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 in Ukraine.
Affected populations will be screened for HCV and HIV and those HCV positive treated with direct with direct acting anti-HCV agents (DAAs), a fixed-dose combination of sofosbuvir/ledipasvir (SOF/LDV) 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 800 patients enrolled on treatment will be followed up at 4, 8, 12 and 24 weeks when Sustained Viral Response (SVR) 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 (GCP). In addition to assessing cost outcomes, the project will assess HCV treatment efficacy in terms of SVR at 12 weeks after end of treatment ( defined as undetected HCV RNA or less than lower limit of detection), compare the cost of low cost viral assay platforms to standard of care, assess rates of ART initiation and virologic suppression of HIV-infected persons within the simplified HCV treatment model and impact of HIV co-infection in participants on the HCV treatment outcome of SVR12. The project will be conducted at 2 treatment sites in Kiev.
Study Type
OBSERVATIONAL
Enrollment
868
SOF/LDV (400mg/90mg) orally once daily with or without food in the morning and will receive treatment for a duration of 12 weeks. In addition, Ribavirin weight-based (1000 mg for patients \<75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food for Genotype 3 patients.
Clinic of the Institute of Epidemiology and Infectious Diseases, National Academy of Medical Sciences of Ukraine
Kiev, Ukraine
Kyiv City Clinical Hospital #5
Kyiv, Ukraine
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 SVR-12 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 investigators will also estimate the average cost to "produce" a successful outcome (SVR-12), 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.
Sustained Viral Response
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 a Care cascade model 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
HCV genotype will be determined at entry for all patients.
Time frame: At baseline
HCV subtype
All genotypes will be subtyped once
Time frame: Baseline
Validity of Cepheid Gene-Xpert in monitoring SVR12
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150 patients will be evaluated for HCV viral load at entry and exit comparing Cepheid Gen-Xpert and Real time PCR using Ampliscence platform.
Time frame: Testing done and baseline and 24 weeks
HIV viral load among HCV/HIV co-infected patients
HCV/HIV co-infected patients will 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 the HIV infected within the simplified HCV testing and treatment model
Time frame: HIV Viral load at 24 weeks ( 12 weeks post HCV treatment)
Reliability of Cepheid Gene-Xpert in monitoring SVR12
Cepheid Gen-Xpert and Real time PCR using Ampliscence platform.
Time frame: Testing done and baseline and 24 weeks