Switching to tenofovir alafenamide for nucleos(t)ide analogue-experienced patients with chronic hepatitis B: week 144 results from a real-world, multi-centre cohort study

Aliment Pharmacol Ther. 2022 Aug;56(4):713-722. doi: 10.1111/apt.17107. Epub 2022 Jun 23.

Abstract

Background: Tenofovir alafenamide (TAF) may be preferable to other nucleos(t)ide analogues (NA) regarding outcomes against chronic hepatitis B virus (HBV) infection.

Aims: To evaluate the longer term virological/biochemical effectiveness of TAF and the renal safety of sequential therapy to TAF in real-world settings METHODS: This multi-centre, retrospective cohort study included consecutive adult patients who were switched from other NAs to TAF. We assessed the virological and biochemical responses up to 144 weeks. We performed sensitivity analyses for a subgroup with chronic kidney disease (CKD) at baseline.

Results: We analysed the data of 391 patients with chronic hepatitis B previously treated with entecavir (ETV) (n = 174), tenofovir disoproxil fumarate (TDF) (n = 116) or an NA combination (n = 101) for ≥ 24 months. HBV DNA <10 IU/ml at week 144 was found for 99% of patients, regardless of prior NA regimen or HBV DNA level at baseline. For patients who switched from TDF to TAF, total, low-density lipoprotein, high-density lipoprotein cholesterol and triglycerides were significantly increased after the switch. Patients who switched from a nucleotide analogue to TAF had an improved estimated glomerular filtration rate, although the rate of hypophosphataemia (<2.5 mg/dl) remained 9.7% at week 144. The virological and biochemical responses of patients with CKD were similar to the overall results.

Conclusions: Switching to TAF remained effective and safe for up to 3 years. Given the increasing comorbidities related to ageing, it will be important to carefully follow the change in the lipid levels of patients with a prior TDF-based regimen.

Keywords: chronic kidney disease; entecavir; hepatitis B virus; tenofovir alafenamide; tenofovir disoproxil fumarate.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenine / adverse effects
  • Adult
  • Alanine / therapeutic use
  • Antiviral Agents / adverse effects
  • DNA, Viral
  • Hepatitis B, Chronic* / drug therapy
  • Humans
  • Renal Insufficiency, Chronic* / drug therapy
  • Retrospective Studies
  • Tenofovir / adverse effects
  • Tenofovir / analogs & derivatives
  • Treatment Outcome

Substances

  • Antiviral Agents
  • DNA, Viral
  • Tenofovir
  • tenofovir alafenamide
  • Adenine
  • Alanine