Elliot B Tapper1, Michael S Hughes, Maria Buti, Jean-Francois Dufour, Steve Flamm, Saima Firdoos, Michael P Curry, Nezam H Afdhal. 1. 1 Division of Gastroenterology/Hepatology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. 2 Harvard Medical School, Boston, MA. 3 Liver Unit, Department of Internal Medicine, Hospital Valle Hebron and Ciberehd del Institut Carlos III, Barcelona, Spain. 4 Hepatology, University Clinic for Visceral Surgery and Medicine, Inselspital, University of Berne, Switzerland. 5 Division of Gastroenterology/Hepatology, Northwestern University, Chicago, IL.
Abstract
BACKGROUND: Ledipasvir (LDV)/sofosbuvir (SOF) has demonstrated high efficacy, safety, and tolerability in hepatitis C virus (HCV)-infected patients. There is limited data, however, regarding the optimal timing of therapy in the context of possible liver transplantation (LT). METHODS: We compared the cost-effectiveness of 12 weeks of HCV therapy before or after LT or nontreatment using a decision analytical microsimulation state-transition model for a simulated cohort of 10 000 patients with HCV Genotype 1 or 4 with Child B or C cirrhosis. All model parameters regarding the efficacy of therapy, adverse events and the effect of therapy on changes in model for end-stage liver disease (MELD) scores were derived from the SOLAR-1 and 2 trials. The simulations were repeated with 10 000 samples from the parameter distributions. The primary outcome was cost (2014 US dollars) per quality adjusted life year. RESULTS: Treatment before LT yielded more quality-adjusted life year for less money than treatment after LT or nontreatment. Treatment before LT was cost-effective in 100% of samples at a willingness-to-pay threshold of US $100 000 in the base-case and when the analysis was restricted to Child B alone, Child C, or MELD > 15. Treatment before transplant was not cost-effective when MELD was 6-10. In sensitivity analyses, the MELD after which treatment before transplant was cost-effective was 13 and the maximum cost of LDV/SOF therapy at which treatment before LT is cost-effective is US $177 381. CONCLUSIONS: From a societal perspective, HCV therapy using LDV/SOF with ribavirin before LT is the most cost-effective strategy for patients with decompensated cirrhosis and MELD score greater than 13.
BACKGROUND:Ledipasvir (LDV)/sofosbuvir (SOF) has demonstrated high efficacy, safety, and tolerability in hepatitis C virus (HCV)-infectedpatients. There is limited data, however, regarding the optimal timing of therapy in the context of possible liver transplantation (LT). METHODS: We compared the cost-effectiveness of 12 weeks of HCV therapy before or after LT or nontreatment using a decision analytical microsimulation state-transition model for a simulated cohort of 10 000 patients with HCV Genotype 1 or 4 with Child B or C cirrhosis. All model parameters regarding the efficacy of therapy, adverse events and the effect of therapy on changes in model for end-stage liver disease (MELD) scores were derived from the SOLAR-1 and 2 trials. The simulations were repeated with 10 000 samples from the parameter distributions. The primary outcome was cost (2014 US dollars) per quality adjusted life year. RESULTS: Treatment before LT yielded more quality-adjusted life year for less money than treatment after LT or nontreatment. Treatment before LT was cost-effective in 100% of samples at a willingness-to-pay threshold of US $100 000 in the base-case and when the analysis was restricted to Child B alone, Child C, or MELD > 15. Treatment before transplant was not cost-effective when MELD was 6-10. In sensitivity analyses, the MELD after which treatment before transplant was cost-effective was 13 and the maximum cost of LDV/SOF therapy at which treatment before LT is cost-effective is US $177 381. CONCLUSIONS: From a societal perspective, HCV therapy using LDV/SOF with ribavirin before LT is the most cost-effective strategy for patients with decompensated cirrhosis and MELD score greater than 13.
Authors: Sumeyye Samur; Brian Kues; Turgay Ayer; Mark S Roberts; Fasiha Kanwal; Chin Hur; Drew Michael S Donnell; Raymond T Chung; Jagpreet Chhatwal Journal: Clin Gastroenterol Hepatol Date: 2017-06-17 Impact factor: 11.382
Authors: Jagpreet Chhatwal; Sumeyye Samur; Brian Kues; Turgay Ayer; Mark S Roberts; Fasiha Kanwal; Chin Hur; Drew Michael S Donnell; Raymond T Chung Journal: Hepatology Date: 2017-01-06 Impact factor: 17.425
Authors: Ashton A Shaffer; Alvin G Thomas; Mary Grace Bowring; Sarah E Van Pilsum Rasmussen; Ayla Cash; Lauren M Kucirka; Saleh A Alqahtani; Ahmet Gurakar; Mark S Sulkowski; Andrew M Cameron; Dorry L Segev; Christine M Durand Journal: Transpl Infect Dis Date: 2018-09-21 Impact factor: 2.228
Authors: Juliet A Emamaullee; Mariusz Bral; Glenda Meeberg; Aldo J Montano-Loza; Vincent G Bain; Kelly Warren Burak; David Bigam; A M James Shapiro; Norman Kneteman Journal: Can J Gastroenterol Hepatol Date: 2019-01-17