Good safety profile and efficacy of leucocyte interferon-alpha in combination with oral ribavirin in treatment-naive patients with chronic hepatitis C: a multicentre, randomised, controlled study.
BACKGROUND
The differential tolerability profile of various interferon (IFN)-alpha preparations used in combination with ribavirin for the treatment of chronic hepatitis C needs to be elucidated. Approximately 8% of patients receiving recombinant IFNalpha-2b plus ribavirin discontinue treatment because of adverse events. Human leucocyte IFNalpha is deemed to have a better safety profile than recombinant IFNalpha. We therefore compared the safety profile and efficacy of ribavirin combined with leucocyte IFNalpha or with recombinant IFNalpha-2b in treatment-naive patients with chronic hepatitis C.


METHODS
We randomised 423 patients to either leucocyte IFNalpha 3MU three times weekly plus ribavirin (210 patients) or the same dose of recombinant IFNalpha-2b plus ribavirin (213 patients). Patients were treated for 24 weeks and followed-up for a further 48 weeks. The primary endpoint was the safety profile of the two therapies; the secondary endpoint was the rate of sustained response.


RESULTS
In patients receiving leucocyte IFNalpha, the total number of adverse events was lower than in the group receiving recombinant IFNalpha (259 vs 441 patients), and the percentage of patients discontinuing treatment because of adverse events or laboratory abnormalities was significantly reduced (4% vs 11%; p = 0.013). Sustained response was observed in 47% of patients receiving leucocyte IFNalpha plus ribavirin and in 44% of patients receiving IFNalpha-2b plus ribavirin.


CONCLUSIONS
Both therapeutic regimens were effective in inducing a sustained response in naive patients. However, the safety profile of leucocyte IFNalpha plus ribavirin was more favourable than that observed with the administration of recombinant IFNalpha-2b plus ribavirin, suggesting that leucocyte IFNalpha may be an alternative option in patients with reduced tolerability to other IFNs.
Barbaro
Giuseppe
G
Department of Emergency Medicine, University La Sapienza, Rome, Italy.
Grisorio
Benvenuto
B
Fruttaldo
Luigi
L
Bacca
Donato
D
Babudieri
Sergio
S
Torre
Donato
D
Francavilla
Ruggiero
R
Rizzo
Giovanni
G
Belloni
Giancarlo
G
Lucchini
Alfio
A
Annese
Mauro
M
Matarazzo
Filippo
F
Hazra
Christina
C
Barbarini
Giorgio
G
D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin