title: Peg-interferon alone or combined with ribavirin in HCV cirrhosis with portal hypertension: a randomized controlled trial.
abstract: OBJECTIVE
  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.
authors: Cattedra di Gastroenterologia and Unità Operativa Complessa di Gastroenterologia ed Epatologia, Di.Bi.M.I.S, Piazza delle Cliniche 2, 90127 Palermo, Italy. vito.dimarco@tin.it
authors: Vito
authors: V
authors: Di Marco
authors: Piero Luigi
authors: PL
authors: Almasio
authors: Donatella
authors: D
authors: Ferraro
authors: Vincenza
authors: V
authors: Calvaruso
authors: Giuseppe
authors: G
authors: Alaimo
authors: Sergio
authors: S
authors: Peralta
authors: Rosa
authors: R
authors: Di Stefano
authors: Antonio
authors: A
authors: Craxì
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D006975:Hypertension, Portal / Q000188:drug therapy* / Q000821:virology; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b