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发表于 2004-5-2 00:53
Pegasys Monotherapy Produces Significantly Higher Sustained Response Rates (SVR) Compared to Epivir-HBV
Conventional interferon alfa (IFN) and lamivudine (Epivir-HBV) are first-line treatments for chronic hepatitis B (CHB). Recent data have shown that peginterferon alfa-2a (40KD) (PEGASYS) is superior to conventional IFN in HBeAg-positive CHB (Cooksley et al, J Viral Hepat 2003).?
The aim of the current study was to compare PEGASYS with and without lamivudine to lamivudine alone in the treatment of HBeAg-negative CHB.?
Adult patients (n=537) with HBeAg-negative CHB received PEGASYS 180 microgram once weekly plus placebo, PEGASYS 180 microgram once-weekly plus lamivudine 100 mg daily, or lamivudine 100 mg daily, for 48 weeks, with 24-weeks follow-up.?
Results
Baseline characteristics were comparable in all treatment groups. At end-of-follow-up (week 72), using the intent-to-treat analysis, the percentage of patients with normalized ALT or HBV-DNA <20,000 copies/mL was significantly higher in the PEGASYS plus placebo and PEGASYS plus lamivudine groups than the lamivudine group (see table).?
Histological response (>=2 point reduction in HAI) was reported in 47% of patients receiving PEGASYS plus placebo, 37% receiving PEGASYS plus lamivudine, and 39% receiving lamivudine.
HBsAg response (HBsAg loss ?detection of HBsAb at end-of-follow-up) was reported in 12 patients receiving PEGASYS (?lamivudine) compared with none receiving lamivudine alone.?
Conclusions
The authors conclude, 揝ignificantly higher sustained response rates were observed with PEGASYS monotherapy than with lamivudine monotherapy in the treatment of HBeAg-negative CHB.?/span>
揟he combination of lamivudine and PEGASYS did not improve end-of-follow-up response rates over PEGASYS monotherapy.?br>
Week 72 primary PEGASYS PEGASYS lamivudine
endpoints + placebo (n=177) + lamivudine (n=179) (n=181)
ALT normalisation 59%* 60% 44%*
HBV-DNA ,20,000 cp/mL 43%** 44% 29%**
*P=0.004, ** P=0.007
04/30/04
Reference
P Marcellin and others. PEGINTERFERON ALFA-2A (40KD) (PEGASYS? MONOTHERAPY IS MORE EFFECTIVE THAN LAMIVUDINE MONOTHERAPY IN THE TREATMENT OF HBEAG-NEGATIVE CHRONIC HEPATITIS B: 72-WEEK RESULTS FROM A PHASE III, PARTIALLY DOUBLE-BLIND STUDY OF PEGASYS? ALONE VS PEGASYS?PLUS LAM. Abstract 95. 39th EASL. April 14-18, 2004. Berlin, Germany.
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