Eight versus twelve weeks of sofosbuvir-velpatasvir in treatment-naïve non-cirrhotic patients with chronic hepatitis C virus infection: Study protocol for a multicentric, open labelled, randomized, non-inferiority trial (RESOLVE trial)

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 combinati...

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Bibliographic Details
Published in:PloS one 2023-05, Vol.18 (5), p.e0285725-e0285725
Main Authors: Awasthi, Ashish, Katiyar, Harshita, Rungta, Sumit, Deep, Amar, Kumar, Vinod, Shalimar, Kumar, Ajay, Tiwari, Prachi, Goel, Amit
Format: Article
Language:English
Subjects:
Adolescent
Adult
Antiviral Agents
Antiviral drugs
Biology and life sciences
Chronic illnesses
Chronic infection
Cirrhosis
Computer and Information Sciences
Drug therapy
Equivalence Trials as Topic
Gastroenterology
Genotype
Genotypes
Hemodialysis
Hepacivirus - genetics
Hepatitis
Hepatitis C
Hepatitis C - drug therapy
Hepatitis C, Chronic - complications
Hepatitis C, Chronic - drug therapy
Hepatocellular carcinoma
Heterocyclic Compounds, 4 or More Rings
HIV
Human immunodeficiency virus
Humans
Infections
Informed consent
Laboratories
Liver
Liver cancer
Liver cirrhosis
Liver Cirrhosis - chemically induced
Liver Cirrhosis - etiology
Liver diseases
Management
Medicine and health sciences
Multicenter Studies as Topic
Patient compliance
Patients
People and Places
Public health
Randomized Controlled Trials as Topic
Research and Analysis Methods
Sofosbuvir
Stiffness
Study Protocol
Treatment Outcome
Viruses
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Summary: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. This multicentric, randomized, open-label, non-inferiority trial will include 880 (2 arms x 440) treatment naïve, 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. 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. Registered with Clinical Trial Registry of India (http://ctri.nic.in) Registration No. CTRI/2022/03/041368 [Registered on: 24/03/2022]-Trial Registered Prospectively.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0285725