OBJECTIVE: This trial reports the 6-month results of a pilot study using lymphoblastoid interferon alpha (IFNalpha) and acetylcysteine (N-acetylcysteine) separately and in combination in patients with chronic hepatitis C, genotype 1b, who were nonresponders to previous treatment with recombinant IFNalpha alone. PATIENTS AND METHODS: 21 patients were randomly divided into three groups of seven each. Group A was treated with lymphoblastoid IFNalpha 6MU three times a week for 6 months; group B received the same schedule of lymphoblastoid IFNalpha as group A plus acetylcysteine 1200 mg/day per os in two administrations, and group C received only acetylcysteine 1200 mg/day per os in two administrations. RESULTS:Mean serum alanine aminotransferase (ALT) levels at 6 months in groups A and B, but not in group C, were significantly lower than baseline values (p < 0.05 and p < 0.03, respectively). Two patients in group A (28.6%) and three in group B (42.9%), but none in group C, had normalised ALT levels at 6 months. During follow-up, levels flared in one group A and in one group B patient. Thus, at the end of follow-up one group A and two group B patients were sustained responders. At the end of therapy and follow-up, hepatitis C virus (HCV)-RNA was negative in one patient in group A and two patients in group B. As no serious adverse effects were observed, therapy was never interrupted or suspended. CONCLUSION:Acetylcysteine alone had no effect on hepatic cytolysis and viral replication; lymphoblastoid IFNalpha showed a modest, but better, response than recombinant IFNalpha, and the combination therapy, although in a limited number of patients, appeared to be more efficient than lymphoblastoid IFNalpha alone.
RCT Entities:
OBJECTIVE: This trial reports the 6-month results of a pilot study using lymphoblastoid interferon alpha (IFNalpha) and acetylcysteine (N-acetylcysteine) separately and in combination in patients with chronic hepatitis C, genotype 1b, who were nonresponders to previous treatment with recombinant IFNalpha alone. PATIENTS AND METHODS: 21 patients were randomly divided into three groups of seven each. Group A was treated with lymphoblastoid IFNalpha 6MU three times a week for 6 months; group B received the same schedule of lymphoblastoid IFNalpha as group A plus acetylcysteine 1200 mg/day per os in two administrations, and group C received only acetylcysteine 1200 mg/day per os in two administrations. RESULTS: Mean serum alanine aminotransferase (ALT) levels at 6 months in groups A and B, but not in group C, were significantly lower than baseline values (p < 0.05 and p < 0.03, respectively). Two patients in group A (28.6%) and three in group B (42.9%), but none in group C, had normalised ALT levels at 6 months. During follow-up, levels flared in one group A and in one group B patient. Thus, at the end of follow-up one group A and two group B patients were sustained responders. At the end of therapy and follow-up, hepatitis C virus (HCV)-RNA was negative in one patient in group A and two patients in group B. As no serious adverse effects were observed, therapy was never interrupted or suspended. CONCLUSION:Acetylcysteine alone had no effect on hepatic cytolysis and viral replication; lymphoblastoid IFNalpha showed a modest, but better, response than recombinant IFNalpha, and the combination therapy, although in a limited number of patients, appeared to be more efficient than lymphoblastoid IFNalpha alone.
Authors: S W Schalm; B E Hansen; L Chemello; A Bellobuono; J T Brouwer; O Weiland; L Cavalletto; R Schvarcz; G Ideo; A Alberti Journal: J Hepatol Date: 1997-05 Impact factor: 25.083
Authors: M Roederer; F J Staal; P A Raju; S W Ela; L A Herzenberg; L A Herzenberg Journal: Proc Natl Acad Sci U S A Date: 1990-06 Impact factor: 11.205
Authors: M Martinot-Peignoux; P Marcellin; M Pouteau; C Castelnau; N Boyer; M Poliquin; C Degott; I Descombes; V Le Breton; V Milotova Journal: Hepatology Date: 1995-10 Impact factor: 17.425
Authors: G Montalto; S Tripi; A Cartabellotta; M Fulco; M Soresi; G Di Gaetano; A Carroccio; M Levrero Journal: Am J Gastroenterol Date: 1998-06 Impact factor: 10.864
Authors: E Boucher; H Jouanolle; P Andre; A Ruffault; D Guyader; R Moirand; B Turlin; C Jacquelinet; P Brissot; Y Deugnier Journal: Hepatology Date: 1995-02 Impact factor: 17.425
Authors: T Poynard; P Bedossa; M Chevallier; P Mathurin; C Lemonnier; C Trepo; P Couzigou; J L Payen; M Sajus; J M Costa Journal: N Engl J Med Date: 1995-06-01 Impact factor: 91.245
Authors: P Pontisso; M G Ruvoletto; M Nicoletti; S Tisminetzky; M Gerotto; M Levrero; M Artini; M Baldi; G Ballardini; L Barbara Journal: J Viral Hepat Date: 1995 Impact factor: 3.728