Background: There is limited information on antiviral therapy for hepatitis B virus (HBV) infection among pregnant women coinfected with human immunodeficiency virus (HIV) and HBV.
Methods: A phase 2 randomized, controlled trial of a regimen containing tenofovir (TDF)/lamivudine (3TC) and a regimen containing 3TC in HIV/HBV-coinfected pregnant women in China. The HBV virological response was compared in study arms.
Results: The median decline in the HBV DNA level was 2.60 log10 copies/mL in the TDF/3TC arm and 2.24 log10 copies/mL in the 3TC arm (P = .41). All women achieved HBV DNA levels of <6 log10 copies/mL at delivery.
Conclusions: Initiation of either regimen led to achievement of HBV DNA levels below the threshold associated with perinatal HBV transmission.
Clinical trials registration: NCT01125696.
Keywords: HBV DNV viral load; HBV suppression; HIV/HBV coinfection; lamivudine; pregnancy; tenofovir.
Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.