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Comparable efficacy with entecavir monotherapy and tenofovir–entecavir combination in chronic hepatitis B patients
  1. Sumbella Baqai1,
  2. James Proudfoot2,
  3. Ronghui Xu3,4,
  4. Steve Kane5,
  5. Margaret Clark6,
  6. Robert Gish7,8,9,10,11
  1. 1Department of Internal Medicine, Eden Medical Center, Castro Valley, California, USA
  2. 2Biostatistics Unit, Clinical and Translational Research Institute, University of California, San Diego, San Diego, California, USA
  3. 3Department of Mathematics, University of California, San Diego, San Diego, California, USA
  4. 4Department of Family and Preventive Medicine, University of California, San Diego, San Diego, California, USA
  5. 5Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, California, USA
  6. 6Ibrahim El-Hefni Liver Biorepository, Department of Transplantation, California Pacific Medical Center, San Francisco, California, USA
  7. 7Liver Transplant Program, Stanford University Medical Center, Stanford, California, USA
  8. 8Hepatitis B Foundation, Doylestown, Pennsylvania, USA
  9. 9St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
  10. 10University of Nevada, Las Vegas, Nevada, USA
  11. 11Robert G. Gish Consultants, LLC, San Diego, California, USA
  1. Correspondence to Dr Robert Gish; rgish{at}robertgish.com

Abstract

Objectives The long-term goal for chronic hepatitis B patients is to maintain viral suppression in order to reduce disease progression risk. Because patients with previous treatment failure may have multiple viral resistance mutations, finding effective therapy is challenging. Because recent studies have shown that the combination of entecavir and tenofovir is effective in achieving virological response in many patients with prior treatment failure and multiple drug resistance mutations, we compared outcomes with this combination versus monotherapy.

Methods With a retrospective chart review we compared results in 35 patients with previous treatment failure treated with the entecavir-tenofovir combination to results in patients treated with entecavir monotherapy.

Results Although combination therapy resulted in significantly faster achievement of DNA negativity compared to entecavir monotherapy, the modest ten-week advantage is unlikely to be important for most patients since entecavir resistance develops extremely slowly. Significantly more patients on combination therapy experienced viral breakthroughs, most of which were attributed to non-adherence due to difficulties with the combination regimen.

Conclusions Our findings of reasonably comparable efficacy over time in the combination and monotherapy arms combined with the increased costs and compliance issues related to combination therapy weigh in favor of entecavir monotherapy in patients with previous treatment failure. However, because our study was a retrospective analysis of a small patient population, it will be important to confirm these findings with a randomised, controlled trial that compares these treatment approaches in treatment-experienced patients.

  • HEPATITIS B
  • ANTIVIRAL THERAPY
  • ADVERSE DRUG REACTIONS

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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