PMID- 38169058 OWN - NLM STAT- MEDLINE DCOM- 20240206 LR - 20240425 IS - 1865-8652 (Electronic) IS - 0741-238X (Print) IS - 0741-238X (Linking) VI - 41 IP - 2 DP - 2024 Feb TI - Real-World Safety and Effectiveness of an 8-Week Regimen of Glecaprevir/Pibrentasvir in Patients with Hepatitis C and Cirrhosis. PG - 744-758 LID - 10.1007/s12325-023-02748-y [doi] AB - INTRODUCTION: In 2019, an 8-week regimen of glecaprevir/ pibrentasvir (GLE/PIB) was FDA-approved for treatment of chronic hepatitis C (HCV) in patients with cirrhosis. We used data from the Chronic Hepatitis Cohort Study (CHeCS) to evaluate treatment response and adverse events among patients with HCV and cirrhosis under routine clinical care. METHODS: Using an intention-to-treat (ITT)/modified ITT (mITT) approach, endpoints were (1) sustained virological response (SVR) at 12 weeks (SVR12) post-treatment; and (2) adverse events (AEs)/serious AEs during treatment. Patients with cirrhosis from two CHeCS sites were included if they were prescribed GLE/PIB from August 2017 to June 2020. Detailed treatment and clinical data were collected. Patient baseline characteristics were described with mean/standard deviation (std) for continuous variables, and proportions for categorical variables. Analyses were propensity score adjusted. The final model retained variables that were significant with p value < 0.05. RESULTS: The ITT sample included 166 patients, with 43, 116, and 7 patients in the 8-week, 12-week, and > 12-week planned treatment groups. Among them, 159 had confirmed SVR (95.8%, LCL 93.2%). The mITT analysis included 160 patients after excluding 6 with unknown HCV RNA results; 159 achieved SVR (99.4%, LCL 98.3%). There were no significant differences in rates of SVR between the 8-week and 12-week regimens in either analysis, nor any association with patient characteristics. SAEs were experienced by 1 patient (2%) in the 8-week group, 7 (5%) in the 12-week group (including one death), and 2 (29%) in the > 12-week group; 4 patients (from the 12-week group) experienced serious AEs or hepatic events that were "likely attributable" to GLE/PIB treatment. CONCLUSION: An 8-week regimen of GLE/PIB is well tolerated and highly effective among US patients with HCV and cirrhosis receiving routine clinical care. CI - (c) 2023. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature. FAU - Lu, Mei AU - Lu M AD - Department of Public Health Sciences, Henry Ford Health, One Ford Place, Detroit, MI, 48202, USA. mlu1@hfhs.org. AD - Department of Epidemiology and Biostatistics, College of Human Medicine, Michigan State University, East Lansing, MI, USA. mlu1@hfhs.org. FAU - Rupp, Loralee B AU - Rupp LB AD - Department of Health Policy and Health Services Research, Henry Ford Health, Detroit, MI, USA. FAU - Melkonian, Christina AU - Melkonian C AD - Department of Public Health Sciences, Henry Ford Health, One Ford Place, Detroit, MI, 48202, USA. FAU - Trudeau, Sheri AU - Trudeau S AD - Department of Public Health Sciences, Henry Ford Health, One Ford Place, Detroit, MI, 48202, USA. FAU - Daida, Yihe G AU - Daida YG AD - Center for Integrated Health Care Research, Kaiser Permanente Hawaii, Honolulu, HI, USA. FAU - Schmidt, Mark A AU - Schmidt MA AD - Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA. FAU - Gordon, Stuart C AU - Gordon SC AD - Department of Gastroenterology and Hepatology, Henry Ford Health, Detroit, MI, USA. AD - School of Medicine, Wayne State University, Detroit, MI, USA. LA - eng PT - Journal Article DEP - 20240102 PL - United States TA - Adv Ther JT - Advances in therapy JID - 8611864 RN - K6BUU8J72P (glecaprevir) RN - 2WU922TK3L (pibrentasvir) RN - 0 (Quinoxalines) RN - 0 (Pyrrolidines) RN - 0 (Antiviral Agents) RN - 0 (Sulfonamides) RN - 0 (Aminoisobutyric Acids) RN - 0 (Lactams, Macrocyclic) RN - 0 (Cyclopropanes) RN - GMW67QNF9C (Leucine) RN - 0 (Benzimidazoles) RN - 9DLQ4CIU6V (Proline) EIN - Adv Ther. 2024 Apr 10;:. PMID: 38598114 MH - Humans MH - Cohort Studies MH - Treatment Outcome MH - *Liver Cirrhosis/complications/drug therapy MH - Quinoxalines/adverse effects MH - Pyrrolidines/therapeutic use MH - *Hepatitis C, Chronic/complications/drug therapy/genetics MH - Hepacivirus/genetics MH - Antiviral Agents/adverse effects MH - Genotype MH - *Sulfonamides MH - *Aminoisobutyric Acids MH - *Lactams, Macrocyclic MH - *Cyclopropanes MH - Leucine/*analogs & derivatives MH - *Benzimidazoles MH - Proline/*analogs & derivatives PMC - PMC11006752 OTO - NOTNLM OT - Decompensated cirrhosis OT - Direct acting antiviral OT - Mavyret OT - Observational OT - Safety COIS- Stuart C. Gordon receives grant/research support from AbbVie Pharmaceuticals, CymaBay, Genfit, Gilead Sciences, GlaxoSmithKline, Intercept Pharmaceuticals, and Viking Therapeutics. Mei Lu and Loralee B. Rupp receive research grant support from GlaxoSmithKline, AbbVie, and Intercept Pharmaceuticals. Yihe G. Daida receives research support from GlaxoSmithKline, Sanofi and Vir Biotech. Mark A. Schmidt receives research support from GlaxoSmithKline and Intercept Pharmaceuticals. EDAT- 2024/01/04 01:18 MHDA- 2024/02/06 06:42 PMCR- 2024/01/02 CRDT- 2024/01/03 11:13 PHST- 2023/10/17 00:00 [received] PHST- 2023/11/21 00:00 [accepted] PHST- 2024/02/06 06:42 [medline] PHST- 2024/01/04 01:18 [pubmed] PHST- 2024/01/03 11:13 [entrez] PHST- 2024/01/02 00:00 [pmc-release] AID - 10.1007/s12325-023-02748-y [pii] AID - 2748 [pii] AID - 10.1007/s12325-023-02748-y [doi] PST - ppublish SO - Adv Ther. 2024 Feb;41(2):744-758. doi: 10.1007/s12325-023-02748-y. Epub 2024 Jan 2.