Background and aim: Patients with chronic hepatitis C (CHC) and persistently normal ALT levels have recently been included in the guidelines for antiviral treatment. To evaluate the efficacy of PEG-Interferon alpha-2a plus weight-based ribavirin doses in patients with these characteristics in a single Italian centre. Material and methods: Patients with CHC and at least 3 normal ALT values over a 12-months period were offered a treatment with PEG-IFN alpha-2a 180 mg/wk plus ribavirin (800 mg/day for weight <60 kg; 1000 mg/day for weight 60-75 kg; 1200 mg/day for weight >75 kg) for 24 weeks [according to genotype 2 or 3 (group 1)] or for 48 weeks [according to genotype 1 or 4 (group 2)]. Each patients at baseline underwent liver stiffness (LS) examination. Data were analyzed according to the intention to treat criteria. Results: 206 patients (58 male, 148 female of mean age 47.5±11.8 years) were enrolled into the study; 135 subjects were allocated in group 1 (129 with genotype 2 and 6 with genotype 3) and 71 patients in group 2 (62 with genotype 1, and 9 with genotype 4). According to the LS measurement patients were classified as follows: 137 presented absent or mild fibrosis (LS: 2.5-7.0 KPa), 61 have significant fibrosis (LS: 7.0-9.5 KPa), 4 have severe fibrosis (LS: 9.5-12.5 kPa) and 4 have cirrhosis; 3 of the latter group were in group 2. Twelve subjects (5.8%) dropped out within 4 months for side-effects, whereas 192 subjects completed the study. At overall, 15 patients were considered non-responders (7.3%). The sustained virological response (SVR) rate was 83%, eight patients (3.9%) were relapsers to the therapy. The SVR was higher in “easy” genoypes (2-3) in respect to “difficult” genotypes (1-4) [90.4% vs 69.0%, p <0.001]. No statistical difference was found in the SVR rate between patients presenting absent or mild fibrosis vs those with significant fibrosis. Conclusions: Patients with CHC with “easy genotype” and with persistently normal transaminases have a 90.4% chance to clear the virus with conventional antiviral treatment.
P.1.158: PEG-INTERFERON ALPHA-2A WITH WEIGHT-BASED RIBAVIRIN DOSES IN PATIENTS WITH CHRONIC HEPATITIS C AND PERSISTENTLY NORMAL TRANSAMINASES: A PILOT STUDY IN A SINGLE CENTRE
Cazzagon, N.;BOEMO, DERIS GIANNI;Baldovin, T.;Baldo, V.;EGOUE MONGOUE, REMY JOEL;Antoniazzi, S.;Floreani, A.
2011
Abstract
Background and aim: Patients with chronic hepatitis C (CHC) and persistently normal ALT levels have recently been included in the guidelines for antiviral treatment. To evaluate the efficacy of PEG-Interferon alpha-2a plus weight-based ribavirin doses in patients with these characteristics in a single Italian centre. Material and methods: Patients with CHC and at least 3 normal ALT values over a 12-months period were offered a treatment with PEG-IFN alpha-2a 180 mg/wk plus ribavirin (800 mg/day for weight <60 kg; 1000 mg/day for weight 60-75 kg; 1200 mg/day for weight >75 kg) for 24 weeks [according to genotype 2 or 3 (group 1)] or for 48 weeks [according to genotype 1 or 4 (group 2)]. Each patients at baseline underwent liver stiffness (LS) examination. Data were analyzed according to the intention to treat criteria. Results: 206 patients (58 male, 148 female of mean age 47.5±11.8 years) were enrolled into the study; 135 subjects were allocated in group 1 (129 with genotype 2 and 6 with genotype 3) and 71 patients in group 2 (62 with genotype 1, and 9 with genotype 4). According to the LS measurement patients were classified as follows: 137 presented absent or mild fibrosis (LS: 2.5-7.0 KPa), 61 have significant fibrosis (LS: 7.0-9.5 KPa), 4 have severe fibrosis (LS: 9.5-12.5 kPa) and 4 have cirrhosis; 3 of the latter group were in group 2. Twelve subjects (5.8%) dropped out within 4 months for side-effects, whereas 192 subjects completed the study. At overall, 15 patients were considered non-responders (7.3%). The sustained virological response (SVR) rate was 83%, eight patients (3.9%) were relapsers to the therapy. The SVR was higher in “easy” genoypes (2-3) in respect to “difficult” genotypes (1-4) [90.4% vs 69.0%, p <0.001]. No statistical difference was found in the SVR rate between patients presenting absent or mild fibrosis vs those with significant fibrosis. Conclusions: Patients with CHC with “easy genotype” and with persistently normal transaminases have a 90.4% chance to clear the virus with conventional antiviral treatment.Pubblicazioni consigliate
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