Del Bello David, Cha Agnes, Sorbera Maria, Bichoupan Kian, Levine Calley, Doyle Erin, Harty Alyson, Patel Neal, Ng Michel, Gardenier Donald, Odin Joseph, Schiano Thomas D, Fierer Daniel S, Berkowitz Leonard, Perumalswami Ponni V, Dieterich Douglas T, Branch Andrea D
Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai.
Department of Pharmacotherapy, Brooklyn Hospital Center.
Clin Infect Dis. 2016 Jun 15;62(12):1497-1504. doi: 10.1093/cid/ciw119. Epub 2016 Mar 1.
Patients with hepatitis C virus (HCV) with or without human immunodeficiency virus (HIV) achieve high sustained virological response (SVR) rates on sofosbuvir (SOF)-containing regimens in clinical trials. Real world data on patients coinfected with HCV and HIV treated with SOF-based regimens are lacking.
This observational cohort study included HIV/HCV-coinfected adults with genotype 1 HCV who initiated treatment with a SOF-containing regimen between December 2013 and December 2014 (n = 89) at the Mount Sinai Hospital or the Brooklyn Hospital Center. The primary outcome was SVR at 12 weeks after the end of treatment. The secondary outcomes were risk factors for treatment failure, serious adverse events, and side effects. A post hoc per protocol analysis of SVR was performed on patients who completed treatment and follow-up.
In an intention-to-treat analysis, SVR rates were 76% (31/41) for simeprevir (SMV)/SOF, 94% (16/17) for SMV/SOF/ribavirin (RBV), and 52% (16/31) for SOF/RBV. The SVR rates of SMV/SOF/RBV and SMV/SOF did not differ significantly in this small study (P = .15). However the SVR rate of SMV/SOF/RBV was higher than that of SOF/RBV (P < .01). In a per protocol analysis, SMV/SOF/RBV had a higher SVR rate than SOF/RBV: 100% (16/16) vs 57% (16/28) (P < .01). The most commonly reported adverse effects were rash, pruritus, fatigue, and insomnia. One patient who had decompensated cirrhosis prior to treatment initiation died after receiving SMV/SOF.
SMV/SOF ± RBV is an effective option with minimal adverse effects for most HIV-positive patients with genotype 1 HCV. SMV should be used with caution in patients with decompensated cirrhosis.
在临床试验中，感染或未感染人类免疫缺陷病毒（HIV）的丙型肝炎病毒（HCV）患者采用含索磷布韦（SOF）的治疗方案可实现较高的持续病毒学应答（SVR）率。目前缺乏关于接受基于SOF方案治疗的HCV和HIV合并感染患者的真实世界数据。
这项观察性队列研究纳入了2013年12月至2014年12月期间在西奈山医院或布鲁克林医院中心开始接受含SOF方案治疗的1型HCV合并HIV感染的成年患者（n = 89）。主要结局是治疗结束后12周的SVR。次要结局是治疗失败的危险因素、严重不良事件和副作用。对完成治疗和随访的患者进行了事后符合方案的SVR分析。
在意向性分析中，simeprevir（SMV）/SOF的SVR率为76%（31/41），SMV/SOF/利巴韦林（RBV）为94%（16/17），SOF/RBV为52%（16/31）。在这项小型研究中，SMV/SOF/RBV和SMV/SOF的SVR率无显著差异（P = 0.15）。然而，SMV/SOF/RBV的SVR率高于SOF/RBV（P < 0.01）。在符合方案分析中，SMV/SOF/RBV的SVR率高于SOF/RBV：100%（16/16）对57%（16/28）（P < 0.01）。最常报告的不良反应是皮疹、瘙痒、疲劳和失眠。一名在开始治疗前有失代偿性肝硬化的患者在接受SMV/SOF治疗后死亡。
对于大多数1型HCV合并HIV阳性患者，SMV/SOF±RBV是一种有效的选择，不良反应最小。失代偿性肝硬化患者应谨慎使用SMV。
