Is the use of Tenofovir Dipivoxil fumarate effective and safe in preventing vertical transmission in pregnant women with chronic HBV with high viral load?

OBJECTIVE: In our country, transmission from mother to baby is the most common form of transmission of viral hepatitis B. A high viral load in the mother and HBeAg positivity pose the greatest risk of transmission from mother to baby. The best way to prevent this is to try to eliminate the viral load in the mother by using a strong antiviral such as prenatal TDF in mothers with a high viral load during pregnancy. This study aimed to evaluate the efficacy and safety of TDF in pregnant women with high viral load.

PATIENTS AND METHODS: Seventy patients with hepatitis B e-antigen positive and negative were included in the retrospective study conducted in our clinic. In 35 cases, pregnant women with HBeAg (+) positive chronic HBV and HBV-DNA levels of 107 copies/mL were between 18 and 27 weeks of pregnancy. The pregnant women took 300 mg of TDF per day. There were 35 untreated HBeAg-negative, chronic HBV patients in the control group. Babies born to HBeAg-positive and HBeAg-negative mothers are given an initial dose of 200 IU of hepatitis B immune globulin (HBIG) and 20 g of recombinant hepatitis B vaccine in the first 12 hours after birth, followed by 4, 8, and 24 weeks. HBsAg and HBV-DNA findings were examined in newborn serum 28 weeks after birth.

RESULTS: Postpartum 28 weeks, none of the babies born to HBeAg-positive mothers treated with TDF had HBsAg positivity, while 3.5% of babies born to HBeAg-negative mothers and not treated with TDF had HBsAg positivity and immunoprophylaxis failure. There was no statistically significant difference between the treatment and control groups regarding maternal height, weight, gestational age, or congenital malformations (p<0.05). There was no significant difference between the side effects seen in mothers. In the examination performed at the 28th week postpartum, a statistically significant decrease in HBV-DNA levels was observed in mothers who received TDF treatment compared to those who did not (88.5%) (p<0.05). In 31 of the 35 patients receiving TDF treatment, ALT was reported to be normalized in 25 of the 35 patients who did not receive TDF treatment (p<0.05).

CONCLUSIONS: It has been observed that the use of TDF, which has a strong efficacy and high barrier, in the second and/or third trimester of pregnancy reduces transmission rates without causing side effects in both the mother and the newborn, thereby preventing vertical transmission of viral hepatitis B from the mother to child.