Impact of Antiretroviral Regimen on Pregnancy and Infant Outcomes in Women With HIV/HBV Coinfection

Flavia Matovu Kiweewa, PhD; Camlin Tierney, PhD; Kevin Butler, MS; Marion G. Peters, MD; Tichaona Vhembo, MD; Dhayendre Moodley, PhD; Vani Govender, BSc; Neaka Mohtashemi, BA; Hannah Ship, BA; Philippa Musoke, MD; Dingase Dula, MBBS; Kathy George, MPH; Nahida Chakhtoura, MD; Mary G. Fowler, MD; Judith S. Currier, MD; Debika Bhattacharya, MD


J Acquir Immune Defic Syndr. 2022;91(1):79-84. 

In This Article

Abstract and Introduction


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.


About 3%–12% of pregnant women are living with HIV and HBV yet data on the impact of antiretroviral (ARV) regimens on pregnancy and infant outcomes in HIV/HBV coinfection are limited.[1,2] Tenofovir disoproxil fumarate (TDF) is the preferred agent for treating HBV in pregnancy, given its high barrier to resistance, favorable safety profile, and efficacy for HIV and HBV.[3–5] Previously a cornerstone ARV, lamivudine (3TC) decreases perinatal HBV transmission and is safe in pregnancy.[6,7] Similarly, emtricitabine (FTC) possesses anti-HBV activity.[8]

The PROMISE study demonstrated that infant mortality was increased with ritonavir-boosted lopinavir (LPV/r)+TDF/FTC compared with antepartum zidovudine (ZDV) alone, but whether such differences also exist in the context of HBV-active regimens in HIV/HBV coinfection is unknown. In this secondary analysis, our objective was to compare the impact of ARV regimen on pregnancy and infant adverse outcomes among people living with HIV and HBV. We further assessed the association of maternal baseline HBeAg status and HBV viral load with pregnancy and infant outcomes.