Hepatitis CPhase 4DRIVE-CNCT03537196

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

A Phase 4 study testing Sofosbuvir 400 mg and Daclatasvir 60 mg, Sofosbuvir 400 mg and Daclatasvir 90 mg and Ribavirin in people with Hepatitis C and Drug Use, run by ANRS, Emerging Infectious Diseases at 2 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Drug Use, Viral Hepatitis C
What is being tested?: Sofosbuvir 400 mg and Daclatasvir 60 mg, Sofosbuvir 400 mg and Daclatasvir 90 mg and Ribavirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 979 participants
Where: 2 sitesVietnam
Study dates: 13 Nov 2018to 30 Dec 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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;

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

Hai Phong University of Medicine and Pharmacy
Haiphong
Viet Tiep Hospital
Haiphong

Other trials in Vietnam

About this study

Official title: Towards HCV Elimination: Evaluation of an Integrated Model of HCV Care Targeting People Who Inject Drugs in Hai Phong, Vietnam

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.

Read the detailed description

Objectives :

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:

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: Hepatitis C, Drug Use, Viral Hepatitis C
Being tested: Sofosbuvir 400 mg and Daclatasvir 60 mg, Sofosbuvir 400 mg and Daclatasvir 90 mg, Ribavirin, Sofosbuvir and Daclatasvir for 24 weeks
Keywords: People who inject drugs, Hepatitis C, Direct Acting Antiviral, HCV Elimination, Vietnam, Viral hepatitis C
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sofosbuvir 400 mg and Daclatasvir 60 mgDrug
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 mgDrug
For HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day.
RibavirinDrug
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 weeksDrug
In case of cirrhose and of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.

Study groups in NCT03537196
Study group	Role	What they receive
All patients	Other	All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks. Receives: 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) Receives: Drug: Sofosbuvir 400 mg and Daclatasvir 90 mg
Cirrhosis	Other	In case of cirrhosis : ribavirin will be added to sofosbuvir / daclatasvir 12 weeks Receives: Drug: Ribavirin
Cirrhosis with ribavirin contra-indication	Other	In case of cirrhosis with ribavirin contra-indication : sofosbuvir and daclatasvir for 24 weeks Receives: Drug: Sofosbuvir and Daclatasvir for 24 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 48

Secondary outcomes (13)

Proportion of patients with detectable HCV RNA
Proportion of patients with HCV RNA > 15 IU/mL among those with positive HCV Ab
Measured: Screening pre-inclusion
Proportion of patients enrolled in care
Proportion of patients with HCV RNA > 15 IU/mL who attended the pre inclusion visit at HCV clinic among those with hepatitis C infection;
Measured: Pre-inclusion visit
Proportion of patients initiating DAA treatment
Proportion of patients who initiate the treatment among patients enrolled in care and eligible for treatment
Measured: Initiation treatment visit
Proportion of patients cured
Number of patients with HCV RNA < 15 IU/mL among those initiating the treatment eligible
Measured: Week 24
Rate of reinfection
Number of patients with HCV RNA ≥ 15 IU/mL at the end of the study among cured patients
Measured: Week 48
Rate of mortality
Rate of deaths among all participants with hepatitis C infection
Measured: Week 48
Frequency, type and time to grade 3 or 4 adverse clinical or biological events.
All adverse events will be graded according to the ANRS adverse events grading table
Measured: Week 48
Frequency, type and time to drug-related clinical or biological adverse reactions
All drug-related clinical or biological adverse reactions of grade 3 or 4 or leading to treatment interruption
Measured: Week 48
Adherence assessment
Self-questionnaire on DAA drug intake and drug accountability for DAA
Measured: Week 12
Factors associated with HCV treatment failure
Socio-demographic, co-infection, virological, adherence, behavioral, psychiatric disorders, intervention contact, recent incarceration, homelessness factors
Measured: Week 24
Factors associated with HCV reinfection
Socio-demographic, co-infection, virological, adherence, behavioral, psychiatric disorders, intervention contact, recent incarceration, homelessness factors
Measured: Week 48
Effect of the HCV treatment intervention
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
Measured: Week 48
Incremental cost-effectiveness ratio (ICER)
Estimation of the mean ICER which will be compared against standard thresholds for intervention's being cost-effective in LMIC settings
Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 201830 Dec 2022

