Comprehensive review of telbivudine in pregnant women with chronic hepatitis B

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.