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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537196
Recruitment Status : Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug Use Viral Hepatitis C Drug: Sofosbuvir 400 mg and Daclatasvir 60 mg Drug: Sofosbuvir 400 mg and Daclatasvir 90 mg Drug: Ribavirin Drug: Sofosbuvir and Daclatasvir for 24 weeks Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 978 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All patients with detectable HCV RNA, eligible for treatment, will receive Direct Acting Antiviral drugs.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Towards HCV Elimination: Evaluation of an Integrated Model of HCV Care Targeting People Who Inject Drugs in Hai Phong, Vietnam
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
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.
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.
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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;

  3. 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

  4. Proportion of patients cured [ Time Frame: Week 24 ]
    Number of patients with HCV RNA < 15 IU/mL among those initiating the treatment eligible

  5. 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

  6. Rate of mortality [ Time Frame: Week 48 ]
    Rate of deaths among all participants with hepatitis C infection

  7. 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

  8. 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

  9. Adherence assessment [ Time Frame: Week 12 ]
    Self-questionnaire on DAA drug intake and drug accountability for DAA

  10. 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

  11. Factors associated with HCV reinfection [ Time Frame: Week 48 ]
    Socio-demographic, co-infection, virological, adherence, behavioral, psychiatric disorders, intervention contact, recent incarceration, homelessness factors

  12. 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

  13. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537196


Locations
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Vietnam
Hai Phong University of Medicine and Pharmacy
Hai Phong, Vietnam
Viet Tiep Hospital
Hải Phòng, Vietnam
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
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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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03537196    
Other Study ID Numbers: ANRS 12380 DRIVE-C
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
People who inject drugs
Hepatitis C
Direct Acting Antiviral
 HCV Elimination
Vietnam
Viral hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents