Sofosbuvir/Velpatasvir Is Effective and Safe in Patients with Concomitant Proton PUMP Inhibitor Use in Clinical Studies

Document Type

Conference Proceeding

Publication Date


Publication Title

Can Liver J


BACKGROUND: Prior to the availability of Phase 1 drug interaction data, concomitant proton pump inhibitor (PPI) use was prohibited in clinical trials of Sofosbuvir/Velpatasvir (SOF/VEL). Later, clinical studies allowed use of up to 20 mg omeprazole or equivalent dosing. PURPOSE: This analysis evaluated the efficacy and safety of patients with and without compensated cirrhosis who received SOF/VEL for 12 weeks 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 where patients of all genotypes with and without compensated cirrhosis received 12 weeks of SOF/VEL and reported concomitant use of a PPI. Efficacy was assessed by sustained virologic response 12 weeks after treatment (SVR12) and relapse rates and safety was assessed by treatment- emergent adverse events (AEs). RESULT(S): 87 patients reported concomitant use of a PPI. The mean age (range) was 57 years (26- 78), 79% were male and 75% white; 56% of patients were infected with HCV genotype 3 and 29% with genotype 1; 37% of patients had compensated cirrhosis and 39% were treatment experienced. The most common PPI was omeprazole (68% of patients). SVR12 was 97% (84 of 87 patients). Of the 3 patients who did not achieve SVR12, 2 patients relapsed (relapse rate 2%) and one patient with history of diabetes discontinued SOF/VEL after 7 days of dosing due to hyperglycemia. No other patient had an AE leading to discontinuation or interruption of SOF/VEL. 78% of patients had an AE, most of which were mild, and 11% had a serious AE. These efficacy and safety values are comparable to patients enrolled in the same studies who received SOF/VEL for 12 weeks without concomitant use of a PPI (SVR12 97% [2,445 of 2,517 patients]; relapse rate 2% [40 of 2488 patients]). CONCLUSION(S): In Phase 2 and Phase 3 clinical studies, SOF/VEL for 12 weeks was effective and safe in patients with concomitant PPI use. These data support the use of SOF/VEL according to labeled recommendations with respect to co-administration of PPIs and other acid reducing agents.





First Page


This document is currently not available here.