A key focus of the study is Hepatitis C, but HIV, hepatiti s B , STI, and TB are also included. The target population is people who currently inject or use drugs or previously injected or used drugs, as well as at other high-risk groups People Who Inject Drugs Hepatitis C HIV Hepatitis B TB STI
Conditions
Interventions
The study regimen consists in the association of a fixed dose of Sofosbuvir (400 mg) and Ravidasvir (200 mg) taken orally once daily with or without food for 12 weeks treatment course for those with n
Experimental Drug
Sofosbuvir/Ravidasvir
Sponsors
Dreamlopments Foundation
Global Fund/USAID
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male, female, or transgender person. Aged 18 years old or older. Former or active injecting or non-injecting drug user. PWID/PWUD are expected to represent the largest sub-population of participants enrolling in the study. Men-who-have-se-with-men (MSM). Sexual or life partner of a current or former drug user, or other high-risk group (MSM, TG women). Consenting to participate in the study. Willing to undertake at least HIV Ab testing and/or HCV Ab testing. Candidates with evidence (written medical/laboratory report) of prior testing (including positive testing) for HIV, HCV, HBV, STI, or LTBI infection can also enroll into the cohort study. Consenting to participant in the study
Exclusion criteria
Exclusion criteria: Inability, in the opinion of the study staff, to provide an informed consent decision to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline prevalence of HCV, HBV and HIV in the study population. 69 months Proportion,Proportion of HIV-infected PWID/PWUD, other high-risk groups and partners, eligible for ART, who have initiated ART, remain in care and have HIV suppression at the end of study. 69 months Propotion,Proportion of participants with active HCV infection initiating therapy who achieve Sustained Virological Response (SVR) 12 weeks after end of therapy. 24 weeks Propotion | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants started on SOF/RAV who present a Grade 3, 4 adverse event (AE), a serious adverse event (SAE) or who prematurely discontinue therapy for any reason. 69 months Number and proportion of events,Incidence of HCV and HIV over the study period among PWID/PWUD, other high-risk groups and partners with previous negative testing. 69 months Incidence per 100 person-years,Proportion of participants from the different high-risk groups who initiate or already receive, and maintain, HIV pre-exposure prophylaxis. 69 months Propotion,Proportion of participants non-immune to, and uninfected with HBV, who accept HBV vaccination. 69 months Propotion,Proportion of participants who are vaccinated against HBV who seroconvert Anti-HBs/develop Hepatitis B surface antibodies. 69 months Propotion,Proportion of participants who tested positively for syphilis, gonococcal and chlamydial infection. 69 months Propotion,Proportion of participant who tested positively for latent tuberculosis infection, and are found to have active tuberculosis disease. 69 months Propotion,HCV reinfection rate in participants with spontaneous clearance or sustained virological response (SVR) post HCV treatment. 69 months Number and proportion of events | — |
Countries
Thailand
Contacts
Public ContactNicolas Durier
Dreamlopments Foundation
Outcome results
None listed