Prisons Evaluation of a One-stop-shop InterVentiOn

Inclusion criteria

• has provided written, informed consent to participate;
• is male and ≥18 years of age on enrolment;
• has been incarcerated within the last six weeks;
• is HCV DAA treatment naïve;
• is able and willing to provide informed consent and abide by the requirements of the study.

For HCV RNA positive participants commencing treatment:

• if HIV-1 infected must also meet the following criteria:

• HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Baseline) and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load; and
• be on HIV antiretroviral therapy (ART) for at least 4 weeks prior to study entry using an ART regimen that is allowable with the selected DAA regimen as determined by the current PI and the Liverpool drug interaction website (http://www.hiv-druginteractions.org/ )

Exclusion criteria

For HCV RNA positive participants commencing treatment, the subject will be excluded if they have:

• untreated HIV co-infection;
• chronic HBV co-infection;
• any clinically significant condition, history or concomitant medication known to contraindicate DAA therapy or would not be suitable for management within a prison-based treatment setting;
• is unable to gain an accurate reading on the fibroscan or the result is invalid;
• known clinical or laboratory evidence of cirrhosis, or cirrhosis documented on fibro-elastography (> 12.5 Kpa).