Murray Miranda I, Markowitz Martin, Frank Ian, Grant Robert M, Mayer Kenneth H, Hudson Krischan J, Stancil Britt S, Ford Susan L, Patel Parul, Rinehart Alex R, Spreen William R, Margolis David A
a ViiV Healthcare , London , UK.
b The Aaron Diamond AIDS Research Center, an affiliate of the Rockefeller University , New York , NY , USA.
HIV Clin Trials. 2018 Aug;19(4):129-138. doi: 10.1080/15284336.2018.1511346. Epub 2018 Nov 16.
Cabotegravir (GSK1265744) is an integrase strand transfer inhibitor in development as a long-acting (LA) intramuscular injectable suspension for HIV-1 pre-exposure prophylaxis (PrEP).
We report participant outcomes from the phase IIa ECLAIR study related to tolerability, acceptability, and satisfaction of cabotegravir LA.
The ECLAIR study (ClinicalTrials.gov identifier, NCT02076178) was a randomized, placebo-controlled study in healthy men not at high risk of acquiring HIV-1. Participants were randomized (5:1) to once-daily oral cabotegravir 30 mg or placebo tablets for 4 weeks, followed by gluteal intramuscular injections of cabotegravir LA 800 mg or saline placebo every 12 weeks. The primary objective was to evaluate the safety of cabotegravir LA over three injection cycles (to Week 41). Secondary objectives assessed the tolerability, satisfaction, and acceptability of cabotegravir LA.
Among 115 participants who received injections in the cabotegravir (n = 94) and placebo (n = 21) groups, 93% (n = 87) and 95% (n = 20) completed the injection phase, respectively. Injection intolerability led to withdrawal in 4 participants (4%) receiving cabotegravir LA. The most frequently reported Grade ≥2 adverse event was injection-site pain. Most participants (74% [n = 67]) receiving consecutive injections favored cabotegravir LA vs oral cabotegravir. Most participants were satisfied with cabotegravir LA (75% [n = 64]), were willing to continue (79% [n = 68]), and would recommend (87% [n = 75]) the therapy.
While Grade ≥2 injection-site pain was common, most participants reported overall satisfaction with and preference for cabotegravir LA, with few discontinuations due to injection intolerance. These findings support investigation of cabotegravir LA as an alternative to daily oral PrEP regimens.
卡博特韦（GSK1265744）是一种整合酶链转移抑制剂，正处于研发阶段，作为一种长效（LA）肌肉注射混悬液用于HIV-1暴露前预防（PrEP）。
我们报告了IIa期ECLAIR研究中与卡博特韦长效制剂的耐受性、可接受性和满意度相关的参与者结果。
ECLAIR研究（ClinicalTrials.gov标识符，NCT02076178）是一项针对无感染HIV-1高风险的健康男性的随机、安慰剂对照研究。参与者被随机分组（5:1），每天口服30mg卡博特韦或安慰剂片剂，持续4周，随后每12周在臀肌处肌肉注射800mg卡博特韦长效制剂或生理盐水安慰剂。主要目的是评估三个注射周期（至第41周）内卡博特韦长效制剂的安全性。次要目的是评估卡博特韦长效制剂的耐受性、满意度和可接受性。
在卡博特韦组（n = 94）和安慰剂组（n = 21）中接受注射的115名参与者中，分别有93%（n = 87）和95%（n = 20）完成了注射阶段。注射不耐受导致4名接受卡博特韦长效制剂的参与者（4%）退出。最常报告的≥2级不良事件是注射部位疼痛。大多数接受连续注射的参与者（74% [n = 67]）更喜欢卡博特韦长效制剂而非口服卡博特韦。大多数参与者对卡博特韦长效制剂感到满意（75% [n = 64]），愿意继续使用（79% [n = 68]），并会推荐（87% [n = 75]）该疗法。
虽然≥2级注射部位疼痛很常见，但大多数参与者报告对卡博特韦长效制剂总体满意且更倾向于使用，因注射不耐受而停药的情况很少。这些发现支持对卡博特韦长效制剂作为每日口服PrEP方案替代方案的研究。
