{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T11:02:18Z","timestamp":1792839738243,"version":"4.5.0"},"reference-count":33,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2023,9,29]],"date-time":"2023-09-29T00:00:00Z","timestamp":1695945600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Gilead Sciences, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>A fixed-dose combination of sofosbuvir\/velpatasvir (SOF\/VEL) plus weight-based ribavirin (RBV) for 12 weeks is recommended for the treatment of patients with hepatitis C virus (HCV)-associated decompensated cirrhosis. However, large global studies, while confirming the effectiveness of SOF\/VEL in a broad range of patients, often exclude these patients. This Phase 2, single-arm, open-label study in adult patients with HCV-associated decompensated cirrhosis in France and the USA aimed to provide further data on the safety and efficacy of SOF\/VEL plus RBV for 12 weeks in this population. Patients were treated with a fixed-dose combination of SOF 400 mg\/VEL 100 mg plus weight-based RBV once daily for 12 weeks. The inclusion criteria were chronic HCV infection (\u22656 months), quantifiable HCV RNA at screening, Child\u2013Turcotte\u2013Pugh class B or C cirrhosis, and liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma. Among 32 patients who initiated treatment, 78.1% achieved sustained virologic response 12 weeks after the end of treatment (SVR12). Failure to achieve SVR12 was due to non-virologic reasons (investigator discretion, n = 1; death, n = 6). All 25 patients in the per-protocol population achieved SVR12 and all but one achieved sustained virologic response 24 weeks after the end of treatment. Adverse events (AEs) were as expected for a patient population with advanced liver disease. All Grade 3\u20134 and serious AEs and deaths were deemed unrelated to treatment. In patients with HCV-associated decompensated cirrhosis, SOF\/VEL plus RBV achieved high SVR12 rates and was generally well tolerated.<\/jats:p>","DOI":"10.3390\/v15102026","type":"journal-article","created":{"date-parts":[[2023,9,29]],"date-time":"2023-09-29T09:39:32Z","timestamp":1695980372000},"page":"2026","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Efficacy and Safety of Sofosbuvir\/Velpatasvir Plus Ribavirin in Patients with Hepatitis C Virus-Related Decompensated Cirrhosis"],"prefix":"10.3390","volume":"15","author":[{"given":"Steven","family":"Flamm","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Division of Digestive Diseases and Nutrition, Rush University Medical Center, Chicago, IL 60612, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Lawitz","sequence":"additional","affiliation":[{"name":"Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX 78215, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Borg","sequence":"additional","affiliation":[{"name":"Southern Therapy and Advanced Research LLC, Jackson, MS 39216, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Charlton","sequence":"additional","affiliation":[{"name":"Intermountain Medical Center, Murray, UT 84107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Landis","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, University of Washington, Seattle, WA 98101, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. Rajender","family":"Reddy","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA 19104, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell","family":"Shiffman","sequence":"additional","affiliation":[{"name":"Bon Secours Mercy Health, Liver Institute of Virginia, Richmond, VA 23226, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angel","family":"Alsina","sequence":"additional","affiliation":[{"name":"Tampa General Medical Group, Tampa, FL 33609, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charissa","family":"Chang","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natarajan","family":"Ravendhran","sequence":"additional","affiliation":[{"name":"Digestive Disease Associates, Catonsville, MD 21228, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Candido","family":"Hernandez","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc., Foster City, CA 94404, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christophe","family":"H\u00e9zode","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc., Foster City, CA 94404, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacey","family":"Scherbakovsky","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc., Foster City, CA 94404, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5983-6732","authenticated-orcid":false,"given":"Renee-Claude","family":"Mercier","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc., Foster City, CA 94404, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Didier","family":"Samuel","sequence":"additional","affiliation":[{"name":"Centre H\u00e9patobiliaire, H\u00f4pital Paul-Brousse, Inserm Research Unit 1193, Universit\u00e9 Paris-Saclay, 94800 Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,9,29]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (2023, July 25). Hepatitis C Fact Sheet, Available online: https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/hepatitis-c."