Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV

Calvin Q. Pan, Ting Tsung Chang, Si Hyun Bae, Maurizia Brunetto, Wai Kay Seto, Carla S. Coffin, Susanna K. Tan, Shuyuan Mo, John F. Flaherty, Anuj Gaggar, Mindie H. Nguyen, Mustafa Kemal Celen, Alexander Thompson, Edward J. Gane

研究成果: Article同行評審

摘要

Background/Purpose Use of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing motherto- child transmission (pMTCT) of the hepatitis B virus (HBV) in mothers with chronic HBV and high viral loads. Given the lack of data for tenofovir alafenamide (TAF) in pMTCT, rates of early viral suppression with TAF and TDF were evaluated in women of childbearing potential (WOCBP) participating in 2 randomized, double-blind, Phase 3 studies in chronic HBV. Methods In a patient subset meeting WOCBP criteria and with baseline HBV DNA >200,000 IU/mL, rates of viral suppression with TAF or TDF in achieving the target of HBV DNA <200,000 IU/ mL at weeks 12 and 24 were assessed. Multivariate logistic regression was used to identify factors predictive of failure to suppress HBV DNA to the target level. Results In 275 of 1298 (21%) patients meeting WOCBP criteria with high viral load, 93% and 96% had HBV DNA <200,000 IU/mL at weeks 12 and 24, respectively. Results for TAF (n = 194) vs TDF (n = 81) treatment were similar at weeks 12 and 24 (94% vs. 90% and 97% vs. 93%), respectively. High baseline HBV DNA level, genotype D infection, and prior interferon (week 24 only) were predictive of failure to achieve the target level. Both treatments were well tolerated with TAF showing less impact on renal and bone parameters. Conclusions In WOCBP with high VL, no differences were found between TAF and TDF in reducing HBV DNA to levels associated with lower transmission risk. These data support ongoing studies of TAF for pMTCT.

原文English
文章編號e0251552
期刊PloS one
16
發行號5 May
DOIs
出版狀態Published - 2021 五月

All Science Journal Classification (ASJC) codes

  • 多學科

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