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1905Excellent Theraputic Response to Tenofovir Dipivoxil Fumarate (TDF) in Chronic Hepatitis B Pregnant Women with Resistance to Prior Anti-viral Therapy
Hua Zhang1, Calvin Q. Pan2, Xin Liu1, Qian Bian1, Qiumei Pang1, Yun X. Zhu1, Qing Liu1, Ruihua Tian1;1Department of Obstetrics and Gynecology, Beijing Youan Hospital, Capital Medical University, Beijing, China; 2Division of Gastroenterology and Hepa-tology, NYU Langone Medical Center, NYU School of Medicine, Flushing, NY
Pregnant women with chronic hepatitis B (CHB) who receive antiviral treatment prior to or during pregnancy for the active disease can develop antiviral-resistance. Antiviral therapy may be required during pregnancy to control maternal disease or to prevent vertical transmission at the third trimester. We pro-spectively study the efficacy and safety of TDF in managing these patients.
METHODS Treatment experienced HBeAg + mothers who required antiviral treatment during pregnancy were screened. Those with antiviral resistance were prospectively enrolled and treated with TDF until 52 weeks postpartum. Primary endpoints were HBV DNA < 5log10 copies/mL at delivery and the percentage of patients with HBV DNA unde-tectable at postpartum week 52. Secondary endpoints were safety, tolerability, serological and biochemical responses.
RESULTS During 3/2012-3/2013, 29 consecutive treatment experience mothers were screened, but only 14 were found to have genotypic resistance and enrolled. Maternal baseline values are shown in table 1. All subjects received TDF 300 mg daily with a mean (range) duration of 17.1 (9-39) weeks prior to delivery. At delivery, a significant reduction of HBV DNA was observed when compared to those at the baseline (2.8 vs. 7.1 log10 copies/mL, p<0.001), all mothers achieved HBV DNA reduction to the levels below 5log10 copies/mL. The treatment was well tolerated with no viral breakthrough. At postpartum week 4, four patients self-discontinued TDF without severe ALT flares. At postpartum week 52, 57% of mothers had undectable HBV DNA levels. In addition, 7.1% percent of patients (1/14) had HBeAg loss/seroconversion; 64.3% of patients (9/14) achieved normalization of alanine aminotrans-ferase; no patients had HBsAg loss. The adverse events were mild in severity (<grade II), which included cough, pruritus, insomnia, nausea, and fatigue. The mean gestation age for their infants was 39.2 weeks. Infant's baseline values are also shown in table 1. HBsAg was positive in 28.6% of newborns but all became HBsAg negative at the age of 52 weeks after the appropriate immunoprophylaxis. No congenital defect was observed except for 1 infant, who had congenital umbilical hernia.
CONCLUSIONS In our cohort, mothers with antiviral resistance had excellent response to TDF during pregnancy. The therapy was well tolerated with no safety concerns. TDF treatment is effective not only in managing maternal disease, but also in preventing vertical transmission in mothers with high level of viremia. Further large multicenter studies are needed to verify our findings.
Table 1. Baseline values
Lam = lamividine, ADF = adefovir, ETV = entecavir, LdT = telbivu-dine
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: Hua Zhang, Xin Liu, Qian Bian, Qiumei Pang, Yun X. Zhu, Qing Liu, Ruihua Tian
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发表于 2014-10-29 12:18
