标题: sequential peginterferon-alpha and telbivudine 48 weeks in HbeAG-ve [打印本页] 作者: 肝胆速递 时间: 2012-8-30 13:22 标题: sequential peginterferon-alpha and telbivudine 48 weeks in HbeAG-ve
Antivir Ther. 2012 Aug 6. doi: 10.3851/IMP2281. [Epub ahead of print]
A randomized controlled trial of sequential peginterferon-alpha and telbivudine or vice versa for 48 weeks in HBeAg-negative chronic hepatitis B.
Piccolo P, Lenci I, di Paolo D, Demelia L, Sorbello O, Nosotti L, Angelico M.
Source
Hepatology Unit, Tor Vergata University, Rome, Italy. [email protected].
Abstract
Background
Short-term treatment for HBeAg-negative chronic hepatitis B remains unsatisfactory. Aim of our study was to compare efficacy and safety of two sequential regimens of peginterferon α (PEG-IFN) and telbivudine (LdT).Methods Adult patients with biopsy-proven HBeAg-negative chronic hepatitis B, elevated ALT, serum HBV DNA≥2000 IU/ml were randomized 1:1 at baseline to receive PEG-IFN 180 mcg/week for 24 weeks followed by LdT 600 mg/die for 24 weeks (PEG-IFN first), or vice versa (LdT first), plus 24-week follow-up; HCV, HDV or HIV coinfections and lamivudine-resistance were excluded. Primary endpoints were serum HBV DNA <2000 IU/ml and normal ALT at week 72.
Results
Thirty patients (86% male; median age, 48 years) were enrolled: baseline serum HBV DNA, 5.56±1.4 Log IU/ml; mean ALT 2.9±2.5 times normal. At end of follow-up (week 72), HBV DNA<2000 IU/ml was achieved in 13.3% in PEG-IFN first group vs. 46.7% in LdT first group (p=0.046). Mean ALT levels were significantly lower in LdT first group (1.3±0.9 vs. 3.2±2.7 times normal, p=0.03).PEG-IFN dose was reduced in 2 patients (7%). One patient (7%) dropped out due to myalgia.
Conclusion
Sequential treatment with 24 weeks PEG-IFN followed or preceded by 24 weeks of LdT is safe. Virological response rate at week 72 was significantly higher in patients treated with LdT followed by PEG-IFN than vice versa. A sequential antiviral regimen of LdT followed by PEG-IFN, if confirmed in larger series, could improve response rates compared to standard PEG-IFN monotherapy.