Common TitleION-4
Official Title Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1
Purpose / DescriptionIn this phase 3, open-label, multicenter study in the United States, Canada, and New Zealand, investigators enrolled 335 patients with hepatitis C and HIV coinfection to receive a 12-week course of ledipasvir-sofosbuvir. Enrollment included genotype 1 or 4 HCV treatment-naive and experienced patients without cirrhosis and those with compensated cirrhosis. The HIV enrollment criteria consisted of HIV RNA less than 50 copies/ml and CD4 count greater than 100 cells/mm3. The antiretroviral regimens that were allowed consisted of tenofovir-emtricitabine plus either efavirenz, rilpivirine, or raltegravir. Most (98%) of the patients enrolled had genotype 1 HCV infection and 55% were treatment experienced. Overall, 321 (96%) of 335 treated patients achieved an SVR12. The results were similar regardless of prior treatment status or presence of cirrhosis.
Phase Phase III
ClinicalTrials.gov NCT02073656
Treatments
Ledipasvir-Sofosbuvir

Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences