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Real‐world clinical and virological outcomes in a retrospective multiethnic cohort study of 341 untreated and tenofovir disoproxil fumarate‐treated chronic hepatitis B pregnant patients in North America
Author(s) -
Samadi Kochaksaraei Golasa,
Castillo Eliana,
Sadler Matthew D.,
Seow Cynthia H.T.,
Barkema Herman W.,
Martin Steven R.,
Israelson Heidi,
Pinto Jacqueline,
Williams Sarah,
Aspinall AIexander I.,
Stinton Laura M.,
Borman Meredith A.,
Burak Kelly W.,
Swain Mark G.,
Congly Stephen E.,
Lee Samuel S.,
Shaheen Abdel Aziz,
Coffin Carla S.
Publication year - 2020
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.16123
Subject(s) - medicine , pregnancy , hbeag , retrospective cohort study , obstetrics , hbsag , cohort , hepatitis b , cohort study , hepatitis b virus , immunology , virus , genetics , biology
Summary Background There are limited long‐term data on outcomes of chronic hepatitis B (CHB) in untreated and tenofovir disoproxil fumarate (TDF)‐treated women during pregnancy. Aims To assess clinical outcomes in a multiethnic cohort of patients during pregnancy and post‐partum in a low HBV endemic region. Methods Retrospective real‐world study of women with CHB (treated or untreated with TDF) from 2011 to 2019; data including ALT, HBV DNA, HBeAg and liver stiffness measurement were collected during pregnancy and post‐partum. Results In 341 women (446 pregnancies) followed for a median of 33 months (IQR: 26.7‐39.5) post‐partum, 19% (65/341) received TDF (11 initiated pre‐pregnancy, 53 for mother‐to‐child transmission (MTCT) prevention). During follow‐up, 72/341 had subsequent pregnancy, including 18/53 on TDF for MTCT risk, of whom 7/18 were re‐treated. In all TDF‐treated women, HBV DNA declined but rebounded after TDF withdrawal (median baseline, near birth and early follow‐up levels were 7.2, 3.0 and 5.5 log IU/mL respectively [ P < 0.01]). In HBeAg+ patients (65/341) ALT flares were more common ( P = 0.03), especially for those who stopped TDF post‐partum, requiring re‐treatment in 21% (11/53). In comparison, 54% (116/215) of untreated women had a post‐partum ALT flare; one with fulminant hepatitis underwent transplant 13 months post‐partum. HBsAg clearance occurred in 2.6% (9/341, 3/9 HBeAg+, 2/9 TDF treated) at median 30 months (IQR: 23‐40) and 37% (24/65) of HBeAg+ patients had HBeAg loss at median 17 months (IQR: 12‐26) post‐partum. Conclusions Post‐partum ALT flares were common, especially after TDF withdrawal. Overall, 37% achieved HBeAg clearance and 2.9% had HBsAg loss during long‐term follow‐up.