A randomized controlled trial of sequential peginterferon-alpha and
telbivudine or vice versa for 48 weeks in HBeAg-negative chronic
hepatitis B.
Source
Hepatology Unit, Tor Vergata University, Rome, Italy.
paola.***@****.
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 ? (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.