title: Hepatitis B virus and human immunodeficiency virus drugs in pregnancy: findings from the Antiretroviral Pregnancy Registry.
abstract: OBJECTIVE
  Fetal safety of antiviral therapies is important given the long-term treatment of women with chronic hepatitis B (CHB) infection who may become pregnant. We analyzed neonatal safety data from the Antiretroviral Pregnancy Registry (APR), the largest safety database in pregnancy for antivirals used for HIV and CHB.
  
  
  METHODS
  Data were extracted from APR cases prospectively enrolled between 1989 and 2011. Primary outcomes were major birth defects rates with exposure to all antivirals, individual classes, and drugs compared to population-based controls. Relevant to CHB, only lamivudine (LAM) and tenofovir disoproxil fumarate (TDF) had sufficient individual data for review (≥200 cases).
  
  
  RESULTS
  Of 13,711 cases analyzed, the overall birth defect prevalence (2.8%, 95% CI 2.6-3.1%) was comparable to Centers for Disease Control population-based data (2.72%, 2.68-2.76%, p=0.87) and two prospective antiretroviral exposed newborn cohorts (2.8%, 2.5-3.2%, p=0.90 and 1.5%, 1.1-2.0%, p<0.001). The birth defects prevalence between first and second/third trimesters exposure was similar (3.0% vs. 2.7%). No increased risk of major birth defects with LAM or TDF exposure compared to population-based controls was observed. No specific pattern of major birth defects was observed for individual antivirals or overall.
  
  
  CONCLUSIONS
  No increased risk of major birth defects including in non-live births was observed for pregnant women exposed to antivirals relevant to CHB treatment overall or to LAM or TDF compared to population-based controls. Continued safety and efficacy reporting on antivirals in pregnancy are essential to inform patients on their risks and benefits during pregnancy.
authors: Center for Liver Disease and Transplantation, Columbia University Medical Center, New York, NY 10032, United States. rb464@columbia.edu
authors: Robert S
authors: RS
authors: Brown
authors: Elizabeth C
authors: EC
authors: Verna
authors: Marcus R
authors: MR
authors: Pereira
authors: Hugh H
authors: HH
authors: Tilson
authors: Christopher
authors: C
authors: Aguilar
authors: Cheng-Shiun
authors: CS
authors: Leu
authors: Maria
authors: M
authors: Buti
authors: Elizabeth A
authors: EA
authors: Fagan
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000494:pharmacology / Q000627:therapeutic use; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D000013:Congenital Abnormalities / Q000453:epidemiology; D005260:Female; D006678:HIV / Q000187:drug effects; D015658:HIV Infections / Q000188:drug therapy*; D006509:Hepatitis B / Q000188:drug therapy*; D006515:Hepatitis B virus / Q000187:drug effects; D006801:Humans; D019259:Lamivudine / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D010757:Phosphorous Acids / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D015995:Prevalence; D011446:Prospective Studies; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: C574165:9-(2-((bis(pivaloyloxymethoxy)phosphinoyl)methoxy)propyl)adenine; D000998:Antiviral Agents; D010757:Phosphorous Acids; D019259:Lamivudine; D000225:Adenine