Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C in Ukraine
ICF «Alliance for Public Health» (hereandafter – Alliance) is one of the key implementers of the Demonstration Project on Assessment of Simplified Antiviral Treatment Strategy for Hepatitis C (hereandafter – Project). The Project is launched in partnership with EQUIP and financial support from (USAID), PEPFAR.
Purpose of the Project:
- To improve access to HCV treatment among key populations in Ukraine (people who inject drugs [PWID], commercial sex worker [CSW], men who have sex with men [MSM]), and enhance ART initiation and adherence in HIV/HCV co-infected persons.
- To develop, implement and evaluate cost and treatment outcomes of a simplified HCV testing, treatment and care model integrated with HIV testing and treatment among key affected populations in Ukraine.
Representatives of key populations will be screened for HCV and HIV and treated with directly acting anti-HCV agents (DAAs) and referred for anti-retroviral drugs for those HIV/HCV co-infected.
Representatives of key populations enrolled for HCV treatment will receive social peer support and further linked to HIV care and treatment, harm reduction services (e.g. access to needle, syringes exchange program, opioid substitution treatment).
Patients’ selection criteria:
- Persons from key population groups and their partners: people who inject drugs (PWID), medication assisted treatment (MAT) participants, Commercial Sex Workers (CSW) or men having sex with men (MSM)
- Patients treated with pegylated interferon and with/without ribavirin previously (patients without previous experience of treatment with DAAs)
- Men and women age ³ 18 years
- Chronic HCV infection laboratory confirmed
- HCV mono infected or co-infected HIV/HCV
- Genotypes 1, 2, 3, 4, 5 or 6.
Ability and willingness of participant to provide informed consent is a must.
Participants with compensated cirrhosis or Hepatitis B are eligible to participate in this Project. Patients with decompensated liver cirrhosis or prior HCV treatment with DAAs are not eligible.
Treatment regimen: Fixed-dose combination of sofosbuvir/ledipasvir (SOF/LDV 400mg/90mg) for 12 weeks with/without ribavirin at doctor’s solution.
Duration: 24 weeks [12 weeks on treatment, 12 weeks post-treatment period].
Project Sample Size: Patients will be enrollment in two phases. 400 patients of Phase I will be recruited at two treatment sites in Kyiv. At Phase II other 400 patients are planned for recruitment (treatment sites to be announced later).
At Phase I Alliance is supervising testing, laboratory diagnostics, treatment of HCV and social support of 200 patients enrolled in Institute of Epidemiology and Infectious Diseases named after L. Gromashevskiy (hereandafter – Institute). Meanwhile All-Ukrainian Network of PLWH coordinates the same activities launched for other 200 patients in Kyiv City Hospital # 5.
Among the key Alliance responsibilities under the Project is procurement and supply of medicines, laboratory equipment, medical items, laboratory services, etc. for all health facilities involved in the treatment within the Project.
Contact – Zhanna Tsenilova