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High rates of sustained virologic response with daclatasvir plus sofosbuvir for HCV

This week's issue of the New England Journal of Medicine investigates the use of daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.

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All-oral combination therapy is desirable for patients with chronic hepatitis C virus (HCV) infection.

Dr Mark Sulkowski and colleagues evaluated daclatasvir plus sofosbuvir in patients infected with HCV genotype 1, 2, or 3.

In this open-label study, the researchers initially randomly assigned 44 previously untreated patients with HCV genotype 1 infection and 44 patients infected with HCV genotype 2 or 3 to daclatasvir at a dose of 60 mg orally once daily plus sofosbuvir at a dose of 400 mg orally once daily, with or without ribavirin, for 24 weeks.

The study was expanded to include 123 additional patients with genotype 1 infection who were randomly assigned to daclatasvir plus sofosbuvir, with or without ribavirin, for 12 weeks or 24 weeks.

The primary end point was a sustained virologic response at week 12 after the end of therapy.

92% of patients with genotype 2 infection had a sustained virologic response at week 12
New England Journal of Medicine

Overall, 211 patients received treatment.

Among patients with genotype 1 infection, 98% of 126 previously untreated patients, and 98% of 41 patients who did not have a sustained virologic response with HCV protease inhibitors had a sustained virologic response at week 12 after the end of therapy.

The research team found that a total of 92% of 26 patients with genotype 2 infection and 89% of 18 patients with genotype 3 infection had a sustained virologic response at week 12.

The team observed high rates of sustained virologic response at week 12 among patients with HCV subtypes 1a and 1b, and those with CC and non-CC IL28B genotypes, as well as among patients who received ribavirin and those who did not.

The most common adverse events were fatigue, headache, and nausea.

Dr Sulkowski's team concludes, "Once-daily oral daclatasvir plus sofosbuvir was associated with high rates of sustained virologic response among patients infected with HCV genotype 1, 2, or 3, including patients with no response to prior therapy with telaprevir or boceprevir."

N Engl J Med 2014; 370:211-221
17 January 2014

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