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Pegasys Superior to Lamivudine Over 3 Years in HBV DNA Decline, ALT Normalization & HBsAg Loss (8% vs 0) & Seroconversion (4% vs 0)
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Reported by Jules Levin
EASL, April 11-15, 2007, Barcelona, Spain
Virological and biochemical response in patients with HBeAg-negative chronic hepatitis B treated with peginterferon alfa-2a (40KD) ± lamivudine: 3-year follow-up results
P Marcellin*, F Bonino, GKK Lau,
P Farci, C Yurdaydin,
T Piratvisuth, K-X Luo, S Gurel,
S Hadziyannis, Y Wang, M Popescu
*Service d'Hepatologie, Hôpital Beaujon,
University of Paris, Clichy, France
AUTHOR SUMMARY
3 years post-treatment, the rates of biochemical and HBV DNA response were significantly higher in patients treated with PEGASYS compared with those treated with lamivudine
Virological response rates remained stable from 1 year through to 3 years post-treatment
Durability of virological response 88% from years 1 to 3
The rate of HBsAg loss in patients treated with PEGASYS increased to 8%
None of the patients treated with lamivudine alone achieved HBsAg loss
Marcellin concludes:
PEGASYS should be considered as first-line therapy in patients with HBeAg-negative CHB because of its:
-- Long-term, durable efficacy
-- Fixed duration of treatment
-- Lack of resistance
Long-term follow-up study in
HBeAg-negative CHB: Design
Patients with HBeAg-negative chronic HBV received 180 ug peginterferon a-2a (40kD) (Pegasys) qw plus either placebo qd or 100 mg lamivudine qd for 48 weeks, and were assessed 6 months post-treatment. In the roll-over long-term observational study, 116/177 of those receiving peginterferon a-2a plus placebo, 114/179 receiving the combination with lamivudine, and 88/181 receiving lamivudine were assessed for HBV DNA suppression and ALT normalization and additional parameters up to 3 years post-treatment.
Marcellin said: Results of the initial part of this large international randomized study have documented: Superior efficacy 6 months post-treatment (ALT normalization, HBV DNA suppression) of pegylated interferon alfa-2a (40kD) [PEGASYS] over lamivudine [Marcellin et al. N Engl J Med 2004]. No benefit of combining PEGASYS and lamivudine.
METHODIOGICAL CONSIDERATIONS
Overall, 78% (42/54) of the study centers and 59% (315/537) of the total study population participated in the long-term (LT) follow-up study.
Significantly more patients in the PEGASYS-containing arms (66% and 64%) than the lamivudine arm (47%) participated (P≦0.01).
Participants in the LT study were more likely to have a response at the end of the initial study, especially in the lamivudine arm.
Biochemical and virological response 3 years post-treatment
-- HBV DNA <400 cp/mL: 18% Pegasys (n=21); 13% Pegasys+LAM (n=15); 6% LAM (n=5) (Pegasys +/- LAM vs LAM, p=0.023).
-- ALT normal: 31% Pegasys, 31% (n=36), Pegasys+LAM (n=35), 18% LAM (n=15) (Pegasys +/- LAM vs LAM, p=0.022).
-- HBV DNA <20,000 cp/mL: 30% Pegasys (=35), 27% Pegasys+LAM (n=31), 15% LAM (n=13) (Pegasys +/- LAM vs LAM, p=0.019).
--HBV DNA <10,000 cp/mL: 28% Pegasys (n=32), 25% Pegasys+LAM (n=9), 15% LAM (n=15) (Pegasys +/- LAM vs LAM, p=0.05).
Virological response 1, 2 and 3 years post-treatment: HBV DNA <20,000 cp/mL (~2,000 IU/mL)
Marcellin commented the viral responses to Pegasys & Pegasys+LAM were relatively stable over the course of followup through 1, 2 and 3 years: at 1 year 35% 7 35%, respectively; at 2 years 29% & 25% , respectively,; at 3 yrs 30% & 27%, respectively. For LAM the viral responses were 24% at year 1, 14% after 2 years, and 15% after 3 years.
Durability of HBV DNA response
This is for patients who took Pegasys alone. At year 1, 25 patients had <20,000 cp/mL and at year 3 looking at the same patients 22 patients had <20, 000 cp/mL. 88% durability.
Sustained HBsAg loss and seroconversion
Marcellin noted the importance of this data. HBsAg loss and seroconversion was 0% for LAM at 1, 2, and 3 years. But for Pegasys+LAM HBsAg loss increased from 3% at 1 year to 6% at year 2 and 8% after 3 years. HBsAg seroconversion was 3% at year 1, 4% at year 2, and 4% after 3 years. For Pegasys+LAM HBsAg loss was 4% at 1 year, 5% at 2 years, and 8% after 3 years; and HBsAg seroconversion was 3%, 2%, and 3% after year 1, 2 and 3.
Summary of results 3 years
post-treatment
ALT normal: 31% Pegasys, 18% LAM (p=0.011)
HBV DNA <20,000 cp/mL: 30% Pegasys, 15% LAM (p=0.019),
HBsAg loss: 8% Pegasys, 0% LAM (p=0.009)
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