Sofosbuvir/Velpatasvir is effective and safe in patients with concomitant proton pump inhibitor use in clinical studies.
Esteban R, Agarwal K, Jose CL, Dufour FJ, Flamm SL, Gordon SC, Lu WY, Lu C, Stamm L, Ni YL, Brainard D, Kowdley KV, Cooper C, Juan PA, Castells L, Buti M, and Lens S. Sofosbuvir/Velpatasvir is effective and safe in patients with concomitant proton pump inhibitor use in clinical studies. Hepatol Int 2019; 13(Suppl 1):S78.
Background: Prior to the availability of Phase 1 drug interaction data, concomitant PPI use was prohibited in clinical trials of SOF/ VEL. Later clinical studies allowed for the use of up to 20 mg omeprazole or equivalent dosing. This analysis evaluated the efficacy and safety of patients who received SOF/VEL and reported concomitant use of a PPI. Methods: This was a retrospective analysis of efficacy and safety data from 12 Phase 2 and Phase 3 clinical studies in which patients received 12 weeks of SOF/VEL and reported concomitant use of a PPI. Efficacy was assessed by SVR12 and safety was assessed by treatment-emergent AEs. Results: 87 patients reported concomitant use of a PPI. The mean age was 57 years (26-78), 79% were male and 75% were white; 56% were infected with genotype 3 and 29% with genotype 1; 37% had compensated cirrhosis and 39% were treatment experienced. The most common PPI was omeprazole reported by 68% of patients. The SVR12 rate was 97% (84 of 87 patients). 78% of patients had an AE, 11% had a serious AE. These efficacy and safety are comparable to patients enrolled in the same studies who received SOF/VEL for 12 weeks without concomitant use of a PPI (SVR12 rate 97% [2445 of 2517 patients]. Conclusion: In Phase 2 and Phase 3 clinical studies, SOF/VEL was effective and safe in patients with concomitant PPI use. These data support the use of SOF/VEL according to labeled recommendations co-administrated with PPIs and other acid reducing agents.