Title

Sofosbuvir/Velpatasvir is effective and safe in patients with concomitant proton pump inhibitor use in clinical studies.

Document Type

Conference Proceeding

Publication Date

3-2019

Publication Title

Hepatol Int

Abstract

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.

Volume

13

Issue

(Suppl 1)

First Page

s78

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