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

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

Affiliations
Clinical Trial

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

Liming Wang et al. J Infect Dis. .

Abstract

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.

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Conflict of interest statement

Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Hepatitis B virus (HBV) loads from baseline to delivery among pregnant women coinfected with human immunodeficiency virus and HBV, by study arm, in the Tenofovir in Pregnancy study. Abbreviation: HBeAg, HBV e antigen.

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