Table 1 . Pregnancy category of US Food and Drug Adminis tration-approved treatments for chronic hepatitis B virus.
Drugs | Pregnancy category |
IFN-a | C |
Peg-IFN-a | C |
Adefovir | C |
Entecavir | C |
Lamivudine | C |
Telbivudine | B |
Tenofovir | B |
Category A drugs: controlled studies in women fail to demonstrate a risk to the fetus.
Category B drugs: no teratogenic/embryogenic risk in animal studies and no controlled human studies available or risk in animal studies, but controlled human studies refute these.
Category C drugs: teratogenic/embryocidal effects in animals, and no controlled studies in humans.
Category D drugs: positive evidence of human fetal risk, but benefits from use in pregnant women may be acceptable despite the risk.