Phase 3 results presented today at The International Liver Congress 2015 show that a combination of daclatasvir (DCV), sofosbuvir (SOF) and ribavirin (RBV) for 12 weeks was effective and well tolerated amongst patients with hepatitis C virus (HCV) infection with advanced cirrhosis and post-transplant recurrence. Sustained virologic response rates at 12 weeks (SVR12) were >90% in patients with Child-Pugh class A or B cirrhosis but lower in Child-Pugh class C. SVR12 was achieved by 94% of liver transplant recipients with HCV recurrence.
ALLY-1 is an open-label study, including treatment-naive or -experienced adults with HCV infection of any genotype.
The most common adverse events (AEs) were headache, fatigue, anaemia, diarrhoea and nausea. There were no treatment-related serious AEs. One post-transplant patient discontinued all therapy after 31 days due to headache but achieved SVR12.
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DACLATASVIR, SOFOSBUVIR, AND RIBAVIRIN COMBINATION FOR HCV PATIENTS WITH ADVANCED CIRRHOSIS OR POSTTRANSPLANT RECURRENCE: PHASE 3 ALLY-1 STUDY, The International Liver Congress 2015.