Liming Wang1,2,3, Jeffrey Wiener4, Marc Bulterys1,5, Xiaoyu Wei1, Lili Chen6, Wei Liu7, Shujia Liang7, Colin Shepard1,5, Linhong Wang8, Ailing Wang8, Fujie Zhang2,3,9, Athena P Kourtis4. 1. Global AIDS Program China Office, Division of HIV and Tuberculosis, Center for Global Health, US Centers for Disease Control and Prevention (CDC). 2. Beijing Ditan Hospital. 3. Clinical Center for HIV/AIDS, Capital Medical University. 4. Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion. 5. Center for Global Health, CDC, Atlanta, Georgia. 6. Guangxi Zhuang Autonomous Region Health and Family Planning Commission. 7. Guangxi Provincial Center for Disease Control and Prevention, Nanning, China. 8. National Center for Women and Children's Health. 9. National Center for AIDS/STD Prevention and Control, Chinese Center for Disease Control and Prevention, Beijing.
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. 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.
RCT Entities:
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. 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.