Muir and colleagues reported results from Study 107, an open-label rollover study evaluating the addition of telaprevir to peginterferon alfa-2a and ribavirin in patients with genotype 1 chronic hepatitis C virus (HCV) who did not attain sustained virologic response (SVR) with peginterferon/ribavirin during a phase II trial of telaprevir. The study included null responders (patients with HCV RNA reductions <1 log10 at Week 4 or <2 log10 at Week 12), partial responders (patients with >2 log10 decrease in HCV RNA at Week 12 but with detectable HCV RNA at Week 24), patients with viral breakthrough, and patients with HCV relapse. The analysis included 117 patients from the PROVE1/2/3 studies. Patients initially received telaprevir 750 mg every 8 hours plus standard-dose peginterferon/ribavirin for 12 weeks, followed by 12 weeks of standard-dose peginterferon/ribavirin. The study design was amended to allow an additional 24 weeks of peginterferon/ribavirin in patients with detectable HCV RNA at Week 4 and/or Week 12 and in null responders. The patient population included patients with genotype 1A (59%) and genotype 1B (33%) HCV; 83% of patients had HCV RNA levels of at least 800,000 IU/mL; 38% had cirrhosis or bridging fibrosis. Viral breakthrough occurred in 25% of prior null responders, 10% of prior partial responders, 13% of patients with prior viral breakthrough, and no patients with prior relapse. Relapse rates in the same subgroups were 23%, 22%, 0%, and 4%. The discontinuation rate due to adverse events was 9%, including 4% due to rash and 2% due to anemia. Rates of grade 3 rash and anemia were 5% each.
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