Simplified Monitoring Myanmar SM2 Study

Kirby Institute

Status: Completed

Conditions: Liver Cirrhoses; Liver Inflammation; Hepatitis C; HIV Infections

Treatments: Device: HCV point of care machine

Study type: Interventional

Funder types: Other

Identifiers

NCT04113629

VHCRP1803

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects must meet all of the following inclusion criteria to participate in this study.

1. Have voluntarily signed the consent form.
2. 18 years of age or older.
3. HCV antibody positive.
4. HIV antibody positive.

Exclusion criteria

Subjects who meet any of the exclusion criteria are not to be enrolled in this study.

1. 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.
2. Creatinine clearance (CLcr) < 30mL/min at screening.
3. Pregnant or nursing female.
4. Use of prohibited concomitant medications.
5. Inability or unwillingness to provide informed consent or abide by the study requirements.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Sofosbuvir/Daclatasvir

Other group

Description:

standard DAA therapy: 12 or 24 weeks of sofosbuvir/daclatasvir

Treatment:

Device: HCV point of care machine