Antivirals for prevention of hepatitis B virus mother‐to‐child transmission in human immunodeficiency virus positive pregnant women co‐infected with hepatitis B virus

Background Hepatitis B virus (HBV)‐human Immunodeficiency virus (HIV) co‐infection promotes an aggressive disease course of HBV infection. In the only available non‐Cochrane systematic review on antiviral therapy during pregnancy for prevention of mother‐to‐child transmission of HBV, none of the women studied had HBV‐HIV co‐infection but were either HBV‐ or HIV‐seropositive. Treatment of HBV alone may develop HIV‐strains that are resistant to non‐nucleoside reverse transcriptase inhibitors. Accordingly, co‐treatment of the HIV infection is recommended. Objectives To evaluate the benefits and harms of tenofovir‐based antiviral combination regimens versus placebo, tenofovir alone, or non‐tenofovir‐based antiviral regimen either alone or in combination with HBV for the prevention of mother‐to‐child transmission of HBV in HIV‐positive pregnant women co‐infected with HBV. Search methods We searched the Cochrane Hepato‐Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase Ovid, LILACS (Bireme), Science Citation Index Expanded (Web of Science), and Conference Proceedings Citation Index‐Science (Web of Science) on 30 January 2023. We manually searched the reference lists of included trials, searched on‐line trial registries, and contacted experts in the field and pharmaceutical companies for any further potential trials. Selection criteria We aimed to include randomised clinical trials comparing tenofovir‐based antiviral combination regimens (anti‐HIV regimen with lopinavir‐ritonavir therapy, or any other antiviral therapy, and two drugs with activity against HBV, specifically, tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), plus lamivudine or emtricitabine) with placebo alone, or tenofovir alone, or non‐tenofovir‐based antiviral regimen (zidovudine, lamivudine, telbivudine, emtricitabine, entecavir, lopinavir‐ritonavir, or any other antiviral therapy) either alone or in combination with at least two other antivirals. Data collection and analysis We used standard methodological procedures expected by Cochrane. Primary outcomes included all‐cause infant mortality, proportion of infants with serious adverse events, proportion of infants with HBV mother‐to‐child transmission, all‐cause maternal mortality, and proportion of mothers with serious adverse events. Secondary outcomes included proportion of infants with adverse events not considered serious, proportion of mothers with detectable HB