The Administration of Tenofovir Disoproxil Fumarate for Pregnant Japanese Women with Chronic Hepatitis B

Abstract

The appropriate management of hepatitis B virus (HBV) infection during pregnancy has not been established in Japan. We herein report five HBV-infected pregnant Japanese women who received tenofovir disoproxil fumarate (TDF). Two of them had been born after the introduction of nationwide immunoprophylaxis and were vertically infected with HBV, highlighting the need to address mother-to-child transmission further. In both entecavir-experienced and nucleoside/nucleotide analog-naïve mothers, TDF suppressed HBV replication without serious adverse events. All five children were free from congenital disorders, growth impairment, and HBV infection. TDF showed safety and efficacy for pregnant woman with chronic hepatitis B and might have helped prevent mother-to-child transmission.

Entecavir administration to pregnant Japanese woman with chronic hepatitis B and hepatocellular carcinoma: A case report

“…12,13 From the child's point of view, the adverse effects of NAs on the fetus, particularly regarding teratogenicity, constitute serious concerns. 9 There is less clinical experience with the use of ETV during pregnancy despite its higher resistance barrier relative to that of LAM. In the treatment guidelines for hepatitis B of the Japan Society of Hepatology, ETV is not suitable for long-term continuous treatment of women who wish to have children because of the risk of teratogenicity.…”

“…From the mother's point of view, although CHB typically remains stable during and after pregnancy, the acute exacerbation may progress to hepatic decompensation or liver failure 12,13 . From the child's point of view, the adverse effects of NAs on the fetus, particularly regarding teratogenicity, constitute serious concerns 9 . There is less clinical experience with the use of ETV during pregnancy despite its higher resistance barrier relative to that of LAM.…”

“…8 According to the US Food and Drug Administration's criteria for drug fetal risk classification, LAM and ETV are classified into category C where it is not possible to deny the risk, and TDF is classified into category B where there is no evidence of fetal risk in humans. 9 For TAF, there is no evidence of fetal safety. 8 We report a case of a Japanese child born to a mother treated with ETV for CHB and hepatocellular carcinomas (HCCs) during pregnancy when TDF was not approved for treatment of chronic hepatitis by public insurance in Japan.…”

“…The guidelines for HB (version 3.2) published by the Japan Society of Hepatology only mention that TDF is recommended over the other two first‐choice NAs of ETV and TAF for women who are pregnant or wish to become so 8 . According to the US Food and Drug Administration's criteria for drug fetal risk classification, LAM and ETV are classified into category C where it is not possible to deny the risk, and TDF is classified into category B where there is no evidence of fetal risk in humans 9 . For TAF, there is no evidence of fetal safety 8…”