TAF useful in pregnant women with chronic hepatitis B infection

Treatment with tenofovir alafenamide (TAF) for pregnant women with active chronic hepatitis B (CHB) infection, when administered throughout or initiated early in pregnancy, is effective and safe in both mothers and infants, according to a study.

The study included pregnant women with active CHB who were treated with TAF (n=103) or tenofovir disoproxil fumarate (TDF; n=104); all infants received immunoprophylaxis. Treatment was initiated at 1.3 and 1.0 weeks into pregnancy in the TAF and TDF groups, respectively; there were 53 (51.5 percent) and 50 (48.1 percent) women who started treatment before pregnancy.

At treatment initiation in the TAF group, the mean age of the women was 29.3 years, the gestational age was 1.3 weeks, the alanine aminotransferase level was 122.2 U/L, and viral loads were 5.1 log₁₀ IU/ml.

Long-term TAF treatment was well tolerated. Nausea was the most common adverse event (29.1 percent) recorded over a mean of 2 years of treatment. Of note, one TAF-treated pregnant woman underwent induced abortion due to noncausal foetal cleft lip and palate. None of the infants in either group had birth defects.

TAF treatment resulted in a hepatitis B e-antigen seroconversion rate of 20.7 percent at postpartum month 6. Moreover, infants had normal growth parameters, and none tested positive for HBsAg at 7 months.

TDF had similar safety and effectiveness profiles.