FDA approves Harvoni (ledipasvir + sofosbuvir) for hepatitis C + HIV- Gilead Sciences

The FDA has approved Harvoni (ledipasvir + sofosbuvir) for use in patients with hepatitis C virus (HCV) infection co-infected with HIV. Patients with HCV/HIV co-infection represent approximately 30% of the total HIV-infected population in the United States.

The sNDA approval for patients with HCV/HIV-1 co-infection was supported by data from the Phase III open-label ION-4 study, which evaluated Harvoni for 12 weeks for the treatment of genotypes 1 or 4 chronic HCV infection among patients co-infected with HIV. Data demonstrate that 96% (321/335) of patients achieved SVR12. The study included HCV treatment-naïve (45%) and treatment-experienced (55%) patients, including patients with compensated cirrhosis (20%). The majority of patients were taking one of three HIV antiretroviral (ARV) regimens: tenofovir disoproxil fumarate (TDF) and emtricitabine with efavirenz (Atripla), raltegravir or rilpivirine (Complera). The most common adverse events (in at least 10% of subjects) were headache (20%) and fatigue (17%).