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

NCT03537196 | Completed Phase 4

• 1 other identifier: ANRS 12380 DRIVE-C
• Study Type: interventional
• Target: 979
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis C; Drug Use; Viral Hepatitis C

Keywords

People who inject drugs; Hepatitis C; Direct Acting Antiviral; HCV Elimination; Vietnam; Viral hepatitis C

Outcome Measures

Primary Outcomes (1)

• Proportion of all patients in success of the model of care

  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 Outcomes (13)

• Proportion of patients with detectable HCV RNA

  Screening pre-inclusion

• Proportion of patients enrolled in care

  Pre-inclusion visit

• Proportion of patients initiating DAA treatment

  Initiation treatment visit

• Proportion of patients cured

  Week 24

• Rate of reinfection

  Week 48

Study Arms (4)

All patients

OTHER

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

HIV/HCV co-infected patients

OTHER

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

Cirrhosis

OTHER

In case of cirrhosis : ribavirin will be added to sofosbuvir / daclatasvir 12 weeks

Drug: Ribavirin

Cirrhosis with ribavirin contra-indication

OTHER

In case of cirrhosis with ribavirin contra-indication : sofosbuvir and daclatasvir for 24 weeks

Drug: Sofosbuvir and Daclatasvir for 24 weeks

Interventions

Sofosbuvir 400 mg and Daclatasvir 60 mg DRUG

All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.

All patients

Sofosbuvir 400 mg and Daclatasvir 90 mg DRUG

For HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day.

HIV/HCV co-infected patients

Ribavirin DRUG

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

Sofosbuvir and Daclatasvir for 24 weeks DRUG

In case of cirrhose and of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.

Cirrhosis with ribavirin contra-indication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (2)

Hai Phong University of Medicine and Pharmacy

Haiphong, Vietnam

Location

Viet Tiep Hospital

Haiphong, Vietnam

Location

Related Publications (24)

• 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.

  PMID: 25086286 BACKGROUND

• 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.

  PMID: 23172780 BACKGROUND

• 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.

  PMID: 22828983 BACKGROUND

• 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.

  PMID: 20041309 BACKGROUND

• 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.

  PMID: 22098550 BACKGROUND

• 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.

  PMID: 20196807 BACKGROUND

• 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.

  PMID: 19839502 BACKGROUND

• 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.

  PMID: 20572071 BACKGROUND

• 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.

  PMID: 23675659 BACKGROUND

• 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.

  PMID: 25920094 BACKGROUND

• 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.

  PMID: 23553643 BACKGROUND

• 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.

  PMID: 23728143 BACKGROUND

• 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.

  PMID: 27667367 BACKGROUND

• 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.

  PMID: 25245939 BACKGROUND

• 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.

  PMID: 27178119 BACKGROUND

• 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/

  PMID: 27227200 BACKGROUND

• 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.

  PMID: 27148964 BACKGROUND

• 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.

  PMID: 23884064 BACKGROUND

• 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.

  PMID: 27427455 BACKGROUND

• 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.

  PMID: 22564041 BACKGROUND

• 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.

  PMID: 26298331 BACKGROUND

• 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.

  PMID: 27349488 BACKGROUND

• 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.

  PMID: 41017776 DERIVED

• 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.

  PMID: 33208326 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; daclatasvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Study Officials

• KHUE M. PHAM, MD, PhD

  Hai Phong University of Medicine and Pharmacy, Vietnam

  PRINCIPAL INVESTIGATOR

• DIDIER LAUREILLARD, MD

  Nîmes University Hospital, France

  PRINCIPAL INVESTIGATOR

• NICOLAS NAGOT, MD, PhD

  Pathogenesis and Control of Chronic Infections (PCCI) UMR 1058 - INSERM, Univ Montpellier, EFS, Montpellier, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: All patients with detectable HCV RNA, eligible for treatment, will receive Direct Acting Antiviral drugs.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: November 13, 2018
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2022
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)