Pegasys Suppresses HBV DNA More Than Lamivudine Over 3 Years

HBeAg negative chronic hepatitis B is associated with poorer prognosis, low treatment response rates, and a high relapse rate, especially following treatment with nucleoside/nucleotide analogs such as lamivudine (Epivir-HBV).

Previously, in a large international trial, a significantly higher response rate 24 weeks post-treatment was demonstrated in HBeAg-negative patients who received 180 mcg/week pegylated interferon alpha-2a (Pegasys), with or without 100 mg/day lamivudine for 48 weeks, compared with those who received lamivudine alone.

In a rollover long-term observational study, reported at last month's 42nd Annual Meeting of the European Association for the Study of the Liver, researchers evaluated the durability of virological and biochemical response to Pegasys, with or without lamivudine, for up to 3 years post-treatment. The follow-up study included 114 of the initial 179 subjects receiving Pegasys plus lamivudine and 116 of the initial 177 patients receiving Pegasys monotherapy.

Results

• 3 years post-treatment, similar proportions of patients achieved HBV DNA suppression < 20,000 copies/mL in the Pegasys/lamivudine and Pegasys monotherapy arms (31% vs 30%, respectively).

• 25% and 28%, respectively, achieved HBV DNA < 10,000 copies/mL.

• 31% of subjects in both arms experienced ALT normalization (30 U/L or less).

• 10 of 114 patients (8.7%) in the Pegasys/lamivudine group lost HBsAg during follow-up.

• 11 of 116 patients (9.5%) treated with Pegasys monotherapy lost HBsAg during follow-up.

• 1 patient in this group who lost HBsAg 6 months post-treatment reverted to HBsAg-positive status 1 year post-treatment and was lost to follow-up.

Conclusion

"A 48-week course of peginterferon alfa-2a provides durable ALT normalization sustained 3 years post-treatment in one third of the patients with HBeAg-negative chronic hepatitis B," the researchers concluded. "In these patients, HBV DNA levels were suppressed to ~10,000 copies/mL or below, a level associated with a considerably reduced risk of disease complications and hepatocellular carcinoma. The number of patients losing HBsAg increased over time to 8% at 3 years post-treatment."

Hôpital Beaujon, University of Paris, Clichy, France; Fondazione Istituto di Ricovero E Cura A Carattere Scientifico, Ospedale Maggiore di Milano Policlinico, Milano, Italy; Queen Mary Hospital, Hong Kong-S.A.R., China; Università di Cagliari, Monserrato, Italy; University of Ankara, Ankara, Turkey; Songklanagarind Hospital, Prince of Songkla University, Hat Yai, Thailand; Nanfang Hospital, Guangzhou, China; Uludag University, Bursa, Turkey; Henry Dunant Hospital, Athens, Greece; Xinan Hospital, Chongqin, China.

05/04/07

Reference
P Marcellin, F Bonino, GK Lau, and others. Virological and biochemical response in patient with HBeAg-negative CHB treated with peginterferon alfa-2a (40KD) ± lamivudine: 3-yer follow-up results. 42nd Annual Meeting of the European Association for the Study of the Liver. April 11-15, 2007. Barcelona, Spain.