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"European Association for the Study of the Liver (2020). EASL recommendations on treatment of hepatitis C: Final update of the series. J. Hepatol., 73, 1170\u20131218.","DOI":"10.1016\/j.jhep.2020.08.018"},{"key":"ref_3","unstructured":"American Association for the Study of Liver Diseases (2023, July 25). HCV Guidance: Recommendations for Testing, Managing and Treating Hepatitis C. Available online: www.hcvguidelines.org."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"2618","DOI":"10.1056\/NEJMoa1512614","article-title":"Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis","volume":"373","author":"Curry","year":"2015","journal-title":"N. Engl. J. Med."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1007\/s00535-018-1503-x","article-title":"Efficacy and safety of sofosbuvir-velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: An open-label Phase 3 trial","volume":"54","author":"Takehara","year":"2019","journal-title":"J. Gastroenterol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"575","DOI":"10.3350\/cmh.2021.0155","article-title":"Sofosbuvir\/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis","volume":"27","author":"Liu","year":"2021","journal-title":"Clin. Mol. Hepatol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"485","DOI":"10.1007\/s40121-021-00576-7","article-title":"Sofosbuvir\/velpatasvir for hepatitis C virus infection: Real-world effectiveness and safety from a nationwide registry in Taiwan","volume":"11","author":"Cheng","year":"2022","journal-title":"Infect. Dis. Ther."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1841","DOI":"10.1111\/liv.14537","article-title":"Global real-world evidence of sofosbuvir\/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts","volume":"40","author":"Mangia","year":"2020","journal-title":"Liver Int."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"628","DOI":"10.1002\/lt.500030613","article-title":"Minimal criteria for placement of adults on the liver transplant waiting list: A report of a national conference organized by the American Society of Transplant Physicians and the American Association for the Study of Liver Diseases","volume":"3","author":"Lucey","year":"1997","journal-title":"Liver Transplant. Surg."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"897","DOI":"10.1016\/j.jhep.2004.02.010","article-title":"Model for end stage liver disease score predicts mortality across a broad spectrum of liver disease","volume":"40","author":"Said","year":"2004","journal-title":"J. Hepatol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"a3006","DOI":"10.1136\/bmj.a3006","article-title":"Reporting and interpretation of SF-36 outcomes in randomised trials: Systematic review","volume":"338","author":"Karvouni","year":"2009","journal-title":"BMJ"},{"key":"ref_12","first-page":"1372","article-title":"Worker productivity outcome measures in arthritis","volume":"34","author":"Escorpizo","year":"2007","journal-title":"J. Rheumatol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1186\/1477-7525-1-79","article-title":"The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: Properties, applications, and interpretation","volume":"1","author":"Webster","year":"2003","journal-title":"Health Qual. Life Outcomes"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"295","DOI":"10.1136\/gut.45.2.295","article-title":"Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease","volume":"45","author":"Younossi","year":"1999","journal-title":"Gut"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"2608","DOI":"10.1056\/NEJMoa1512612","article-title":"Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection","volume":"373","author":"Foster","year":"2015","journal-title":"N. Engl. J. Med."},{"key":"ref_16","first-page":"144","article-title":"Efficacy and safety of sofosbuvir-based regimens in hepatitis C patients with decompensated cirrhosis: A systematic review and meta-analysis","volume":"11","author":"Zhang","year":"2023","journal-title":"J. Clin. Transl. Hepatol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"842","DOI":"10.1111\/j.1572-0241.2006.00505.x","article-title":"Ribavirin monotherapy for chronic hepatitis C infection: A Cochrane Hepato-Biliary Group systematic review and meta-analysis of randomized trials","volume":"101","author":"Brok","year":"2006","journal-title":"Am. J. Gastroenterol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1623","DOI":"10.1046\/j.1365-2036.2002.01326.x","article-title":"Meta-analysis: Ribavirin-induced haemolytic anaemia in patients with chronic hepatitis C","volume":"16","author":"Chang","year":"2002","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"591","DOI":"10.1016\/S0168-8278(96)80225-X","article-title":"Ribavirin treatment for patients with chronic hepatitis C: Results of a placebo-controlled study","volume":"25","author":"Dusheiko","year":"1996","journal-title":"J. Hepatol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"S67","DOI":"10.1016\/S0168-8278(18)30356-8","article-title":"Long-term follow-up of patients with chronic HCV infection and compensated or decompensated cirrhosis following treatment with sofosbuvir-based regimens","volume":"68","author":"Mangia","year":"2018","journal-title":"J. Hepatol."