In addition to treating hepatitis B virus (HBV) infection, Novartis’s antiviral drug telbivudine, effectively protects against mother-to-infant transmission.
To evaluate the drug’s potential in preventing perinatal HBV transmission, researchers prospectively studied 450 HBV-positive pregnant women with high viral loads during their second or third trimester. Of this group, 279 women received telbivudine 600 mg daily for weeks 24 through 32 of gestation, while the remaining 171 women were unwilling to take antiviral drugs, and thus served as control subjects.
After birth, all newborns were treated according to standard immunoprophylaxis procedure, meaning they received a recombinant HBV vaccine and hepatitis B immune globulin. When the infants were 6 months old, the researchers determined potential mother-to-child HPV transmission through detection of hepatitis B surface antigen and HBV DNA levels.
None of the infants whose mothers were treated with telbivudine while pregnant were HBV-positive at 6 months after birth, compared with 14.7% of infants in the control group. Furthermore, nearly all of the telbivudine-treated new mothers (99.1%) had undetectable levels of HBV DNA in cord blood, compared with only 61.5% of control subjects.
No severe adverse events or complications related to telbivudine treatment were observed in women or infants, which led the researchers to conclude that the drug is safe and well tolerated in both populations.
“Telbivudine has demonstrated a wonderful long-term safety profile in both mothers and their infants. It has also demonstrated an excellent efficacy—as high as 100%—in the protection rate of mother-to-infant transmission,” study author Yuming Wang, MD, told Pharmacy Times in an e-mail. “These 2 pros are very important because pregnant HBV patients are a very special population, including both mothers and babies.”
Dr. Wang noted some health care professionals worry about telbivudine’s potential side effects, which includecreatine kinase elevation or hepatitis flares after drug withdrawal. However, the study results, which were published in Clinical Gastroenterology and Hepatology, “showed that both of them are rarely seen and easy to treat,” he said.
"If we are to decrease the global burden of hepatitis B, we need to start by addressing mother-to-infant transmission, which is the primary pathway of HBV infection," Dr. Wang noted.
The researchers said the long-term effects of telbivudine use, especially when compared to tenofovir, remain to be explored.
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