Comprehensive review of telbivudine in pregnant women with chronic hepatitis B

Table 2 Reproductive and developmental toxicity with telbivudine

Study type	Route of administration	Species	No. of animals	Doses (mg/kg per day)	Treatment	Reference
Rat studies
Fertility, reproduction,	Oral gavage	Sprague Dawley rats	25 males	0, 100, 500, 1000	Males: -28 AC to DG 17	Study 1314-001
developmental			25 females		Females: -15 AC to DG 17
Fertility	Oral gavage	Sprague Dawley rats	25 males	0, 1000, 2000	Males: -28 AC to DG 13	Study 1314-005
			25 females
Fertility	Oral gavage	Sprague Dawley rats	25 males	0, 2000	Females: -15 AC to DG 7	Study 1314-006
			25 females
Peri/postnatal	Oral gavage	Sprague Dawley rats	25 females	0, 100, 250, 1000	Females: DG 7 to DL 20	Study 1314-003
Rabbit study
Developmental	Oral gavage	New Zealand White rabbits	20 females	0, 50, 250, 1000	Females: DG 6-18	Study 1314-002

AC: Ante coitum; DG: Gestation day; DL: Lactation day.