DNA polymerase inhibitors for treating hepatitis B: a safety evaluation

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

Article highlights

• Comprehensive review of significant adverse effects associated with the use of nucleos(t)ide analogs in HBV patients.

• Detailed discussion of each drug-related toxicity with real life data.

• Discussion of identified predictive factors associated with drug-related adverse effects.

• Discussion of renoprotective effect of telbivudine in patients with chronic kidney disease and its potential role in preventing drug-related nephrotoxicity in patients receiving nucleotide analogs.

• Evaluation of usage of nucleos(t)ide analogs in pregnancy and lactating patients.

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Declaration of Interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.