Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting - Trial NCT03740906

Timeline & Enrollment

Primary Outcome

To evaluate the incidence of HCV reinfection following successful DAA therapy among people with chronic HCV infection and recent injecting drug use in the prison setting.

Summary

SHARP-P is an observational cohort study investigating the effect of direct-acting antiviral
 (DAA) therapy and reinfection in people with chronic hepatitis C virus (HCV) and recent
 injecting drug use. A prospective, observational cohort design will be used to enrol patients
 from correctional centres in New South Wales, Australia.
 
 Participants will be prescribed a direct-acting HCV medication as per the standard of care.
 The on treatment phase will vary dependent on the type of a direct-acting antiviral
 prescribed as per the standard of care. Once patients have completed their treatment course
 they will be followed up every 3 months for up to 3 years following the end of treatment
 phase.
 
 The study will aim to evaluate the incidence of HCV reinfection following successful DAA
 treatment over the three years of follow up. The study will also evaluate the proportion of
 patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) with
 direct-acting anti-viral HCV therapy.

ICD-10 Classifications