Adverse event | Pegylated interferon α-2a (n = 25) | Standard interferon α-2a (n = 25) |
Fever* | 3 (12) | 11 (44) |
Rigour | 4 (16) | 8 (32) |
Fatigue | 12 (48) | 14 (56) |
Headache | 8 (32) | 9 (36) |
Myalgia | 7 (28) | 7 (28) |
Insomnia | 6 (24) | 7 (28) |
Irritability | 3 (12) | 5 (20) |
Depression | 2 (12) | 3 (12) |
Dizziness | 2 (8) | 2 (8) |
Anorexia | 5 (20) | 11 (44) |
Vomiting | 3 (12) | 5 (20) |
Diarrhoea | 2 (8) | 5 (20) |
Constipation | 2 (8) | 3 (12) |
Cough | 2 (8) | 3 (12) |
Dermatitis | 5 (20) | 6 (24) |
Injection reaction | 3 (12) | 4 (16) |
Hair loss/alopecia | 5 (20) | 7 (28) |
Leucopenia | 0 (0) | 0 (0) |
Thrombocytopenia | 3 (12) | 5 (20) |
Serious adverse events | ||
Retinal haemorrhage† | 0 (0) | 1 (4) |
Death‡ | 0 (0) | 1 (4) |
Overall withdrawal rate | 0 (0) | 5 (20) |
Interferon related§ | 0 (0) | 5 (20) |
Non-interferon related | 0 (0) | 0 (0) |
*p = 0.03.
†At week 12 after the treatment with impaired visual acuity.
‡Cardiogenic pulmonary oedema 4 weeks off therapy with standard interferon α-2a therapy (week 28) related to standard interferon therapy.
§Included four patients without completion of 24 weeks of standard interferon α-2a therapy due to retinal haemorrhage, fever, fatigue and dermatitis, and one death 4 weeks off therapy with standard interferon α-2a therapy, p = 0.04.