AIM: To determine the role of interferon (IFN) with or without ribavirin in preventing or delaying hepatocellular carcinoma (HCC) development in patients with hepatitis C virus (HCV) related cirrhosis. Data on the preventive effect of IFN plus ribavirin treatment are lacking. METHODS: A total of 101 patients (62 males and 39 females, mean age 55.1+/-1.4 years) with histologically proven HCV related liver cirrhosis plus compatible biochemistry and ultrasonography were enrolled in the study. Biochemistry and ultrasonography were performed every 6 mo. Ultrasound guided liver biopsy was performed on all detected focal lesions. Follow-up lasted for 5 years. Cellular proliferation, evaluated by measuring Ag-NOR proteins in hepatocytes nuclei, was expressed as AgNOR-Proliferative index (AgNOR-PI) (cut-off = 2.5). Forty-one patients (27 males, 14 females) were only followed up after the end of an yearly treatment with IFN-alpha2b (old treatment control group = OTCG). Sixty naive patients were stratified according to sex and AgNOR-PI and then randomized in two groups: 30 were treated withIFN-alpha2b + ribavirin (treatment group = TG), the remaining were not treated (control group = CG). Nonresponders (NR) or relapsers in the TG received further IFN/ribavirin treatments after a 6 mo of withdrawal. RESULTS:AgNOR-PI was significantly lowered by IFN (P<0.001). HCC incidence was higher in patients with AgNOR-PI>2.5 (26% vs 3%, P<0.01). Two NR in the OTCG, none in the TG and 9 patients in the CG developed HCC during follow-up. The Kaplan-Mayer survival curves showed statistically significant differences both between OTCG and CG (P<0.004) and between TG and CG (P<0.003). CONCLUSION:IFN/ribavirin treatment associated with re-treatment courses of NR seems to produce the best results in terms of HCC prevention. AgNOR-PI is a useful marker of possible HCC development.
RCT Entities:
AIM: To determine the role of interferon (IFN) with or without ribavirin in preventing or delaying hepatocellular carcinoma (HCC) development in patients with hepatitis C virus (HCV) related cirrhosis. Data on the preventive effect of IFN plus ribavirin treatment are lacking. METHODS: A total of 101 patients (62 males and 39 females, mean age 55.1+/-1.4 years) with histologically proven HCV related liver cirrhosis plus compatible biochemistry and ultrasonography were enrolled in the study. Biochemistry and ultrasonography were performed every 6 mo. Ultrasound guided liver biopsy was performed on all detected focal lesions. Follow-up lasted for 5 years. Cellular proliferation, evaluated by measuring Ag-NOR proteins in hepatocytes nuclei, was expressed as AgNOR-Proliferative index (AgNOR-PI) (cut-off = 2.5). Forty-one patients (27 males, 14 females) were only followed up after the end of an yearly treatment with IFN-alpha2b (old treatment control group = OTCG). Sixty naive patients were stratified according to sex and AgNOR-PI and then randomized in two groups: 30 were treated with IFN-alpha2b + ribavirin (treatment group = TG), the remaining were not treated (control group = CG). Nonresponders (NR) or relapsers in the TG received further IFN/ribavirin treatments after a 6 mo of withdrawal. RESULTS: AgNOR-PI was significantly lowered by IFN (P<0.001). HCC incidence was higher in patients with AgNOR-PI>2.5 (26% vs 3%, P<0.01). Two NR in the OTCG, none in the TG and 9 patients in the CG developed HCC during follow-up. The Kaplan-Mayer survival curves showed statistically significant differences both between OTCG and CG (P<0.004) and between TG and CG (P<0.003). CONCLUSION:IFN/ribavirin treatment associated with re-treatment courses of NR seems to produce the best results in terms of HCC prevention. AgNOR-PI is a useful marker of possible HCC development.
Authors: K Hino; A Kitase; Y Satoh; D Fujiwara; Y Yamaguchi; M Korenaga; Y Shingai; T Konishi; S Yamashita; K Uchida; K Mori; H Hanada; T Kodama; K Nukui; K Okita Journal: J Viral Hepat Date: 2002-09 Impact factor: 3.728
Authors: K Ikeda; S Saitoh; Y Arase; K Chayama; Y Suzuki; M Kobayashi; A Tsubota; I Nakamura; N Murashima; H Kumada; M Kawanishi Journal: Hepatology Date: 1999-04 Impact factor: 17.425
Authors: M F Donato; E Arosio; E Del Ninno; G Ronchi; P Lampertico; A Morabito; M R Balestrieri; M Colombo Journal: Hepatology Date: 2001-09 Impact factor: 17.425
Authors: Y Imai; S Kawata; S Tamura; I Yabuuchi; S Noda; M Inada; Y Maeda; Y Shirai; T Fukuzaki; I Kaji; H Ishikawa; Y Matsuda; M Nishikawa; K Seki; Y Matsuzawa Journal: Ann Intern Med Date: 1998-07-15 Impact factor: 25.391
Authors: S Nishiguchi; T Kuroki; S Nakatani; H Morimoto; T Takeda; S Nakajima; S Shiomi; S Seki; K Kobayashi; S Otani Journal: Lancet Date: 1995-10-21 Impact factor: 79.321
Authors: Francesca Lodato; Giuseppe Mazzella; Davide Festi; Francesco Azzaroli; Antonio Colecchia; Enrico Roda Journal: World J Gastroenterol Date: 2006-12-07 Impact factor: 5.742