Addition of daclatasvir to interferon-based HCV therapy improved treatment response, shortened duration
October 9, 2013
SAN FRANCISCO – Patients with hepatitis C treated with daclatasvir in addition to pegylated interferon and ribavirin had better response rates within shorter treatment duration than those who received peginterferon and ribavirin alone in a study presented at ID Week 2013.
Researchers randomly assigned treatment-naive adults with hepatitis C genotype 2 (GT2) or 3 (GT3) to 12 weeks (n=50) or 16 weeks (n=50) of daclatasvir (DCV) plus peginterferon alfa-2a and ribavirin, or 24 weeks of peginterferon and ribavirin with placebo for 24 weeks (n=51). An HCV RNA level below the LLOQ at 4 weeks and undetectable at 10 weeks was the protocol-defined response (PDR).
The cohort included 24 placebo recipients, 24 12-week and 23 16-week DCV recipients with GT2 and 27 placebo recipients, 26 12-week and 27 16-week DCV recipients with GT3. Seventy-eight percent to 88% of patients treated with DCV achieved PDR across groups, and 89% to 96% of DCV recipients achieved end-of-treatment response.
Sustained virologic response at 12 and 24 weeks occurred more frequently among patients with GT2 than GT3, regardless of treatment duration. SVR24 rates were greater among DCV recipients than among placebo recipients for both genotypes.
Relapse occurred in one DCV recipient with GT2 and 12 with GT3. Patients with GT3 and cirrhosis were more likely to relapse than noncirrhotics in the 12-week arm (43% of cases vs. 16%), but not in the 16-week arm (25% for both).
“Shorter treatment duration (12 or 16 weeks) with DCV/peg-alfa/RBV demonstrated higher SVR rates than 24 weeks of peg-alfa/RBV in patients with GT2 or GT3 infection, with higher SVR rates in GT2 with all regimens,” the researchers wrote. “These results support further evaluation of DCV-containing regimens for different HCV genotypes.”