The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia.
Vancouver Infectious Diseases Center, Vancouver, Canada.
Int J Drug Policy. 2018 Dec;62:94-103. doi: 10.1016/j.drugpo.2018.10.004. Epub 2018 Oct 29.
Direct-acting antiviral therapy for hepatitis C virus (HCV) infection is safe and effective, but there are little data among people who have recently injected drugs. This study evaluated the efficacy, and safety of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for chronic HCV genotype (G) 1 among people with recent injecting drug use and/or receiving OST.
D3FEAT is an international open-label study that recruited treatment-naïve participants with recent injecting drug use (previous 6 months) and/or receiving OST with chronic HCV G1 infection between June 2016 and February 2017 in seven countries. Participants received paritaprevir/ritonavir, ombitasvir, dasabuvir with (G1a) or without ribavirin (G1b) administered twice daily in a one-week electronic blister pack (records timing of each dose) for 12 weeks. The primary endpoint was undetectable HCV RNA 12 weeks post-treatment (SVR12).
Among 87 participants (median age 48 years), 23% were female, 8% had cirrhosis, and 90% had G1a. Overall, 71% were receiving OST, 61% injected in the previous six months, 45% injected in the previous month, and 15% injected > daily. Treatment completion was 97% (84 of 87). There were no virological breakthroughs, but three discontinuations (loss to follow-up, n = 1; non-adherence, n = 1; incarceration, n = 1). SVR was 91% (79 of 87, 95% CI, 83%-96%). Five participants who completed treatment did not have SVR (loss to follow-up, n = 1; death, n = 1; virologic relapse, n = 3). Drug use prior to and during treatment did not impact SVR12. Treatment-related adverse events were observed in 46 (53%) patients (six grade 3, no grade 4). Five (6%) patients had at least one serious adverse event (two possibly/probably related to therapy; nausea and myoclonus). Two cases of reinfection were observed.
Paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without ribavirin for 12 weeks is effective among people with HCV genotype 1 with recent injecting drug use and/or receiving OST.
直接作用抗病毒药物治疗丙型肝炎病毒 (HCV) 感染安全有效，但在最近注射吸毒者中数据较少。本研究评估了帕利瑞韦/利托那韦、奥比他韦、达萨布韦联合或不联合利巴韦林治疗慢性 HCV 基因型 1（G）在近期有注射吸毒史和/或正在接受 OST 的人群中的疗效和安全性。
D3FEAT 是一项国际性、开放性标签研究，于 2016 年 6 月至 2017 年 2 月期间在 7 个国家招募了最近有注射吸毒史（过去 6 个月内）和/或慢性 HCV G1 感染且正在接受 OST 的治疗初治参与者。参与者接受帕利瑞韦/利托那韦、奥比他韦、达沙布韦（G1a 型）或无利巴韦林（G1b 型），每日两次，共 12 周，使用一周电子泡罩包装（记录每次剂量的时间）。主要终点是治疗后 12 周 HCV RNA 不可检测（SVR12）。
87 名参与者（中位年龄 48 岁）中，23%为女性，8%有肝硬化，90%为 G1a 型。总体而言，71%正在接受 OST，61%在过去 6 个月内注射，45%在过去 1 个月内注射，15%每日注射>1 次。治疗完成率为 97%（87 例中的 84 例）。没有病毒学突破，但有 3 例停药（失访，n=1；不依从，n=1；监禁，n=1）。SVR 为 91%（79 例中的 79 例，95%CI，83%-96%）。5 例完成治疗但未达到 SVR（失访，n=1；死亡，n=1；病毒学复发，n=3）。治疗前和治疗期间的药物使用并未影响 SVR12。46 名（53%）患者观察到治疗相关不良事件（6 例为 3 级，无 4 级）。5 名（6%）患者发生至少 1 例严重不良事件（2 例可能/极可能与治疗相关；恶心和肌阵挛）。观察到 2 例再感染。
帕利瑞韦/利托那韦、奥比他韦和达沙布韦联合或不联合利巴韦林治疗 12 周，对近期有注射吸毒史和/或正在接受 OST 的 HCV 基因型 1 患者有效。
