Mancinelli Sandro, Galluzzo Clementina Maria, Andreotti Mauro, Liotta Giuseppe, Jere Haswel, Sagno Jean-Baptiste, Amici Roberta, Pirillo Maria Franca, Scarcella Paola, Marazzi Maria Cristina, Vella Stefano, Palombi Leonardo, Giuliano Marina
1 Department of Biomedicine and Prevention, University of Rome Tor Vergata , Rome, Italy .
2 Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità , Rome, Italy .
AIDS Res Hum Retroviruses. 2016 Aug;32(8):737-42. doi: 10.1089/AID.2015.0366. Epub 2016 May 5.
The objective of this study was to determine the virological response and the possible emergence of drug resistance at 1 and 2 years postpartum in HIV-positive pregnant women enrolled under the Option B approach and meeting the criteria for treatment. In the study, women with baseline CD4(+) <350/mm(3) received a combination of stavudine, lamivudine, and nevirapine during pregnancy (from week 25 of gestation) and continued it indefinitely after delivery. HIV-RNA was measured at 12 and 24 months postpartum. Drug resistance mutations were assessed in those with HIV-RNA >50 copies/ml. Baseline resistance mutations were assessed in the entire cohort. A total of 107 women were studied. At baseline, resistance mutations were seen in 6.6% of the women. At 12 months, 26.7% of the women had >50 copies/ml and among them 12.9% had virological failure (HIV-RNA >1,000 copies/ml). At 24 months, detectable HIV-RNA was seen in 28.3% of the women and virological failure in 10.1% of the women. Resistance mutations (mainly non-nucleoside reverse transcriptase inhibitors mutations) were seen in 40% of the women with detectable HIV-RNA. Baseline mutations did not correlate with virological failure or the emergence of resistance at later time points. Virological failure 2 years postpartum and emergence of resistance were rare in this cohort of HIV-infected women. These findings are reassuring in the light of the new strategies for the prevention of mother-to-child HIV transmission, recommending life-long antiretroviral therapy administration.
本研究的目的是确定采用B方案登记入组且符合治疗标准的HIV阳性孕妇在产后1年和2年时的病毒学反应以及可能出现的耐药情况。在该研究中，基线CD4(+)细胞计数<350/mm(3)的女性在孕期（从妊娠第25周起）接受司他夫定、拉米夫定和奈韦拉平联合治疗，并在分娩后无限期继续用药。在产后12个月和24个月时检测HIV-RNA。对HIV-RNA>50拷贝/ml的患者评估耐药突变情况。对整个队列评估基线耐药突变情况。共研究了107名女性。基线时，6.6%的女性存在耐药突变。在12个月时，26.7%的女性HIV-RNA>50拷贝/ml，其中12.9%出现病毒学失败（HIV-RNA>1000拷贝/ml）。在24个月时，28.3%的女性可检测到HIV-RNA，10.1%出现病毒学失败。在可检测到HIV-RNA的女性中，40%出现耐药突变（主要是非核苷类逆转录酶抑制剂突变）。基线突变与病毒学失败或后期耐药的出现无关。在这一队列的HIV感染女性中，产后2年出现病毒学失败和耐药的情况罕见。鉴于预防母婴HIV传播的新策略建议进行终身抗逆转录病毒治疗，这些发现令人安心。
