Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar)

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Status: Completed

Conditions: Hepatitis C

Treatments: Diagnostic Test: Xpert HCV VL

Study type: Interventional

Funder types: Other

Identifiers

NCT03939013

CT2/Alfred244-17/DMR2018-144

Details and patient eligibility

About

Implementation-effectiveness hybrid trial assessing acceptability, feasibility and cost-effectiveness of community-based point-of-care testing and treatment for hepatitis C. Utilises Cepheid GeneXpert HCV VL device as diagnostic tool (diagnosis of chronic infection and assessment of treatment outcome) and sofosbuvir/daclatasvir for HCV therapy (local standard of care).

Full description

Historically, testing and treatment for hepatitis C has been confined to centralised laboratories and tertiary hospitals respectively. Recent advancements in point-of-care testing for hepatitis C (anti-HCV antibody and HCV RNA/VL) and treatment options with the introduction of direct acting antivirals allows for testing and treatment to occur in de-centralised primary care settings.

This study is an effectiveness-implementation hybrid study to assess the feasibility, acceptability, effectiveness and cost-effectiveness of a de-centralised approach to hepatitis C testing and treatment at community-based clinics in Yangon, Myanmar. Generalist doctors trained in hepatitis C treatment will prescribe direct acting antiviral therapy to eligible participants.

The study will utilise SD Bioline HCV RDT and Cepheid GeneXpert HCV VL test; and sofosbuvir/daclatasvir to treat hepatitis C. Test of cure will be performed at 12 weeks post-treatment completion to assess sustained virological response (SVR).

Study inclusion criteria prior to recruitment into study:

• Aged ≥18 years
• Attendance at study site
• Willing and able to provide written informed consent

Study exclusion criteria prior to recruitment into study:

• Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment
• Treatment experienced (either DAA or pegylated interferon)
• Hepatitis B virus (HBV) infected
• Human Immunodeficiency Virus (HIV) infected
• estimated glomerular filtration rate (eGFR) <30
• Active tuberculosis (if known active tuberculosis or as per symptom screening assessment)
• Pregnant women
• Serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking

Enrollment: 634 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged ≥18 years
• Attendance at study site
• Willing and able to provide written informed consent

Exclusion criteria

• Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment
• Treatment experienced (either DAA or pegylated interferon)
• Hepatitis B virus (HBV) infected
• Human Immunodeficiency Virus (HIV) infected
• estimated glomerular filtration rate (eGFR) <30
• Active tuberculosis (if known active tuberculosis or as per symptom screening assessment)
• Pregnant women
• Serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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634 participants in 1 patient group

Xpert HCV VL, sof/dac (local standard of care therapy)

Experimental group

Description:

Use of Cepheid GeneXpert HCV VL device as diagnostic tool to test for HCV RNA for diagnosis of chronic hepatitis C infection, for assessment of sustained virological response at 12 weeks post treatment completion

Treatment:

Diagnostic Test: Xpert HCV VL