Simplified Monitoring Myanmar SM2 Study

Study Overview
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Brief Summary
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The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.

Detailed Description
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A total of 200 HIV/HCV co-infected patients who plan to commence DAA therapy at Specialist Hospital Waibargi and Mingaladon, will be enrolled by simple random sampling. In addition to standard of care medical procedures, each participant will complete a questionnaire and have blood taken for standard HCV RNA testing. They will also have a finger-stick capillary blood sample collected for a HCV point of care test, using the the Xpert HCV Assay performed in the GeneXpert point of care machine. Dried blood spot collection (DBS) for HCV core antigen and HCV RNA testing will be collected as a research sample. Concordance between standard of care method and new DBS method will be evaluated. The proportion of patients reaching SVR will be calculated.

Official Title
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Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)

Conditions
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Hepatitis C, Liver Cirrhoses, Liver Inflammation, HIV Infections

Intervention / Treatment
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* Device: HCV point of care machine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following inclusion criteria to participate in this study. Have voluntarily signed the consent form. 18 years of age or older. HCV antibody positive. HIV antibody positive. Exclusion Criteria: Subjects who meet any of the exclusion criteria are not to be enrolled in this study. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the subject treatment, assessment or compliance with the protocol. Creatinine clearance (CLcr) < 30mL/min at screening. Pregnant or nursing female. Use of prohibited concomitant medications. Inability or unwillingness to provide informed consent or abide by the study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sofosbuvir/Daclatasvir<br>standard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir | Device: HCV point of care machine<br>* Xpert HCV Assay performed on the GeneXpert point of care machine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) | To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring. | 12 weeks post completion of commenced treatment |