Abstract

Research on effects of anti-hepatitis B virus (HBV) nucleoside analogs on male fertility and birth defects is limited and safety of nucleoside analogs in pregnancy is still a concern. Chronic hepatitis B (CHB) patients in Guangdong province were surveyed using a structured questionnaire. We collected data including medication type, fertility, and birth defects. Moreover, a survey of the knowledge of antiviral nucleoside analogs safety in fertility of male patients was conducted among physicians nationwide. Semen samples of 30 patients were collected. We screened 1050 HBV-positive male patients. Reasons for not receiving antivirals in 150 patients were “did not meet criteria for antiviral therapy,” fertility, and financial. Furthermore, 900 participants received antivirals (85.71%, 900/1050), including 792 patients with children and 15.15% (120/792) took anti-HBV treatment when preparing for pregnancy. Based on whether they received antiviral therapy during conception or not, we divided patients into two groups. In the child-bearing age group, 88.33% (106/120) of patients received telbivudine (LDT), whereas the other group mainly received entecavir (ETV) (87.20%, 586/672). No significant difference occurred in birth defect incidence rates between both groups. Furthermore, 558 physicians completed questionnaires. Reasons that influenced drug selection were “patient's condition,” “fertility demand,” “financial condition,” and “compliance.” Telbivudine was the first-choice drug (32.80%, 183/558) while tenofovir (TDF) was the second (2.69%, 15/558). Additionally, 61.47% of physicians considered telbivudine or tenofovir as the first choice for male patients who met antiviral criteria, whereas 19% suggested delayed therapy and follow-up until childbirth. No significant changes occurred in semen volume, concentration, mobility, and percentage before and after administration of anti-HBV nucleoside analogs, which did not affect male fertility and birth defect incidence while the desire for pregnancy influenced drug selection and timing of administration. Further research on the effects of analogs on male fertility and fetal safety is required.

Highlights

  • Despite substantial progress in global hepatitis B virus (HBV) immunization programs over the past two decades [1], chronic HBV (CHB) infection and its complications, cirrhosis and hepatocellular carcinoma (HCC), remain major public health problems, especially in male patients [2]

  • From the questionnaire survey of 558 liver disease specialists, the answer to “according to priority, what are the considerations when setting a plan for male patients who met criteria for antiviral therapy” question showed that 71.86% of the physicians considered state of illness as the basis for clinical administration, whereas 11.29% put “desire not meet criteria desire for pregnancy (a) economy personal reason desire for pregnancy no desire for pregnancy (b)

  • By conducting a nationwide questionnaire survey of liver disease specialists and male HBV-positive patients in the Guangdong Province, we evaluated the current state of antiviral nucleoside analogs treatment on child-bearing age male HBV patients and physicians’ considerations of antiviral therapy selection

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Summary

Introduction

Despite substantial progress in global hepatitis B virus (HBV) immunization programs over the past two decades [1], chronic HBV (CHB) infection and its complications, cirrhosis and hepatocellular carcinoma (HCC), remain major public health problems, especially in male patients [2]. The effect and safety of antiviral nucleoside analogs in child-bearing age male patients has not been well studied. Antiviral nucleoside analogs inhibit HBV replication by targeting viral reverse transcriptase or polymerase [6]. They simulate natural nucleoside structure and competitively act on central enzyme activity in the polymerase synthesis process [7]. We conducted a questionnaire survey of child-bearing age male HBV patients and liver disease specialists, to understand the toxicity of antiviral agents on male reproduction and the current knowledge of physicians on antiviral nucleoside analogs effect on male fertility, birth defects, and drug selection. The aim was to better manage child-bearing age male HBV patients, optimal treatment selection, and timing of administration

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