Twenty-four weeks of treatment with Bristol-Myers Squibb’s (BMS) daclatasvir and asunaprevir, without interferon or ribavirin, cured 87 percent of people with genotype 1b of hepatitis C virus (HCV) who were interferon-ineligible or intolerant and 81 percent who did not respond to a previous treatment, HIVandHepatitis reports. Publishing their findings in Hepatology, researchers conducted a Phase III study of the NS5A replication complex inhibitor daclatasvir plus the NS3 protease inhibitor asunaprevir.

The study included 135 people with genotype 1b who were interferon-intolerant or ineligible to take interferon and 87 who did not respond to a previous treatment. They were all treated for 24 weeks.

Eighty-seven percent of the interferon-intolerant/ineligible group achieved a sustained virologic response 24 weeks after completing treatment (SVR24, considered a cure). Eighty-one percent of the prior non-responders were cured.  

There were similar respective cure rates between those who had cirrhosis and those who did not: At 91 percent and 84 percent, these rates were not statistically significant, meaning the difference between them could have happened by chance. Those who had either the IL28B CC or non-CC gene variants of hep C were all cured at a rate of 85 percent.

Six percent of the participants experienced serious side effects, with 5 percent stopping therapy as a consequence. The most common side effects included upper respiratory inflammation, increased ALT and AST liver enzymes, headache, diarrhea, and fever.

BMS submitted an application in April to the U.S. Food and Drug Administration (FDA) for approval of the combination therapy.

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