Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar
Simplified Antiviral Treatment Strategy for Hepatitis C in Myanmar
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.
Inclusion Criteria:

 1. Ability and willingness of participant to provide informed consent.

 2. Men and women age 18 years.

 3. Active HCV infection as defined by detectable serum or plasma HCV RNA at any time
 prior to study entry. Documentation may be obtained from medical records if available.
 NOTE: If no medical records on HCV infection are available, active HCV infection must
 be confirmed by a detectable HCV RNA PCR prior to project entry.

 4. Allowed HCV treatment history:

 1. HCV treatment naïve defined as not having been previously treated for Hepatitis C
 infection with any medications approved for the treatment of HCV in any country.

 2. HCV treatment experienced with interferon with or without ribavirin only (no
 prior DAA treatment).

 5. Chronic Hepatitis B status must be documented by hepatitis B surface antigen (HBsAg),
 hepatitis B surface antibody (HBsAb), and hepatitis B core antibody (HBcAb) testing.
 Participants with positive HBsAg must be already on an active HBV regimen at study
 entry.

 6. HIV-1 infection status must be documented as either absent or present, as defined
 below:

 1. Absence of HIV-1 infection, as documented by rapid HIV test or HIV-1 enzyme
 immunoassay (ELISA) test kit, within 60 days prior to entry.

 OR

 2. Presence of HIV-1 infection, documented by rapid HIV test or HIV-1 ELISA test kit
 at any time prior to entry.

 OR

 3. HIV-1 infection confirmed by medical documentation as participant is registered
 in care at AIDS Center and receiving or preparing to initiate ARV treatment.

 7. HIV co-infected participants taking ART or planning to initiate ART, should be:

 1. Tolerating ART for at least 2 weeks without signs of needing to modify or
 discontinue the ART regimen before initiating HCV treatment.

 AND

 2. The ART regimen must be a regimen that can be co-administered with SOF/VEL.

 8. Participants who are assigned to receive ribavirin as part of the treatment protocol
 must have hemoglobin ≥11.0 g/dL

 9. For females of reproductive potential who will receive ribavirin, a negative urine
 pregnancy test (urine -HCG with a sensitivity of <25 mIU/mL) within 48 hours prior to
 project entry (HCV treatment initiation) must be documented.

 10. Male and female participants who are able to impregnate or become pregnant (ie, of
 reproductive potential) and are participating in sexual activity that could lead to
 pregnancy must agree to practice contraception/birth control as indicated below or
 agree to not participate in a conception process while on treatment with ribavirin
 through at least 12 weeks post-treatment.

 11. Life expectancy >12 months, in the opinion of the site investigator

 Exclusion Criteria:

 1. Child-Pugh Score corresponding to Class B or C (decompensated cirrhosis). This
 requires assessment for encephalopathy and ascites, as well as measurement of serum
 bilirubin, albumin, and international normalized ratio (prothrombin time).

 2. Breastfeeding or pregnancy if patient will be receiving ribavirin.

 3. Known allergy/sensitivity or any hypersensitivity to components of drug(s) or their
 formulation.

 4. Acute tuberculosis (TB) infection. They will be followed and offered enrolment when
 they complete TB treatment.

 5. Renal impairment defined as estimated glomerular filtration rate (eGFR) < 30
 ml/min/1.73m2 or end-stage renal disease receiving dialysis as treatment with SOF/VEL
 is contraindicated (https://www.mdcalc.com/mdrd-gfr-equation).

 6. Unwilling to provide informed consent for participation in the project.

 7. Prior treatment with any HCV Direct Acting Agents (DAA).

 8. Unable or unwilling to adhere to the HCV treatment course and monitoring in the
 opinion of the investigator.