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Patients with Chronic Hepatitis B Have Better Safety and Quality of Life When Treated with Peginterferon Alfa-2a (Pegasys) Monotherapy Compared to Those with Chronic Hepatitis C

The safety profile of peginterferon alfa-2a (40KD) (Pegasys) and its effects on quality of life (QoL) have been well documented in previous studies of chronic hepatitis C (CHC) [Fried et al, N Engl J Med 2002; Rasenack et al, Pharmacoeconomics 2003].

Recently, the safety and tolerability of peginterferon alfa-2a, and its effects on QoL, have been assessed in patients with HBeAg-negative chronic hepatitis B (CHB) or HBeAg-positive CHB enrolled in two, randomized, multicentre studies of peginterferon alfa-2a with and without lamivudine versus lamivudine alone. Patients with HBeAg-negative CHB (n=177) or HBeAg-positive CHB (n=271) received peginterferon alfa-2a (40KD) (PEGASYS?/sup>) 180 μg once weekly + placebo once daily for 48 weeks, and were followed up for a 24-week treatment-free period.

Safety was assessed at baseline and throughout treatment and follow-up. QoL was measured using the SF-36 questionnaire which was completed by patients at baseline and weeks 12, 24, 48 and 72.

Data from the two CHB studies were compared with pooled peginterferon alfa-2a monotherapy data from three studies in CHC, which used the same therapeutic schedule and identical methodology for assessing safety and QoL. Results

Adverse events were qualitatively similar, but the frequency of interferon-related adverse events was generally lower with peginterferon alfa-2a in patients with CHB than previously reported for patients with CHC with the exception of pyrexia (see table).

The difference between the rate of adverse events seen in patients with CHB and CHC was not affected by population differences and was the same in Asians and Caucasians.

Importantly, the incidence of depression and the rates of withdrawal were much lower in patients with CHB than CHC. Similarly, patients with CHB had better QoL during treatment than patients with CHC and these differences were clinically significant (>3 points) for most of the SF-36 categories. Conclusions

In conclusion the authors write, 揚eginterferon alfa-2a (40KD) (PAgasys) monotherapy appears to be better tolerated in patients with CHB than in patients with CHC. This improved tolerability was also reflected in the QoL results and lower withdrawal rates.?/span>

揑t is currently unclear whether the markedly lower rates of depression observed in patients with CHB were due to viral-specific factors and/or host susceptibility.?/span>

PEGASYS?/sup> in HBeAg-negative CHB (n=177)

PEGASYS?/sup> in HBeAg-positive CHB (n=271)

PEGASYS?/sup> in CHC (n=575)

Adverse event

Pyrexia

59 [52-67]

49 [43-55]

38 [34-42]

Fatigue

42 [34-49]

37 [31-42]

51 [50-58]

Myalgia

27 [20-33]

26 [20-31]

43 [39-47]

Headache

24 [18-31]

28 [23-34]

55 [51-59]

Decreased appetite

18 [12-23]

6 [3-9]

15 [12-19]

Arthralgia

15 [10-21]

9 [5-12]

29 [22-35] ?/span>

Alopecia

14 [8-19]

20 [15-25]

23 [20-27]

Diarrhoea

11 [6-16]

7 [4-11]

21 [16-25] ?/span>

Injection site reaction

6 [2-9]

11 [7-15]

15 [11-19] ?/span>

Depression

3 [0-6]

6 [3-8]

19 [16-22]

Withdrawals

For any reason

8 [4-12]

6 [3-8]

19 [16-23]

For adverse events

7 [3-11]

3 [1-5]

8 [5-11] ?/span>

For lab abnormality

1

2

<1?/span>

?(n=351) ?(n=224) Included in this table are adverse events which occurred with an incidence of >10% in any study arm in one of the CHB studies and depression.

11/01/04 Reference P Marcellin and others. BETTER SAFETY AND QUALITY OF LIFE IN PATIENTS WITH CHRONIC HEPATITIS B THAN IN PATIENTS WITH CHRONIC HEPATITIS C WHEN TREATED WITH PEGINTERFERON ALFA-2A (40KD) (PEGASYS?/sup>) MONOTHERAPY. Abstract 1158 (poster). 55th AASLD. October 29-November 2, 2004. Boston, MA.