Preliminary Analysis Of The Prime Study; A Randomized Controlled Trial Comparing The Hepatitis C Care Cascade In Primary Care Vs. Tertiary Care


Author: Wade AJ, Doyle JS, Gane E, Stedman C, Draper B, Iser D, Roberts SK, Kemp W, Petrie D, Scott N , Higgs P, Agius PA, Roney J, Stothers L, Thompson AJ, Hellard ME

Theme: Epidemiology & Public Health Research Year: 2018

Background: In order to eliminate hepatitis C it is essential to increase access to treatment, especially for people who inject drugs (PWID). The Prime Study is an Australasian study that aims to measure the feasibility and efficacy of providing direct acting antivirals (DAAs) in primary care. Methods: People with hepatitis C were recruited in primary care and randomized to receive assessment and DAAs in primary care (intervention arm), or the local tertiary hospital (standard of care (SOC) arm). Participants assessed as cirrhotic were ineligible. Study endpoints included key milestones in the care cascade. Participants could exit the study by failing to attend or declining to schedule further appointments. We report descriptive preliminary results from the first 120 participants. Results: 49% had injected in the last six months. 116 participants were randomized; 59 to the intervention arm and 57 to SOC. Of 59 participants in the intervention arm; 52 (88%) completed assessment (39 were eligible, 13 were ineligible) and 7 exited the study. Of the 39 eligible participants, 34 commenced DAAs and 5 exited. The treatment rate, excluding ineligible participants, was 34/46 (74%). 32 participants have reached their SVR12 time-point; 15 have completed a test demonstrating SVR12, 1 has an SVR11 and 16 are yet to have a test. Of 57 participants in the SOC arm; 38 (67%) completed assessment (25 were eligible, 13 were ineligible) and 19 exited the study. Of the 25 eligible participants 17 commenced DAAs and 8 exited. The treatment rate, excluding ineligible participants, was 17/44 (39%). 16 participants have reached their SVR12 time-point; 11 completed a test demonstrating SVR12 and 5 are yet to have a test. 2 Conclusion: Preliminary analysis suggests that providing liver assessment and DAAs in primary care may increase treatment uptake, including in PWID – which is key to eliminating hepatitis C.

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