MONDAY, July 28, 2014 (HealthDay News) -- For patients with hepatitis C virus genotype 1, promising new treatment options may be available, according to two studies published online July 28 in The Lancet.
Michael Manns, M.D., from the Hannover Medical School in Germany, and colleagues conducted a phase 3, multicohort study at 116 sites in 18 countries to examine all-oral therapy with daclatasvir plus asunaprevir in patients with hepatitis C virus genotype 1b infection. Participants included 307 treatment-naive patients, 205 non-responders, and 235 intolerant, ineligible, or intolerant and ineligible patients. The researchers observed a sustained virological response with daclatasvir plus asunaprevir in 90 percent of patients in the treatment-naive cohort, 82 percent in the non-responder cohort, and in 82 percent of the ineligible, intolerant, or ineligible and intolerant cohort.
Eric Lawitz, M.D., from the University of Texas Health Science Center in San Antonio, and colleagues examined the efficacy of combined simeprevir and sofosbuvir in patients with hepatitis C virus genotype 1 who were non-responders to peginterferon and ribavirin or were treatment-naive. Participants were randomized to receive simeprevir and sofosbuvir for 24 weeks with (cohort 1; 80 patients) or without ribavirin (cohort 2; 87 patients). The researchers found that 90 percent of cohort 1 and 94 percent of cohort 2 achieved sustained virological response 12 weeks after stopping treatment. In the pooled groups, the most common adverse events were fatigue, headache, and nausea.
"Combined simeprevir and sofosbuvir was efficacious and well tolerated," Lawitz and colleagues write.
The first study was funded by Bristol-Myers Squibb, the manufacturer of daclatasvir and asunaprevir. The second study was funded by Janssen, the manufacturer of simeprevir.
Abstract - Manns
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Abstract - Lawitz
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