First posted25 May 2018
Study start13 Nov 2018
Primary completion30 Nov 2020
Study completion30 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: All patients with detectable HCV RNA, eligible for treatment, will receive Direct Acting Antiviral drugs.
Masking: None (open label)
Enrolment: 979 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03537196
Sponsor's protocol ID: ANRS 12380 DRIVE-C
Acronym: DRIVE-C
Status last verified: Oct 2023
First submitted: 15 May 2018
Last updated: 26 Oct 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 25086286
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.
PubMed 23172780
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.
PubMed 22828983
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.
PubMed 20041309
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.
PubMed 22098550
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.
PubMed 20196807
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.
PubMed 19839502
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.
PubMed 20572071
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.
PubMed 23675659
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.
PubMed 25920094
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.
PubMed 23553643
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.
PubMed 23728143
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.
PubMed 27667367
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.
PubMed 25245939
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.
PubMed 27178119

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Towards HCV Elimination: Evaluation of an Integrated Model of HCV Care Targeting People Who Inject Drugs in Hai Phong, Vietnam
ClinicalTrials.gov ID: NCT03537196
Acronym / sponsor ID: DRIVE-C / ANRS 12380 DRIVE-C
Conditions: Hepatitis C, Drug Use, Viral Hepatitis C
Keywords: People who inject drugs, Hepatitis C, Direct Acting Antiviral, HCV Elimination, Vietnam, Viral hepatitis C
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 979 participants (actual)
Lead sponsor: ANRS, Emerging Infectious DiseasesOther government
Study start: 13 Nov 2018 (actual)
Primary completion: 30 Nov 2020 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 25 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objectives :

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:

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.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4
Model description: All patients with detectable HCV RNA, eligible for treatment, will receive Direct Acting Antiviral drugs.

Arm	Type	Receives
All patients	Other	Drug: Sofosbuvir 400 mg and Daclatasvir 60 mgAll patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.
HIV/HCV co-infected patients	Other	Drug: Sofosbuvir 400 mg and Daclatasvir 90 mgFor 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)
Cirrhosis	Other	Drug: RibavirinIn case of cirrhosis : ribavirin will be added to sofosbuvir / daclatasvir 12 weeks
Cirrhosis with ribavirin contra-indication	Other	Drug: Sofosbuvir and Daclatasvir for 24 weeksIn case of cirrhosis with ribavirin contra-indication : sofosbuvir and daclatasvir for 24 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (11 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sofosbuvir 400 mg and Daclatasvir 60 mgAll patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.	Drug	All patients
Sofosbuvir 400 mg and Daclatasvir 90 mgFor HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day.	Drug	HIV/HCV co-infected patients
RibavirinIn 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.	Drug	Cirrhosis
Sofosbuvir and Daclatasvir for 24 weeksIn case of cirrhose and of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.	Drug	Cirrhosis with ribavirin contra-indication

Primary outcome

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.

13 secondary outcomes

Proportion of patients with detectable HCV RNA
Time frame: Screening pre-inclusion
Proportion of patients enrolled in care
Time frame: Pre-inclusion visit
Proportion of patients initiating DAA treatment
Time frame: Initiation treatment visit
Proportion of patients cured
Time frame: Week 24
Rate of reinfection
Time frame: Week 48
Rate of mortality
Time frame: Week 48
Frequency, type and time to grade 3 or 4 adverse clinical or biological events.
Time frame: Week 48
Frequency, type and time to drug-related clinical or biological adverse reactions
Time frame: Week 48
Adherence assessment
Time frame: Week 12
Factors associated with HCV treatment failure
Time frame: Week 24
Factors associated with HCV reinfection
Time frame: Week 48
Effect of the HCV treatment intervention
Time frame: Week 48
Incremental cost-effectiveness ratio (ICER)
Time frame: Week 48

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
Background: PubMed 25086286Gower 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.
Background: PubMed 23172780Mohd 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.
Background: PubMed 22828983Sereno 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.
Background: PubMed 20041309Clatts 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.
Background: PubMed 22098550Gish 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.
Background: PubMed 20196807Kallman 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.
Background: PubMed 19839502Pham 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.
Background: PubMed 20572071Tanimoto 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.
Background: PubMed 23675659Liang 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.
Background: PubMed 25920094Pawlotsky 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.
Background: PubMed 23553643Martin 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.
Background: PubMed 23728143Grebely 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.
Individual participant dataSharing planned: No

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Hepatitis D, Hepatitis C
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Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
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Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

KHUE M. PHAM, MD, PhD principal investigator

Hai Phong University of Medicine and Pharmacy, Vietnam

DIDIER LAUREILLARD, MD principal investigator

Nîmes University Hospital, France

NICOLAS NAGOT, MD, PhD study director

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of all patients in success of the model of care (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03537196, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.