A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study
Status:
Completed
Trial end date:
2020-12-21
Target enrollment:
Participant gender:
Summary
Hepatitis C is a blood borne virus that can seriously damage the liver. An estimated 50,000
Scots have been infected with Hepatitis C virus (HCV). The main driver for spread of HCV
infection is intravenous drug use. As HCV is highly infectious by the blood borne route
through needle sharing, it can infect the person who injects drugs (PWID) early in their
habit.
Around two thirds of people who are infected are unaware of it, and often show no symptoms
over a long period of time. While there is presently no vaccination for Hepatitis C, improved
treatments with shorter duration are now available. This raises the possibility of using
therapy as prevention, turning the epidemic off at source, by targeting active PWID who are
the main source of new infections. Modelling work illustrates the startling possibility and
impact of treating drug users to reduce the prevalence of HCV.
The focus of this trial will be to ascertain whether oral treatment regimens are effective in
the treatment as prevention scenario in an active PWID population where illicit drug taking
and poor adherence may reduce treatment efficacy. The investigators will trial 3 different
methods of delivering treatment and will trial an unlicensed combined treatment against HCV
genotype 3 infection of shortened duration since current regimens for this genotype are
limited.
The investigators will recruit 135 participants and randomise them to one of three arms:
daily, directly observed therapy; fortnightly dispensing of drugs; fortnightly dispensing of
drugs with a psychological adherence intervention. Randomisation will be stratified according
to HCV genotype. Participants will be treated for 12 or 8 weeks depending on genotype and
followed up 12 weeks post treatment for the measurement of sustained viral response (SVR).
The primary outcome measure will be SVR at 12 weeks post treatment (SVR12), as this measure
of cure is the determinant of sufficient compliance and efficacy within the 3 treatment arms.
Analysis will be by modified intention to treat of all participants who receive one dose of
therapy, to show non-inferiority fortnightly dispensing is easier to deliver than daily
dispensing.