SVR12 rates ≥ 90% were attained regardless of RBV use or treatment duration.
97% of patients in this historically challenging patient population achieved SVR12, with no episodes of acute or chronic liver graft rejection.
Among the 50 patients with genotype 1 HCV infection in this study, 100% achieved SVR12 after 12 weeks of retreatment; single relapse was misclassified patient later found to have genotype 3a HCV infection.
High SVR12 rates and improved liver function with low rates of treatment-emergent adverse events.
To date, regimens allowing removal of peginterferon most commonly selected: sofosbuvir plus ribavirin in patients with genotype 2/3 infection and sofosbuvir plus simeprevir with or without ribavirin in genotype 1 HCV infection.
Low levels of discontinuation due to adverse events; no virologic failure with 100-mg dose of GS-5816. Inclusion of ribavirin associated with more frequent adverse events with no efficacy benefit.
In this phase II trial, sofosbuvir plus GS-5816 with or without ribavirin was generally safe and well tolerated with only 1 patient discontinuing treatment because of adverse events.
In logistic regression analysis, IL28B TT genotype, previous null response to peginterferon/ribavirin, and genotype 1a HCV only factors significantly associated with not achieving SVR12.
Similar SVR12 rates with 24-week ribavirin-free regimen vs 12-week ribavirin-containing regimen in treatment-experienced cirrhotics.
The addition of ribavirin resulted in higher SVR rates, and extension of therapy to 24 weeks beneficial for cirrhotic patients with a previous null response to peginterferon/ribavirin.
Reduced relapse rates with RBV-containing vs RBV-free regimens in both treatment-naive and treatment-experienced cirrhotic patients with genotype 1a receiving daclatasvir/asunaprevir/beclabuvir.
SVR12 rates substantially lower for both treatment-naive and treatment-experienced cirrhotics vs noncirrhotics.
SVR4/8 rates higher in patients with genotype 1b HCV infection, IL28B CC genotype, or lower baseline HCV RNA level.
SVR12 rate of approximately 90% for both treatment-naive and treatment-experienced patients.
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