Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. The efficacy of NS5A inhibitors for the treatment of patients chronically infected with hepatitis C virus (HCV) can be affected by the presence of NS5A resistance-associated substitutions (RASs). Pre-existence of resistance associated substitutions (RASs) to direct antiviral agents (DAAs) reduces sustained virologic response (SVR) rates by 3-53% in hepatitis C virus (HCV) genotype 3 infected patients depending on different predictors and the DAA regimen used. This study will prospectively analyze data from the MukhMantri Punjab Hepatitis C Relief Fund (MMPHCRF) to determine the posttreatment prevalence of various NS5A RASs, and their effect on outcomes of treatment with daclatasvir-sofosbuvir or sofosbuvir-ledipasvirin patients with chronic HCV. The study aims to assess the prevalence and effect of RASs on sustained virological response (SVR) rates in patients with treatment failure to a regimen containing sofosbuvir and ledipasvir/daclatasvir.
Study Type
OBSERVATIONAL
Enrollment
200
All subjects with viremic chronic hepatitis C will be given DAAs based on the MMPHCRF Treatment algorithm. Patients will be assessed for cirrhosis, prior treatment exposure, high risk groups like dialysis patients, HIV-HCV coinfection, etc. Accordingly treatment will be provided at any of the 25 peripheral centres or at the apex nodal treatment centre (PGIMER) of the MMPHCRF. Baseline and post treatment RAS samples will be collected with consent.
Post Graduate Institute of Medical Education and Research
Chandigarh, India
RECRUITINGPostgraduate Institute of Medical Education and Research
Chandigarh, India
RECRUITINGAchievement of sustained virological response
SVR12
Time frame: 12 weeks after treatment completion
Assessment of RAS
12 weeks after treatment completion
Time frame: 12 weeks after treatment completion
Assessment of RAS in treatment failures
Comparison of variants in those who achieve or fail to achieve SVR12
Time frame: 12 weeks after treatment completion
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