Leroy Valériane, Sakarovitch Charlotte, Cortina-Borja Mario, McIntyre James, Coovadia Hoosen, Dabis Francois, Newell Marie-Louise, Saba J, Gray G, Ndugwa Ch, Kilewo Ch, Massawe A, Kituuka P, Okong P, Grulich A, von Briesen H, Goudsmit J, Biberfeld G, Haverkamp G, Weverling G J, Lange J M A
INSERM U. 593, Institut d'Epidémiologie, Santé Publique et Développement (ISPED), Université Victor Segalen Bordeaux 2, Bordeaux, France.
AIDS. 2005 Nov 4;19(16):1865-75. doi: 10.1097/01.aids.0000188423.02786.55.
Peripartum antiretroviral regimens have been shown to prevent mother-to-child transmission of HIV (MTCT) in randomized clinical trials; however, direct comparison of published results is impossible given methodological and population differences.
To directly compare the efficacy of different antiretroviral regimens in reducing the risk of 6-week MTCT rate in African breastfeeding populations.
Pooled analysis including all mother-infant pairs from any relevant trial: West African ZDV-placebo trials, Petra ZDV+3TC [two regimens A (pre/intra/post-partum) and B (intra/post-partum), placebo from Uganda and Tanzania], SAINT (NVP and Petra arm B), HIVNET012 (NVP, ultra short ZDV pp) and the Vitamin A trial (as placebo arm in South Africa). Peripartum HIV infection was any positive RNA or DNA polymerase chain reaction test < day 60. The MTCT risk was estimated at 6 weeks for each treatment arm and compared with placebo or single-dose NVP using logistic regression adjusting for maternal CD4 cell count, breastfeeding and birthweight.
Overall, 4125 singleton live-births were included; 3629 (88%) were assessed for HIV status at 6 weeks of age. In comparison with placebo, zidovudine + lamivudine (ZDV+3TC) arm A [adjusted odds ratio (AOR), 0.23; P < 0.0001], ZDV+3TC arm B (AOR, 0.49; P < 0.001), antenatal ZDV short (AOR, 0.55; P = 0.006) and nevirapine (NVP) (AOR, 0.60; P = 0.0007) significantly reduced MTCT. In comparison with NVP, only the longest regimen of ZDV+3TC (AOR, 0.39, P < 0.0005) was significantly more effective.
These results are in line with current World Health Organisation guidelines suggesting equivalence of choice between single-dose NVP and short-course ZDV, and confirm the greater efficacy of ZDV+3TC than with any single antiretroviral drug.
围产期抗逆转录病毒治疗方案已在随机临床试验中被证明可预防母婴传播艾滋病毒(MTCT);然而,鉴于方法学和人群差异,无法直接比较已发表的结果。
直接比较不同抗逆转录病毒治疗方案在降低非洲母乳喂养人群6周龄MTCT率风险方面的疗效。
汇总分析纳入了任何相关试验中的所有母婴对:西非齐多夫定-安慰剂试验、佩特拉试验(齐多夫定+拉米夫定,两种方案A(产前/产时/产后)和B(产时/产后),乌干达和坦桑尼亚的安慰剂)、圣徒试验(奈韦拉平与佩特拉试验方案B)、HIVNET012试验(奈韦拉平、超短疗程齐多夫定产后用药)以及维生素A试验(作为南非的安慰剂组)。围产期艾滋病毒感染定义为任何在第60天之前的阳性RNA或DNA聚合酶链反应检测结果。对每个治疗组在6周龄时的MTCT风险进行估计,并使用逻辑回归分析,对母亲的CD4细胞计数、母乳喂养情况和出生体重进行校正,与安慰剂或单剂量奈韦拉平进行比较。
总体而言,纳入了4125例单胎活产;其中3629例(88%)在6周龄时接受了艾滋病毒状况评估。与安慰剂相比,齐多夫定+拉米夫定(ZDV+3TC)方案A(校正比值比(AOR),0.23;P<0.0001)、ZDV+3TC方案B(AOR,0.49;P<0.001)、产前短疗程齐多夫定(AOR,0.55;P=0.006)和奈韦拉平(NVP)(AOR,0.60;P=0.0007)显著降低了MTCT。与奈韦拉平相比,只有最长疗程的ZDV+3TC(AOR,0.39,P<0.0005)显著更有效。
这些结果与世界卫生组织目前的指南一致,该指南表明单剂量奈韦拉平和短疗程齐多夫定在选择上等效,并证实ZDV+3TC比任何单一抗逆转录病毒药物更有效。