},{"key":"ref_21","first-page":"3540","article-title":"DAA therapy and long-term hepatic function in advanced\/decompensated cirrhosis: Real-world experience from HCV-TARGET cohort","volume":"7","author":"Verna","year":"2020","journal-title":"J. Hepatol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"279","DOI":"10.1002\/lt.24383","article-title":"Model for end-stage liver disease limbo, model for end-stage liver disease purgatory, and the dilemma of treating hepatitis C in patients awaiting liver transplantation","volume":"22","author":"Carrion","year":"2016","journal-title":"Liver Transplant."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"408","DOI":"10.1111\/jvh.12534","article-title":"Treat chronic hepatitis C virus infection in decompensated cirrhosis\u2014Pre- or post-liver transplantation? The ironic conundrum in the era of effective and well-tolerated therapy","volume":"23","author":"Bunchorntavakul","year":"2016","journal-title":"J. Viral Hepat."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"524","DOI":"10.1016\/j.jhep.2016.05.010","article-title":"on behalf of the European Liver and Intestine Association (ELITA). Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: A European study","volume":"65","author":"Belli","year":"2016","journal-title":"J. Hepatol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"777","DOI":"10.1002\/hep.28926","article-title":"Optimal timing of hepatitis C treatment for patients on the liver transplant waiting list","volume":"65","author":"Chhatwal","year":"2017","journal-title":"Hepatology"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"945","DOI":"10.1097\/TP.0000000000001708","article-title":"International Liver Transplantation Society consensus statement on hepatitis C management in liver transplant candidates","volume":"101","author":"Terrault","year":"2017","journal-title":"Transplantation"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1002\/cld.763","article-title":"Barriers and limitations to access to liver transplantation in Latin America","volume":"13","author":"Andraus","year":"2019","journal-title":"Clin. Liver Dis."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"1401","DOI":"10.1002\/lt.24502","article-title":"Liver transplantation in Japan","volume":"22","author":"Soyama","year":"2016","journal-title":"Liver Transplant."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"411","DOI":"10.1053\/j.gastro.2018.04.008","article-title":"Incidence of hepatocellular carcinoma in patients with HCV-associated cirrhosis treated with direct-acting antiviral agents","volume":"155","author":"CalvCalvaruso","year":"2018","journal-title":"Gastroenterology"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"1033","DOI":"10.1111\/liv.14041","article-title":"Treatment with direct-acting antivirals for HCV decreases but does not eliminate the risk of hepatocellular carcinoma","volume":"39","author":"Mendizabal","year":"2019","journal-title":"Liver Int."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"1053","DOI":"10.1016\/j.jhep.2020.11.021","article-title":"Clinical outcomes following DAA therapy in patients with HCV-related cirrhosis depend on disease severity","volume":"74","author":"Krassenburg","year":"2021","journal-title":"J. Hepatol."},{"key":"ref_32","doi-asserted-by":"crossref","unstructured":"Van Der Plas, S.M., Hansen, B.E., De Boer, J.B., Stijnen, T., Passchier, J., De Man, R.A., and Schalm, S.W. (2003). Generic and disease-specific health related quality of life in non-cirrhotic, cirrhotic and transplanted liver patients: A cross-sectional study. BMC Gastroenterol., 3.","DOI":"10.1186\/1471-230X-3-33"},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"1123","DOI":"10.1111\/j.1365-2036.2011.04842.x","article-title":"PROMIS computerised adaptive tests are dynamic instruments to measure health-related quality of life in patients with cirrhosis","volume":"34","author":"Bajaj","year":"2011","journal-title":"Aliment. Pharmacol. Ther."}],"container-title":["Viruses"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1999-4915\/15\/10\/2026\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:02:14Z","timestamp":1760130134000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1999-4915\/15\/10\/2026"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,29]]},"references-count":33,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2023,10]]}},"alternative-id":["v15102026"],"URL":"https:\/\/doi.org\/10.3390\/v15102026","relation":{},"ISSN":["1999-4915"],"issn-type":[{"value":"1999-4915","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,29]]}}}