BOSTON, MA—Use of telbivudine and tenofovir in middle-to-late pregnancy was equally effective in reducing mother-to-infant chronic hepatitis B virus (HBV) infection vertical transmission, a real world study in China reported at The Liver Meeting® 2016.
These prospective observational cohort data also showed that the treatments were well tolerated, noted Jinfeng Liu, MD, Department of Infectious Disease, Xi’an Jiaotong University, Xi’an, Shaanxi Province, China.
Dr. Liu and colleagues enrolled 711 pregnant women with chronic HBV undergoing routine consultations from January 2010 to January 2015. Of the women enrolled, 671 completed the 52-week study, with 671 live births.
Telbivudine (n=312) or tenofovir (n=223) was administrated from gestation week 24 or 28 until postpartum week 12. Some women received no treatment (n=136). The investigators assessed HBV load and titers of HBV markers every 4 weeks until 12 weeks postpartum.
“All infants received standard combined immunoprophylaxis after birth and were followed for up to 52 weeks,” Dr. Liu stated.
Telbivudine treatment resulted in a mean HBV DNA decline of 5.23 ± 2.08 log10IU/mL at delivery, comparable to tenofovir (5.18 ± 2.04, range 2.03–8.57 log10IU/mL).
At delivery, 159 of the 312 women who received telbivudine (51.0%) “displayed undetectable HBV DNA vs. 50.2% in the tenofovir treatment group,” they found.
A similar trend in decline in HBV virus was shown with both telbivudine and tenofovir treatment. Multivariate analysis indicated only HBsAg titer at baseline correlated with viral DNA decrease (P=0.015).
Alanine aminotransferase normalization was observed in 81.2% of telbivudine-treated women vs. 82.9% of tenofovir-treated women (χ2=0.078; P=0.781).
At Week 52, only one infant from a mother treated with telbivudine showed HBsAg(+).
An intent-to-treat analysis indicated significantly fewer infants in the telbivudine and tenofovir treatment groups (23 of 557) were HBsAg(+) compared to those who received no treatment (34 of 154), 4.13% (95% confidence interval [CI]: 2.33, 5.57) vs. 22.08% (95% CI: 15.45, 28.70; χ2=13.608; P<0.001).
No difference in HBsAg(+) rate was observed between infants from the telbivudine and tenofovir groups (4.01% vs. 4.29%; χ2=0.027, P=0.870).
Among infants in all 3 groups, congenital abnormalities and neonatal growth were comparable to the normal population.
The treatments were well tolerated; however, among women, a significantly higher rate of gastrointestinal symptoms was observed in the tenofovir group (χ =31.815, P<0.001). These results led the investigators to state more attention should be paid to mothers with digestive tract symptoms during tenofovir administration.