February 12, 2014

Presented at CDDW

Tags: Hepatitis, ribavirin, sofosbuvir

By Thomas S. May

TORONTO -- February 11, 2014 -- A 24-week course of ribavirin plus sofosbuvir resulted in sustained virologic response rates 12 weeks after treatment (SVR12) in over 90% of treatment-naïve patients with hepatitis C virus (HCV) genotype 3.

The findings were presented here on February 10 at Canadian Digestive Diseases Week 2014 (CDDW) by Josée Brisebois, MD, Gilead Sciences Canada, Mississauga, Ontario.

Analysis of the data from the phase 3 VALENCE trial also indicated that the dual regimen of sofosbuvir and ribavirin yielded high SVR rates in treatment-experienced patients with HCV genotype 3 without cirrhosis and in patients with genotype 2 after 12 weeks of treatment.

In the VALENCE study, treatment-naïve or treatment-experienced patients with HCV genotype 2 or 3 were randomised 4:1 to receive sofosbuvir (400 mg/day) plus ribavirin (1,000 or 1,200 mg/day) or placebo for a period of 12 weeks. The trial was subsequently amended to extend treatment duration to 24 weeks for patients with HCV genotype 3, due to emerging data suggesting that these patients would benefit from longer treatment.

The current analysis included a total of 419 patients: 73 with HCV genotype 2, 261 with genotype 3 -- including 11 treated for 12 weeks before the protocol change -- and 85 patients with genotype 2 or genotype 3 who received placebo. Approximately 60% of the participants had been treated previously for HCV but were either null-responders or prior relapsers.

Results showed that a high percentage of patients responded to treatment in both arms. SVR12 was achieved by 68 of 73 (93%) of those with HCV genotype 2 after 12 weeks of treatment, while 212 of 250 (85%) of those with genotype 3 disease achieved SVR12 following 24 weeks of treatment.

Patients with HCV genotype 2 had high response rates regardless of previous treatment status and cirrhosis status with 12 weeks of sofosbuvir/ribavirin. SVR12 rates were 97% for treatment-naïve patients without cirrhosis, 100% for treatment-naïve patients with cirrhosis, 91% for treatment-experienced patients without cirrhosis, and 88% for treatment-experienced patients with cirrhosis.

Treatment with sofosbuvir plus ribavirin was generally safe and well tolerated, with headache and fatigue being the most frequently occurring adverse events. The investigators also noted that no additional adverse events were associated with the extension of treatment from 12 weeks to 24 weeks.

Funding for this study was provided by Gilead Sciences Inc.

Canadian Digestive Diseases Week 2014 is presented by the Canadian Association of Gastroenterology (CAG) and the Canadian Association for the Study of the Liver (CASL).

[Presentation title: Sofosbuvir Plus Ribavirin for 12 or 24 Weeks for Patients With HCV Genotype 2 or 3: The Valence Trial. Abstract A340]

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