BACKGROUND: To achieve the World Health Organization hepatitis C elimination targets, it is essential to increase access to direct acting antivirals (DAAs) - especially amongst people who inject drugs (PWID). We aimed to determine the effectiveness of providing DAAs in primary care compared with hospital-based specialist care. METHODS: We randomised PWID with hepatitis C attending primary care sites in Australia or New Zealand to receive DAAs at their primary care site or local hospital (standard of care (SOC)). The primary outcome was to determine if people treated in primary care had a non-inferior sustained virologic response at week 12 (SVR12) rate compared to historical controls (consistent with DAA trials at the time of study design); secondary outcomes included comparison of treatment initiation, SVR12 rates, and the care cascade by study arm. RESULTS: We recruited 140 participants and randomised 136; 70 to primary care and 66 to SOC. The SVR12 rate (100%, 95% CI, 87.7-100) of people treated in primary care was non-inferior when compared to historical controls (85% assumed). Intention to treat analysis revealed that the proportion of participants commencing treatment in primary care (75%, 43/57) was significantly higher than in SOC (34%, 18/53) (p<0.001; RR 2.48; 95% CI, 1.54-3.95), and the proportion of participants with SVR12 was significantly higher in primary care compared to SOC (49%, 28/57 and 30%, 16/53) (p=0.043; RR 1.63; 95% CI,1.0-2.65). CONCLUSION: Providing hepatitis C treatment in primary care increases treatment uptake and cure. Approaches that increase treatment uptake amongst PWID will accelerate elimination strategies.
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