Direct Acting Antiviral Agents, Hepatitis C, Public Health, Resistance Associated Substitutions
Conditions
Keywords
Resistance associated substitutions, HCV
Brief summary
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.
Interventions
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.
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* All viremic chronic hepatitis C
Exclusion criteria
* People with disseminated malignancy, advanced cardiovascular, 18 pulmonary, or neurological disease with short life expectancy were not enrolled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of sustained virological response | 12 weeks after treatment completion | SVR12 |
| Assessment of RAS | 12 weeks after treatment completion | 12 weeks after treatment completion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of RAS in treatment failures | 12 weeks after treatment completion | Comparison of variants in those who achieve or fail to achieve SVR12 |
Countries
India
Outcome results
None listed