Clinical trial
Towards HCV Elimination: Evaluation of an Integrated Model of HCV Care Targeting People Who Inject Drugs in Hai Phong, Vietnam
Name
ANRS 12380 DRIVE-C
Description
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.
Trial arms
Trial start
2018-11-13
Estimated PCD
2020-11-30
Trial end
2022-12-30
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
All patients
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.
Arms:
HIV/HCV co-infected patients
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.
Arms:
Cirrhosis
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.
Arms:
Cirrhosis with ribavirin contra-indication
Size
979
Primary endpoint
Proportion of all patients in success of the model of care
Week 48
Eligibility 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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients with detectable HCV RNA, eligible for treatment, will receive Direct Acting Antiviral drugs.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 979, 'type': 'ACTUAL'}}
Updated at
2023-10-26
1 organization
2 products
2 indications
Organization
ANRS, Emerging Infectious DiseasesProduct
Sofosbuvir + DaclatasvirIndication
Hepatitis CIndication
Substance Use DisorderProduct
Ribavirin