Author: Beer LJ, Byrne C, Inglis SK, Malaguti A, Robinson EM, Dillon JF

Theme: Clinical Research Year: 2019

Background: Direct Acting Antivirals (DAA) are the standard for Hepatitis C (HCV) treatment and are
efficacious in people who inject drugs (PWID), if taken for the recommended duration. However,
sustained viral response (SVR12)may still be achieved in cases where participants are non-compliant with
the recommended regimen. ADVANCE HCV is an ongoing randomised clinical trial of DAA HCV
treatment in PWID attending an injecting equipment provision site in Tayside, Scotland. Data presented
shows efficacy of shortened HCV treatment in ADVANCE HCV.
Methods: ADVANCE HCV participants are randomised to one of three treatment pathways and stratified
by gender and genotype (GT1 or GT3).
1. Directly Observed Therapy
2. Fortnightly dispensed
3. Fortnightly dispensed with a one off, psychological intervention to promote treatment
GT1 participants are treated with 12 weeks of elbasvir/grazoprevir and GT3 with 8 weeks of
elbasvir/grazoprevir plus sofosbuvir. If a participant misses 7 consecutive doses after commencing
treatment, therapy is stopped. Those with shortened treatment were followed up to SVR12.
Results: 77 participants initiated treatment, 12 had shortened regimens due to non-compliance and
were followed up to SVR12. 8 (66%) of these participants are male, 8 (66%) GT3 and 8 (66%) fortnightly
dispensed treatment. Consistent with the overall trial population.
GT1 shortened therapy; <2 weeks, 1. Two weeks, 1. Eight weeks, 1. Ten weeks, 1. GT3 shortened therapy; <2 weeks, 3. Four weeks, 2. Six weeks, 3. Of participants who took >2 weeks of therapy, 7/8 (88%) achieved SVR12. Of those who took <2 weeks, 0/4 achieved SVR. Conclusion: Although sample size is small, patient non-compliance with treatment is not always prohibitive to SVR12. While the recommended regimen offers the greatest likelihood of SVR12, PWID who do not comply with the full course of therapy, provided they have had over 2 weeks, should be followed up with to SVR12 with optimism. Disclosure of Interest Statement: This study is an Investigator initiated study funded by Merck Sharp & Dohme.Elbasvir/grazoprevir was provided gratis by Merck Sharp & Dohme as Zepatier. LJB, CB, SKI, AM, EMR declare no conflict of interest. JFD has honoraria for lectures and research grants from Janssen-Cilag, Roche, Merck Sharp & Dohme, AbbVie, Bristol-Myers Squibb, & Gilead.

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