Treatment for One Year with PEG-Intron Plus

OCD

Epivir-HBV Has a Comparable Safety Profile to Short Term Use of Standard Interferon (Intron A)

Interferon alfa (IFN) treatment in chronic hepatitis B is associated with clinically relevant adverse effects. In an international, multicenter, randomized controlled trial in The Netherlands, investigators are studying the safety of PEG-Intron (peginterferon alfa-2b=PEG-IFN) in combination with Epivir-HBV (lamivudine).

Three-hundred HBeAg-positive patients (ALT>2xULN) with compensated liver disease were treated with PEG-IFN for 52 weeks, combined with either lamivudine 100mg/day or placebo. The dose of PEG-IFN was 100 mcg once a week and halved after 32 weeks.

As yet all patients have been treated for at least 32 weeks and 221 patients have finished treatment.

The most frequently encountered side-effects were flu-like symptoms (67%), headache (36%), myalgia (29%), fatigue (26%) and anorexia (25%). No deaths occurred during treatment or follow-up. A total of 24 (8%) serious adverse events were reported, of which 11 were regarded to be probably related to PEG-IFN (psychiatric n=5; neutropenia n=3; hepatitis flare n=2; seizures n=1).

In 55 (18%) patients the dose of PEG-IFN was reduced prematurely, in 39 (13%) because of a granulocytopenia. Therapy was discontinued early in 24 (8%) patients. The most frequent reasons for early discontinuation were psychiatric side effects (depression, psychosis) and flu-like symptoms. The number of side effects and the proportion of patients requiring dose reduction or interruption were similar to 162 historical controls treated with 10 MU t.i.w. of conventional IFN 10MU tiw for 16-32 weeks: IFN reduction 14% and IFN interruption 9% (Hepatology 1999;30: 238-43).

The researchers conclude that in compensated chronic hepatitis B (CHB) patients, prolonged PEG-IFN therapy has a comparable safety profile to short courses of conventional IFN therapy.

03/29/03

Reference
M van Zonneveld and others. CHRONIC HBV TREATMENT WITH ONE YEAR OF PEGYLATYED-INTERFERON ALPHA-2B (PEG-IFN) HAS A COMPARABLE SAFETY PROFILE TO SHORT TERM CONVENTIONAL INTERFERON ALPHA-2B. Abstract 3902.00. Abstracts of the 38th Annual Meeting of the European Association of the Study of the Liver (EASL).