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Nucleotide polymerase inhibitor plus ribavirin is effective for Hep C

This week's issue of the New England Journal of Medicine investigates sofosbuvir, an oral nucleotide inhibitor of HCV polymerase, in interferon-sparing and interferon-free regimens for the treatment of Hepatitis C virus infection.

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The standard treatment for hepatitis C virus infection is interferon, which is administered subcutaneously and can have troublesome side effects.

Dr Edward Gane and colleagues from New Zeland evaluated sofosbuvir, an oral nucleotide inhibitor of HCV polymerase, in interferon-sparing and interferon-free regimens for the treatment of  hepatitis C virus infection.

The team provided open-label treatment to 8 groups of patients.

The research team randomly assigned a total of 40 previously untreated patients with  hepatitis C virus genotype 2 or 3 infection to 4 groups.

All four groups received sofosbuvir plus ribavirin for 12 weeks.

The team reported that 3 of these groups also received peginterferon alfa-2a for 4, 8, or 12 weeks.

The research team report that 2 additional groups of previously untreated patients with hepatitis C virus genotype 2 or 3 infection received sofosbuvir monotherapy for 12 weeks or sofosbuvir plus peginterferon alfa-2a and ribavirin for 8 weeks.

There were 2 groups of patients with  hepatitis C virus genotype 1 infection that received sofosbuvir and ribavirin for 12 weeks, of which 10 patients had no response to prior treatment, and 25 with no previous treatment.

The team report the rate of sustained virologic response 24 weeks after therapy.

Common adverse events were headache, and fatigue
New England Journal of Medicine

The team of doctors found that of the 40 patients who underwent randomization, all 10 who received sofosbuvir plus ribavirin without interferon, and all 30 who received sofosbuvir plus ribavirin for 12 weeks and interferon for 4, 8, or 12 weeks had a sustained virologic response at 24 weeks.

For the other patients with hepatitis C virus genotype 2 or 3 infection, all 10 who received sofosbuvir plus peginterferon alfa-2a and ribavirin for 8 weeks had a sustained virologic response at 24 weeks, as did 6 of 10  who received sofosbuvir monotherapy.

The researchers assessed that among patients with  hepatitis C virus genotype 1 infection, 21 of 25 previously untreated patients and 1 of 10 with no response to previous therapy had a sustained virologic response at 24 weeks.

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

Dr Gane's team concluded that, "Sofosbuvir plus ribavirin for 12 weeks may be effective in previously untreated patients with HCV genotype 1, 2, or 3 infection."

N Engl J Med 2013; 368: 34-44
09 January 2013

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