Gilead Sciences announced results from ION-4, a Phase 3 study evaluating Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV.
ION-4 is a multicenter, open-label study investigating the efficacy, safety and tolerability of Harvoni treatment for 12 weeks in 335 patients with HCV genotype 1a (75%), 1b (23%) or 4 (2%) and HIV-1 co-infection. The study included HCV treatment-naïve (45%) and treatment-experienced (55%) patients, including patients with compensated cirrhosis (20%), whose HIV was suppressed using one of three HIV antiretroviral (ARV) regimens: Atripla (tenofovir/emtricitabine/efavirenz), tenofovir/emtricitabine/raltegravir or Complera (tenofovir/emtricitabine/rilpivirine).
In the trial, 96% (n=321/335) of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). SVR12 rates did not differ significantly by prior HCV treatment status, presence or absence of cirrhosis, or ARV regimen. Of the 14 patients that did not achieve SVR12, two patients experienced virologic failure during treatment (likely due to non-compliance per physician reporting), 10 experienced virologic relapse post-treatment, one was lost to follow up and one died due to causes unrelated to study drug.
Harvoni is already approved as a once-daily single tablet regimen for the treatment of chronic HCV genotype 1 infection in adults.
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