Outcomes of Treatment for Hepatitis C in Primary Care, Compared to Hospital-based Care: A Randomized, Controlled Trial in People Who Inject Drugs
Autor: | David Iser, Catherine A.M. Stedman, L. Stothers, Dennis Petrie, Bridget Draper, William Kemp, Joseph Doyle, Margaret Hellard, Stuart K. Roberts, Paul A. Agius, Alexander J. Thompson, Amanda Wade, Nick Scott, Peter Higgs, Edward Gane, Janine Roney |
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Rok vydání: | 2019 |
Předmět: |
Microbiology (medical)
medicine.medical_specialty Sofosbuvir Hepacivirus Antiviral Agents law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Internal medicine medicine Humans 030212 general & internal medicine Substance Abuse Intravenous Dasabuvir Primary Health Care business.industry Australia Hepatitis C Hepatitis C Chronic medicine.disease Hospitals Confidence interval Clinical trial Substance abuse Infectious Diseases Pharmaceutical Preparations chemistry Relative risk 030211 gastroenterology & hepatology business New Zealand medicine.drug |
Zdroj: | Clinical Infectious Diseases. 70:1900-1906 |
ISSN: | 1537-6591 1058-4838 |
Popis: | 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. |
Databáze: | OpenAIRE |
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