In highly viraemic mothers, initiatingtreatment with tenofovir alafenamide fumarate (TAF) at the 13th gestationalweek or later in pregnancy puts a lid on hepatitis B virus (HBV)and preventsvertical transmission when infants receive standard immunoprophylaxis, as shownin a study.
「We observed that TAF initiated at thesecond or early third trimester appears to be safe for both mothers and infantsduring the 24–28-week follow‐up period,」 according to the investigators. 「Therewas no congenital defects nor malformations found among infants after theexposure.」
The retrospective analysis included 71mothers (mean age, 30.3 years) with chronic HBV infection and had HBV DNA>200,000 IU/mL. All of them received TAF for preventing mother‐to‐childtransmission, administered during the second or third trimester and continuedto delivery, with a mean duration of 12.8 weeks. They were followed for up topostpartum weeks 24–28.
All mothers tolerated TAF well, andnone of them discontinued treatment due to adverse events, such as nausea,vomiting, and upset stomach. There were no severe adverse events documented. Atdelivery, 85.9 percent of the mothers achieved HBV DNA <200,000 IU/L.Seventy‐three infants (two sets of twins) were born in total. [Aliment Pharmacol Ther 2020;doi:10.1111/apt.16043]
The babies received the hepatitis Bimmune globulin (100 IU) and HBV vaccine (10 µg; additionalvaccinations administered at 1 and 6 months) after a median of 5.5 hours oftheir birth; 45 percent of them received the immunoprophylaxis within2 hours.
In the 24–28 weeks of life, allinfants had negative hepatitis B surface antigen and undetectable HBV DNAlevels (<100 IU/mL). Body weight, height, and head circumferences correspondedwith national standards for physical development.
「With the use of maternal TAF treatmentduring pregnancy in combination with standard infant HBV immunoprophylaxis, therewas a 100-percent success rate in preventing mother-to-child transmission in thecurrent study,」 the investigators pointed out.
「In the short-term outcome assessments,there were no safety concerns on maternal use of and foetal exposure to TAF,except that maternal renal function should be monitored,」 they added.
Most women in the current study stoppedthe therapy after delivery. Postpartum alanine aminotransferase (ALT) flares,which are a major concern for both clinicians and patients, occurred in 11(15.5 percent) women, with a mean ALT peak level of 140.2 U/mL. Theinvestigators acknowledged a need for better data to understanding thepostpartum ALT flares in mothers after therapy discontinuation.
「To the best of our knowledge, this isthe first study involving a significant number of infants with foetal exposureto TAF for the evaluation of efficacy and safety of TAF in highly viraemicchronic hepatitis B mothers,」 they said.
Despite the presence of severallimitations, 「our investigation provides very important evidence to support theuse of TAF during pregnancy in highly viraemic mothers as an alternative optionto tenofovir disoproxil (TDF) therapy,」 they pointed out. 「In addition, thestudy data was generated from multiple centres in a real‐world setting withclear clinical implications, which may help enhance … generalizability.」
An orally bioavailable prodrug oftenofovir, TAF was designed to have greater plasma stability than TDF to allowmore efficient delivery of the active metabolite, tenofovir diphosphate, tohepatocytes than TDF. The two drugs exert similar HBV DNA-reduction effects inpivotal trials.[Lancet Gastroenterol Hepatol 2016;1:185‐206]
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