Extended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community: Results of a Double-Blind, Placebo-Controlled Randomized Trial.
Extended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community: Results of a Double-Blind, Placebo-Controlled Randomized Trial.
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DOI：
10.1097/qai.0000000000001634
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发表时间：
2018-05-01
期刊：
影响因子：
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通讯作者：
Altice FL
中科院分区：
文献类型：
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作者：
Springer SA;Di Paola A;Azar MM;Barbour R;Biondi BE;Desabrais M;Lincoln T;Skiest DJ;Altice FL
确定缓释纳曲酮（XR-NTX）是否会改善或维持艾滋病毒和阿片类药物使用障碍（OUD）向社区过渡的囚犯或监狱在押人员的病毒抑制（VS）。在2010年9月至2016年3月期间，一项四站点、前瞻性、随机、双盲、安慰剂对照试验在监狱和监狱囚犯中进行，这些囚犯携带艾滋病毒和OUD向社区过渡。符合条件的参与者（N=93）按2:1随机分配，从释放开始接受6个月注射XR-NTX （N= 66）或安慰剂（N= 27），观察6个月。主要终点是从基线到6个月维持或改善VS（<50拷贝/mL）的比例。分配给XR-NTX的参与者从基线（37.9%）到6个月（60.6%）显著改善到VS(<50拷贝/mL) (p=0.002)，而安慰剂组没有（基线55.6%到6个月40.7% p=0.294）。然而，6个月时XR-NTX（60.6%）与安慰剂（40.7%）的VS水平无统计学差异（p=0.087）。在控制其他因素后，仅分配XR-NTX （aOR=2.90; 95% CI= 1.04-8.14, p=0.043）与主要结局相关。治疗组之间从基线到6个月的VS轨迹有显著差异（p=0.017），不一致值的差异也有显著差异（p=0.041）： XR-NTX组比安慰剂组更有可能改善VS (30.3% VS 18.5%)；维持VS (30.3% VS . 27.3%)，并且在6个月内不太可能失去VS （7.6% VS . 33.3%）。XR-NTX改善或维持被监禁的患有OUD的PLH释放后的VS。
To determine if extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among prisoners or jail detainees with HIV and opioid use disorders (OUD) transitioning to the community. A four-site, prospective randomized double-blind, placebo-controlled trial was conducted among prison and jail inmates with HIV and OUD transitioning to the community from September 2010 through March 2016. Eligible participants (N=93) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n=66) or placebo (n=27) starting at release and observed for 6 months. The primary outcome was the proportion that maintained or improved VS (<50 copies/mL) from baseline to 6 months. Participants allocated to XR-NTX significantly improved to VS (<50 copies/mL) from baseline (37.9%) to 6-months (60.6%) (p=0.002), while the placebo group did not (55.6% at baseline to 40.7% at 6-months p=0.294). There was, however, no statistical significant difference in VS levels at 6 months between XR-NTX (60.6%) vs. Placebo (40.7%) (p=0.087). After controlling for other factors, only allocation to XR-NTX (aOR=2.90; 95% CI=1.04–8.14, p=0.043) was associated with the primary outcome. Trajectories in VS from baseline to 6 months differed significantly (p=0.017) between treatment groups, and the differences in the discordant values were significantly different as well (p=0.041): the XR-NTX group was more likely than the placebo group to improve VS (30.3% vs 18.5%); maintain VS (30.3% vs. 27.3), and less likely to lose VS (7.6% vs. 33.3%) by 6 months. XR-NTX improves or maintains VS after release to the community for incarcerated PLH with OUD.