美国内布拉斯加大学医学中心Susan Swindells研究组近日取得一项新成果。他们研究了长效Cabotegravir和Rilpivirine维持HIV-1抑制的效果。该项研究成果发表在2020年3月4日出版的《新英格兰医学杂志》上。

治疗1型人类免疫缺陷病毒（HIV-1）感染的简化方案可能会提高患者满意度并促进依从性。

在一项临床3期、开放标签、多中心、非劣效性试验中，研究组招募了接受标准口服抗逆转录病毒治疗，且血浆HIV-1 RNA水平低于每毫升50拷贝至少6个月的患者，将其随机分组，其中308例继续口服治疗，308例转为每月一次肌肉注射长效Cabotegravir和Rilpivirine。

治疗第48周，长效治疗组中有5名参与者（1.6%）的HIV-1 RNA水平超过每毫升50拷贝，而口服治疗组中有3名（1.0%），符合非劣效标准。第48周时，长效治疗组中有92.5%的患者HIV-1 RNA水平低于每毫升50拷贝，而口服治疗组中有95.5%，同样符合非劣效标准。

长效治疗组中有3名患者确认病毒学失败，口服治疗组有4名。长效治疗组中包括注射部位疼痛的不良事件更为常见，发生率为75%，但在大多数情况下为轻度或中度。1％的人因不良事件而退出。但两组患者中严重不良事件的发生率均不超过5％。

总之，每月长效注射Cabotegravir和Rilpivirine的疗效均不逊于维持HIV-1抑制的标准口服疗法。注射相关的不良事件常见但轻微，很少导致停药。

附：英文原文

Title: Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression | NEJM

Author: Susan Swindells, M.B., B.S.,, Jaime-Federico Andrade-Villanueva, M.D.,, Gary J. Richmond, M.D.,, Giuliano Rizzardini, M.D.,, Axel Baumgarten, M.D.,, Mar Masiá, M.D.,, Gulam Latiff, M.D.,, Vadim Pokrovsky, M.D.,, Fritz Bredeek, M.D.,, Graham Smith, M.D.,, Pedro Cahn, M.D.,, Yeon-Sook Kim, M.D., Ph.D.,, Susan L. Ford, Pharm.D.,, Christine L. Talarico, M.S.,, Parul Patel, Pharm.D.,, Vasiliki Chounta, M.S.,, Herta Crauwels, Ph.D.,, Wim Parys, M.D.,, Simon Vanveggel, M.S.,, Joseph Mrus, M.D.,, Jenny Huang, M.S.,, Conn M. Harrington, B.A.,, Krischan J. Hudson, Ph.D.,, David A. Margolis, M.D.,, Kimberly Y. Smith, M.D.,, Peter E. Williams, Ph.D.,, and William R. Spreen, Pharm.D.

Issue&Volume: 2020-03-04

Abstract: AbstractBackgroundSimplified regimens for the treatment of human immunodeficiency virus type 1 (HIV-1) infection may increase patient satisfaction and facilitate adherence.MethodsIn this phase 3, open-label, multicenter, noninferiority trial involving patients who had had plasma HIV-1 RNA levels of less than 50 copies per milliliter for at least 6 months while taking standard oral antiretroviral therapy, we randomly assigned participants (1:1) to either continue their oral therapy or switch to monthly intramuscular injections of long-acting cabotegravir, an HIV-1 integrase strand-transfer inhibitor, and long-acting rilpivirine, a nonnucleoside reverse-transcriptase inhibitor. The primary end point was the percentage of participants with an HIV-1 RNA level of 50 copies per milliliter or higher at week 48, determined with the use of the Food and Drug Administration snapshot algorithm.ResultsTreatment was initiated in 308 participants per group. At week 48, HIV-1 RNA levels of 50 copies per milliliter or higher were found in 5 participants (1.6%) receiving long-acting therapy and in 3 (1.0%) receiving oral therapy (adjusted difference, 0.6 percentage points; 95% confidence interval [CI], 1.2 to 2.5), a result that met the criterion for noninferiority for the primary end point (noninferiority margin, 6 percentage points). An HIV-1 RNA level of less than 50 copies per milliliter at week 48 was found in 92.5% of participants receiving long-acting therapy and in 95.5% of those receiving oral therapy (adjusted difference, 3.0 percentage points; 95% CI, 6.7 to 0.7), a result that met the criterion for noninferiority for this end point (noninferiority margin, 10 percentage points). Virologic failure was confirmed in 3 participants who received long-acting therapy and 4 participants who received oral therapy. Adverse events were more common in the long-acting–therapy group and included injection-site pain, which occurred in 231 recipients (75%) of long-acting therapy and was mild or moderate in most cases; 1% withdrew because of this event. Serious adverse events were reported in no more than 5% of participants in each group.ConclusionsMonthly injections of long-acting cabotegravir and rilpivirine were noninferior to standard oral therapy for maintaining HIV-1 suppression. Injection-related adverse events were common but only infrequently led to medication withdrawal.

DOI: 10.1056/NEJMoa1904398

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1904398