DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C)
NCT ID: NCT03537196
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
979 participants
INTERVENTIONAL
2018-11-13
2022-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study
NCT03236506
Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia
NCT02339038
HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection
NCT02309918
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
NCT01701401
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
NCT02631772
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
All patients
All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.
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)
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
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Hepatitis C infection defined by a positive HCV RNA
* Signed informed consent form
Exclusion Criteria
* 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;
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
KHUE M. PHAM, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hai Phong University of Medicine and Pharmacy, Vietnam
DIDIER LAUREILLARD, MD
Role: PRINCIPAL_INVESTIGATOR
Nîmes University Hospital, France
NICOLAS NAGOT, MD, PhD
Role: STUDY_DIRECTOR
Pathogenesis and Control of Chronic Infections (PCCI) UMR 1058 - INSERM, Univ Montpellier, EFS, Montpellier, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hai Phong University of Medicine and Pharmacy
Haiphong, , Vietnam
Viet Tiep Hospital
Haiphong, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014 Nov;61(1 Suppl):S45-57. doi: 10.1016/j.jhep.2014.07.027. Epub 2014 Jul 30.
Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013 Apr;57(4):1333-42. doi: 10.1002/hep.26141. Epub 2013 Feb 4.
Sereno L, Mesquita F, Kato M, Jacka D, Nguyen TT, Nguyen TN. Epidemiology, responses, and way forward: the silent epidemic of viral hepatitis and HIV coinfection in Vietnam. J Int Assoc Physicians AIDS Care (Chic). 2012 Sep-Oct;11(5):311-20. doi: 10.1177/1545109712453939. Epub 2012 Jul 24.
Clatts MC, Colon-Lopez V, Giang LM, Goldsamt LA. Prevalence and incidence of HCV infection among Vietnam heroin users with recent onset of injection. J Urban Health. 2010 Mar;87(2):278-291. doi: 10.1007/s11524-009-9417-9.
Gish RG, Bui TD, Nguyen CT, Nguyen DT, Tran HV, Tran DM, Trinh HN; International Group for Liver Health in Viet Nam. Liver disease in Viet Nam: screening, surveillance, management and education: a 5-year plan and call to action. J Gastroenterol Hepatol. 2012 Feb;27(2):238-47. doi: 10.1111/j.1440-1746.2011.06974.x.
Kallman JB, Tran S, Arsalla A, Haddad D, Stepanova M, Fang Y, Wrobel VJ, Srishord M, Younossi ZM. Vietnamese community screening for hepatitis B virus and hepatitis C virus. J Viral Hepat. 2011 Jan;18(1):70-6. doi: 10.1111/j.1365-2893.2010.01278.x.
Pham DA, Leuangwutiwong P, Jittmittraphap A, Luplertlop N, Bach HK, Akkarathamrongsin S, Theamboonlers A, Poovorawan Y. High prevalence of Hepatitis C virus genotype 6 in Vietnam. Asian Pac J Allergy Immunol. 2009 Jun-Sep;27(2-3):153-60.
Tanimoto T, Nguyen HC, Ishizaki A, Chung PT, Hoang TT, Nguyen VT, Kageyama S, Oka S, Pham VT, Ichimura H. Multiple routes of hepatitis C virus transmission among injection drug users in Hai Phong, Northern Vietnam. J Med Virol. 2010 Aug;82(8):1355-63. doi: 10.1002/jmv.21787.
Liang TJ, Ghany MG. Current and future therapies for hepatitis C virus infection. N Engl J Med. 2013 May 16;368(20):1907-17. doi: 10.1056/NEJMra1213651.
Pawlotsky JM, Feld JJ, Zeuzem S, Hoofnagle JH. From non-A, non-B hepatitis to hepatitis C virus cure. J Hepatol. 2015 Apr;62(1 Suppl):S87-99. doi: 10.1016/j.jhep.2015.02.006.
Martin NK, Vickerman P, Grebely J, Hellard M, Hutchinson SJ, Lima VD, Foster GR, Dillon JF, Goldberg DJ, Dore GJ, Hickman M. Hepatitis C virus treatment for prevention among people who inject drugs: Modeling treatment scale-up in the age of direct-acting antivirals. Hepatology. 2013 Nov;58(5):1598-609. doi: 10.1002/hep.26431. Epub 2013 Aug 26.
Grebely J, Matthews GV, Lloyd AR, Dore GJ. Elimination of hepatitis C virus infection among people who inject drugs through treatment as prevention: feasibility and future requirements. Clin Infect Dis. 2013 Oct;57(7):1014-20. doi: 10.1093/cid/cit377. Epub 2013 May 31.
European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol. 2017 Jan;66(1):153-194. doi: 10.1016/j.jhep.2016.09.001. Epub 2016 Sep 22. No abstract available.
