoo job.
In 2012, Gane, Hopkins' doctor, was able to access a new drug Sovaldi from pharmaceutical company Gilead Sciences on compassionate grounds.
After just two weeks of treatment, Hopkins was free of the virus. "It was unreal, I couldn't believe it."
Hopkins murmurs the word "hero" at first mention of Gane.
"He's very blunt, but knows exactly what he's on about. If it was up to me, I would give him a medal," he says.
Despite the stigma attached to Hep C sufferers, Hopkins wanted to see a wider public conversation about the disease, which once had him knocking on death's door.
"When people find out they've got Hep C there's an automatic assumption you're a drug user.
"When I first got it I knew nothing about Hep C."
As for the estimated 50,000 New Zealanders still waiting for access to the drugs? "It's really frustrating,they just can't get to it," Hopkins says.
For Sarah, it was like "walking around in a marshmallow", a permanent hangover even though she had given up drinking 15 years earlier. She lived with it even before the disease was identified by science. After 40 years suffering from Hepatitis C, a blood-borne disease that attacks the liver, earlier this month she was finally accepted on to a clinical trial for a new wonder-drug that promises to cure her. "I burst into tears when they told me," she says. "I felt so happy, so lucky. It was like I had won Lotto."
This morning, Sarah hopes she will awake in an Auckland hospital bed to be told she finally has the all clear. All it took was eating two slices of toast and taking three small white pills at 11.30am each morning for a few weeks .
SUPPLIED
According to cured Hep C sufferer Craig Hopkins, Dr Ed Gane, pictured, deserves a medal.
He's been trialling versions of them for major drug companies for the past five years, and those trials have given selected patients like Sarah the chance of a new life. But for the rest of the estimated 50,000 New Zealanders living with Hep C, there's still a long wait ahead for these drugs to be approved and then publicly funded.
For those who can't wait, there's a man in Tasmania, factories in India and China, and a tiptoe across the lines of legality to try and rid yourself of a disease that many carriers simply don't know they have – until their health has taken a very definite turn for the worse.
STACY SQUIRES/FAIRFAX NZ
Craig Hopkins, 52, nearly died from liver failure after
contracting Hepatitis C virus from an amateur tattoo. He was finally
cured after treatment with a new unsubsidised drug made available on
compassionate grounds.
In the history of mankind, only one disease has been conquered by the combined forces of science.
Smallpox, which first emerged in about 10,000 BC, claimed victims including Louis XV of France, Jules Leotard (inventor of his namesake garment) and Ramses V, Pharoah of Egypt, and about 500 million others in the course of the 20th century. In 1979, a group of scientists worldwide were able to declare it eradicated.
If, in about 20 years time, we are able to add Hepatitis C to that list, among the foot-soldiers who brought about that triumph will be Gane, a tousled, cheerful doctor who heads the National Liver Centre at Auckland's Greenlane Hospital, whose part in the research about Hep C has contributed hugely, leading many cutting-edge trials. "It has been a privilege for me to be involved in clinical research in a field of medicine which has witnessed such a rapid evolution in management from an incurable disease, to something that can be eradicated within our lifetime," Gane says.
Hepatitis C, one of five lettered strains of the disease, eventually causes liver failure or liver cancer. It's blood borne, and can be contracted in several ways but mostly these days, it's through the sharing of needles. Many of the New Zealand cases date back to a more liberal, pre-AIDS era – the average age of a Kiwi sufferer is 48. Many don't know they have it, and those who do rarely want to draw attention to it.
Only about one per cent of the infected population begin treatment each year. This, admits Gane, is because the existing regimen is hardly appealing: based on a drug called Interferon, it requires a daily injection for a year, causes depression, weight loss, rashes, poor concentration, irritability, is unsuited to those over 60 and has a success rate of just 50 per cent. The ageing cohort of sufferers also raises the prospect that most eventually won't be able to take Interferon, even if they chose to.
Rob, 50, an Auckland tradie, tried Interferon 13 years ago. He describes it as "shite" and says he would never have agreed to try it if he'd known the low success rates and how painful the side effects were.
