HCV RAS Testing in Public Health Programs

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Postgraduate Institute of Medical Education and Research
Updated on 22 September 2021
liver transplant
antiviral drugs
chronic hepatitis
sofosbuvir
daclatasvir
ledipasvir
direct acting antivirals
ledipasvir/sofosbuvir

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.

Details
Condition Public Health, Hepatitis C, Hepatitis C virus, Direct Acting Antiviral Agents, Resistance Associated Substitutions
Treatment Direct Acting Antivirals
Clinical Study IdentifierNCT04242433
SponsorPostgraduate Institute of Medical Education and Research
Last Modified on22 September 2021

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