Asselah T, Shafran SD, Bourgeois S, et al. - Among patients randomized to the placebo group in the ASTRAL-1 study, researchers performed a single-arm, open-label, phase 3, deferred treatment study examining the effectiveness and safety of sofosbuvir-velpatasvir. Sofosbuvir-velpatasvir (400/100 mg) once daily was given to patients for 12 weeks. The proportion of patients with sustained virologic response 12 weeks after the end of therapy (SVR12) was assessed as the primary efficacy endpoint. Any adverse event leading to the permanent discontinuation of study drug was assessed as the primary safety endpoint. SVR12 was achieved in 108/111 patients, and virological failure was reported in only one patient. As per outcomes, untreated and previously treated patients with hepatitis C virus genotype 1, 2, 4 or 6 infection, including those with compensated cirrhosis, were effectively treated with sofosbuvir-velpatasvir for 12 weeks with good tolerability. During treatment, the safety profile was comparable to that seen in patients taking placebo; headache, fatigue and nausea were the most common AEs.