Outcomes of Treatment for Hepatitis C in Primary Care, Compared to Hospital-based Care: A Randomized, Controlled Trial in People Who Inject Drugs

Abstract

Background To achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to direct-acting antivirals (DAAs), especially among 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 randomized PWID with HCV 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 whether people treated in primary care had a noninferior rate of sustained virologic response at Week 12 (SVR12), compared to historical controls (consistent with DAA trials at the time of the study design); secondary outcomes included comparisons of treatment initiation, SVR12 rates, and the care cascade by study arm. Results We recruited 140 participants and randomized 136: 70 to the primary care arm and 66 to the SOC arm. The SVR12 rate (100%, 95% confidence interval [CI] 87.7–100) of people treated in primary care was noninferior when compared to historical controls (85% assumed). An intention-to-treat analysis revealed that the proportion of participants commencing treatment in the primary care arm (75%, 43/57) was significantly higher than in the SOC arm (34%, 18/53; P < .001; relative risk [RR] 2.48, 95% CI 1.54–3.95), and the proportion of participants with SVR12 was significantly higher in the primary care arm, compared to in the SOC arm (49% [28/57] and 30% [16/53], respectively; P = .043; RR 1.63, 95% CI 1.0–2.65). Conclusions Providing HCV treatment in primary care increases treatment uptake and cure rates. Approaches that increase treatment uptake among PWID will accelerate elimination strategies. Clinical Trials Registration NCT02555475.

Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs

“…One of the critical obstacles to HCV care in this population is the lack of treatment models within specialist healthcare adapted to marginalized individuals [15][16][17]. The current standard of care, involving referral of patients to specialist care at hospital outpatient clinics, has proven ineffective in this group due to low attendance and lack of retention in the care cascade [18][19][20][21]. Even low-threshold outreach clinics may be unable to reach the most marginalized individuals [22], e.g.…”

In support of community‐based hepatitis C treatment with triage of people at risk of cirrhosis to specialist care

“…2 We conducted a randomized study comparing community-based hepatitis C care with hospital-based care (The Prime Study) in people who inject drugs (PWID), which showed substantially higher treatment uptake in the community care group. 3 Current guidelines recommend that people with cirrhosis require specialist care; therefore, PWID at risk of cirrhosis were ineligible for the Prime Study and were referred to a hospital specialist. 4 We were concerned that this group may not attend and realize the benefits of hepatitis C treatment, because of previous negative experiences of hospital care.…”

“…Amanda J. Wade 1,2 Joseph S. Doyle 1,3 Bridget Draper 1 Jessica Howell 1,4 David Iser 3,4 Stuart K. Roberts 5,6 William Kemp 5,6 Alexander J. Thompson 4,7 Margaret E. Hellard 1,2,8…”

Decentralized, Community-Based Hepatitis C Point-of-Care Testing and Direct-Acting Antiviral Treatment for People Who Inject Drugs and the General Population in Myanmar: Protocol for a Feasibility Study

“…Given that hepatitis C treatment is now simple and safe, there is a push to simplify clinical care pathways to enable rapid scale-up and access to treatments. Although the advent of DAAs made decentralized models of care led by general practitioners (GPs) in primary care settings possible [ 8 , 9 ], the dominant model remains as specialist physicians prescribing at tertiary hospitals. Alongside the introduction of these new treatments, there are various World Health Organization (WHO) prequalified point-of-care (POC) testing and diagnostic technologies available for hepatitis C [ 10 , 11 ].…”