Effect of interruption of nucleos(t)ide analogues before pregnancy in women with chronic hepatitis B on the pregnancy outcomes

Objective To explore the effect of interruption of nucleos(t)ide analogues before pregnancy in women with chronic hepatitis B on the pregnancy outcome. Methods The medical records of pregnant patients in Beijing Ditan Hospital, Capital Medical University from November 1st, 2008 to November 30th, 2016 were analyzed retrospectively. These patients had chronic hepatitis B and accepted anti-hepatitis B virus (HBV) treatment with nucleos(t)ide analogues before pregnancy. They were divided into the obser-vation group and the control group. In the observation group anti-HBV treatment was interrupted for 1 month at least before pregnancy. The control group maintained anti-HBV treatment with telbivudine till pregnancy occurred. Two groups of patients with liver disease progression, pregnant complication, fetal results, and adverse drug reactions were analyzed. Results A total of 265 patients were enrolled into the analysis. There were 94 cases in observation group aged from 21 to 45 years with average age of (29±4) years. There were 171 cases in control group aged from 20 to 43 years with average age of (31±4) years. The proportions of HBeAg positive, elevated alanine aminotransferase level and the proportion of cases with HBV DNA>1×105 IU/ml and median level of alanine aminotransferase in the observation group in the first pregnancy examination were significantly higher than those of the control group [81.9% (77/94) vs. 70.2%(120/171), P=0.036; 40.4% (38/94) vs. 9.4% (16/171), P 0.05). Gestational age of newborns in the observation group was different from that of the control group [(38.4±1.7) weeks vs. (38.8±1.2) weeks, t=2.352, P=0.019]. The proportion of birth defects, birth weight, the proportion of preterm infants or low birth weight infants in both groups were not significantly different (all P>0.05). One case in every group had adverse reaction related to telbivudine, they were elevated level of creatine kinase and peripheral neuropathy, respectively. Conclusions Patients with chronic hepatitis B had the risk of hepatitis B progression once they interrupted anti-HBV treatment before meeting the criteria for termination of the treatment. No evidence showed that telbivudine or lamivudine caused relevant adverse pregnant complication or inborn abnormality of infants during pregnancy. Key words: Hepatitis B, chronic; Antiviral agents; Pregnancy; Safety