Proton Pump Inhibitor (PPI) Therapy Does Not Affect SVR Rates Among Patients Treated With Ledipasvir/Sofosbuvir Combination Therapy

Abstract

Introduction: Ledipasvir, the NS5a component of ledipasvir/sofosbuvir combination therapy for hepatitis C (HCV) infection requires an acidic gastric environment for maximal absorption. The use of PPI acid reducing therapy may decrease ledipasvir absorption and diminish the cure rates for this therapy. While registration studies prohibited the use of PPIs in treated patients, PPI use is common among patients treated in clinical practice which could lower overall SVR rates. Methods: We conducted a retrospective review of all patients treated for genotype 1 HCV infection with ledipasvir/sofosbuvir combination therapy between November 2014 and October, 2016 at the University of South Alabama gastroenterology division. Prior to initiation of therapy, a detailed medication list was recorded to assess for potential drug-drug interactions. Patients who were on PPI therapy and continued PPIs during antiviral therapy were considered “PPI users”. Patients not on PPIs or who discontinued PPI prior to initiating antiviral therapy were “non-PPI users”. SVR rates were compared among PPI users and non-users using Chi-squared analysis. Patients for whom SVR-12 data was not available were considered failures. SVR-12 results were reported as ITT-SVR = SVR for all patients treated, and “per protocol” or PP-SVR, SVR for patients for whom SVR-12 data was available. Results: 261 genotype 1 HCV patients were treated with ledipasvir/sofosbuvir combination therapy. Of these, 81 (31%) were on PPIs. SVR-12 data was available in 62 (77%) on PPI during antiviral therapy. PPIs used by this cohort included: omeprazole 20mg: n=64, omeprazole 40mg: n=4, pantoprazole 20mg: n=9, esomeprazole 40mg: n=1; lansoprazole 15: n=3. SVR rates for the PPI and non-PPI groups are shown in the table. Conclusion: The use of PPI therapy during ledipasvir/sofosbuvir combination therapy did not result in a reduction in SVR.Table: Table. SVR-12 Rates