DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C) (DRIVE-C)

October 25, 2023 updated by: ANRS, Emerging Infectious Diseases

Towards HCV Elimination: Evaluation of an Integrated Model of HCV Care Targeting People Who Inject Drugs in Hai Phong, Vietnam

The study aims to assess the effectiveness of a model of hepatitis C screening and integrated care, targeting people who inject drugs (PWIDs) in Hai Phong, Vietnam. In a wider perspective, this model linked to mass screening through repeated Respondent Driven Sampling (RDS) surveys, to simplified treatment protocol, and to large community-based support to improve referral to care, retention in care, adherence to treatment and prevention of reinfection, may have the potential to eliminate HCV among PWIDs in this city.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives :

The primary objective of this study is to assess the effectiveness of a model of hepatitis C screening and integrated care targeting PWIDs in Hai Phong, Vietnam.

This model will encompass all steps involved in achieving HCV cure among PWIDs:

i) Mass detection of hepatitis C infection among PWIDs: in the community through a large community-based Respondent Driven Sampling survey (RDS); and in HIV out-patient clinics and methadone treatment centers where serological testing should have been made, but not HCV RNA to confirm hepatitis C infection.

ii) a community-based support to improve referral to specific care for those with hepatitis C infection; iii) a HCV care system delivery integrated within the existing health system with a simplified treatment protocol taking into account PWIDs specificities such as frequent HIV co-infection and methadone treatment; iv) an optimized treatment adherence through a combination of health care therapeutic education and CBO support; v) an increase in harm reduction activities to encompass HCV risk transmission and to prevent HCV reinfection.

Secondary objectives are:

  • to assess all steps of the hepatitis C cascade of care (Hepatitis C infection diagnosis; HCV care enrolment; HCV treatment initiation; HCV treatment success);
  • to assess the occurrence of adverse events (death, morbidity) and drug-related side-effects;
  • to evaluate adherence to HCV treatment;
  • to determine factors associated with treatment failure defined by a positive HCV RNA 12 weeks after the end of HCV treatment;
  • to estimate the reinfection rate at the end of the study and to identify risk factors of HCV reinfection;
  • to project the impact and cost-effectiveness of the implemented HCV treatment intervention.

Study design : the effectiveness-implementation hybrid study type 1 design will simultaneously allow assessing the effectiveness of Direct-Acting Antivirals (DAA) care strategy among PWIDs in Vietnam, and the potential obstacles to widespread implementation.

The strategy of care includes a large community-based mass screening, a simplified treatment protocol based on a combination of DAAs, taking into account co-morbidities (addiction, HIV), physician training and important support of Community Based Organizations (CBO's) for linkage to care after screening, treatment adherence and prevention of reinfection after cure.

In addition, 2 others components are included in the study:

  • A modeling exercise to assess the impact of the intervention at the population level,
  • A cost-effectiveness analysis to further inform policy-makers.

Patients will be followed for 48 weeks after initiating HCV treatment. The estimated enrolment is 1050 participants.

Study population: people who currently inject drugs or who have recently started opioid substitution treatment.

Implementation: The study is linked to the NIDA RO1 DA041978 / ANRS 12353 DRIVE project. Participant recruitment will take place through DRIVE RDS survey and DRIVE cohort follow-up visit in two community sites managed by peer-groups in Hai Phong. All participants with positive HCV serology will be screened for hepatitis C and positive HCV RNA will be proposed for DAA treatment in 3 hospital-based HCV clinics. All participants will attend 9 study visits, comprising of clinical examination, blood collection for side effects and viral load assessment, therapeutic education, questionnaires on alcohol use, on sexual, drug use and other behaviors focusing on HCV infection risks or HCV reinfection risks and on quality of life, and harm reduction activities with the support of CBOs.

Study Type

Interventional

Enrollment (Actual)

979

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hai Phong, Vietnam
        • Hai Phong University of Medicine and Pharmacy
      • Hải Phòng, Vietnam
        • Viet Tiep Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA

  • Participants of the ANRS 12353/NIDA ROI DA 041978 DRIVE study (age > 18 years; positive urine test for heroin an/o methamphetamine & skin marks of injection ) who either participated to the DRIVE RDS3 survey, or to the HIV-positive and HIV-negative DRIVE cohorts;
  • Hepatitis C infection defined by a positive HCV RNA
  • Signed informed consent form

