来迪派韦与索磷布韦复方制剂用于HIV阳性合并丙型肝炎病毒2型感染患者的真实世界经验：一项多中心回顾性研究
Real-World Experience with Coformulated Ledipasvir and Sofosbuvir for HIV-Positive Patients with HCV Genotype 2 Infection: A Multicenter, Retrospective Study.
作者信息
Liou Bo-Huang, Sun Hsin-Yun, Yang Chia-Jui, Syue Ling-Shan, Lee Yu-Lin, Tang Hung-Jen, Tsai Hung-Chin, Lin Chi-Ying, Chen Tun-Chieh, Lee Chun-Yuan, Huang Sung-Hsi, Liu Chia-Wei, Lu Po-Liang, Lin Shih-Ping, Wang Ning-Chi, Cheng Aristine, Ko Wen-Chien, Cheng Shu-Hsing, Hung Chien-Ching
机构信息
Department of Internal Medicine, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.
Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
出版信息
Infect Dis Ther. 2021 Jun;10(2):827-838. doi: 10.1007/s40121-021-00424-8. Epub 2021 Mar 18.
INTRODUCTION
While coformulated ledipasvir (90 mg)/sofosbuvir (400 mg) (LDV/SOF) is approved for the treatment of hepatitis C virus (HCV) genotype 2 (GT2) infection in Taiwan, Japan, and New Zealand, data regarding its use for HIV (Human Immunodeficiency Virus)-positive patients infected with HCV GT2 are sparse. We aimed to assess the effectiveness and tolerability of LDV/SOF for HIV-positive patients with HCV GT2 coinfection.
METHODS
From January 2019 to July 2020, consecutive HIV-positive Taiwanese patients infected with HCV GT2 who received LDV/SOF were retrospectively included for analysis. The effectiveness was determined by sustained virologic response 12 weeks off-therapy (SVR12).
RESULTS
Of the 114 patients (mean age, 38.6 years) initiating LDV/SOF during the study period, 0.9% had liver cirrhosis and 4.4% were HCV treatment-experienced. All patients had estimated glomerular filtration rate (eGFR) > 30 ml/min/1.73 m and were receiving antiretroviral therapy with 98.2% having CD4 counts ≥ 200 cells/mm and 93.9% plasma HIV RNA load < 50 copies/ml. Antiretrovirals prescribed included tenofovir alafenamide/emtricitabine in 42.1%, tenofovir disoproxil fumarate (TDF)/emtricitabine 18.4%, other nucleoside reverse transcriptase inhibitors (NRTIs) 39.5%, non-NRTIs 12.3%, protease inhibitors 13.2%, and integrase inhibitors 74.6%. All patients had undetectable plasma HCV RNA load at the end of treatment, and 96.5% achieved SVR12 in intention-to-treat analysis. The on-treatment eGFR decline was more pronounced in those receiving TDF-containing antiretroviral therapy (mean change, - 8.33 ml/min/1.73 m), which was reversible after discontinuation of LDV/SOF. None of the patients interrupted LDV/SOF during the 12-week treatment course.
CONCLUSION
Similar to the response observed among HIV-negative patients, LDV/SOF is effective for HIV-positive patients coinfected with HCV GT2.
引言
虽然复方雷迪帕韦（90毫克）/索磷布韦（400毫克）（LDV/SOF）已在台湾、日本和新西兰获批用于治疗丙型肝炎病毒（HCV）基因2型（GT2）感染，但关于其在感染HCV GT2的人类免疫缺陷病毒（HIV）阳性患者中的应用数据稀少。我们旨在评估LDV/SOF对HCV GT2合并感染的HIV阳性患者的有效性和耐受性。
方法
回顾性纳入2019年1月至2020年7月期间连续接受LDV/SOF治疗的感染HCV GT2的HIV阳性台湾患者进行分析。有效性通过治疗停药12周后的持续病毒学应答（SVR12）来确定。
结果
在研究期间开始使用LDV/SOF的114例患者（平均年龄38.6岁）中，0.9%有肝硬化，4.4%有HCV治疗史。所有患者的估计肾小球滤过率（eGFR）>30毫升/分钟/1.73平方米，并且正在接受抗逆转录病毒治疗，98.2%的患者CD4细胞计数≥200个/立方毫米，93.9%的患者血浆HIV RNA载量<50拷贝/毫升。所开具的抗逆转录病毒药物包括42.1%的丙酚替诺福韦/恩曲他滨、18.4%的富马酸替诺福韦二吡呋酯（TDF）/恩曲他滨、39.5%的其他核苷类逆转录酶抑制剂（NRTIs）、12.3%的非核苷类逆转录酶抑制剂、13.2%的蛋白酶抑制剂以及74.6%的整合酶抑制剂。所有患者在治疗结束时血浆HCV RNA载量均检测不到，在意向性分析中96.5%的患者实现了SVR12。接受含TDF抗逆转录病毒治疗的患者治疗期间eGFR下降更为明显（平均变化-8.33毫升/分钟/1.73平方米），在停用LDV/SOF后可逆转。在12周治疗过程中没有患者中断LDV/SOF治疗。
结论
与在HIV阴性患者中观察到的应答相似，LDV/SOF对合并HCV GT2感染的HIV阳性患者有效。
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