Tenofovir to Prevent Hepatitis B Transmission in Mothers with High Viral Load

Abstract

In a cohort of HBeAg-positive mothers with an HBV DNA level of more than 200,000 IU per milliliter during the third trimester, the rate of mother-to-child transmission was lower among those who received TDF therapy than among those who received usual care without antiviral therapy. (Funded by Gilead Sciences; ClinicalTrials.gov number, NCT01488526.).

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

“…1 Among the last two agents, TDF should be preferred, because it has a better resistance profile and more extensive safety data in pregnant HBV positive women. 1,[196][197][198] In a woman of childbearing age without advanced fibrosis who plans a pregnancy in the near future, it may be prudent to delay therapy until the child is born. In a woman of childbearing age with advanced fibrosis or cirrhosis who agrees for a ''planned pregnancy'' in the future, PegIFNa therapy may be tried as it is given for a finite duration.…”

“…[198][199][200][201] NA prophylaxis could be also useful in the few HBeAg-negative women with high levels of viremia but normal ALT levels. [198][199][200][201] These mothers should be informed that utilising a NA to reduce their viremia levels increase the effectiveness to HBIG and vaccination. LAM, TBV or TDF prophylaxis has been used in this setting during the last trimester of pregnancy.…”

“…In a randomised study in pregnant HBsAg-positive women with high HBV DNA levels ([200,000 IU/ml), the rate of mother to child HBV transmission at post-partum week 28 was 0% in those treated with TDF compared to 7% in the placebo control group per protocol analysis having a similar safety profile. 198 If NA therapy is given as prophylaxis, i.e., only for the prevention of perinatal transmission, its duration is not well defined (stopping at delivery or within the first 3 months after delivery). The potential advantage of stopping at delivery is no interference in breast feeding.…”

Review article: long‐term safety of oral anti‐viral treatment for chronic hepatitis B

“…The indications of NAs and especially TDF in pregnancy has also been expanded to the prophylaxis of maternal-to-foetal transmission in high-risk patients (HBeAg-positive and HBV DNA >200 000 IU/mL), as demonstrated by a randomised controlled trial comparing TDF plus standard-of-care versus standard-of-care only. 16 The safety of different NAs with regard to pregnancy and breastfeeding are depicted in Table 2.…”

“…13,14 Other rarer side effects including lactic acidosis which may happen in very sick cirrhotic patients. 15 With the rising preemptive use of TDF to reduce mother-to-child transmission of HBV, 16 safety in pregnancy and breastfeeding has become an essential topic for both hepatologists and obstetricians. Given the eminent number of patients receiving NAs worldwide, even a small risk of any of these toxicities can be translated into a major medical issue.…”