Brites Carlos, Nóbrega Isabella, Luz Estela, Travassos Ana Gabriela, Lorenzo Cynthia, Netto Eduardo M
a LAPI - Laboratório de Pesquisa em Infectologia , Comlexo Hospitalar Prof. Edgard Santos, Universidade Federal da Bahia , Salvador , Brazil.
b Secretaria de Saúde do Estado da Bahia , CEDAP - Centro Estadual Especializado em Diagnóstico, Assistência e Pesquisa , Salvador , Brazil.
HIV Clin Trials. 2018 Jun;19(3):94-100. doi: 10.1080/15284336.2018.1459343. Epub 2018 Apr 9.
Background Late-presenting pregnant women pose a challenge in the prevention of HIV-1 mother-to-child-transmission. We compared the safety and efficacy of raltegravir and lopinavir/ritonavir for this population. Methods We did a single-center, pilot, open-label, randomized trial in Brazil (N = 44). We randomly allocated late-presenting HIV-infected pregnant women (older than 18 years with a plasma HIV-1 RNA >1000 copies/mL) to receive raltegravir 400 mg twice a day or lopinavir/ritonavir 400/100 mg twice a day plus zidovudine and lamivudine (1:1). The primary endpoint was virological suppression at delivery (HIV-1 RNA <50 copies per mL), in all patients who received at least one dose of study drugs (modified intention-to-treat analysis). Missing information was treated as failure. We assessed safety in all patients. Results We enrolled and randomly assigned treatment to 33 patients (17 in raltegravir group) between June 2015 and June 2017. The study was interrupted by the IRB because a significant difference between arms was detected in an interim analysis. All patients completed follow up at delivery. At delivery, virological suppression was achieved by 13/17 (76.5%) of patients in raltegravir group, versus 4/16 (25.0%) in lopinavir/ritonavir group (RR 3.1, 95% CI: 1.3-7.4). Patients in raltegravir group had significantly higher proportion of virological suppression at 2, 4, and 6 weeks than lopinavir/ritonavir group. Adverse events were most of mild intensity, but patients in lopinavir/ritonavir group had significantly more gastrointestinal adverse events. There was neither discontinuation nor deaths in this trial. Conclusion Raltegravir might be a first-line option for treatment of HIV-infected late-presenting pregnant women.
背景 晚期就诊的孕妇在预防HIV-1母婴传播方面面临挑战。我们比较了雷特格韦和洛匹那韦/利托那韦用于该人群的安全性和有效性。方法 我们在巴西开展了一项单中心、试点、开放标签、随机试验（N = 44）。我们将晚期就诊的HIV感染孕妇（年龄大于18岁，血浆HIV-1 RNA>1000拷贝/mL）随机分配，使其接受每日两次400 mg雷特格韦治疗，或每日两次400/100 mg洛匹那韦/利托那韦联合齐多夫定和拉米夫定治疗（1:1）。主要终点是在所有接受至少一剂研究药物的患者中，分娩时病毒学抑制（HIV-1 RNA<50拷贝/mL）（改良意向性治疗分析）。缺失信息视为治疗失败。我们评估了所有患者的安全性。结果 2015年6月至2017年6月期间，我们纳入了33例患者并随机分配治疗（雷特格韦组17例）。由于在中期分析中检测到两组之间存在显著差异，该研究被机构审查委员会中断。所有患者均在分娩时完成随访。分娩时，雷特格韦组13/17（76.5%）的患者实现了病毒学抑制，而洛匹那韦/利托那韦组为4/16（25.0%）（相对危险度3.1，95%置信区间：1.3 - 7.4）。雷特格韦组患者在2、4和6周时病毒学抑制的比例显著高于洛匹那韦/利托那韦组。不良事件大多为轻度，但洛匹那韦/利托那韦组患者的胃肠道不良事件显著更多。该试验中既没有停药情况也没有死亡病例。结论 雷特格韦可能是治疗晚期就诊的HIV感染孕妇的一线选择。
