Access and response to direct antiviral agents (DAA) in HIV-HCV co-infected patients in Italy: Data from the Icona cohort.
Access and response to direct antiviral agents (DAA) in HIV-HCV co-infected patients in Italy: Data from the Icona cohort.
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DOI：
10.1371/journal.pone.0177402
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发表时间：
2017
期刊：
影响因子：
3.7
通讯作者：
Icona Foundation and HepaIcona Study Group
中科院分区：
文献类型：
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作者：
d'Arminio Monforte A;Cozzi-Lepri A;Ceccherini-Silberstein F;De Luca A;Lo Caputo S;Castagna A;Mussini C;Cingolani A;Tavelli A;Shanyinde M;Gori A;Girardi E;Andreoni M;Antinori A;Puoti M;Icona Foundation and HepaIcona Study Group
缺乏关于 HIV-HCV 合并感染者使用直接抗病毒药物 (DAA) 和对其反应的真实数据。包括来自 Icona 和 Hepaicona 队列的 HCV 病毒血症、HIV 阳性患者，这些患者在 2013 年 1 月之前未接受过 DAA。对起始 DAA 的获取和预测因素进行了评估。描述了开始 DAA 时抗逆转录病毒药物的转换。我们计算了治疗结束 (EOT) 后 12 周的持续病毒学应答 (SVR12)，并将治疗失败 (TF) 定义为在 EOT 之前停止 DAA 或非 SVR12。统计分析包括Kaplan-Meier曲线、单变量和多变量分析，评估获得DAA和治疗结果（非SVR和TF）的预测因素。包括 2,607 名患者。在中位随访 38 个月（IQR：30-41）个月期间，920 名患者（35.3%）开始了 DAA。报销资格是获得治疗的最强预测因素：761/1,090 人（69.8%）有资格获得 DAA 报销，159/1,517 人（10.5%）没有资格获得 DAA 报销。对于符合 DAA 报销资格的人来说，年龄较大、HIV-RNA≤50 拷贝/mL 与更快的 DAA 启动、更高的 CD4 计数和 HCV 基因型 3 以及延迟的 DAA 启动相关。高达 28% 的患者（其中 36% 接受利托那韦增强蛋白酶抑制剂 (PI/r) 治疗）在 DAA 开始时接受了抗逆转录病毒 (ART) 修饰。 545/595 (91.6%) 达到 EOT 的患者达到了 SVR12。总体而言，61/606 名患者 (10.1%) 发生 TF，其中 11 名患者在 EOT 前停用 DAA。次优 DAA 是非 SVR12（AHR 2.52，95%CI：1.24–5.12）和 TF（AHR：2.19；95%CI：1.13–4.22）的唯一独立预测因子。只有 35.3% 的人获得了 HCV 治疗。尽管 SVR12 率很高 (91.6%)，但我们的 HIV-HCV 合并感染患者中只有 21% (545/2,607) 被治愈。
Real-life data on access and response to direct antiviral agents (DAA) in HIV-HCV coinfected individuals are lacking. HCV viremic, HIV-positive patients from Icona and Hepaicona cohorts naïve to DAA by January 2013 were included. Access and predictors of starting DAA were evaluated. Switches of antiretroviral drugs at starting DAA were described. We calculated sustained virological response (SVR12) in those reaching 12 weeks after end-of-treatment (EOT), and defined treatment failure (TF) as discontinuation of DAA before EOT or non-SVR12. Statistical analyses included Kaplan-Meier curves, univariable and multivariable analyses evaluating predictors of access to DAA and of treatment outcome (non-SVR and TF). 2,607 patients included. During a median follow-up of 38 (IQR:30–41) months, 920 (35.3%) patients started DAA. Eligibility for reimbursement was the strongest predictor to access to treatment: 761/1,090 (69.8%) eligible and 159/1,517 (10.5%) non-eligible to DAA reimbursement. Older age, HIV-RNA≤50 copies/mL were associated to faster DAA initiation, higher CD4 count and HCV-genotype 3 with delayed DAA initiation in those eligible to DAA reimbursement. Up to 28% of patients (36% of those on ritonavir-boosted protease inhibitors, PI/r) underwent antiretroviral (ART) modification at DAA initiation. 545/595 (91.6%) patients reaching EOT achieved SVR12. Overall, TF occurred in 61/606 patients (10.1%), with 11 discontinuing DAA before EOT. Suboptimal DAA was the only independent predictor of both non-SVR12 (AHR 2.52, 95%CI:1.24–5.12) and TF (AHR: 2.19; 95%CI:1.13–4.22). Only 35.3% had access to HCV treatment. Despite excellent rates of SVR12 rates (91.6%), only 21% (545/2,607) of our HIV-HCV co-infected patients are cured.