Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial
Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial
复制标题
DOI：
10.1016/s0140-6736(13)61127-7
复制
发表时间：
2013-06-15
期刊：
影响因子：
168.9
通讯作者：
Vanichseni, Suphak
中科院分区：
文献类型：
--
作者：
Choopanya, Kachit;Martin, Michael;Vanichseni, Suphak
抗逆转录病毒暴露前预防可减少艾滋病毒的性传播。我们评估是否每天口服替诺福韦酯富马酸（替诺福韦），抗逆转录病毒药物，可以减少艾滋病毒的传播注射吸毒者。方法在这个随机，双盲，安慰剂对照试验，我们招募了志愿者从17个药物治疗诊所在曼谷，泰国。如果参与者年龄在20-60岁之间，艾滋病毒呈阴性，并报告在前一年注射毒品，则有资格参加。我们使用计算机生成的随机序列将参与者随机分配（1：1;四个区组）到替诺福韦或安慰剂组。参与者选择每日直接观察治疗或每月访视，并可在每月访视时转换。参与者每月接受艾滋病毒检测和个性化的风险降低和依从性咨询，每3个月进行一次血液安全评估，并提供避孕套和美沙酮治疗。主要疗效终点为HIV感染，采用改良的意向治疗分析进行分析。该试验注册于ClinicalTrials.gov，编号NCT 00119106。结果在2005年6月9日至2010年7月22日期间，我们招募了2413名参与者，其中1204名分配给替诺福韦，1209名分配给安慰剂。两名参与者在登记时感染了HIV，50名参与者在随访期间感染了HIV：替诺福韦组17人（发病率为0.35/100人年），安慰剂组33人（0.68/100人年），表明HIV发病率降低了48.9%（95%CI 9.6-72.2; p=0.01）。两组严重不良事件的发生率基本相同（p=0.35）。恶心在替诺福韦组的参与者中比在安慰剂组中更常见（p=0.002）。解释在这项研究中，每日口服替诺福韦降低了注射毒品的人感染艾滋病毒的风险。现在可以考虑将替诺福韦暴露前预防作为注射吸毒者艾滋病毒预防一揽子计划的一部分。
Background Antiretroviral pre-exposure prophylaxis reduces sexual transmission of HIV. We assessed whether daily oral use of tenofovir disoproxil fumarate (tenofovir), an antiretroviral, can reduce HIV transmission in injecting drug users.Methods In this randomised, double-blind, placebo-controlled trial, we enrolled volunteers from 17 drug-treatment clinics in Bangkok, Thailand. Participants were eligible if they were aged 20-60 years, were HIV-negative, and reported injecting drugs during the previous year. We randomly assigned participants (1: 1; blocks of four) to either tenofovir or placebo using a computer-generated randomisation sequence. Participants chose either daily directly observed treatment or monthly visits and could switch at monthly visits. Participants received monthly HIV testing and individualised risk-reduction and adherence counselling, blood safety assessments every 3 months, and were offered condoms and methadone treatment. The primary efficacy endpoint was HIV infection, analysed by modified intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00119106.Findings Between June 9, 2005, and July 22, 2010, we enrolled 2413 participants, assigning 1204 to tenofovir and 1209 to placebo. Two participants had HIV at enrolment and 50 became infected during follow-up: 17 in the tenofovir group (an incidence of 0.35 per 100 person-years) and 33 in the placebo group (0.68 per 100 person-years), indicating a 48.9% reduction in HIV incidence (95% CI 9.6-72.2; p=0.01). The occurrence of serious adverse events was much the same between the two groups (p=0.35). Nausea was more common in participants in the tenofovir group than in the placebo group (p=0.002).Interpretation In this study, daily oral tenofovir reduced the risk of HIV infection in people who inject drugs. Pre-exposure prophylaxis with tenofovir can now be considered for use as part of an HIV prevention package for people who inject drugs.