Gilead Sciences’ newly approved Harvoni (ledipasvir/sofosbuvir) is proving highly successful at treating hepatitis C virus (HCV) among people coinfected with HIV and genotype 1 of hep C in an ongoing small trial, the National AIDS Treatment Advocacy Project (NATAP) reports. Fifty people coinfected with HIV and genotype 1 of hep C who were hep C treatment-naive were given Harvoni for 12 weeks. Thirteen of the participants were not taking antiretrovirals to treat HIV, and the remaining 37 were taking ARVs. Interim results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
All of those taking ARVs were on Truvada (tenofovir/emtricitabine) plus Sustiva (efavirenz), Isentress (raltegravir) or Edurant (rilpivirine), or some pairing of the latter three drugs.
Not all of the participants have passed 12 weeks after the end of HCV therapy, so only partial results are available at this time. All 10 of those who are not taking ARVs and who have made it 12 weeks past the end of hep C therapy achieved a sustained virologic response (SVR12, considered a cure). All 22 of those who are taking ARVs and who have made it 4 weeks past the end of hep C treatment have achieved a sustained virologic response (SVR4, considered a good indication that they will be cured).
There were no significant changes in CD4 counts or HIV viral load. There was no evidence of kidney toxicity. Harvoni has been well tolerated, with no discontinuations thus far.
To read the NATAP report, click here.
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