The project will evaluate cost and treatment outcomes of a simplified hepatitis C virus (HCV) testing, treatment and care model integrated with HIV testing and treatment among key affected populations including people who inject drugs (PWID) in Myanmar.
Affected populations will be screened for HCV and HIV and treated with direct a fixed-dose combination of sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin. Before and after completion of the treatment course viral load assessments will be undertaken using low-cost laboratory monitoring for comparison to standard HCV viral load measurement. Up to 800 patients enrolled on treatment will be followed up at 4, 8, 12 and 24 weeks when Sustained Viral Load ( SVL) will be determined. Safety monitoring will be undertaken at applicable visits for those on Ribavirin and all adverse events will be reported based on Good Clinical Practice. In addition to assessing to assessing cost outcomes, the project will assess HCV treatment efficacy in terms of sustained virologic response at 12 weeks after end of HCV treatment (defined as undetected HCV RNA or less than lower limit of detection), compare the cost of low cost HCV viral assay platforms to standard of care, assess rates of ART initiation and virologic suppression of HIV-infected persons within the simplified HCV testing and treatment model and impact of HIV co-infection in participants on the HCV treatment outcome of sustained virologic response (SVR12). The project will be conducted 3 treatment sites in Yangon, Mandalay, and Kachin state in Myanmar.
Study Type
OBSERVATIONAL
Enrollment
803
Direct Acting anti-HCV drugs given to all HCV infected participants at baseline.Those with Co-infections like HIV and or HBV will be given treatment as per national guidelines.
Waimaw
Kāchen, Kachin State, Burma
Myanmar Liver Foundation Clinic
Mandalay, Burma
Myanmar Liver Foundation Charity Clinic
Yangon, Burma
Estimated cost of HCV screening per patient screened and per case identified and the cost per successfully treated patient for HCV mono-infected and co-infected participants
The average cost to the provider per patient achieving SVR12 will be estimated, as will the average cost per other outcomes achieved, such as per patient screened and per patient remaining in care by other specified endpoints, stratified by HIV status and by any other important patient or site characteristics that are identified as drivers of cost. The study will also estimate the average cost to "produce" a successful outcome (SVR12), which is the ratio of total costs for the intervention for the entire sample enrolled to the number of patients achieving the primary outcome. This latter estimate captures the costs incurred for patients who do not have successful outcomes and thus relates resource utilization to health outcomes.
Time frame: Two years. This will be after data on Viral load response is complete.
Overall Sustained Viral load response (SVR12) across all groups of HCV genotype, fibrosis stage, HIV and HBV co-infection.
This will be the main treatment outcome of all patients initiated on treatment. Baseline viral load is done at entry with treatment initiated for those positive and eligible. Patients initiated on treatment will be assessed for viral load response at 24 weeks ( 12 weeks post treatment). This will also help in development of Care cascade for HCV testing, treatment and SVR12 in key populations co-infected with HIV/HCV, HIV/HCV/HBV, HBV/HCV and HCV mono-infected.
Time frame: 24 weeks ( 12 weeks post treatment)
HCV genotype and subtype
HCV Genotype and subtypes will be determined at entry for all patients. Frequency of resistance associated substitutions (RAS) among participants registered for the project will also be determined.
Time frame: At baseline
Validity and reliability of Cepheid GeneXpert in monitoring SVR12
150 patients will be evaluated for HCV viral load at entry and exit ( SVR12) comparing cepheid Gene Xpert and Roche real time PCR ( Standard method)
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Time frame: Testing done at baseline and 24 weeks
HIV Viral load among HCV/HIV co-infected patients
HCV/HIV co-infected patients will either be on treatment at the time of HCV treatment initiation but those not on ART will be initiated and will assess rates of ART initiation and virologic suppression of HIV-infected persons within the simplified HCV testing and treatment model.
Time frame: HIV Viral load at 24 weeks ( 12 weeks post HCV treatment)