DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C) (DRIVE-C)
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ClinicalTrials.gov Identifier: NCT03537196 |
Recruitment Status :
Completed
First Posted : May 25, 2018
Last Update Posted : January 29, 2021
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Condition or disease | Intervention/treatment | Phase |
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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 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 979 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 |
Actual Primary Completion Date : | November 30, 2020 |
Actual Study Completion Date : | November 30, 2020 |

Arm | Intervention/treatment |
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All patients
All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.
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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)
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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
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Drug: Ribavirin
In case of cirrhosis:
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Cirrhosis with ribavirin contra-indication
In case of cirrhosis with ribavirin contra-indication : sofosbuvir and daclatasvir for 24 weeks
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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. |
- 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.
- 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
- 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;
- 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
- Proportion of patients cured [ Time Frame: Week 24 ]Number of patients with HCV RNA < 15 IU/mL among those initiating the treatment eligible
- 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
- Rate of mortality [ Time Frame: Week 48 ]Rate of deaths among all participants with hepatitis C infection
- 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
- 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
- Adherence assessment [ Time Frame: Week 12 ]Self-questionnaire on DAA drug intake and drug accountability for DAA
- 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
- Factors associated with HCV reinfection [ Time Frame: Week 48 ]Socio-demographic, co-infection, virological, adherence, behavioral, psychiatric disorders, intervention contact, recent incarceration, homelessness factors
- 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
- 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

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

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
Vietnam | |
Hai Phong University of Medicine and Pharmacy | |
Hai Phong, Vietnam | |
Viet Tiep Hospital | |
Hải Phòng, Vietnam |
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | ANRS, Emerging Infectious Diseases |
ClinicalTrials.gov Identifier: | NCT03537196 |
Other Study ID Numbers: |
ANRS 12380 DRIVE-C |
First Posted: | May 25, 2018 Key Record Dates |
Last Update Posted: | January 29, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
People who inject drugs Hepatitis C Direct Acting Antiviral |
HCV Elimination Vietnam Viral hepatitis C |
Hepatitis A Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Ribavirin Sofosbuvir Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |