Lancet:两种处方预防HIV母婴传播效果相当

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目前，母乳喂养仍然是预防HIV-1母婴传播的重要障碍。与预防成年人性行为传播HIV相似，预防母乳喂养传播HIV主要有两种方法：1.通过对已经感染的患者的治疗，降低传染力（母体抗病毒治疗，ART）；2.对尚未被感染的婴儿进行抗病毒预防（PreP）。临床试验表明，婴儿PreP和母体ART都是有效的。但是，目前仍然没有关于婴儿暴露超过六个月的的处方。而目前推荐的哺乳时间为12个月。

为此，研究人员在非洲四个国家开展了一项临床试验。比较两种婴儿HIV预防母乳喂养超过50周的HIV-1传染的处方的有效性和安全性。两种处方分别是拉米夫定或洛匹那韦-利托那韦。共有1236名婴儿参与此次临床试验。其中615人被随机分配使用洛匹那韦-利托那韦，另外621人使用拉米夫定。主要结果是婴儿在出生7天后到50周内的HIV-1感染情况，每三个月进行一次诊断。在研究进行期间，出现了17例HIV-1感染（洛匹那韦-利托那韦组8例，拉米夫定组9例）。两种的累积感染率分别为1.4%和1.5%。两组之间的感染率并没有显著性差异。两组间的临床和生物学严重不良反应数量也没有差异。

此次研究表明，用于预防婴儿HIV-1感染的两种处方，洛匹那韦-利托那韦并不优于拉米夫定。两种处方都可以使得出生后HIV-1感染率降低。婴儿暴露前预防应该延长到HIV-1暴露终点。母亲也应当被告知母乳喂养传播HIV的持久性风险。

来源：MedSci

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Extended pre-exposure prophylaxis with lopinavir–ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial

Nicolas Nagot, MDa, b, c, *, Chipepo Kankasa, MDd, *, James K Tumwine, MDe, Nicolas Meda, MDf, G Justus Hofmeyr, MDg, h, Roselyne Vallo, MSca, b, Mwiya Mwiya, MDd, Mary Kwagala, MDe, Hugues Traore, MDf, Amwe Sunday, MDg, h, Mandisa Singata, MScg, h, Chafye Siuluta, MScd, Eric Some, MDf, David Rutagwera, MScd, Desire Neboua, MDf, Grace Ndeezi, MDe, Debra Jackson, DSch, Valérie Maréchal, PhDa, b, Dorine Neveu, PhDa, b, Ingunn M S Engebretsen, PhDi, Carl Lombard, PhDj, Stéphane Blanche, MDk, Halvor Sommerfelt, MDi, l, m, Claire Rekacewicz, MDn, Thorkild Tylleskär, MDi, †, Prof Philippe Van de Perre, MDa, b, c, †, , , for the ANRS 12174 Trial Group‡


Background
Strategies to prevent postnatal mother-to-child transmission of HIV-1 in Africa, including infant prophylaxis, have never been assessed past 6 months of breastfeeding, despite breastfeeding being recommended up to 12 months after birth. We aimed to compare the efficacy and safety of infant prophylaxis with the two drug regimens (lamivudine or lopinavir–ritonavir) to prevent postnatal HIV-1 transmission up to 50 weeks of breastfeeding.

Methods
We did a randomised controlled trial in four sites in Burkina Faso, South Africa, Uganda, and Zambia in children born to HIV-1-infected mothers not eligible for antiretroviral therapy (CD4 count >350 cells per μL). An independent researcher electronically generated a randomisation schedule; we then used sequentially numbered envelopes to randomly assign (1:1) HIV-1-uninfected breastfed infants aged 7 days to either lopinavir–ritonavir or lamivudine (paediatric liquid formulations, twice a day) up to 1 week after complete cessation of breastfeeding or at the final visit at week 50. We stratified the randomisation by country and used permuted blocks of four and six. We used a study label on drug bottles to mask participants, study physicians, and assessors to the treatment allocation. The primary outcome was infant HIV-1 infection between age 7 days and 50 weeks, diagnosed every 3 months with HIV-1 DNA PCR, in the modified intention-to-treat population (all who attended at least one follow-up visit). This trial is registered with ClinicalTrials.gov, number NCT00640263.

Findings
Between Nov 16, 2009, and May 7, 2012, we enrolled and randomised 1273 infants and analysed 1236; 615 assigned to lopinavir–ritonavir or 621 assigned to lamivudine. 17 HIV-1 infections were diagnosed in the study period (eight in the lopinavir–ritonavir group and nine in the lamivudine group), resulting in cumulative HIV-1 infection of 1·4% (95% CI 0·4–2·5) and 1·5% (0·7–2·5), respectively. Infection rates did not differ between the two drug regimens (hazard ratio [HR] of lopinavir–ritonavir versus lamivudine of 0·90, 95% CI 0·35–2·34; p=0·83). Clinical and biological severe adverse events did not differ between groups; 251 (51%) infants had a grade 3–4 event in the lopinavir–ritonavir group compared with 246 (50%) in the lamivudine group.

Interpretation
Infant HIV-1 prophylaxis with lopinavir–ritonavir was not superior to lamivudine and both drugs led to very low rates of HIV-1 postnatal transmission for up to 50 weeks of breastfeeding. Infant pre-exposure prophylaxis should be extended until the end of HIV-1 exposure and mothers should be informed about the persistent risk of transmission throughout breastfeeding.

http://www.sciencedirect.com/sci ... i/S0140673615009848