Abstract | BACKGROUND: There are limited data on the impact of antenatal antiretroviral regimens (ARV) on pregnancy and infant outcomes in HIV/HBV coinfection. We compared outcomes among 3 antenatal antiretroviral regimens for pregnant women with HIV/HBV. METHODS: The PROMISE study enrolled ARV-naive pregnant women with HIV. Women with HBV were randomized to (no anti-HBV)- zidovudine (ZDV) + intrapartum nevirapine and 1 week of tenofovir disoproxil fumarate and emtricitabine (TDF- FTC); (3TC)-3TC + ZDV + LPV/r; or ( FTC-TDF)- FTC + TDF + LPV/r. Pairwise group comparisons were performed with Fisher exact, t , or log rank tests. Adverse pregnancy outcome (APO) was a composite of low birth weight, preterm delivery, spontaneous abortion, stillbirth, or congenital anomaly. RESULTS: Of 138 women with HIV/HBV, 42, 48, and 48 were analyzed in the no anti-HBV, 3TC, and FTC-TDF arms. Median age was 27 years. APOs trended lower in the no anti-HBV (26%) vs 3TC (38%), and FTC-TDF arms (35%), P ≥ 0.25). More infant deaths occurred among the FTC-TDF [6 (13%)] vs no anti-HBV [2 (5%)] and 3TC [3 (7%)] arms. There were no differences in time-to-death, HIV-free survival, birth or one-year WHO Z-score length-for-age, and head circumference. Hepatitis B e antigen ( HBeAg) was associated with an increased risk of APO, 48% vs 27% (odds ratio 2.79, 95% confidence interval: 1.19 to 6.67, post hoc ). CONCLUSION: With HBV/ HIV coinfection, the risk of an APO was increased with maternal ARV compared with ZDV alone, although the differences were not statistically significant. Maternal HBeAg was associated with a significantly increased risk of APO. Infant mortality was highest with FTC + TDF + LPV/r. Early assessment of HBeAg could assist in identifying high-risk pregnancies for close monitoring.
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Authors | Flavia Matovu Kiweewa, Camlin Tierney, Kevin Butler, Marion G Peters, Tichaona Vhembo, Dhayendre Moodley, Vani Govender, Neaka Mohtashemi, Hannah Ship, Philippa Musoke, Dingase Dula, Kathy George, Nahida Chakhtoura, Mary G Fowler, Judith S Currier, Debika Bhattacharya |
Journal | Journal of acquired immune deficiency syndromes (1999)
(J Acquir Immune Defic Syndr)
Vol. 91
Issue 1
Pg. 79-84
(09 01 2022)
ISSN: 1944-7884 [Electronic] United States |
PMID | 35621877
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. |
Chemical References |
- Anti-HIV Agents
- Anti-Retroviral Agents
- Hepatitis B e Antigens
- Lamivudine
- Zidovudine
- Tenofovir
- Emtricitabine
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Topics |
- Adult
- Anti-HIV Agents
(therapeutic use)
- Anti-Retroviral Agents
(therapeutic use)
- Coinfection
(complications, drug therapy)
- Emtricitabine
(therapeutic use)
- Female
- HIV Infections
(complications, drug therapy)
- Hepatitis B e Antigens
(therapeutic use)
- Humans
- Infant, Newborn
- Lamivudine
(therapeutic use)
- Pregnancy
- Pregnancy Outcome
- Tenofovir
(therapeutic use)
- Zidovudine
(therapeutic use)
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