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本帖最后由 StephenW 于 2014-10-18 12:04 编辑
1862Clinical outcomes of tenofovir disoproxil fumarate (TDF) treatment versus no treatment for pregnant women with active chronic hepatitis B (CHB) and elevated alanine aminotransaminase (ALT)Wei Yi1, Calvin Q. Pan2, Min Liu1, Haodong Cai1;1Department of Obstetrics and gynaecology, Beijing Ditan Hospital, Capital Medical University, Beijing, China; 2Division of Gastroenterology and Hepatology, NYU Langone Medical Center, NYU School of Medicine, Flushing, NYAntiviral therapy for CHB during pregnancy remains a challenge as the safety data is limited. We evaluated the safety use of TDF for the entire pregnancy in managing mothers with elevated ALT. Methods: Mothers with active CHB who started or switched to TDF at the first trimester and mothers who preferred no treatment during pregnancy were enrolled. Patients were prospectively followed until postpartum week 28. Primary endpoints were safety of mothers and infants. Secondary end points were HBV DNA suppression with ALT normalization throughout the pregnancy and vertical transmission rates. Results: Among 139 mothers screened, 85 were enrolled with 39 mothers who received TDF and 46 mothers who were untreated. Their baseline values are shown in table 1. The mean (range) duration of TDF exposure for the treated group was 38 (28-41) weeks. TDF was well tolerated without significant adverse events (>grade II). Prior to the delivery, mean (SD) serum creatine levels were 52.92 (±8.36) mmol/L in the TDF group vs. 50.55 (±9.89) mmol/L in the untreated group (p=0.242); The serum phosphorus levels were similar between the treated and untreated groups (1.07 vs. 1.06 mmol/L, p=0.763); a complete virologic response (HBV DNA<500 copies/mL) was achieved in 38/39 (97.4%) patients on TDF treated vs. 2.2 %in the untreated group (p<0.001); ALT normalization was observed in 97.4 %in the TDF group vs. 56.5 %in the untreated group (p<0.001). The birth defect/congenital malformation rates were similar when comparing infants in the treated vs. untreated group (2.6 %vs. 2.2%, p=1.000). The infant baselines are also shown in table 1. Both infant groups received appropriate immunoprophylaxis and completed the follow ups. At the age 28 weeks, lower percentage of infants with HBsAg+ was observed in the TDF group vs. those in the untreated group (0 %vs. 6.5%, p=0.246). Conclusion: TDF treatment for entire pregnancy was safe for both mothers and infants. TDF therapy suppressed maternal viremia with normalization of ALT and may reduce immunoprophylaxis failure in infants.
Table 1. Baseline values
Disclosures:
Calvin Q. Pan - Advisory Committees or Review Panels: BMS, Gilead; Consulting: BMS, Gilead, Merck, Abbvie, Janssen ; Grant/Research Support: BMS, Gilead, Genentech, Merck; Speaking and Teaching: BMS, Gilead, Onyx
The following people have nothing to disclose: Wei Yi, Min Liu, Haodong Cai
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