EXCLUSION CRITERIA

  • Severe associated diseases requiring specific treatment (including all specific AIDS defining illnesses, any severe sepsis, severe decompensated cirrhosis, suspicion of hepatocellular carcinoma);
  • Any condition which might, in the investigator's opinion, compromise the safety of the patient by participating in the study including very severe clinical condition;
  • Previous history of DAA use;
  • Contraindication for treatment with sofosbuvir or daclatasvir;
  • For women of childbearing potential i.e. women of childbearing age who are not menopausal, or permanently sterilized or not refraining from sexual activity:
  • Pregnancy and breastfeeding
  • Refusal to use a contraceptive method
  • Renal failure with creatinine clearance ≤ 30 milliliter per minute;
  • Person deprived of freedom by a judicial or administrative decision;
  • Person who plan to move out from Hai Phong in the next 12 months;
  • Person unable to understand the study;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All patients
All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.
Drug: Sofosbuvir 400 mg and Daclatasvir 60 mg
All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.
Other: HIV/HCV co-infected patients
For HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day (sofosbuvir 400 mg and daclatasvir 90 mg)
Drug: Sofosbuvir 400 mg and Daclatasvir 90 mg
For HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day.
Other: Cirrhosis
In case of cirrhosis : ribavirin will be added to sofosbuvir / daclatasvir 12 weeks
Drug: Ribavirin

In case of cirrhosis:

  • Ribavirin will be added to sofosbuvir/daclatasvir during the 12 weeks of treatment. The dose will be adapted to the patient weight although the vast majority of patients (weight < 75 kg) will receive 500 mg x 2/day.
  • In case of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.
Other: Cirrhosis with ribavirin contra-indication
In case of cirrhosis with ribavirin contra-indication : sofosbuvir and daclatasvir for 24 weeks
Drug: Sofosbuvir and Daclatasvir for 24 weeks
In case of cirrhose and of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of all patients in success of the model of care
Time Frame: Week 48
Proportion of patients with HCV RNA < 15 IU/mL at the end of the study among patients who have signed the informed consent.
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with detectable HCV RNA
Time Frame: Screening pre-inclusion
Proportion of patients with HCV RNA > 15 IU/mL among those with positive HCV Ab
Screening pre-inclusion
Proportion of patients enrolled in care
Time Frame: Pre-inclusion visit
Proportion of patients with HCV RNA > 15 IU/mL who attended the pre inclusion visit at HCV clinic among those with hepatitis C infection;
Pre-inclusion visit
Proportion of patients initiating DAA treatment
Time Frame: Initiation treatment visit
Proportion of patients who initiate the treatment among patients enrolled in care and eligible for treatment
Initiation treatment visit
Proportion of patients cured
Time Frame: Week 24
Number of patients with HCV RNA < 15 IU/mL among those initiating the treatment eligible
Week 24
Rate of reinfection
Time Frame: Week 48
Number of patients with HCV RNA ≥ 15 IU/mL at the end of the study among cured patients
Week 48
Rate of mortality
Time Frame: Week 48
Rate of deaths among all participants with hepatitis C infection
Week 48
Frequency, type and time to grade 3 or 4 adverse clinical or biological events.
Time Frame: Week 48
All adverse events will be graded according to the ANRS adverse events grading table
Week 48
Frequency, type and time to drug-related clinical or biological adverse reactions
Time Frame: Week 48
All drug-related clinical or biological adverse reactions of grade 3 or 4 or leading to treatment interruption
Week 48
Adherence assessment
Time Frame: Week 12
Self-questionnaire on DAA drug intake and drug accountability for DAA
Week 12
Factors associated with HCV treatment failure
Time Frame: Week 24
Socio-demographic, co-infection, virological, adherence, behavioral, psychiatric disorders, intervention contact, recent incarceration, homelessness factors
Week 24
Factors associated with HCV reinfection
Time Frame: Week 48
Socio-demographic, co-infection, virological, adherence, behavioral, psychiatric disorders, intervention contact, recent incarceration, homelessness factors
Week 48
Effect of the HCV treatment intervention
Time Frame: Week 48
Estimation of the impact of the intervention on HCV infections and DALYs averted, QALYs saved, HCV incidence and prevalence as projected by the model under various scenarios
Week 48
Incremental cost-effectiveness ratio (ICER)
Time Frame: Week 48
Estimation of the mean ICER which will be compared against standard thresholds for intervention's being cost-effective in LMIC settings
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: KHUE M. PHAM, MD, PhD, Hai Phong University of Medicine and Pharmacy, Vietnam
  • Principal Investigator: DIDIER LAUREILLARD, MD, Nîmes University Hospital, France
  • Study Director: NICOLAS NAGOT, MD, PhD, Pathogenesis and Control of Chronic Infections (PCCI) UMR 1058 - INSERM, Univ Montpellier, EFS, Montpellier, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2018

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 12380 DRIVE-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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