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News

Sofosbuvir for previously untreated chronic Hep C infection

A study published in this week's issue of the New England Journal of Medicine investigates the use of sofosbuvir for previously untreated chronic Hepatitis C infection.

News image

Dr Eric Lawitz and colleagues conducted 2 phase 3 studies in previously untreated patients with HCV infection.

In a single-group, open-label study, the researchers administered a 12-week regimen of sofosbuvir plus peginterferon alfa-2a and ribavirin in 327 patients with HCV genotype 1, 4, 5, or 6 (of whom 98% had genotype 1 or 4).

In a noninferiority trial, 499 patients with HCV genotype 2 or 3 infection were randomly assigned to receive sofosbuvir plus ribavirin for 12 weeks or peginterferon alfa-2a plus ribavirin for 24 weeks.

In the 2 studies, the primary end point was a sustained virologic response at 12 weeks after the end of therapy.

The sustained virologic response in the single-group study was 90%
New England Journal of Medicine

In the single-group study, the team reported a sustained virologic response in 90% of patients.

In the noninferiority trial, a sustained response was reported in 67% of patients in both the sofosbuvir–ribavirin group and the peginterferon–ribavirin group.

The research team found that response rates in the sofosbuvir–ribavirin group were lower among patients with genotype 3 infection than among those with genotype 2 infection.

Adverse events (including fatigue, headache, nausea, and neutropenia) were less common with sofosbuvir than with peginterferon.

Dr Lawitz's team concludes, "In a single-group study of sofosbuvir combined with peginterferon–ribavirin, patients with predominantly genotype 1 or 4 HCV infection had a rate of sustained virologic response of 90% at 12 weeks."

"In a noninferiority trial, patients with genotype 2 or 3 infection who received either sofosbuvir or peginterferon with ribavirin had nearly identical rates of response."

"Adverse events were less frequent with sofosbuvir than with peginterferon."

N Engl J Med 2013; 368: 1878-1887
21 May 2013

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