The safety of a dolutegravir (DTG)-based antiretroviral treatment (ART) regimen for pregnancy and birth outcomes in Ethiopia: evidence from multicenter cohort study.

ABSTRACT:

Background

A dolutegravir (DTG)-based antiretroviral regimen has been rolled out for pregnant women in low- and middle-income countries since 2020. However, available safety data are limited to a few clinical trials and observational studies. Hence, we present real-world pregnancy and birth outcome safety data from a large sample multicenter cohort study in Ethiopia.

Methods

A retrospective cohort study was conducted in fourteen hospitals across Ethiopia from 2017 to 2022. HIV-infected pregnant women were followed from the date of prevention of mother-to-child transmission (PMTCT) care enrolment until the infant was 6-8 weeks old. The primary safety outcome was a composite of adverse pregnancy events comprising spontaneous abortion, intrauterine fetal death (IUFD) before ons

SUBMITTER: Gedefaw A 

PROVIDER: S-EPMC11367911 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature