Solomon Marc M, Mayer Kenneth H, Glidden David V, Liu Albert Y, McMahan Vanessa M, Guanira Juan V, Chariyalertsak Suwat, Fernandez Telmo, Grant Robert M
The Gladstone Institutes University of California, San Francisco.
Fenway Health, Beth Israel Deaconess Medical Center, Fenway Institute Harvard Medical School, Boston, Massachusetts.
Clin Infect Dis. 2014 Oct;59(7):1020-6. doi: 10.1093/cid/ciu450. Epub 2014 Jun 13.
Syphilis infection may potentiate transmission of human immunodeficiency virus (HIV). We sought to determine the extent to which HIV acquisition was associated with syphilis infection within an HIV preexposure prophylaxis (PrEP) trial and whether emtricitabine/tenofovir (FTC/TDF) modified that association.
The Preexposure Prophylaxis Initiative (iPrEx) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men (MSM) to receive oral daily FTC/TDF or placebo. Syphilis prevalence at screening and incidence during follow-up were measured. Hazard ratios for the effect of incident syphilis on HIV acquisition were calculated. The effect of FTC/TDF on incident syphilis and HIV acquisition was assessed.
Of 2499 individuals, 360 (14.4%) had a positive rapid plasma reagin test at screening; 333 (92.5%) had a positive confirmatory test, which did not differ between the arms (FTC/TDF vs placebo, P = .81). The overall syphilis incidence during the trial was 7.3 cases per 100 person-years. There was no difference in syphilis incidence between the study arms (7.8 cases per 100 person-years for FTC/TDF vs 6.8 cases per 100 person-years for placebo, P = .304). HIV incidence varied by incident syphilis (2.8 cases per 100 person-years for no syphilis vs 8.0 cases per 100 person-years for incident syphilis), reflecting a hazard ratio of 2.6 (95% confidence interval, 1.6-4.4; P < .001). There was no evidence for interaction between randomization to the FTC/TDF arm and incident syphilis on HIV incidence.
In HIV-seronegative MSM, syphilis infection was associated with HIV acquisition in this PrEP trial; a syphilis diagnosis should prompt providers to offer PrEP unless otherwise contraindicated.
梅毒感染可能会增强人类免疫缺陷病毒（HIV）的传播。我们试图确定在一项HIV暴露前预防（PrEP）试验中，HIV感染与梅毒感染的关联程度，以及恩曲他滨/替诺福韦（FTC/TDF）是否会改变这种关联。
暴露前预防倡议（iPrEx）研究将2499名HIV血清学阴性的男男性行为者（MSM）随机分为每日口服FTC/TDF组或安慰剂组。测量筛查时的梅毒患病率和随访期间的发病率。计算梅毒发病对HIV感染影响的风险比。评估FTC/TDF对梅毒发病和HIV感染的影响。
在2499名个体中，360人（14.4%）在筛查时快速血浆反应素试验呈阳性；333人（92.5%）确诊试验呈阳性，两组之间无差异（FTC/TDF组与安慰剂组，P = 0.81）。试验期间梅毒总发病率为每100人年7.3例。研究组之间梅毒发病率无差异（FTC/TDF组为每100人年7.8例，安慰剂组为每100人年6.8例，P = 0.304）。HIV发病率因梅毒发病情况而异（无梅毒者为每100人年2.8例，梅毒发病者为每100人年8.0例），风险比为2.6（95%置信区间，1.6 - 4.4；P < 0.001）。没有证据表明随机分配到FTC/TDF组与梅毒发病对HIV发病率有交互作用。
在HIV血清学阴性的男男性行为者中，梅毒感染与本PrEP试验中的HIV感染相关；梅毒诊断应促使医疗服务提供者提供PrEP，除非有其他禁忌证。
