The Food and Drug Administration (FDA) has approved updated labeling for Viread (tenofovir disoproxil fumarate; Gilead) to include safety and pregnancy-related outcome information in pregnant women with chronic hepatitis B virus (HBV) infection.
According to data from 3 controlled clinical trials, no new safety findings were observed among 327 pregnant women with chronic HBV administered Viread from 28 to 32 weeks gestations through 1 to 2 months postpartum; patients were followed for up to 12 months after delivery. Moreover, an increased risk of adverse pregnancy-related outcomes was not observed in these studies and no clinically relevant drug-related safety findings were noted in infants exposed to Viread during late gestation.
Viread is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. It is approved for the treatment of chronic HBV, as well as HIV-1 infection in combination with other antiretroviral agents, in adults and pediatric patients 2 years of age and older weighing at least 10kg.
Healthcare providers are encouraged to register pregnant patients on Viread therapy by calling the Antiretroviral Pregnancy Registry at 1-800-258-4263.
For more information visit FDA.gov.