Hepatitis B Virus (HBV) Load Response to 2 Antiviral Regimens, Tenofovir/Lamivudine and Lamivudine, in HIV/ HBV-Coinfected Pregnant Women in Guangxi, China: The Tenofovir in Pregnancy (TiP) Study

J Infect Dis. 2016 Dec 1;214(11):1695-1699. doi: 10.1093/infdis/jiw439. Epub 2016 Sep 22.


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.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage*
  • China
  • Coinfection / drug therapy
  • Female
  • HIV Infections / complications
  • HIV Infections / drug therapy*
  • Hepatitis B / complications
  • Hepatitis B / drug therapy*
  • Hepatitis B virus / isolation & purification
  • Humans
  • Lamivudine / administration & dosage*
  • Pregnancy
  • Pregnancy Complications, Infectious / drug therapy*
  • Tenofovir / administration & dosage*
  • Treatment Outcome
  • Viral Load*
  • Young Adult


  • Antiviral Agents
  • Lamivudine
  • Tenofovir

Associated data

  • ClinicalTrials.gov/NCT01125696