Brites Carlos, Luz Estela, Nóbrega Isabella, Luz Ivana, Zajdenverg Roberto, de Ruiter Annemiek, Jones Bryn, Lorenzo Cynthia R, Travassos Ana Gabriela
Department of Medicine, Universidade Federal da Bahia, Salvador, Bahia, Brazil.
Fundação Bahiana de Infectologia, Salvador, Bahia, Brazil.
Open Forum Infect Dis. 2024 Nov 12;11(12):ofae672. doi: 10.1093/ofid/ofae672. eCollection 2024 Dec.
The prevention of perinatal human immunodeficiency virus (HIV) transmission depends on the safe and effective use of antiretroviral therapy (ART). Simplifying treatment reduces drug exposure for both mother and child. We evaluated the safety and efficacy of dolutegravir (DTG) plus lamivudine (3TC) for antiretroviral-naive pregnant women with HIV.
This proof-of-concept trial enrolled ART-naive pregnant women ≥15 years old with HIV infection and a gestational age between 14 and 28 weeks. Participants received a fixed-dose combination of DTG/3TC. Baseline HIV genotyping was performed. Participants were monitored at baseline, every 4 weeks, and at delivery. Infants were assessed at birth, 4 weeks, and 6 weeks of age. Outcomes included the proportion of women achieving an undetectable HIV type 1 plasma viral load (<50 copies/mL) at delivery, therapy modification frequency, perinatal HIV transmission rate, and adverse events.
Between January 2019 and March 2021, 20 women were enrolled. At baseline, the median CD4 cell count was 401.6 ± 113.6 cells/μL, increasing to 690.2 ± 266 cells/μL at delivery. Median viral load was 9514 copies/mL. All women achieved an undetectable viral load after an average of 40 days. No cases of perinatal HIV transmission were detected. No therapy modifications were necessary during the study, and no adverse events were related to the ART.
In this pilot trial, DTG/3TC demonstrated safety and efficacy, with all participants achieving viral suppression before delivery. There were no cases of perinatal HIV transmission and no drug-related adverse events. DTG/3TC can be an option for initial treatment of drug-naive pregnant women with HIV.
围产期人类免疫缺陷病毒（HIV）传播的预防取决于抗逆转录病毒疗法（ART）的安全有效使用。简化治疗可减少母婴双方的药物暴露。我们评估了多替拉韦（DTG）联合拉米夫定（3TC）用于未接受过抗逆转录病毒治疗的HIV感染孕妇的安全性和有效性。
这项概念验证试验纳入了年龄≥15岁、感染HIV且孕周在14至28周之间的未接受过抗逆转录病毒治疗的孕妇。参与者接受DTG/3TC固定剂量组合治疗。进行基线HIV基因分型。在基线、每4周以及分娩时对参与者进行监测。对婴儿在出生时、4周龄和6周龄时进行评估。结局指标包括分娩时HIV-1血浆病毒载量低于检测下限（<50拷贝/毫升）的女性比例、治疗调整频率、围产期HIV传播率以及不良事件。
2019年1月至2021年3月期间，共纳入20名女性。基线时，CD4细胞计数中位数为401.6±113.6个/微升，分娩时增至690.2±266个/微升。病毒载量中位数为9514拷贝/毫升。所有女性在平均40天后病毒载量均低于检测下限。未检测到围产期HIV传播病例。研究期间无需调整治疗方案，且无不良事件与抗逆转录病毒治疗相关。
在这项初步试验中，DTG/3TC显示出安全性和有效性，所有参与者在分娩前均实现了病毒抑制。未发生围产期HIV传播病例，也未出现与药物相关的不良事件。DTG/3TC可作为未接受过治疗的HIV感染孕妇初始治疗的一种选择。
