Patel Manish, Rab Saira, Kalapila Aley G, Kyle Alison, Okosun Ike Solomon, Miller Lesley
Department of Pharmacy and Drug Information and.
Infectious Diseases Program, Grady Health System, Atlanta, Georgia; Divisions of.
Open Forum Infect Dis. 2017 Apr 5;4(2):ofx062. doi: 10.1093/ofid/ofx062. eCollection 2017 Spring.
The introduction of direct-acting antivirals (DAAs) created a major paradigm shift in the treatment of chronic hepatitis C. Currently, there is little "real-world" data regarding hepatitis C virus (HCV) treatment outcomes in the human immunodeficiency virus (HIV)/HCV-coinfected population.
This retrospective cohort study examined HCV treatment outcomes of HIV/HCV-coinfected patients at a large, urban, Ryan White-funded clinic caring for an underserved population. All HIV patients initiating HCV treatment from January 1, 2013 to November 30, 2015 were included in the analysis. The primary end point was sustained virologic response 12 weeks after the end of therapy (SVR12).
A total of 172 patients initiated HCV treatment within the study period: 79% were male, 83% were black, 95% were HCV genotype 1, 79% were HCV treatment naive, and 16% had cirrhosis. At baseline, median CD4 was 494 cells/μL (interquartile range, 316-722) and 92% had HIV ribonucleic acid less than 40 copies/mL. The most common DAA initiated was ledipasvir/sofosbuvir (LDV/SOF) (85%), with 92% receiving 12 weeks of treatment. Overall, SVR12 was 93% by intention-to-treat analysis and 98% by per-protocol analysis. The majority of patients on LDV/SOF did not report any adverse effect. One patient in the ribavirin plus SOF group discontinued treatment due to adverse effect.
In a cohort of mainly black, male, HIV/HCV-coinfected patients at a large, urban, Ryan White clinic, HCV treatment with DAAs resulted in high SVR12 rates and was well tolerated despite real-world challenges including medication access barriers and drug interaction concerns.
直接抗病毒药物(DAAs)的引入使慢性丙型肝炎的治疗发生了重大范式转变。目前,关于人类免疫缺陷病毒(HIV)/丙型肝炎病毒(HCV)合并感染人群中丙型肝炎病毒(HCV)治疗结果的“真实世界”数据很少。
这项回顾性队列研究在一家大型城市的、由瑞安·怀特基金资助的诊所,对服务不足人群中HIV/HCV合并感染患者的HCV治疗结果进行了研究。分析纳入了2013年1月1日至2015年11月30日期间开始HCV治疗的所有HIV患者。主要终点是治疗结束后12周的持续病毒学应答(SVR12)。
在研究期间,共有172例患者开始HCV治疗:79%为男性,83%为黑人,95%为HCV基因1型,79%为初治HCV患者,16%有肝硬化。基线时,CD4中位数为494个细胞/μL(四分位间距,316 - 722),92%的患者HIV核糖核酸低于40拷贝/mL。最常用的起始DAA是来迪派韦/索磷布韦(LDV/SOF)(85%),92%的患者接受12周治疗。总体而言,意向性分析的SVR12为93%,符合方案分析为98%。大多数接受LDV/SOF治疗的患者未报告任何不良反应。利巴韦林加SOF组有1例患者因不良反应停药。
在一家大型城市的瑞安·怀特诊所中,以黑人、男性为主的HIV/HCV合并感染患者队列中,使用DAAs进行HCV治疗导致SVR12率较高,尽管存在包括药物获取障碍和药物相互作用担忧等现实挑战,但耐受性良好。