Twelve weeks of Gilead Sciences’ newly approved Harvoni (ledipasvir/sofosbuvir) cured nearly all people with genotype 1 of hepatitis C virus (HCV) who were coinfected with HIV in a recent trial, reports. Researchers in the ERADICATE trial treated 50 coinfected participants with 12 weeks of Harvoni and reported their results at the Annual Meeting of the American Association for the Study of Liver Diseases in Boston.

About a quarter of the participants had advanced fibrosis, although none had cirrhosis. Approximately 80 percent had genotype 1a of hep C and the same proportion were African American. Thirteen of the participants were not taking antiretrovirals (ARVs) to treat HIV. Those on ARVs were taking Truvada (tenofovir/emtricitabine) with either Sustiva (efavirenz), Isentress (raltegravir) or Edurant (rilpivirine).

One hundred percent of those who were not treated with ARVs achieved a sustained virologic response 12 weeks after completing Harvoni therapy (SVR12, considered a cure), while 36 out of 37, or 97 percent, of those treated with ARVs achieved an SVR12 from taking Harvoni.

No one in the trial died.  And no one experienced a drug-related serious adverse side effect or stopped treatment for this reason. Side effects, reported by 5 percent or more of the participants, included nasal congestion, sore throat, fatigue, diarrhea, nausea, pain, headache and tooth infections.

While Harvoni has been found to raise levels of Viread (tenofovir, a component of Truvada), a thorough analysis did not detect significant abnormalities. However, three people did develop protein in their urine.

To read the HIVandHepatitis story, click here.