1Department of Internal Medicine , Eden Medical Center , Castro Valley, California , USA.
2Biostatistics Unit , Clinical and Translational Research Institute, University of California, San Diego , San Diego, California , USA.
3Department of Mathematics , University of California, San Diego , San Diego, California , USA ; Department of Family and Preventive Medicine , University of California, San Diego , San Diego, California , USA.
4Interventional Endoscopy Services , California Pacific Medical Center , San Francisco, California , USA.
5Ibrahim El-Hefni Liver Biorepository, Department of Transplantation , California Pacific Medical Center , San Francisco, California , USA.
6Liver Transplant Program , Stanford University Medical Center , Stanford, California , USA ; Hepatitis B Foundation , Doylestown, Pennsylvania , USA ; St. Joseph's Hospital and Medical Center, Phoenix, Arizona , USA ; University of Nevada , Las Vegas, Nevada , USA ; Robert G. Gish Consultants, LLC, San Diego, California, USA.
AbstractOBJECTIVES: 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.
KEYWORDS: ADVERSE DRUG REACTIONS; ANTIVIRAL THERAPY; HEPATITIS B
