Maternal HBV Viremia and Association With Adverse Infant Outcomes in Women Living With HIV and HBV

Abstract

Background: There is limited information on perinatal outcomes in HIV-hepatitis B virus (HBV) coinfection.

Methods: HIV Prevention Trials Network (HPTN) 046 was a randomized double-blind placebo-controlled trial of perinatal transmission that evaluated 6 months of infant nevirapine versus placebo among breast-fed infants. Women living with HIV and their infants enrolled in sub-Saharan Africa from 2007 to 2010; 78% received antiretroviral therapy (ART). Maternal samples were tested for hepatitis B surface antigen (HBsAg). High and low HBV viral load (VL) was defined as ≥106 IU/mL and <106 IU/mL. The association between HIV-HBV coinfection and maternal and infant outcomes was assessed using multivariate (MV) logistic and Cox regression.

Results: Among 2025 women, 88 (4.3%) had HBV. HIV-HBV women with high HBV VL had lower median CD4, versus HIV alone or HIV-HBV women with low HBV VL [320, 490 and 434 cells/mm3, respectively (P < 0.007)]. In MV analysis, adjusted for maternal CD4, age and maternal ART, infants born to women with high HBV VL were more likely to be low birth weight (LBW), versus HIV+/HBV- and low HBV VL women: [30% (3/10) vs. 10% (194/1953) vs. 6% (5/78), respectively, P = 0.03). High HBV VL was associated with HIV perinatal transmission [(hazard ratio 6.75 (95% confidence interval (CI): 1.86 - 24.50)]. There was no impact on infant mortality or maternal outcomes at 18 months.

Conclusions: In HIV-HBV women, high HBV viral loads increase the risk of LBW and potentially HIV perinatal transmission. Reduction of antepartum HBV viremia may have beneficial effects beyond the prevention of HBV perinatal transmission.

Trial registration: ClinicalTrials.gov NCT00074412.

Conflict of interest statement

D.B. was on the protocol teams for studies within the AIDS Clinical Trials Group (ACTG) for which Abbvie and Regeneron donated or will donate study drug. For the remaining authors, no conflicts of interest to disclose.

Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

Figures

Figure 1:. Flow diagram of HIV and HIV/HBV Women and Infants in HBV Analysis of HPTN 046.

Abbreviations: HIV (Human Immunodifficiency Virus), HBV (Hepatitis B Virus), NVP (Nevirapine), HBsAg (Hepatitis B Surface Antigen), PCR (Polymerase Chain Reaction), HPTN (HIV Prevention Trials Network).

Figure 2:. Kaplan Meier curve for time to infant HIV infection by maternal HBV and HBV VL status.

HIV events and follow-ups were censored at the end of mother’s breast feeding. Abbreviations: HBV (Hepatitis B Virus), HIV (Human Immunodifficiency Virus), VL (Viral Load).