Injectable and oral contraceptives and risk of HIV acquisition in women: an analysis of data from the MDP301 trial.
Injectable and oral contraceptives and risk of HIV acquisition in women: an analysis of data from the MDP301 trial.
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DOI：
10.1093/humrep/deu113
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发表时间：
2014-08
期刊：
影响因子：
--
通讯作者：
McCormack S
中科院分区：
文献类型：
--
作者：
Crook AM;Ford D;Gafos M;Hayes R;Kamali A;Kapiga S;Nunn A;Chisembele M;Ramjee G;Rees H;McCormack S
注射避孕药和口服避孕药是否会增加女性感染人类免疫缺陷病毒 (HIV) 的风险？调整混杂因素后，使用注射去甲羟孕酮 (DMPA) 的女性仍存在 HIV 风险显着增加的证据（风险比 = 1.49，95% 置信区间 (1.06–2.08)），但注射庚酸炔诺酮 (Net-En) 或口服避孕药 (OC) 则不然。之前已经观察到，使用某些类型的激素避孕 (HC) 方法与艾滋病毒风险增加之间存在关联，这可能是通过生殖道环境的变化和免疫反应的改变来实现的，尽管不一致。最近对这些研究的系统回顾强调需要更明确的证据。对 MDP301 3 期杀菌剂试验进行了二次数据分析，以估计使用不同 HC 方法对女性感染艾滋病毒风险的影响。分析中包括中位年龄为 28 岁的 HIV 阴性女性 (n = 8663)； 52 周随访后，382 例 HIV 血清转化； 10% 的女性在 52 周之前失去随访。每 4 周访视一次报告避孕药具的使用情况。 Cox 比例风险 (PH) 模型用于评估基线和当前使用注射 DMPA、注射 Net-En 和 OC 与不使用 HC 相比对 HIV 风险的影响，并调整基线和时间更新的协变量。在加权 Cox 模型中估计了 52 周使用 HC 与不使用 HC 的因果影响，审查了偏离基线 HC 使用（或不使用）或怀孕的女性。基线时，2499 名 (29%) 女性接受 DMPA，1180 名 (14%) 女性接受 Net-En，1410 名 (16%) 女性接受 OC； 3574 (40%) 未接受 HC，后续开始接受 HC。与不使用 HC 相比，基线使用 HC 的调整后风险比 (HR) DMPA 为 1.38（95% 置信区间 (CI) 1.07–1.78）； Net-En 为 1.18 (0.86–1.62)，OC 为 0.97 (0.68–1.38)。 DMPA 和 Net-En 在 52 周内的估计因果效应分别为：HR = 1.49 (95% CI 1.06–2.08) 和 HR = 1.31 (95% CI 0.62–1.61)。该研究的一个主要局限性是，它是对并非旨在调查这个问题的研究数据进行的二次分析。尽管我们尽了最大努力，但我们仍不能排除残留的混杂因素来解释 DMPA 的效果。世界卫生组织应审查这项研究的结果，以确定目前关于在艾滋病毒高流行地区使用 DMPA 的建议是否需要修改。 MDP 是非洲和欧洲学术/政府机构与商业组织的合作伙伴关系，由英国政府（DFID 和 MRC）资助，并得到 IPM 和 EDCTP 的支持。资助者在研究设计、数据收集和分析、发表决定或手稿准备中没有任何作用。竞争利益：无。
Do injectable and oral contraceptives increase the risk of human immunodeficiency virus (HIV) acquisition in women? After adjusting for confounders, evidence of a significantly increased risk of HIV remained for women using injectable depo-medroxyprogesterone (DMPA) (hazard ratio = 1.49, 95% confidence interval (1.06–2.08)) but not for injectable norethisterone-enanthate (Net-En) or oral contraceptive pills (OC). An association between the use of some types of hormonal contraception (HC) methods and an increased risk of HIV, possibly through changes in the genital tract environment and alterations in the immune response, has been previously observed, although not consistently. A recent systematic review of these studies has highlighted the need for more definitive evidence. A secondary data analysis of the MDP301 phase 3 microbicide trial was conducted to estimate the effects of use of different methods of HC on the risk of HIV acquisition in women. HIV-negative women (n = 8663) with a median age of 28 years were included in the analysis; 382 HIV seroconverted by 52 weeks follow-up; 10% of women-years were lost to follow-up before 52 weeks. Contraceptive use was reported at each 4-weekly visit. Cox proportional hazards (PH) models were used to estimate the effects of baseline and current use of injectable DMPA, injectable Net-En and OC compared with no HC, on the risk of HIV, adjusting for baseline and time-updated covariates. Causal effects for 52 weeks of HC use compared with no HC were estimated in a weighted Cox model, censoring women at deviation from baseline HC use (or non-use) or pregnancy. At baseline, 2499 (29%) women were on DMPA, 1180 (14%) on Net-En, and 1410 (16%) on OC; 3574 (40%) not on HC, started HC in follow-up. Adjusted hazard ratios (HR) for baseline HC use, compared with no HC, were 1.38 (95% confidence interval (CI) 1.07–1.78) for DMPA; 1.18 (0.86–1.62) for Net-En and 0.97 (0.68–1.38) for OC. The estimated causal effects of DMPA and Net-En over 52 weeks were: HR = 1.49 (95% CI 1.06–2.08) and HR = 1.31 (95% CI 0.62–1.61), respectively. A main limitation of the study was that it was a secondary analysis of data from a study that was not designed to investigate this question. Despite our best efforts, we cannot exclude residual confounding to explain the effect of DMPA. The results of this study should be reviewed by the World Health Organization to determine whether current recommendations on the use of DMPA in settings with high HIV prevalence require modification. MDP is a partnership of African and European academic/government institutions with commercial organizations, which is funded by the UK Government (DFID and MRC), with support from IPM and EDCTP. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing interests: None.
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DOI：
10.1097/qad.0000000000000036
发表时间：
2013-10
期刊：
AIDS (London, England)
影响因子：
--
作者：
Polis CB;Westreich D;Balkus JE;Heffron R;Participants of the 2013 HC-HIV Observational Analysis Meeting
通讯作者：
Participants of the 2013 HC-HIV Observational Analysis Meeting
影响因子：
5
作者：
Cole, Stephen R.;Hernan, Miguel A.
通讯作者：
Hernan, Miguel A.
影响因子：
3.7
作者：
Pool, Robert;Montgomery, Catherine M.;McCormack, Sheena
通讯作者：
McCormack, Sheena
影响因子：
56.3
作者：
Heffron, Renee;Donnell, Deborah;Rees, Helen;Celum, Connie;Mugo, Nelly;Were, Edwin;de Bruyn, Guy;Nakku-Joloba, Edith;Ngure, Kenneth;Kiarie, James;Coombs, Robert W.;Baeten, Jared M.
通讯作者：
Baeten, Jared M.
DOI：
10.1097/qad.0b013e32833a2537
发表时间：
2010-07-17
期刊：
AIDS (London, England)
影响因子：
--
作者：
Morrison CS;Chen PL;Kwok C;Richardson BA;Chipato T;Mugerwa R;Byamugisha J;Padian N;Celentano DD;Salata RA
通讯作者：
Salata RA