Evaluation of HCV Care and Treatment for HIV-HCV Co-infected Patients in Decentralised Areas in Vietnam

NCT05506475 | Not Yet Recruiting

• 1 other identifier: 2021-084
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

With the advent of direct acting antiviral (DAA) treatment in 2013, HCV elimination has become feasible. Still, achieving HCV elimination in resource-limited countries appears to be arduous as several challenges need to be addressed. In remote settings, absence of HCV VL testing to identify those who require DAA and to monitor DAA success is a first issue. As of today, HCV VL testing is still restricted to central facilities in major cities. Blood sampling using DBS is an appealing option to allow HCV VL monitoring in remote settings as this option is inexpensive, does not require a cold chain for storage and transportation of the samples and can be implemented rapidly. A second issue is DAA access that remains scarce due to logistical and financial limitations. However, more affordable generic DAA, some of them being WHO pre-qualified, are now available. Vietnam is amongst the 20 countries with the highest HCV burden with an estimate of 1.5 million chronic HCV-infected people (HCV prevalence: 1.1%). As observed in many other settings, HCV prevalence is higher among vulnerable populations such as HIV-infected individuals and people who inject drugs (PWID). Vietnam has the will to increase access to DAA in the whole country. However, in remote settings, only some clinical sites will be allowed to dispense DAA. Discussions with the MoH of Vietnam brought to our knowledge that not all clinical sites caring for HIV patients and providing ART will dispense DAA. Thus, some HIV-HCV co-infected patients will be followed in clinical sites where they will receive both antiretroviral therapy and DAA, while some other patients will continue to be followed for HIV in their usual clinical site but will be asked to visit another clinical site for HCV care and to receive DAA. We anticipate that the proportion of patients who will comply with the 12-week DAA will be lower in patients followed for HIV and HCV in two clinical sites than in those followed in a single clinical site.

Conditions

HIV Infection; Hepatitis C Infection

Keywords

Direct Acting Antiviral; Dried Blood Spots

Outcome Measures

Primary Outcomes (1)

• To compare compliance to the 12-week DAA treatment between patients followed in the same clinical site for HIV and HCV infections, and patients followed in two clinical sites for these two infections

  Proportion of patients who have taken ≥90% of daily doses during the 12-week DAA (measured by pill count).

  12 weeks

Secondary Outcomes (6)

• To describe the compliance to the 12-week DAA treatment, and identify factors associated with good compliance

  12 weeks

• To evaluate and compare the efficacy of the DAA treatment (defined by SVR12), and identify factors associated with SVR12

  24 weeks

• To describe the HCV genotypes circulating

  24 weeks

• To describe HCV drug resistances in those not achieving SVR12,

  24 weeks

• To estimate the rate of HCV re-infection within 24 months after SVR12

  30 months

Interventions

Blood samples PROCEDURE

venous blood collected in a 5 mL EDTA tube

Eligibility Criteria

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

Study Population

HIV-HCV co-infected adults already enrolled in HIV care

You may qualify if:

• Age at enrolment ≥18 years.
• Documented HIV-1 infection.
• HCV infection documented by the presence of Anti-HCV antibodies or a positive RDT; if the result was negative but dates from more than 6 months the patient will be tested again.
• Consent to participate in the study

You may not qualify if:

• HCV negative patient.
• Patient not routinely followed for HIV care in the clinical sites participating in the study.
• Previous treatment by DAA.
• Patient for whom the health status, according to the medical staff, may interfere with the study or is not compatible with the sampling planned in the study

Sponsors & Collaborators

• Institut Pasteur: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator
• ANRS, Emerging Infectious Diseases: collaborator

Study Sites (2)

Center for Diseases Control and Prevention of Nghe An province

Vinh, Nghệ An Province, Vietnam

Location

Center for Disease Control and Prevention of Yen Bai Province

Yên Bái, Yen Bai, Vietnam

Location

Related Publications (1)

• Tran TH, Nguyen BT, Nguyen TA, Pham TTP, Nguyen TTT, Mai HTB, Pham HB, Nguyen TM, Phan HTT, Do NT, Ait-Ahmed M, Taieb F, Madec Y. Dried blood spots perform well to identify patients with active HCV infection in Vietnam. J Viral Hepat. 2020 May;27(5):514-519. doi: 10.1111/jvh.13263. Epub 2020 Feb 11.

  PMID: 31981287 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

DBS and plasma samples

MeSH Terms

Conditions

HIV Infections; Hepatitis C

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yoann MADEC, PhD

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

• Tuan Anh NGUYEN, PhD

  National Institute of Hygiene and Epidemiology, Vietnam

  PRINCIPAL INVESTIGATOR

• Thang Hong PHAM, PhD

  National Institute of Hygiene and Epidemiology, Vietnam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoann MADEC, PhD

CONTACT

+33140613828; yoann.madec@pasteur.fr

Mohand AIT AHMED

CONTACT

mohand.ait-ahmed@pasteur.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: May 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)