Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV.
<h4>Background/purpose</h4>Use of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing mother-to-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 pM...
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Public Library of Science (PLoS)
2021
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oai:doaj.org-article:7c9eee4d9c294440a763ea36e111adf42021-12-02T20:04:03ZAntiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV.1932-620310.1371/journal.pone.0251552https://doaj.org/article/7c9eee4d9c294440a763ea36e111adf42021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0251552https://doaj.org/toc/1932-6203<h4>Background/purpose</h4>Use of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing mother-to-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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.Calvin Q PanTing-Tsung ChangSi Hyun BaeMaurizia BrunettoWai-Kay SetoCarla S CoffinSusanna K TanShuyuan MoJohn F FlahertyAnuj GaggarMindie H NguyenMustafa Kemal ÇelenAlexander ThompsonEdward J GanePublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 5, p e0251552 (2021) |
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Medicine R Science Q |
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Medicine R Science Q 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 Çelen Alexander Thompson Edward J Gane Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV. |
| description |
<h4>Background/purpose</h4>Use of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing mother-to-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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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. |
| format |
article |
| author |
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 Çelen Alexander Thompson Edward J Gane |
| author_facet |
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 Çelen Alexander Thompson Edward J Gane |
| author_sort |
Calvin Q Pan |
| title |
Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV. |
| title_short |
Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV. |
| title_full |
Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV. |
| title_fullStr |
Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV. |
| title_full_unstemmed |
Antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic HBV. |
| title_sort |
antiviral kinetics of tenofovir alafenamide and tenofovir disoproxil fumarate over 24 weeks in women of childbearing potential with chronic hbv. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2021 |
| url |
https://doaj.org/article/7c9eee4d9c294440a763ea36e111adf4 |
| work_keys_str_mv |
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| _version_ |
1718375611296120832 |