HCV RAS Testing in Public Health Programs

NCT ID: NCT04242433

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-16

Study Completion Date

2021-08-31

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.

Detailed Description

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Conditions

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Hepatitis C Public Health Direct Acting Antiviral Agents Resistance Associated Substitutions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Viremic Person living with HCV

All persons enrolled in the MMPHCRF treatment programme are provided free of charge direct acting antiviral agents and followed up for outcomes.

Direct Acting Antivirals

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Radha K Dhiman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Post Graduate Institute of Medical Education and Research

Chandigarh, , India

Site Status RECRUITING

Postgraduate Institute of Medical Education and Research

Chandigarh, , India

Site Status RECRUITING

Countries

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India

Facility Contacts

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Radha K Dhiman, DM

Role: primary

911722756335

Radha K Dhiman

Role: primary

+917087009337

Other Identifiers

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IEC-2018-867

Identifier Type: -

Identifier Source: org_study_id

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