Long-Term Efficacy of Tenofovir Disoproxil Fumarate Therapy in Nucleos(t)ide-Experienced Chronic Hepatitis B Patients

Clin Drug Investig. 2016 Jun;36(6):471-8. doi: 10.1007/s40261-016-0392-0.

Abstract

Background and objectives: Tenofovir disoproxil fumarate (TDF) therapy is a therapeutic option for nucleos(t)ide analogue (NA)-experienced chronic hepatitis B (CHB) patients infected with hepatitis B virus (HBV). In this study, we evaluated the efficacy of TDF alone compared with the efficacy of TDF plus additional NA combinations in NA-experienced CHB patients.

Methods: This retrospective cohort study included 108 patients with a serum HBV DNA level above 5.0 log10 IU/ml who were treated with TDF alone (monotherapy group) or TDF combined with additional NAs (combination therapy group) for 30 months.

Results: At month 30, both therapies resulted in the suppression of HBV DNA levels: 66 of 66 patients (100 %) in the monotherapy group and 40 of 42 patients (95.23 %) in the combination therapy group achieved virologic suppression. Kaplan-Meier curves revealed median times for virologic suppression of 3.12 months in the monotherapy group and 5.23 months in the combination therapy group (p = 0.699). The probability of virologic suppression was comparable between treatment groups. At month 6, more patients achieved normal alanine aminotransferase (ALT) levels in the monotherapy group (p = 0.029). During the treatment period, no patients experienced severe renal dysfunction.

Conclusion: TDF monotherapy and TDF plus additional NAs have comparable antiviral efficacy in CHB patients after NA treatment failure.

MeSH terms

  • Adult
  • Aged
  • Alanine Transaminase / blood
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Cohort Studies
  • DNA, Viral / blood
  • Drug Therapy, Combination
  • Female
  • Hepatitis B virus
  • Hepatitis B, Chronic / drug therapy*
  • Hepatitis B, Chronic / virology
  • Humans
  • Kaplan-Meier Estimate
  • Kidney Diseases / chemically induced
  • Kidney Diseases / epidemiology
  • Male
  • Middle Aged
  • Nucleotides / therapeutic use*
  • Retrospective Studies
  • Survival Analysis
  • Tenofovir / adverse effects
  • Tenofovir / therapeutic use*
  • Treatment Outcome
  • Viral Load

Substances

  • Antiviral Agents
  • DNA, Viral
  • Nucleotides
  • Tenofovir
  • Alanine Transaminase