Institute for Global Health, University College London, London, United Kingdom.
CHIP, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
J Acquir Immune Defic Syndr. 2021 Feb 1;86(2):248-257. doi: 10.1097/QAI.0000000000002541.
To investigate the effectiveness, safety, and reasons for premature discontinuation of direct-acting antivirals (DAAs) in a diverse population of HIV/hepatitis C virus (HCV) coinfected individuals in Europe.
All HIV/HCV coinfected individuals in the EuroSIDA study that started interferon free DAA treatment between January 6, 2014, and January 3, 2018, with ≥12 weeks of follow-up after treatment stop were included in this analysis. Sustained virological response (SVR) was defined as a negative HCV-RNA result ≥12 weeks after stopping treatment (SVR12). Logistic regression was used to explore factors associated with SVR12.
1042 individuals started interferon-free DAA treatment after 1/6/2014 and were included, 862 (82.2%) had a known response to treatment, and 789 [91.5%, 95% confidence interval (CI): 89.7 to 93.4] of which achieved SVR12. There were no differences in SVR12 across regions of Europe (P = 0.84). After adjustment, the odds of achieving SVR12 was lower in individuals that received sofosbuvir/simeprevir ± ribavirin (RBV) [adjusted odds ratio 0.21 (95% CI: 0.08 to 0.53)] or ombitasvir/paritaprevir/dasabuvir ± RBV [adjusted odds ratio 0.46 (95% CI: 0.22 to 1.00)] compared with sofosbuvir/ledipasvir ± RBV. Forty-three (4.6%) individuals had one or more components of their HCV regimen stopped early, most commonly because of toxicity (n = 14); of these 14, 11 were treated with ribavirin. Increased bilirubin was the most common grade 3 or 4 laboratory adverse event (n = 15.3%) and was related to treatment with atazanavir and ribavirin.
Our findings from real-world data on HIV/HCV coinfected individuals across Europe show DAA treatment is well tolerated and that high rates of SVR12 can be achieved in all regions of Europe.
研究在欧洲不同人群的 HIV/丙型肝炎病毒 (HCV) 合并感染个体中，直接作用抗病毒药物 (DAA) 的疗效、安全性和停药原因。
本分析纳入了 EuroSIDA 研究中所有于 2014 年 1 月 6 日至 2018 年 1 月 3 日期间开始无干扰素 DAA 治疗且停药后随访时间≥12 周的 HIV/HCV 合并感染个体。持续病毒学应答 (SVR) 定义为停药后 12 周时 HCV-RNA 结果阴性( SVR12)。采用 logistic 回归分析探索与 SVR12 相关的因素。
共有 1042 名个体于 2014 年 1 月 6 日后开始无干扰素 DAA 治疗，其中 862 名(82.2%)已知对治疗有反应，789 名(91.5%，95%置信区间：89.7 至 93.4)实现了 SVR12。欧洲不同地区的 SVR12 无差异(P=0.84)。调整后，接受索非布韦/西米普韦±利巴韦林(Sofosbuvir/Simeprevir ± Ribavirin，RBV)(调整后的优势比 0.21，95%置信区间：0.08 至 0.53)或奥比他韦/帕利他韦/达萨布韦±RBV(Ombitasvir/Paritaprevir/Dasabuvir ± RBV)(调整后的优势比 0.46，95%置信区间：0.22 至 1.00)治疗的个体获得 SVR12 的可能性较低。43 名(4.6%)个体的 HCV 治疗方案的一个或多个组成部分提前停药，最常见的原因是毒性(n=14)；其中 11 名接受利巴韦林治疗。胆红素升高是最常见的 3 级或 4 级实验室不良事件(n=15.3%)，与阿扎那韦和利巴韦林有关。
我们从欧洲 HIV/HCV 合并感染个体的真实世界数据中得到的结果表明，DAA 治疗耐受性良好，在欧洲所有地区都可实现较高的 SVR12 率。
