El Sayed Ahmed, Barbati Zachary R, Turner Samuel S, Foster Andrew L, Morey Tristan, Dieterich Douglas T, Fierer Daniel S
a Division of Infectious Diseases, Department of Medicine , Icahn School of Medicine at Mount Sinai , New York , NY , USA.
b Liver Diseases, Department of Medicine , Icahn School of Medicine at Mount Sinai , New York , NY , USA.
HIV Clin Trials. 2017 Mar;18(2):60-66. doi: 10.1080/15284336.2017.1280594. Epub 2017 Feb 10.
There is an international epidemic of hepatitis C virus (HCV) infection among HIV-infected men who have sex with men. We previously showed that adding telaprevir to pegylated interferon (IFN) and ribavirin (RBV) both shortened treatment and increased the cure rate of early HCV in these men. Whether shortening treatment of early HCV using IFN-free regimens would be similarly successful has not yet been demonstrated.
We performed a pilot study of treatment with sofosbuvir (SOF) + RBV for 12 weeks in early genotype 1 HCV infection in HIV-infected men. The primary endpoint was SVR 12.
Twelve men were treated with 12 weeks SOF + RBV and 11 (92%) achieved SVR 12. Most (63%) were actively using recreational drugs, mostly methamphetamine. The one man who failed had laboratory results more characteristic of chronic than of early HCV infection. The overall safety profile was similar to that known for SOF + RBV.
The success of this short-duration IFN-free treatment in early HCV infection is proof in principle that enhanced treatment responsiveness is an inherent characteristic of early HCV infection and not a function of IFN treatment itself. Future studies should now be done with more potent regimens to try to further shorten therapy. In the mean time, in clinical practice early HCV infection should be treated immediately after detection to take advantage of short-duration treatments, as well as to decrease further HCV transmission among HIV-infected MSM.
丙型肝炎病毒(HCV)感染在男男性行为的HIV感染者中呈国际流行态势。我们之前的研究表明,在聚乙二醇化干扰素(IFN)和利巴韦林(RBV)基础上加用特拉匹韦可缩短治疗时间并提高这些男性早期HCV的治愈率。使用不含IFN的方案缩短早期HCV治疗时间是否同样成功尚未得到证实。
我们开展了一项针对HIV感染男性早期基因1型HCV感染患者使用索磷布韦(SOF)+RBV治疗12周的试点研究。主要终点为治疗结束后12周持续病毒学应答(SVR12)。
12名男性接受了12周的SOF+RBV治疗,其中11名(92%)实现了SVR12。大多数(63%)患者正在积极使用消遣性药物,主要是甲基苯丙胺。唯一治疗失败的患者其实验室检查结果更具慢性HCV感染而非早期感染的特征。总体安全性与已知的SOF+RBV相似。
这种短疗程不含IFN的治疗在早期HCV感染中取得成功,原则上证明了增强的治疗反应性是早期HCV感染的固有特征,而非IFN治疗本身的作用。现在应开展更多使用更有效方案的研究,以进一步缩短治疗疗程。同时,在临床实践中,早期HCV感染一经检测应立即治疗,以利用短疗程治疗的优势,并减少HIV感染的男男性行为者中HCV的进一步传播。