Author:
Bhattacharya Debika,Tierney Camlin,Butler Kevin,Kiweewa Flavia Matovu,Moodley Dhayendre,Govender Vani,Vhembo Tichaona,Mohtashemi Neaka,Ship Hannah,Dula Dingase,George Kathy,Chaktoura Nahida,Fowler Mary Glenn,Peters Marion G.,Currier Judith S.
Abstract
OBJECTIVE:
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.
METHODS:
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.
RESULTS:
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 log10 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.
CONCLUSION:
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.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, NCT01061151.
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Obstetrics and Gynecology