ABSTRACT FINAL ID: 2020
TITLE: Sustained virologic response (SVR) in patients taking ledipasvir-sofosbuvir (LDV/SOF) and a proton pump inhibitor (PPI) in the treatment of chronic hepatitis C virus (HCV)
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This study has no sponsors
Background: Concomitant use of antacids is discouraged in patients taking LDV/SOF for the treatment of chronic HCV, an FDA recommendation based on a decreased LDV exposure in healthy volunteers. The clinical impact of the lower plasma concentrations on SVR in a real world setting is largely unknown. With the high cost of HCV treatment and the easy access to over the counter antacids, including PPIs, patients are extensively counseled to avoid these medications for the best chance of viral clearance. The aim of this study was to retrospectively determine if the use of a PPI decreases the SVR at twelve weeks post treatment (SVR12) in patients taking LDV/SOF. Methods: All patients who began LDV/SOF therapy between 10/2014 and 12/2015 were identified. Charts were reviewed for PPI use, demographic and clinical variables, and treatment response. SVR12 rates and covariates were compared between PPI use cohorts, and logistic regression was used to determine relationships between PPI use, covariates, and SVR12. Results: Of the 533 patients prescribed LDV/SOF, 102 (19.1%) patients reported use of a PPI. Of the 533 patients, 40.7% were African American, 38.4% were cirrhotic, 43% were treatment-experienced, and 3.5% were treated with the addition of ribavirin (RBV). SVR12 was achieved in 93.9% (77/81) in the PPI-use cohort and 95.3% (303/318) in the non-PPI group (p=0.576). In a univariate analysis of those patients who completed greater than eight weeks of therapy, the use of a PPI did not predict SVR12 (OR 0.76, 95% CI 0.27-2.16, p=0.61). Cirrhosis (OR 0.31, 95% CI 0.12-0.80, p=0.015) and the use of concomitant ribavirin (OR 0.04, 95% CI 0.01-0.15, p<0.001) were independently associated with a decreased likelihood of achieving SVR12. Conclusion: This study found no difference in rates of SVR12 in patients taking a PPI when compared to those who did not report use of a PPI. Based on these findings, the initial FDA recommendations against the concomitant use of antacids with LDV/SOF for the treatment of chronic HCV may not correlate with a decrease in SVR12 in a real world setting.