{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T11:38:25Z","timestamp":1790854705768,"version":"4.1.0"},"reference-count":20,"publisher":"Public Library of Science (PLoS)","issue":"5","license":[{"start":{"date-parts":[[2023,5,18]],"date-time":"2023-05-18T00:00:00Z","timestamp":1684368000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001411","name":"Indian Council of Medical Research","doi-asserted-by":"publisher","award":["R.11012\/01\/2022-GIA\/HR"],"award-info":[{"award-number":["R.11012\/01\/2022-GIA\/HR"]}],"id":[{"id":"10.13039\/501100001411","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"\n Background<\/jats:title>\n Hepatitis C virus (HCV) is a common cause of liver cirrhosis and hepatocellular carcinoma. Globally, nearly 71 million people have chronic HCV infection, and approximately 399,000 dies annually. In patients without cirrhosis, HCV infection is treated with 12 weeks of sofosbuvir\/velpatasvir combination. Results from available small, single-centre observational studies suggest that the sofosbuvir\/velpatasvir combination given for 8 weeks may be as effective as the standard 12 weeks of treatment. We propose to compare the treatment response of 12 weeks versus 8 weeks of sofosbuvir\/velpatasvir in non-cirrhotic people with chronic HCV infection.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This multicentric, randomized, open-label, non-inferiority trial will include 880 (2 arms x 440) treatment na\u00efve, viraemic (HCV RNA >10,000 IU\/mL), non-cirrhotic adults (age >18 years) with chronic hepatitis C. People who are at high-risk for HCV reinfection such as haemophiliacs, people who inject drugs, those on maintenance hemodialysis or having HIV will be excluded. The presence or absence of cirrhosis will be determined with a combination of history, examination, ultrasound, liver stiffness measured with transient elastography, APRI, FIB-4, and esophagogastroduodenoscopy. Participants will be randomized to receive either 8- or 12-week sofosbuvir\/velpatasvir treatment. A blood specimen will be collected before starting the treatment (to determine the HCV genotype), after 4 weeks of treatment (for early virological response), and at 12 weeks after treatment discontinuation for SVR12.<\/jats:p>\n <\/jats:sec>\n \n Discussion<\/jats:title>\n The study will provide data on the efficacy of 8 weeks of treatment as compared to the standard of care (12 weeks) in non-cirrhotic patients with chronic HCV infection. Treatment for a shorter duration may improve treatment compliance, reduce the cost of treatment, and ease the treatment implementation from a public health perspective.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n \n Registered with Clinical Trial Registry of India (\n http:\/\/ctri.nic.in<\/jats:ext-link>\n ) Registration No.\n CTRI\/2022\/03\/041368<\/jats:ext-link>\n [Registered on: 24\/03\/2022]\u2014Trial Registered Prospectively.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pone.0285725","type":"journal-article","created":{"date-parts":[[2023,5,18]],"date-time":"2023-05-18T13:51:21Z","timestamp":1684417881000},"page":"e0285725","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":7,"title":["Eight versus twelve weeks of sofosbuvir-velpatasvir in treatment-na\u00efve non-cirrhotic patients with chronic hepatitis C virus infection: Study protocol for a multicentric, open labelled, randomized, non-inferiority trial (RESOLVE trial)"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9308-9782","authenticated-orcid":true,"given":"Ashish","family":"Awasthi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harshita","family":"Katiyar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumit","family":"Rungta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8253-5169","authenticated-orcid":true,"given":"Amar","family":"Deep","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinod","family":"Kumar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"family":"Shalimar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajay","family":"Kumar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prachi","family":"Tiwari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3525-9381","authenticated-orcid":true,"given":"Amit","family":"Goel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2023,5,18]]},"reference":[{"issue":"51","key":"pone.0285725.ref001","doi-asserted-by":"crossref","first-page":"S35","DOI":"10.1053\/jhep.2002.36806","article-title":"Natural history of chronic hepatitis C","volume":"36","author":"LB Seeff","year":"2002","journal-title":"Hepatology"},{"issue":"1","key":"pone.0285725.ref002","doi-asserted-by":"crossref","first-page":"S58","DOI":"10.1016\/j.jhep.2014.07.012","article-title":"Natural history of hepatitis C","volume":"61","author":"RH Westbrook","year":"2014","journal-title":"J Hepatol"},{"key":"pone.0285725.ref003","doi-asserted-by":"crossref","first-page":"g3308","DOI":"10.1136\/bmj.g3308","article-title":"Antiviral treatment of hepatitis C","volume":"348","author":"ER Feeney","year":"2014","journal-title":"BMJ"},{"key":"pone.0285725.ref004","unstructured":"Global hepatitis report 2017. 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