BACKGROUND: Alpha-interferon (alpha-IFN) is the treatment of choice for chronic hepatitis C but most patients experience adverse effects which sometimes lead to the suspension of therapy. Recently, higher doses of alpha-IFN or prolonged therapy have increased the number of cases of intolerance. STUDY DESIGN: In this open study we evaluated the efficacy and safety of leucocyte interferon-alpha (IFNalpha) [6MU three times a week] in 43 patients with chronic hepatitis C who had been intolerant to previous treatment courses with recombinant or lymphoblastoid IFNalpha. All patients were treated for 6 months and followed-up for an additional 6 months.End of treatment responders were patients in whom hepatitis C virus (HCV)-RNA had been eradicated from the blood by the end of treatment, sustained responders were those patients who maintained negative HCV-RNA at the end of follow-up, and the remaining patients were considered non-responders. Adverse effects were monitored by interviews, laboratory and clinical examinations. RESULTS: Five patients (11.6%) discontinued the treatment, four due to the reappearance of previous adverse effects, and one due to an ex novo adverse effect. In six patients the dose had to be halved. At the end of treatment 11 patients (25.6%) had negative serum HCV-RNA. After discontinuation of therapy, disease flared in four patients, thus seven patients were sustained responders. CONCLUSIONS: This study shows that leucocyte IFNalpha at a dose of 6MU three times a week is well tolerated in patients previously intolerant to recombinant or lymphoblastoid IFNalpha, allowing a high percentage of them to complete a course of treatment in terms of duration and dose.
BACKGROUND: Alpha-interferon (alpha-IFN) is the treatment of choice for chronic hepatitis C but most patients experience adverse effects which sometimes lead to the suspension of therapy. Recently, higher doses of alpha-IFN or prolonged therapy have increased the number of cases of intolerance. STUDY DESIGN: In this open study we evaluated the efficacy and safety of leucocyte interferon-alpha (IFNalpha) [6MU three times a week] in 43 patients with chronic hepatitis C who had been intolerant to previous treatment courses with recombinant or lymphoblastoid IFNalpha. All patients were treated for 6 months and followed-up for an additional 6 months.End of treatment responders were patients in whom hepatitis C virus (HCV)-RNA had been eradicated from the blood by the end of treatment, sustained responders were those patients who maintained negative HCV-RNA at the end of follow-up, and the remaining patients were considered non-responders. Adverse effects were monitored by interviews, laboratory and clinical examinations. RESULTS: Five patients (11.6%) discontinued the treatment, four due to the reappearance of previous adverse effects, and one due to an ex novo adverse effect. In six patients the dose had to be halved. At the end of treatment 11 patients (25.6%) had negative serum HCV-RNA. After discontinuation of therapy, disease flared in four patients, thus seven patients were sustained responders. CONCLUSIONS: This study shows that leucocyte IFNalpha at a dose of 6MU three times a week is well tolerated in patients previously intolerant to recombinant or lymphoblastoid IFNalpha, allowing a high percentage of them to complete a course of treatment in terms of duration and dose.
Authors: Luigi E Adinolfi; Emanuele Durante-Mangoni; Marta Salzillo; Aldo Marrone; Marie-Francoise Tripodi; Luciano Restivo; Antonietta Merola; Rosa Zampino; Giuseppe Ruggiero Journal: Intern Emerg Med Date: 2009-12 Impact factor: 3.397