Phase 2a study indicates virologic response with daclatasvir, asunaprevir treatment
THURSDAY, Jan. 19 (HealthDay News) -- Direct-acting antiviral agents may be effective for treating patients with chronic hepatitis C virus (HCV) genotype 1 who don't respond to peginterferon and ribavirin therapies, according to a study published in the Jan. 19 issue of the New England Journal of Medicine.
Anna S. Lok, M.D., of the University of Michigan in Ann Arbor, and colleagues studied a cohort of 21 patients with HCV genotype 1 infection who had not responded after 12 weeks of treatment with peginterferon and ribavirin. Eleven patients were assigned to group A to receive daclatasvir (60 mg daily) and asunaprevir (600 mg twice daily), while group B, with 10 patients, received daclatasvir and asunaprevir in combination with peginterferon alfa-2a and ribavirin.
The researchers found that 36 percent of group A (four patients) had a sustained virologic response at 12 and 24 weeks after treatment. Six patients had viral breakthrough during treatment, with resistance mutations identified in all cases. One patient had a viral response at the end of therapy, but relapsed. All patients in group B had a sustained virologic response at 12 weeks, and this was maintained at 24 weeks in nine of the patients. In both groups, the most common adverse event was diarrhea.
"Overall, these results suggest that further research with combinations of direct-acting antiviral agents, with or without peginterferon and ribavirin, is warranted," the authors conclude.
The study was funded by Bristol-Myers Squibb, which manufactures daclatasvir and asunaprevir; several study authors and the editorial author disclosed financial relationships with pharmaceutical companies, including Bristol-Myers Squibb.
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