DNA polymerase inhibitors for treating hepatitis B: a safety evaluation

Expert Opin Drug Saf. 2016;15(3):383-92. doi: 10.1517/14740338.2016.1139573. Epub 2016 Feb 1.

Abstract

Introduction: Oral nucleoside/ nucleotide analogues (NAs) are currently the mainstay of treatment for patients with chronic hepatitis B virus (HBV) infection. They are generally safe to use. However, since their approval in the last decade and a half, the literature has reported adverse effects associated with the use of NA in HBV patients. A comprehensive review on the drug safety is lacking.

Areas covered: Significant adverse effects associated with NA use in HBV patients including muscle toxicity, peripheral neuropathy, nephrotoxicity and lactic acidosis are discussed. The reported prevalence of each adverse effect, as well as their predictive factors, reversibility and their use in pregnancy and lactating mothers are covered in this review. Novel data regarding reno-protective effect of telbivudine are also discussed.

Expert opinion: Use of NA in HBV is generally safe. Uncommon adverse effects can be minimized or detected early if clinicians exercise adequate precautions when using NA for at-risk populations with regular monitoring.

Keywords: Breast feeding; Chronic hepatitis B; DNA polymerase inhibitor; Fanconi syndrome; Lactic acidosis; Muscle toxicity; Myopathy; Nephrotoxicity; Nucleoside/ nucleotide analogue; Osteomalacia; Peripheral neuropathy; Teratogenecity.

Publication types

  • Review

MeSH terms

  • Animals
  • Antiviral Agents / adverse effects*
  • Antiviral Agents / pharmacology
  • Antiviral Agents / therapeutic use
  • Female
  • Hepatitis B, Chronic / drug therapy*
  • Humans
  • Lactation
  • Nucleic Acid Synthesis Inhibitors / adverse effects*
  • Nucleic Acid Synthesis Inhibitors / pharmacology
  • Nucleic Acid Synthesis Inhibitors / therapeutic use
  • Pregnancy
  • Pregnancy Complications, Infectious / drug therapy
  • Pregnancy Complications, Infectious / virology

Substances

  • Antiviral Agents
  • Nucleic Acid Synthesis Inhibitors