Purpose / DescriptionThe ASTRAL-5 study was a single-arm, open-label phase 3 trial of sofosbuvir-velpatasvir for 12 weeks in patients with HIV and HCV coinfection. The study enrolled 106 patients with genotype 1, 2, 3, 4 or 6 HCV infection; 18% had compensated cirrhosis and 29% were treatment-experienced. The mean CD4 count was 583 cells/mm³ and all patients had suppressed HIV RNA levels. A variety of antiretroviral regimens, including tenofovir disoproxil fumarate (DF) and boosting agents (cobicistat or ritonavir), were permitted. The overall SVR12 rate was 95%; two viral relapses occurred, both in the genotype 1a subgroup. The presence of cirrhosis or treatment experience did not appear to influence treatment response. Creatinine clearance was lower among people taking boosted antiretroviral regimen and tenofovir DF, but it remained relatively stable over time in all groups. No patient experienced HIV viral rebound on HCV treatment.