01; Fisher exact). All 61 (two consecutive pregnancies for one woman) tenofovir exposed babies were born alive. One delivered prematurely at 34

weeks. One had unilateral deafness considered unrelated. There were no other congenital abnormalities. Mean birth weight, length and head circumference were no different to historical controls. All 34 tested babies are HBsAg negative at 9 months; three babies lost to follow up; one unable to be bled; one mother unwilling to consent and the remaining 21 babies are younger than nine months. Conclusion: Tenofovir in this setting achieved better viral suppression than lamivudine. Rate of gastrointestinal intolerance was surprising. No perinatal transmission suggests efficacy of tenofovir when compared to expected rate in this high risk population. Infant growth LY294002 molecular weight parameters and congenital abnormality data were reassuring. H CAI,1 X MA,1 R LI,2 J CHIU,3 D XU1 1Beijing Ditan Hospital, Capital Medical University, Beijing, China, 2Bristol-Myers Squibb, Beijing, China, 3Bristol-Myers Squibb, Shanghai, China Introduction: Long-term treatment

of chronic hepatitis B (CHB) with nucleos(t)ide analogs (NUCs) is often required to achieve a maintained response, but this could impact on fertility/pregnancy. Entecavir, a potent NUC for treatment of CHB, is classified by the FDA as pregnancy category C. Limited data are available on the impact of long-term entecavir therapy on pregnancy outcomes among male CHB patients. Methods: This single-centre retrospective survey assessed the safety of long-term entecavir therapy on pregnancy outcomes among Chinese male CHB patients who fathered LDK378 in vitro children while receiving entecavir (0.5 or 1.0 mg daily) during the entecavir phase II/III studies ETV-012, ETV-023 and ETV-056, and the roll-over study ETV-050. Results: Patients were enrolled between 2002 and 2004, and followed-up until March 2012. Of the 39 male patients, 16 fathered children while on entecavir treatment and were included in this analysis; 18 children were born over the 9 years of follow-up, 上海皓元 all reported

as unplanned pregnancies. At baseline, the mean age was 28 ± 3.7 years, 14 patients were HBeAg(+), and 2 patients were HBeAg(–). All 16 patients received 1.0 mg entecavir, which was administered over a mean duration of 4 years (range 1–8 years). Twelve children were born to fathers who had been treated for 4 or more years. The mean birth weight was 3317 ± 390 grams. There were no cases of low birth weight, birth abnormalities, or congenital disorders. Based on the treating physicians’ assessment, none of the children demonstrated any evidence of cognitive or developmental delays. Conclusion: Within this cohort, for male CHB patients fathering children while on long-term entecavir treatment (even at the 1.0 mg daily) no birth defects, congenital abnormalities, or cognitive/developmental delays of the offspring were observed.