恩替卡韦治疗4年，耐药率0.6%，e抗原血清学转换率52%

interdetect

OUTCOME OF 4-YEAR TREATMENT OF ENTECAVIR FOR TREATMENT-NAïVE CHRONIC HEPATITIS B

W.-K. Seto*, C.-L. Lai, J. Fung, J.C.-H. Yuen, D.K.-H. Wong, M.-F. Yuen
Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong S.A.R.. *[email protected]

Background: Long-term data of uninterrupted entecavir for treatment-naïve chronic hepatitis B (CHB) patients up to 4 years in lacking.
Aim: To determine the serologic, biochemical, virologic responses, resistance profile and safety of continuous entecavir treatment up to 4 years.
Methods: 222 CHB patients were treated continuously with entecavir 0.5mg daily for up to 4 years. The cumulative rates of HBeAg seroconversion, ALT normalization, DNA undetectability and entecavir signature mutations up to year 4 were determined. HBV DNA levels were measured by Roche Taqman real time PCR assay (lower limit of detection: 12 IU/mL). Resistance profile was determined by line probe assay (LiPA) for patients with detectable HBV DNA.
Results: 157 male and 65 female patients, with a median age of 45 years, were recruited. The median duration of follow-up was 36.2 months. 222, 188, 172 and 70 patients were followed up for 1, 2, 3 and 4 years respectively. HBV DNA became undetectable in 81.1%, 90.4%, 93.0% and 95.7% from years 1 to 4. The ALT normalization rate for 181 patients with elevated baseline ALT were 84.0%, 88.8%, 91.2% and 91.2% from years 1 to 4. 90 patients (40.5%) were HBeAg positive at baseline, with HBeAg seroconversion rate of 22.2%, 40.8%, 52.9% and 51.7%from years 1 to 4. One patient developed HBsAg seroconversion at year 2. Virologic breakthrough (>1 log HBV DNA increase from the nadir) was noticed in 4 patients; 1 patient developed entecavir signature mutation at year 3, resulting in a cumulative resistance of 0.6% up to year 4. There were no serious adverse events related to the drug.
Conclusion: Even when using very sensitive assays for HBV DNA and viral resistance measurements, continuous entecavir up to 4 years achieved a more than 95% chance of undetectable HBV DNA and only a 0.6% probability of resistance.

naive病人，恩替卡韦连续治疗4年，
HBV DNA 低于检测限：81.1%, 90.4%, 93.0% and 95.7% from years 1 to 4.
ALT正常化：84.0%, 88.8%, 91.2% and 91.2% from years 1 to 4.
e抗原学清华转化率：22.2%, 40.8%, 52.9% and 51.7%from years 1 to 4.
4年累积耐药率：0.6 %