Peg2a,Peg2a+lam比lam在E+上更好(11.1AASLD)

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Peginterferon Alfa-2a (Pegasys) Monotherapy and in Combination with Lamivudine Is More Effective Than Lamivudine Monotherapy in HBeAg (+) Chronic Hepatitis B

Recent data show that peginterferon alfa-2a (40KD) (Pegasys) gives significantly higher post-therapy response rates than lamivudine in HBeAg-negative chronic hepatitis B (CHB). Combining peginterferon alfa-2a and lamivudine (Epivir-HBV) did not improve response rates over peginterferon alfa-2a alone [Marcellin et al, J Hepatol 2004].

In this study, the efficacy and safety of peginterferon alfa-2a with and without lamivudine vs lamivudine alone has been evaluated in HBeAg-positive CHB. This was a randomized, partially double-blind multinational study. Patients with HBeAg-positive CHB (n=814) received (1:1:1):

1) Peginterferon alfa-2a (40KD) (Pegasys) 180 μg once weekly (qw) + placebo once daily (qd) 2) Peginterferon alfa-2a (40KD) (Pegasys) 180 μg qw + lamivudine 100 mg qd 3) Lamivudine 100 mg qd. Patients were treated for 48 weeks and assessed after 24 weeks of treatment-free follow-up.

Results

Baseline characteristics were comparable in all treatment groups. The overall patient population was predominantly Asian (85-87%). After 24 weeks follow-up (week 72), the proportion of patients achieving predefined co-primary endpoints (HBeAg seroconversion or HBV DNA <100,000 copies/ml), and secondary endpoints (HBeAg loss and ALT normalization), was significantly higher with peginterferon alfa-2a monotherapy or combination therapy than with lamivudine monotherapy (see table). HBsAg seroconversion at week 72 was reported in 16 patients receiving peginterferon alfa-2a (?lamivudine) compared with none receiving lamivudine monotherapy.

Withdrawals from treatment for safety reasons were low across all groups (<=3%). The majority of adverse events were mild in nature and incidence of serious adverse events was low in all treatment groups (2-6%). Adverse events were comparable between peginterferon alfa-2a monotherapy and the combination therapy. Conclusions

Significantly higher post-therapy response rates were achieved with peginterferon alfa-2a (40KD) (Pegasys) monotherapy or combination therapy than with lamivudine monotherapy in patients with HBeAg-positive CHB. Combining peginterferon alfa-2a and lamivudine did not improve response rates over peginterferon alfa-2a alone. No unexpected adverse events were reported for peginterferon alfa-2a and the addition of lamivudine did not significantly alter the peginterferon alfa-2a safety profile.

Pegasys + placebo (n=271)

Pegasys?/sup> + lamivudine (n=271)

lamivudine (n=272)

Co-primary endpoints

HBeAg seroconversion

32% (P<0.001)*

27% (P=0.023)*

19%

HBV DNA <100,000 copies/ml

32% (P=0.012)*

34% (P=0.003)*

22%

Secondary endpoints

HBeAg loss

34% (P<0.001)*

28% (P=0.043)*

21%

ALT normalization

41% (P=0.002)*

39% (P=0.006)*

28%

* compared with lamivudine therapy

11/01/04

Reference G Lau and others. PEGINTERFERON ALFA-2A (40KD) (PEGASYS?/sup>) MONOTHERAPY AND IN COMBINATION WITH LAMIVUDINE IS MORE EFFECTIVE THAN LAMIVUDINE MONOTHERAPY IN HBEAG-POSITIVE CHRONIC HEPATITIS B: RESULTS FROM A LARGE, MULTINATIONAL STUDY. Abstract 20 (poster). 55th AASLD. October 29-November 2, 2004. Boston, MA.