Gilead Sciences’ newly approved Harvoni (ledipasvir/sofosbuvir) cured nearly all people with genotype 4 of hepatitis C virus (HCV) in a small trial, reports. Researchers in the SYNERGY trial gave Harvoni to 21 people with genotype 4 of the virus for 12 weeks. Results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases in Boston.

Thirty-eight percent of the participants had been treated before, but none of them with direct-acting antivirals. Ten percent had advanced fibrosis and 33 percent had compensated cirrhosis.

Twenty participants achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), for a cure rate of 95 percent. The one person who was not cured stopped treatment after the first dose.

The regimen was generally safe and well tolerated. The study had no deaths, serious adverse side effects or grade 4 laboratory abnormalities. There were three grade 3 abnormalities, but they were either not likely related or unrelated to Harvoni treatment. The most common side effects were fatigue, diarrhea and nausea.

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