Comparative safety of dolutegravir-based and second-line antiretroviral therapy on adverse birth outcomes: a retrospective cohort study of HIV-positive women in Nigeria.
- 1Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmaceutical Sciences, Gombe State University, Gombe, Nigeria. [email protected].
- 2Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmaceutical Sciences, Gombe State University, Gombe, Nigeria.
Abstract
Background
The combined antiretroviral therapy (cART) has shown to reduce mother child transmission of HIV. This necessitates robust evidence on the comparative safety of different regimens on birth outcomes. There is paucity of evidence on specific cART regimens and adverse birth outcomes in the Nigerian context.Methods
A retrospective cohort study was conducted among 420 HIV-positive pregnant women. The participants received antenatal and delivery care from 2018 to 2023 at the State Specialist Hospital in Gombe State, Nigeria. Participants were categorized based on their antenatal cART regimen: first-line (Dolutegravir-based regimen (DTG-based)) or second-line (Protease inhibitor (PI)-based regimen). The primary outcomes were neonatal death, low birth weight (LBW), preterm birth, and stillbirth. Adjusted odd ratios were estimated to compare risk of adverse outcomes across HIV regimens, and multivariate logistic regression was used to identify predictors of adverse outcomes. A p-value less than 0.05 (95% confidence interval) was considered statistically significant.Results
The analyses revealed no evidence of a significant association between PI-based ART and adverse birth outcomes compared with DTG-based ART while number of pregnancies (p = 0.02), delivery mode (p = 0.03), virological status during pregnancy (p < 0.005) and occupation (p =0.018) were significantly associated with adverse birth outcomes. Crucially, an unsuppressed maternal viral load (>1000 copies/mL) was the strongest independent predictor of adverse outcomes (adjusted Odds Ratio [aOR]=31.22; 95% CI: 10.29-94.72).Conclusion
This study provided evidence on the safety of first-line and second-line cART regimens among Nigerian women. Infants born to mothers on these regimens have no risks for adverse birth outcomes. The most critical modifiable risk factor was unsuppressed viral load during pregnancy. These findings underscore the paramount importance of achieving viral suppression for optimizing birth outcomes and suggest that regimen choice should be carefully considered alongside maternal virological status.Clinical trial number
Not applicable.
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BibTeX
@article{hedima2026comparative,
title = {{Comparative safety of dolutegravir-based and second-line antiretroviral therapy on adverse birth outcomes: a retrospective cohort study of HIV-positive women in Nigeria.}},
author = {Erick Wesley Hedima and Abubakar Ibrahim Aliyu},
journal = {Maternal health, neonatology and perinatology},
year = {2026},
month = nov,
doi = {10.1186/s40748-026-00306-2},
url = {https://europepmc.org/article/MED/43010109},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Comparative safety of dolutegravir-based and second-line antiretroviral therapy on adverse birth outcomes: a retrospective cohort study of HIV-positive women in Nigeria.
AU - Erick Wesley Hedima
AU - Abubakar Ibrahim Aliyu
PY - 2026
DA - 2026/11/11
JO - Maternal health, neonatology and perinatology
DO - 10.1186/s40748-026-00306-2
UR - https://europepmc.org/article/MED/43010109
AB - Background The combined antiretroviral therapy (cART) has shown to reduce mother child transmission of HIV. This necessitates robust evidence on the comparative safety of different regimens on birth outcomes. There is paucity of evidence on specific cART regimens and adverse birth outcomes in the Nigerian context.Methods A retrospective cohort study was conducted among 420 HIV-positive pregnant women. The participants received antenatal and delivery care from 2018 to 2023 at the State Specialist Hospital in Gombe State, Nigeria. Participants were categorized based on their antenatal cART regimen: first-line (Dolutegravir-based regimen (DTG-based)) or second-line (Protease inhibitor (PI)-based regimen). The primary outcomes were neonatal death, low birth weight (LBW), preterm birth, and stillbirth. Adjusted odd ratios were estimated to compare risk of adverse outcomes across HIV regimens, and multivariate logistic regression was used to identify predictors of adverse outcomes. A p-value less than 0.05 (95% confidence interval) was considered statistically significant.Results The analyses revealed no evidence of a significant association between PI-based ART and adverse birth outcomes compared with DTG-based ART while number of pregnancies (p = 0.02), delivery mode (p = 0.03), virological status during pregnancy (p < 0.005) and occupation (p =0.018) were significantly associated with adverse birth outcomes. Crucially, an unsuppressed maternal viral load (>1000 copies/mL) was the strongest independent predictor of adverse outcomes (adjusted Odds Ratio [aOR]=31.22; 95% CI: 10.29-94.72).Conclusion This study provided evidence on the safety of first-line and second-line cART regimens among Nigerian women. Infants born to mothers on these regimens have no risks for adverse birth outcomes. The most critical modifiable risk factor was unsuppressed viral load during pregnancy. These findings underscore the paramount importance of achieving viral suppression for optimizing birth outcomes and suggest that regimen choice should be carefully considered alongside maternal virological status.Clinical trial number Not applicable.
SN - 2054-958X
ER -