南非使用不同类型注射用孕激素避孕的女性中 HIV-1 感染风险：一项前瞻性队列研究。
Risk of HIV-1 acquisition among women who use diff erent types of injectable progestin contraception in South Africa: a prospective cohort study.
出版信息
Lancet HIV. 2015 Jul;2(7):e279-87. doi: 10.1016/S2352-3018(15)00058-2.
BACKGROUND
Several observational studies have reported that HIV-1 acquisition seems to be higher in women who use depot medroxyprogesterone acetate (DMPA) than in those who do not use hormonal contraception. We aimed to assess whether two injectable progestin-only contraceptives, DMPA and norethisterone enanthate (NET-EN), confer different risks of HIV-1 acquisition.
METHODS
We included data from South African women who used injectable contraception while participating in theVOICE study, a multisite, randomised, placebo-controlled trial that investigated the safety and efficacy of three formulations of tenofovir for prevention of HIV-1 infection in women between Sept 9, 2009, and Aug 13, 2012. Women were assessed monthly for contraceptive use and incident infection. We estimated the difference in incident HIV-1infection between DMPA and NET-EN users by Cox proportional hazards regression analyses in this prospective cohort. The VOICE trial is registered with ClinicalTrials.gov, NCT00705679.
FINDINGS
3141 South African women using injectable contraception were included in the present analysis: 1788 (56·9%)solely used DMPA, 1097 (34·9%) solely used NET-EN, and 256 (8·2%) used both injectable types at different times during follow-up. During 2733·7 person-years of follow-up, 207 incident HIV-1 infections occurred (incidence7·57 per 100 person-years, 95% CI 6·61–8·68). Risk of HIV-1 acquisition was higher among DMPA users (incidence 8·62 per 100 person-years, 95% CI 7·35–10·11) than among NET-EN users (5·67 per 100 person-years, 4·35–7·38;hazard ratio 1·53, 95% CI 1·12–2·08; p=0·007). This association persisted when adjusted for potential confoundingvariables (adjusted hazard ratio [aHR] 1·41, 95% CI 1·06–1·89; p=0·02). Among women seropositive for herpes simplex virus type 2 (HSV-2) at enrolment, the aHR was 2·02 (95% CI 1·26–3·24) compared with 1·09 (0·78–1·52)for HSV-2-seronegative women (pinteraction=0·07).
INTERPRETATION
Although moderate associations in observational analyses should be interpreted with caution, thesefi ndings suggest that NET-EN might be an alternative injectable drug with a lower HIV risk than DMPA in high HIV-1 incidence settings where NET-EN is available.
FUNDING
National Institutes of Health, Mary Meyer Scholars Fund, and the Ruth Freeman Memorial Fund.
背景
几项观察性研究报告称，使用长效醋酸甲羟孕酮（DMPA）的女性感染 HIV-1 的风险似乎高于不使用激素避孕的女性。我们旨在评估两种仅含孕激素的注射避孕药，DMPA 和庚酸炔诺酮（NET-EN），是否具有不同的 HIV-1 感染风险。
方法
我们纳入了参加 VOICE 研究的南非女性的数据，这是一项多中心、随机、安慰剂对照试验，旨在研究三种替诺福韦制剂在预防 2009 年 9 月 9 日至 2012 年 8 月 13 日期间的女性感染 HIV-1 中的安全性和有效性。每月评估女性避孕方法和新发感染情况。我们通过 Cox 比例风险回归分析估计了在该前瞻性队列中 DMPA 和 NET-EN 使用者中 HIV-1 感染的差异。VOICE 试验在 ClinicalTrials.gov 注册，NCT00705679。
结果
本分析纳入了 3141 名使用注射避孕药的南非女性：1788 名（56.9%）仅使用 DMPA，1097 名（34.9%）仅使用 NET-EN，256 名（8.2%）在随访期间不同时间使用两种注射类型。在 2733.7 人年的随访中，发生了 207 例 HIV-1 感染（发病率为每 100 人年 7.57 例，95%CI 6.61-8.68）。与 NET-EN 使用者（5.67 例/100 人年，4.35-7.38；风险比 1.53，95%CI 1.12-2.08；p=0.007）相比，DMPA 使用者感染 HIV-1 的风险更高（发病率为 8.62 例/100 人年，95%CI 7.35-10.11）。当调整潜在的混杂变量时，这种关联仍然存在（调整后的风险比[aHR]1.41，95%CI 1.06-1.89；p=0.02）。在入组时 HSV-2 血清阳性的女性中，aHR 为 2.02（95%CI 1.26-3.24），而 HSV-2 血清阴性的女性为 1.09（95%CI 0.78-1.52）（p 交互=0.07）。
结论
尽管观察性分析中的中度关联应谨慎解释，但这些结果表明，在 HIV-1 发病率较高的环境中，NET-EN 可能是一种替代的注射用药物，与 DMPA 相比，HIV 风险较低，前提是 NET-EN 可获得。
资助
美国国立卫生研究院、玛丽·迈耶学者基金和露丝·弗里曼纪念基金。
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