Janssen Demonstrates Continued Commitment to Combating Hepatitis C in European Patients With Data Presented at Viral Hepatitis Congress

FRANKFURT, Germany I October 10, 2014 I Janssen R&D Ireland (Janssen) today declared the presentation of extra information for the NS3/4A protease inhibitor OLYSIO®(simeprevir) at the Viral Hepatitis Congress (VHC) in Frankfurt, Germany. The information incorporates new investigation of an European and Israeli Hepatitis C (HCV) quiet subset inside of the beforehand displayed ATTAIN Phase 3 study. Extra information exhibited examines treatment contemplations for a wide scope of patient populaces including the renal capacity of those regarded with simeprevir and in addition the polymorphism's commonness of Q80k in European genotype 1 (GT1) patients.

The new examination of the Phase 3 ATTAIN study (n=763), demonstrated maintained virological reaction at 12 weeks (SVR12) to be comparative in European and Israeli patients contrasted with past investigation of the general patient populace (GT1, invalid and former responder patients).1 Importantly these outcomes have demonstrated that Week 4 reaction rates are a decent indicator of SVR12, demonstrating that the larger part of patients treated with simeprevir and pegIFN/RBV with HCV RNA <25 IU/ml at Week 4, were prone to accomplish SVR by week 12.2

"The new ATTAIN information displayed at the Viral Hepatitis Congress adds to the broadness of information that highlights the estimation of simeprevir, in blend with pegylated interferon and ribavirin, and serving to further characterize patients who can profit by this treatment," said PD Dr. med. Holger Hinrichsen, Center for Gastroenterology and Hepatology, Kiel, Germany and agent of the ATTAIN study. "While sans interferon regimens are a center of industry clinical improvement programs, these outcomes show that interferon based treatments still have an essential part to play inside of current measures of treatment."

The most well-known unfriendly occasions amid the initial 12 weeks of treatment happened at a reliably lower recurrence in the simeprevir treatment arm contrasted with the telaprevir treatment arm. Unfriendly occasions included: pruritus (31 percent versus 43 percent); weakness (32 percent versus 38 percent); cerebral pain (25 percent versus 29 percent) and frailty (13 percent versus 37 percent).

Paleness related blood transfusions were essentially lower in the simeprevir treatment arm (0.8%) versus the telaprevir treatment arm (9.1%). Just two percent of patients in the simeprevir arm versus eight percent of patients in the telaprevir arm ended treatment right on time because of an unfavorable event.2

Broadness of information shows guarantee for differing understanding populaces

Extra information likewise displayed at VHC researched the renal capacity in patients treated with simeprevir or fake treatment in blend with Peg-IFN/ribavirin (PR) in HCV genotype-1-tainted, treatment-gullible patients which demonstrated that simeprevir has a decent renal security profile.3 Furthermore, the post-hoc investigation of pooled viability information from the Phase 3 QUEST-1 and QUEST-2 investigations of treatment-credulous genotype 1 HCV patients, bolstered the utilization of simeprevir in mix with PegIFN/RBV to treat HCV patients with moderate liver fibrosis.4

Janssen likewise introduced an examination of the predominance of Q80k polymorphism in a pooled investigation of GT1 patients from telaprevir and simeprevir stage II/III clinical trials. This investigation sets up that there is an extensively lower predominance of the Q80k polymorphism at pattern among patients tainted with HCV GT1 in European nations, contrasted with a past examination in North American patients. This examination exhibited that inside Europe, the commonness of Q80k polymorphism changes impressively between nations, due to some degree to the diverse pervasiveness of GT1b (which does not contain the Q80k polymorphism) and additionally the varying predominance of Q80k in GT1a over the European region.5

"Hepatitis C influences a different patient populace over a scope of genotypes," said Dr. PhD Michael Schlag, Medical Affairs Director, simeprevir, Janssen EMEA. "As the Hepatitis C treatment scene has developed, we must hope to extend our comprehension of how new medications will function for individual patients with the point of giving custom-made medicines to patients that outcomes in enhanced results. These extra information displayed by Janssen at the Viral Hepatitis Congress shows our devotion to keeping the patient at the heart of progressing advances.