Catalyst
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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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Additional Information
- 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)
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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Catalyst Date
Occurred on:
Jul 25, 2016
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Related Keywords
Viekirax, Ombitasvir, Paritaprevir, Ritonavir, Hepatitis C With Compensated Cirrhosis, Child-pugh A
