Elliot B Tapper1, Bruce R Bacon2, Michael P Curry1, Douglas T Dieterich3, Steven L Flamm4, Lauren E Guest5, Kris V Kowdley6, Yoori Lee5, Naoky C Tsai7, Zobair M Younossi8, Nezam H Afdhal1. 1. Division of Gastroenterology/Hepatology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. 2. Division of Gastroenterology/ Hepatology, Saint Louis University School of Medicine, Saint Louis, MO. 3. Division of Liver Diseases, Department of Medicine, Mount Sinai School of Medicine, New York, NY. 4. Division of Hepatology, Northwestern University Feinberg School of Medicine, Chicago, IL. 5. Trio Health Analytics, La Jolla, CA. 6. Liver Care Network, Swedish Medical Center, Seattle, WA. 7. The Liver Center, Queen's Medical Center, Honolulu, HI. 8. Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA.
Abstract
Many patients with chronic hepatitis C virus (HCV) are on prolonged proton-pump inhibitor (PPI) therapy and wish to remain on PPI therapy once treatment for HCV starts. A preliminary report recently suggested decrease rates of sustained virological response (SVR) for patients taking concomitant PPI and ledipasvir/sofosbuvir (LDV/SOF). We sought to determine the effect of PPI use on the rate of SVR in a real-world cohort of 1,979 patients with chronic HCV treated with LDV/SOF. We collected clinical data and pharmacy dispensing records on patients taking 8, 12, or 24 weeks of LDV/SOF ± ribavirin (RBV). The primary outcome was sustained virological response at 12 weeks after treatment completion (SVR12) in a per-protocol analysis in order to determine the effect of PPI use adjusted for confounders. Statistical adjustment was performed in propensity-matched analysis. Among treatment completers, SVR12 was achieved in 441 (97.1%) of PPI recipients compared with 1,497 (98.2%) in PPI nonrecipients (P = 0.19). Neither low- nor high-dose PPI was associated with decreased SVR, although patients taking twice-daily PPI achieved a lower SVR12 rate (91.2%; 95% confidence interval [CI], 77.0-97.0; P = 0.046). After propensity matching for PPI use, there were no significant associations between SVR12 and any dose or frequency of PPI use. However, in a sensitivity analysis focusing on patients with cirrhosis, twice-daily PPI use was associated with lower odds ratio for SVR12 (0.11; 95% CI, 0.02-0.59). CONCLUSION: These data from a cohort of real-world patients receiving hepatitis C antibody therapy with LDF/SOF ± RBV support the prescription labeling suggesting that patients take no more than low-dose (20-mg omeprazole equivalents) PPI daily. (Hepatology 2016;64:1893-1899).
Many patients with chronic hepatitis C virus (HCV) are on prolonged proton-pump inhibitor (PPI) therapy and wish to remain on PPI therapy once treatment for HCV starts. A preliminary report recently suggested decrease rates of sustained virological response (SVR) for patients taking concomitant PPI and ledipasvir/sofosbuvir (LDV/SOF). We sought to determine the effect of PPI use on the rate of SVR in a real-world cohort of 1,979 patients with chronic HCV treated with LDV/SOF. We collected clinical data and pharmacy dispensing records on patients taking 8, 12, or 24 weeks of LDV/SOF ± ribavirin (RBV). The primary outcome was sustained virological response at 12 weeks after treatment completion (SVR12) in a per-protocol analysis in order to determine the effect of PPI use adjusted for confounders. Statistical adjustment was performed in propensity-matched analysis. Among treatment completers, SVR12 was achieved in 441 (97.1%) of PPI recipients compared with 1,497 (98.2%) in PPI nonrecipients (P = 0.19). Neither low- nor high-dose PPI was associated with decreased SVR, although patients taking twice-daily PPI achieved a lower SVR12 rate (91.2%; 95% confidence interval [CI], 77.0-97.0; P = 0.046). After propensity matching for PPI use, there were no significant associations between SVR12 and any dose or frequency of PPI use. However, in a sensitivity analysis focusing on patients with cirrhosis, twice-daily PPI use was associated with lower odds ratio for SVR12 (0.11; 95% CI, 0.02-0.59). CONCLUSION: These data from a cohort of real-world patients receiving hepatitis C antibody therapy with LDF/SOF ± RBV support the prescription labeling suggesting that patients take no more than low-dose (20-mg omeprazole equivalents) PPI daily. (Hepatology 2016;64:1893-1899).
Authors: Mei Lu; Kuan-Han Wu; Jia Li; Anne C Moorman; Philip R Spradling; Eyasu H Teshale; Joseph A Boscarino; Yihe G Daida; Mark A Schmidt; Loralee B Rupp; Talan Zhang; Sheri Trudeau; Stuart C Gordon Journal: J Viral Hepat Date: 2019-07-04 Impact factor: 3.728
Authors: Edward Tam; Anne F Luetkemeyer; Parvez S Mantry; Sanjaya K Satapathy; Peter Ghali; Minhee Kang; Richard Haubrich; Xianlin Shen; Liyun Ni; Gregory Camus; Amanda Copans; Lorenzo Rossaro; Bill Guyer; Robert S Brown Journal: Liver Int Date: 2017-12-05 Impact factor: 5.828