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CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A)

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- The CHMP opinion represents a positive advance toward approval of the 12-week regimen of VIEKIRAX with ribavirin for genotype 4 (GT4) chronic hepatitis C virus (HCV) infected adult patients with or without compensated cirrhosis 
AbbVie's EMA label expansion application supported by 97 percent SVR(12) rate (n=57/59) in a dedicated Phase 3 AGATE-I study of patients with GT4 HCV with compensated cirrhosis(1) 
- In Europe, where nine million people are infected with HCV,(2) GT4 is becoming increasingly prevalent in several countries including Italy, France, Greece and Spain(3)
Clinical Data The CHMP positive opinion is supported by data from a dedicated Phase 3 AGATE-I study of GT4 HCV infected patients with compensated cirrhosis. The randomized, open-label study evaluated the safety and efficacy of VIEKIRAX and RBV for 12 and 16 weeks. Results from the study showed that with 12 weeks of treatment with VIEKIRAX and RBV, 97 percent (n=57/59) of patients achieved sustained virologic response at 12 weeks post-treatment (SVR12 ).
Results from the AGATE-I study also showed that patients treated with 16 weeks of VIEKIRAX and RBV achieved 98 percent (n=60/61) SVR12 rates. The most commonly reported adverse events (?20 percent) in the 12-week arm were asthenia, fatigue and headache (18 percent, 17 percent and 23 percent respectively); and for the 16 week arm were fatigue, asthenia, headache, anemia, nausea, and pruritus (33 percent, 32 percent, 23 percent, 23 percent and 20 percent respectively).1 One patient in the 12-week group experienced virologic breakthrough and one discontinued prematurely after the first day of treatment. One patient missed the post-treatment week 12 visit in the 16-week group.1 The full study results were published online in The Lancet in June 2016.
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Occurred on:
Jul 25, 2016
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Related Keywords Viekirax, Ombitasvir, Paritaprevir, Ritonavir, Hepatitis C With Compensated Cirrhosis, Child-pugh A