NCT03579576

Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar

Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 803 (actual)
• Sponsor: Right to Care · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis C
• Hepatitis B
• HIV Infections

Interventions

Type	Name	Description
DRUG	sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin.	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.

Timeline

• Start date: 2017-12-20
• Primary completion: 2019-03-30
• Completion: 2019-06-30
• First posted: 2018-07-06
• Last updated: 2019-07-29

Locations

3 sites across 1 country: Burma