David Geffen School of Medicine at UCLA, Los Angeles, California; the Harvard T.H. Chan School of Public Health, Boston, Massachusetts; the MU-JHU Research Collaboration and the Makerere University School of Public Health, Kampala, Uganda; Caprisa-University of Kwazulu-Natal and the University of Kwazulu-Natal, Durban, South Africa; the Uz-UCSF Collaborative Research Programme, Harare, Zimbabwe; the Johns Hopkins Research Project, Blantyre, Malawi; Fhi 360, Durham, North Carolina; the National Institutes of Health, Bethesda, Maryland; Johns Hopkins University, Baltimore, Maryland; the University of California, San Francisco, San Francisco, California; and the University of Miami Miller School of Medicine, Miami, Florida.
Obstet Gynecol. 2023 Sep 1;142(3):613-624. doi: 10.1097/AOG.0000000000005302. Epub 2023 Aug 3.
To describe the anti-hepatitis B virus (HBV) efficacy, HBeAg serologic changes, HBV perinatal transmission, and safety in pregnant women who are living with human immunodeficiency virus (HIV) and HBV co-infection who were randomized to various antiretroviral therapy (ART) regimens.
The PROMISE (Promoting Maternal and Infant Survival Everywhere) trial was a multicenter randomized trial for ART-naive pregnant women with HIV infection. Women with HIV and HBV co-infection at 14 or more weeks of gestation were randomized to one of three ART arms: one without HBV treatment (group 1) and two HBV treatment arms with single (group 2) or dual anti-HBV activity (group 3). The primary HBV outcome was HBV viral load antepartum change from baseline (enrollment) to 8 weeks; safety assessments included alanine aminotransferase (ALT) level, aspartate aminotransferase (AST) level, and anemia (hemoglobin less than 10 g/dL). Primary comparison was for the HBV-active treatment arms. Pairwise comparisons applied t test and the Fisher exact tests.
Of 3,543 women, 3.9% were HBsAg-positive; 42 were randomized to group 1, 48 to group 2, and 48 to group 3. Median gestational age at enrollment was 27 weeks. Among HBV-viremic women, mean antepartum HBV viral load change at week 8 was -0.26 log 10 international units/mL in group 1, -1.86 in group 2, and -1.89 in group 3. In those who were HBeAg-positive, HBeAg loss occurred in 44.4% at delivery. Two perinatal HBV transmissions occurred in group 2. During the antepartum period, one woman (2.4%) in group 1 had grade 3 or 4 ALT or AST elevations, two women (4.2%) in group 2, and three women (6.3%) in group 3.
Over a short period of time, HBV DNA suppression was not different with one or two HBV-active agents. HbeAg loss occurred in a substantial proportion of participants. Perinatal transmission of HBV infection was low. Hepatitis B virus-active ART was well-tolerated in pregnancy, with few grade 3 or 4 ALT or AST elevations.
ClinicalTrials.gov , NCT01061151.
描述抗乙型肝炎病毒（HBV）疗效、HBeAg 血清学变化、HBV 围产期传播和安全性，这些是在随机分为不同抗逆转录病毒治疗（ART）方案的人类免疫缺陷病毒（HIV）和 HBV 合并感染的孕妇中。
PROMISE（在世界各地促进母婴生存）试验是一项针对 HIV 感染的初治孕妇的多中心随机试验。在妊娠 14 周或以上时，具有 HIV 和 HBV 合并感染的妇女被随机分为以下三个 ART 组之一：一组无 HBV 治疗（第 1 组），两组 HBV 治疗组分别具有单药（第 2 组）或双重抗 HBV 活性（第 3 组）。主要 HBV 结局是从基线（入组）到 8 周时的 HBV 病毒载量产前变化；安全性评估包括丙氨酸氨基转移酶（ALT）水平、天冬氨酸氨基转移酶（AST）水平和贫血（血红蛋白<10 g/dL）。主要比较是针对 HBV 活性治疗组。两两比较应用 t 检验和 Fisher 精确检验。
在 3543 名妇女中，有 3.9%为 HBsAg 阳性；42 名被随机分配到第 1 组，48 名到第 2 组，48 名到第 3 组。入组时的中位妊娠周数为 27 周。在 HBV 病毒血症妇女中，第 8 周时 HBV 病毒载量的平均产前变化在第 1 组为-0.26 log10 国际单位/毫升，第 2 组为-1.86，第 3 组为-1.89。在 HBeAg 阳性者中，分娩时 HBeAg 丢失发生在 44.4%。第 2 组有 2 例围产期 HBV 传播。在产前期间，第 1 组有 1 名妇女（2.4%）出现 3 级或 4 级 ALT 或 AST 升高，第 2 组有 2 名妇女（4.2%），第 3 组有 3 名妇女（6.3%）。
在短时间内，HBV DNA 抑制没有差异，一种或两种 HBV 活性药物。HbeAg 丢失发生在很大一部分参与者中。HBV 感染的围产期传播率较低。妊娠期间 HBV 活性 ART 耐受性良好，仅少数发生 3 级或 4 级 ALT 或 AST 升高。
ClinicalTrials.gov，NCT01061151。
