Table 4.

Summary of prevalence rates of birth defects, abortion and perinatal transmission rates with telbivudine exposure during pregnancy in literature studies

	Events (n)	Population (N)	Rate in telbivudine treated patients (n/N)	Non-antiviral treatment control in literature studies	Background rates in overall population (prevalence based on surveillance reports)
Birth defects: Live birth prevalence	6	1673	3.6/1000a	3.0/1000	14.5-60/10001
Birth defects: Birth prevalence	6	1673	3.6/1000a	3.0/1000	NA
Birth defects: Total prevalence	7	1674	4.2/1000b	3.0/1000	NA
Spontaneous abortion	7	1682	4.2/1000	NA	16/10002
Elective termination	1	1682	0.6/1000	NA	230/10003
MTCT	11	1572	0.70% (11/1572)d	11.9% (124/1041)	10%-15%4

¹EUROCAT data[48]; MACDP data[49]; Christianson et al[50] (2006); Dai et al[34] (2011);

²US CDC data[51];

³WHO data[52];

⁴Historical data from HBV-infected population without antiviral treatment[10-12].

^aP = 1.0000 vs non-antiviral treatment control in the same literature studies (Fisher’s exact test);

^bP = 0.7502 vs non-antiviral treatment control in the same literature studies (Fisher’s exact test);

^dP < 0.0001 vs non-antiviral treatment control in the same literature studies (Fisher’s exact test). NA: Not available; MTCT: Mother-to-child transmission.