HCV RAS Testing in Public Health Programs

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis C, Public Health, Direct Acting Antiviral Agents, Resistance Associated Substitutions

Intervention / Treatment
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* Drug: Direct Acting Antivirals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Viremic Person living with HCV<br>All persons enrolled in the MMPHCRF treatment programme are provided free of charge direct acting antiviral agents and followed up for outcomes. | Drug: Direct Acting Antivirals<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of sustained virological response | SVR12 | 12 weeks after treatment completion | 
| Assessment of RAS | 12 weeks after treatment completion | 12 weeks after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of RAS in treatment failures | Comparison of variants in those who achieve or fail to achieve SVR12 | 12 weeks after treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistance associated substitutions, HCV