Leukocyte interferon-alpha and ribavirin for treatment of chronic  hepatitis C patients intolerant to pegylated-interferon.
Treatments for chronic hepatitis C (CHC) patients intolerant to pegylated interferons (peg-IFNs) are lacking. Thus, such patients remain at high risk of developing an advanced and decompensated liver disease. Leukocyte IFN-alpha (Le-IFN-alpha) seems to possess a safer profile than other natural and recombinant a-interferons, but no information is available for peg-IFN intolerant patients. Accordingly, we evaluated the safety and efficacy of Le-IFN-alpha in patients intolerant to peg-IFNs. Twenty-five consecutive CHC patients intolerant to peg-IFNs were prospectively enrolled. HCV genotype 1 was present in 80% and cirrhosis in 68% of cases. Thirteen patients (52%) had thrombocytopenia. Le-IFN-alpha (3 MU three times a week) was administered for 48 weeks plus ribavirin 800 or 1,000 mg/day for HCV genotype 2/3 and 1, respectively. The follow-up was at 24 weeks. Compliance with treatment was satisfactory if the patient received 80% of the therapeutic regimen. An intention-to-treat analysis was done. Eighty-eight percent of CHC patients completed the prescribed treatment course with Le-IFN-alpha. In these patients the side effects, when observed, were mild to moderate, and did not require Le-IFN-alpha dose adjustment. Le-IFN-alpha showed significantly less hematological toxicity than peg-IFN (4 vs 48%; P<0.02). The overall sustained virologic response was 32%, i.e., 24% for cirrhotics and 50% for CHC, and 25% for genotype 1 and 60% for genotypes 2/3. The data indicate that Le-IFN-alpha plus ribavirin is a useful and effective treatment for CHC patients who are intolerant to peg-IFNs.
Adinolfi
Luigi E
LE
Internal Medicine and Hepatology, Facoltá di Medicina e Chirurgia,Second University of Naples Medical School, Naples, Italy. luigielio.adinolfi@unina2.it
Durante-Mangoni
Emanuele
E
Salzillo
Marta
M
Marrone
Aldo
A
Tripodi
Marie-Francoise
MF
Restivo
Luciano
L
Merola
Antonietta
A
Zampino
Rosa
R
Ruggiero
Giuseppe
G
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004361:Drug Tolerance; D005260:Female; D018937:Hepatitis C Antibodies / Q000097:blood; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D007558:Italy; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use*
D000998:Antiviral Agents; D018937:Hepatitis C Antibodies; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a