NCT04242433

HCV RAS Testing in Public Health Programs

Patterns of Resistance-associated Substitutions in Patients With Chronic HCV Infection Following Treatment With Direct Acting Antiviral Agents in the Public Health Setting

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C
• Public Health
• Direct Acting Antiviral Agents
• Resistance Associated Substitutions

Interventions

Type	Name	Description
DRUG	Direct Acting Antivirals	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.

Timeline

• Start date: 2017-07-16
• Primary completion: 2021-01-01
• Completion: 2021-08-01
• First posted: 2020-01-27
• Last updated: 2020-01-27

Locations

2 sites across 1 country: India