TY - JOUR
T1 - Peg-interferon alone or combined with ribavirin in HCV cirrhosis with portal hypertension:a randomized controlled trial
AU - Calvaruso, Vincenza
AU - Craxi, Antonio
AU - Almasio, Pier Luigi
AU - Di Marco, Vito
AU - Di Stefano, Rosa
AU - Ferraro, Donatella
AU - Peralta, Sergio
AU - Alaimo, Giuseppe
AU - Calvaruso, Vincenza
AU - Almasio, Piero Luigi
AU - Di Marco, Vito
AU - Craxì, Antonio
PY - 2007
Y1 - 2007
N2 - AbstractBACKGROUND/AIMS: Risks and benefits of antiviral therapy in HCV cirrhosis with portal hypertension are poorly known.METHODS: We performed a randomized controlled trial in 102 HCV patients with compensated cirrhosis and portal hypertension: 51 received 1 microg/kg/week of Pegylated-interferon alpha-2b and 51 Pegylated-interferon plus 800 mg/day of ribavirin up to 52 weeks.RESULTS: By intention-to-treat analysis, five patients on monotherapy and eleven on combination therapy achieved a sustained virological response (9.8% vs. 21.6%, p=0.06). The response was more frequent for genotypes 2 or 3 than genotype 1 (66.6% vs. 11.3%, p=0.001). Genotype 1, who had low viral load at start of therapy, were HCV-RNA negative at 4 weeks, and were adherent to the scheduled therapy had a higher probability of sustained virological response. Patients with sustained virological response had less disease events compared to nonresponders (6.2% vs. 38.3%, p=0.03 by log rank test) during follow-up.CONCLUSIONS: In HCV cirrhosis with portal hypertension Peg-interferon plus ribavirin is a feasible treatment. Although the rate of viral eradication is modest, tailoring by genotype and early viral response allows to keep patients on treatment who are more likely to have viral eradication. Patients with viral eradication have fewer disease complications during follow-up.
AB - AbstractBACKGROUND/AIMS: Risks and benefits of antiviral therapy in HCV cirrhosis with portal hypertension are poorly known.METHODS: We performed a randomized controlled trial in 102 HCV patients with compensated cirrhosis and portal hypertension: 51 received 1 microg/kg/week of Pegylated-interferon alpha-2b and 51 Pegylated-interferon plus 800 mg/day of ribavirin up to 52 weeks.RESULTS: By intention-to-treat analysis, five patients on monotherapy and eleven on combination therapy achieved a sustained virological response (9.8% vs. 21.6%, p=0.06). The response was more frequent for genotypes 2 or 3 than genotype 1 (66.6% vs. 11.3%, p=0.001). Genotype 1, who had low viral load at start of therapy, were HCV-RNA negative at 4 weeks, and were adherent to the scheduled therapy had a higher probability of sustained virological response. Patients with sustained virological response had less disease events compared to nonresponders (6.2% vs. 38.3%, p=0.03 by log rank test) during follow-up.CONCLUSIONS: In HCV cirrhosis with portal hypertension Peg-interferon plus ribavirin is a feasible treatment. Although the rate of viral eradication is modest, tailoring by genotype and early viral response allows to keep patients on treatment who are more likely to have viral eradication. Patients with viral eradication have fewer disease complications during follow-up.
KW - Cirrosi epatica da HCV
KW - terapia antivirale.
KW - Cirrosi epatica da HCV
KW - terapia antivirale.
UR - http://hdl.handle.net/10447/32242
M3 - Article
VL - 47
SP - 484
EP - 491
JO - Journal of Hepatology
JF - Journal of Hepatology
SN - 0168-8278
ER -