For Rob, Hepatitis C was a torture he'd learned to live with. Typically, he had suffered for years without knowing, although he always felt there was something wrong with his health. He's certain he picked it up from experimenting with drugs in his teens – and many of his friends from that time have also been diagnosed. He's been waiting ever since for something better, always worrying his health would deteriorate beyond repair: "Of course, you worry about it," he says. "It's a cloud that hangs over your head all the time."
Earlier this month, he was told he was finally free of Hepatitis C after completing one of Gane's clinical trials. "I'm euphoric," he says. "I've very, very lucky, so fortunate to be put on one of these trials. I've been waiting a while: I'd go and see Ed Gane, and every year he would say the silver bullet is coming. Now it's happened. When they said I could go on the trial I thought 'is it really my turn?' I was still sceptical ... but it is a silver bullet, it's phenomenal. I can't describe it. It's a complete game changer."
Rob was told his course of treatment would have cost him $90,000 if he'd had to pay for it. He'd begun looking at a website run by Tasmanian man Greg Jefferys, who imports cheap generics from India and China, when he received news he'd been selected for the trial. He immediately cut short a planned European holiday to ensure he was available. "I had these two little pots of pills and I was looking at them thinking, jeez, not many people can afford these. I couldn't."
BEHIND THE PACK
Other countries appear to be moving faster than New Zealand to make these drugs widely available: Australia has just agreed a public-funding deal for its patients. In New Zealand, MedSafe – who decide if drugs are fit for use – have approved two early-generation drugs. Pharmac, who decide whether they will pay for them, have yet to rule. One aspect is clearly the prices charged by the big pharmaceutical companies.
For now, that leaves room for Jefferys, who says he's exporting one or two complete treatments a week to New Zealand of generic Indian copies of the drugs, costing $AU1,850 for a 12-week course covering all genotypes. Jefferys was successfully treated for his own Hep C in India, and had his story covered in the Australian media, prompting others to ask him how they could get help. He began importing direct from India, creating his own Dallas Buyers' Club which he calls the FixHepC Buyers Club, for Hep C patients. He asked people to get blood tests at the 14-day mark – and says some returned tests showing the virus was gone, prompting doctors to start supporting him.
A further story on his own case then a piece on ABC television only increased business. "That created an explosion of interest: five months after my return from India, there were thousands of Australians treating their Hep C with Indian generics and it was very very easy to get a prescription and almost all hospitals and most specialists would monitor treatments."
Jefferys says getting the word out in the media is the catalyst to the process. "The only thing preventing the eradication of Hep C in Australia is the will to do so by our government," wrote Jefferys in his blog last year, which is highly critical of the prices charged by the drug companies for their Hep C drugs. From March 1, Australia have said they will make these drugs available to all Hep C patients.
Gane is cautious about this self-medicating, explaining that the various strains of Hepatitis C (there are six genotypes) means prescribing these new drugs is not entirely straightforward and there are question marks about authenticity with some imports, but concedes that he would look after the care of someone who was adamant they would take the imports and urges people to wait for a safe, official dose. "Can they not wait five years?" he asks.
WHAT DO THEY DO?
In layman's terms, the newer drugs have had such an impact because produce molecules which block the enzymes in Hep C – and the newest block three of those enzymes, because AIDS treatment has taught doctors that to block only one gives the virus a chance to develop resistance.
MedSafe has approved two of these drugs, which would cure most people with the predominant version of Hepatitis C - Genotype 1, affecting around 60% of sufferers - but the next generation will be suitable for all six genotypes.
In a statement, Sarah Fitt, the director of operations for Pharmac, said they were "keen to fund new treatments that improve outcomes for patients and are actively looking for ways in which these hepatitis C treatments can be made affordable for New Zealand".
Pharmac were considering four different drugs – with the brand names Sovaldi, Harvoni, Viekira Pak, and Olysio – and said it had advice all were very effective. "Our clinical advisors have therefore given a high priority recommendation for funding for people with hepatitis C at highest risk of progressing to liver transplantation, or at high risk of developing liver cancer."
