HCV RAS Testing in Public Health Programs

Hepatitis C Clinical Trial

— RAS-HCV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04242433
• Other study ID #: IEC-2018-867
• Status: Recruiting
• Start date: July 16, 2017
• Est. completion date: August 2021

Study information

• Verified date: January 2020
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research	Chandigarh
India	Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of sustained virological response	SVR12	12 weeks after treatment completion
Primary	Assessment of RAS	12 weeks after treatment completion	12 weeks after treatment completion
Secondary	Assessment of RAS in treatment failures	Comparison of variants in those who achieve or fail to achieve SVR12	12 weeks after treatment completion