A three-year study on viral suppression and resistance profile for treatment-naive CHB patients receiving continuous entecavir treatment

Abstract

Background: Long-term data of uninterrupted entecavir for treatment-naı¨ve CHB patients in clinical practice is lacking. Aim: To examine the virological and biochemical responses, resistance profile and safety of entecavir for treatment-naı¨ve CHB patients up to 3 years. Methods: 223 CHB patients were treated continuously with entecavir 0.5 mg daily for up to three years. Liver function, HBeAg status, HBV DNA and resistance profile were checked at baseline, year 1, 2 and 3. HBV DNA levels were measured by Roche Taqman real time PCR assay (lower limit of detection: 60 copies/mL). Resistance profile was determined by line probe assay (LiPA) for all patients irrespective of the HBV DNA levels. Results: 157 male and 65 female patients were recruited, with a median age of 47 years. 222, 177 and 65 patients were followed up for 1, 2 and 3 years respectively. The median baseline HBV DNA level was 1.37 9 107 copies/ ml and 95.9% of patients had HBV DNA levels of C105 copies/ml. HBV DNA became undetectable in 81.1, 89.8 and 90.8% from year 1 to 3. The ALT normalization rate for 181 patients with elevated baseline ALT were 84.0, 88.8 and 90.8% from year 1 to 3. 90 patients (40.5%) were HBeAg positive at baseline, with HBeAg seroconversion rate of 22.2, 35.5 and 36.7% from year 1 to 3. Virological breakthrough ([1 log HBV DNA increase from the nadir) was noticed in three patients; these three patients had no resistance detected. Lamivudine resistance substitution was detected at baseline among two patients and at year 3 for one patient; there were no cases of entecavir resistance. There were no serious adverse events related to the drug. Conclusion: For treatment-naı¨ve CHB, entecavir up to 3 years showed excellent virological and biochemical responses. No entecavir resistance was detected up to 3 years of treatment.