That stops short of treating all patients and it comes with a caveat: "However, funding would be a substantial commitment of some tens of millions of dollars, which PHARMAC needs to consider carefully against all our other funding options. Any decision to fund a medicine depends on our ability to negotiate the best possible deal within the funding available. Regardless of the level of budget, choices have to be made. PHARMAC's job is to ensure those choices provide better health for New Zealanders, are value for money, and affordable."
At present, a course would cost about $96,000 per patient, on average. Gane says: "Pharmac are working very hard to make an arrangement... we strongly support what Pharmac is trying to do, when you have a limited budget, first of all treat those who can't wait, then increase it to everyone who has liver disease and then increase it to treat everyone." Gane says if we were simply to continue as we are, Hep C deaths would rise 20% a year and treble by 2030.
TIME TO ACT
Sarah will know today just how effective those drugs are. After waiting two years to be accepted on a trial, she consumed only vegetable smoothies for a month, dropping 14kg, to ensure she was passed fit. Gane had to order extra tests after early scares he liver was too damaged to qualify.
She suspects she caught Hep C from a blood transfusion 40 years ago, and may have caught a second mutation from acupuncture at a music festival around the same time but the disease wasn't recognised worldwide until 1988.
She had been a blood donor for years before she was diagnosed. "So I am responsible for heaps of other people getting it but it's not really my fault – I didn't know.
"When I first got it, I didn't know what was wrong with me, and they didn't either: I was treated like a malingerer, told to get on with it ... you feel like crap most of the time."
Fifteen years ago, she quit drinking to protect her failing liver, and later closed her successful business because she couldn't handle the long hours at a computer; she worked in gardening for a while but is now back part-time in a desk-based role thanks to the drugs.
Until he can hand out the wonder drugs, Gane is doing the next best thing: finding everyone who has Hepatitis C in New Zealand. As a result, the Ministry of Health are due to launch a public awareness and targeted testing campaign to find those hidden sufferers.
Another barrier has been the "terrifying concept" of having a liver biopsy done to confirm cirrhosis. But a fibroscan machine can measure liver health non-invasively - the one at Gane's clinic in Auckland has delivered 12,000 tests in the past five years. They now have one in a handy portable form. I succumb to a test: the hand-held device essays a slightly disconcerting thump against my stomach and moments later a little ticket prints out with my result. That machine is now a regular visitor to Mt Eden Prison and to various charities working with drug users.
But the best way to persuade recalcitrant sufferers to come in for diagnosis and treatment would be to give them these new drugs in the comfort of their GP's surgery, Gane says. "That removes so many barriers – a lot of people still feel stigmatised and don't like coming to hospital."
The question is, could it happen any quicker than that? Shouldn't Pharmac be funding it right now?
"Crikey, I'm bound to say that," says long-time sufferer Rob. "I've had this thing for 30 years and I never thought I would get to this point where it wasn't there any more."
One thing that there's no question about is the life-changing qualities of these drugs. Rob says his entire outlook has changed. "I'm looking at things a bit differently: maybe I won't cark it at the end of my fifties. I might kick on a bit."
GANE 'DESERVES A MEDAL'
A cured Craig Hopkins says Gane deserves a medal for his work.
The Christchurch man suffered from Hep C for 30 years, contracting it at 18 during a back yard tattoo job.
In 2012, Gane, Hopkins' doctor, was able to access a new drug Sovaldi from pharmaceutical company Gilead Sciences on compassionate grounds.
After just two weeks of treatment, Hopkins was free of the virus. "It was unreal, I couldn't believe it."
Hopkins murmurs the word "hero" at first mention of Gane.
"He's very blunt, but knows exactly what he's on about. If it was up to me, I would give him a medal," he says.
Despite the stigma attached to Hep C sufferers, Hopkins wanted to see a wider public conversation about the disease, which once had him knocking on death's door.
"When people find out they've got Hep C there's an automatic assumption you're a drug user.
"When I first got it I knew nothing about Hep C."
As for the estimated 50,000 New Zealanders still waiting for access to the drugs? "It's really frustrating,they just can't get to it," Hopkins says.
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