Bruggmann P, Grebely J. Prevention, treatment and care of hepatitis C virus infection among people who inject drugs. Int J Drug Policy. 2015 Feb;26 Suppl 1:S22-6. doi: 10.1016/j.drugpo.2014.08.014. Epub 2014 Aug 30.
Des Jarlais D, Duong HT, Pham Minh K, Khuat OH, Nham TT, Arasteh K, Feelemyer J, Heckathorn DD, Peries M, Moles JP, Laureillard D, Nagot N; (The Drive Study Team). Integrated respondent-driven sampling and peer support for persons who inject drugs in Haiphong, Vietnam: a case study with implications for interventions. AIDS Care. 2016 Oct;28(10):1312-5. doi: 10.1080/09540121.2016.1178698. Epub 2016 May 13.
Guidelines for the Screening Care and Treatment of Persons with Chronic Hepatitis C Infection: Updated Version. Geneva: World Health Organization; 2016 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK362924/
Nguyen Truong T, Laureillard D, Lacombe K, Duong Thi H, Pham Thi Hanh P, Truong Thi Xuan L, Chu Thi N, Luong Que A, Vu Hai V, Nagot N, Tuaillon E, Dominguez S, Lemoine M. High Proportion of HIV-HCV Coinfected Patients with Advanced Liver Fibrosis Requiring Hepatitis C Treatment in Haiphong, Northern Vietnam (ANRS 12262). PLoS One. 2016 May 5;11(5):e0153744. doi: 10.1371/journal.pone.0153744. eCollection 2016.
Martin NK, Hickman M, Hutchinson SJ, Goldberg DJ, Vickerman P. Combination interventions to prevent HCV transmission among people who inject drugs: modeling the impact of antiviral treatment, needle and syringe programs, and opiate substitution therapy. Clin Infect Dis. 2013 Aug;57 Suppl 2(Suppl 2):S39-45. doi: 10.1093/cid/cit296.
Altice FL, Azbel L, Stone J, Brooks-Pollock E, Smyrnov P, Dvoriak S, Taxman FS, El-Bassel N, Martin NK, Booth R, Stover H, Dolan K, Vickerman P. The perfect storm: incarceration and the high-risk environment perpetuating transmission of HIV, hepatitis C virus, and tuberculosis in Eastern Europe and Central Asia. Lancet. 2016 Sep 17;388(10050):1228-48. doi: 10.1016/S0140-6736(16)30856-X. Epub 2016 Jul 14.
Vickerman P, Martin N, Turner K, Hickman M. Can needle and syringe programmes and opiate substitution therapy achieve substantial reductions in hepatitis C virus prevalence? Model projections for different epidemic settings. Addiction. 2012 Nov;107(11):1984-95. doi: 10.1111/j.1360-0443.2012.03932.x. Epub 2012 Jul 12.
Smith DJ, Combellick J, Jordan AE, Hagan H. Hepatitis C virus (HCV) disease progression in people who inject drugs (PWID): A systematic review and meta-analysis. Int J Drug Policy. 2015 Oct;26(10):911-21. doi: 10.1016/j.drugpo.2015.07.004. Epub 2015 Jul 26.
Conti F, Buonfiglioli F, Scuteri A, Crespi C, Bolondi L, Caraceni P, Foschi FG, Lenzi M, Mazzella G, Verucchi G, Andreone P, Brillanti S. Early occurrence and recurrence of hepatocellular carcinoma in HCV-related cirrhosis treated with direct-acting antivirals. J Hepatol. 2016 Oct;65(4):727-733. doi: 10.1016/j.jhep.2016.06.015. Epub 2016 Jun 24.
Laureillard D, Binh NT, Vinh VH, Hong TT, Quillet C, Thanh NTT, Vallo R, Quynh BTN, Moles JP, Oanh KTH, Huong DT, Rapoud D, Feelemyer J, Michel L, Vickerman P, Fraser H, Weiss L, Lemoine M, Lacombe K, Jarlais DD, Khue PM, Nagot N. High Efficiency and Safety of Hepatitis C Treatment Among People Who Inject Drugs in Vietnam. J Viral Hepat. 2025 Nov;32(11):e70090. doi: 10.1111/jvh.70090.
Rapoud D, Quillet C, Pham Minh K, Vu Hai V, Nguyen Thanh B, Nham Thi Tuyet T, Tran Thi H, Moles JP, Vallo R, Michel L, Feelemyer J, Weiss L, Lemoine M, Vickerman P, Fraser H, Duong Thi H, Khuat Thi Hai O, Des Jarlais D, Nagot N, Laureillard D; DRIVE-C Study Group. Towards HCV elimination among people who inject drugs in Hai Phong, Vietnam: study protocol for an effectiveness-implementation trial evaluating an integrated model of HCV care (DRIVE-C: DRug use & Infections in ViEtnam-hepatitis C). BMJ Open. 2020 Nov 18;10(11):e039234. doi: 10.1136/bmjopen-2020-039234.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANRS 12380 DRIVE-C
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.