Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) cured almost all people with genotype 4 of hepatitis C virus (HCV) in a small trial. Publishing their findings in The Lancet, researchers enrolled 21 HIV-negative people with genotype 4 of hep C in a single-center, open-label, Phase IIa trial of 12 weeks of Harvoni.
The enrollment period spanned September 2013 to November 2014. Participants were both treatment experienced and treatment naive.
Twenty of the participants (95 percent) achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), including seven who had cirrhosis. The one person who was not cured did not adhere to the treatment regimen and ultimately quit the study.
None of the participants discontinued treatment due to adverse side effects. There were no reported grade 3 or 4 adverse side effects. The most common side effects were diarrhea (two participants), fatigue (three participants), nausea (two participants), and upper respiratory infections (two participants).
To read the Harvoni study, click here.
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