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Telbivudine, lamivudine reduced risk for mother-to-child HBV infection

Pregnant patients with hepatitis B virus infection who underwent antiviral therapy with telbivudine or lamivudine had a decreased risk for mother-to-child transmission during birth, according to recent data.

Researchers in China conducted a cohort study with 700 pregnant women, aged 20 to 40 years, who were positive for hepatitis B virus (HBV). Patients who underwent antiviral therapy received either 600 mg telbivudine (LdT; n=263) or 100 mg lamivudine (LAM; n=55) daily between gestational weeks 28 and 30.

Mothers halted treatment at postpartum week 4 and received follow-up every 4 weeks for 12 weeks or until any elevated alanine aminotransferase (ALT) levels returned to normal. Untreated controls (NTx; n=374) had the same follow-up schedule as treated patients. In total, 648 patients completed 52-week follow-up (LdT, n=252; LAM, n=51; NTx, n=345). All infants (n=686) received immunoglobulin G with HBV vaccine within 6 hours of birth and completed all vaccinations.

Researchers said LdT and LAM was well tolerated, and no maternal severe adverse events were observed. Twenty percent of newborns of treated mothers showed hepatitis B surface antigen (HBsAg) at delivery compared with 24% in the NTx group. LdT mothers displayed a reduced mean serum HBV DNA at delivery, resulting in a mean of 3.16 log₁₀ copies/mL, compared with no change in the NTx group (P<.001). Declines in patients treated with LAM resulted in a mean of 3.78 log₁₀ copies/mL vs. no change among controls (P<.001).

At the end of follow-up, on-treatment (2.84% vs. 0%) and intention-to-treat analyses (7.6% vs. 2.2%) revealed HBV transmission was significantly reduced among treated patients compared with controls. Rates between infants of LAM and LdT patients were similar (3.7% vs. 1.9%; P=.758) All infants negative for HBsAg at birth did not develop chronic HBV at 52 weeks.

“Antiviral therapy during pregnancy remains a challenge for clinicians because the safety of fetal exposure to antiviral medication is a primary concern,” the researchers wrote. “We demonstrated that treatment with LdT or LAM did not increase fetus and infant complications or birth defects, compared to infants in the untreated group, thus this study supports the safe use of LdT and LAM in a real-life setting in highly viremic mothers.”

Disclosure: See the study for a full list of relevant financial disclosures.