title: [Efficacy and safety of a protease inhibitor with pegylated interferon and ribavirin in patients with untreated chronic hepatitis C: a meta analysis].
abstract: OBJECTIVE
  To compare the efficacy and safety of a double therapy containing pegylated interferon and ribavirin to a triple therapy (with addition of a protease inhibitor) for untreated chronic hepatitis C with genotype 1 infection.
  
  
  METHODS
  We searched Pub med, EMBASE, OVID, the Cochrane Library Clinical Trials Registry and included relevant randomized controlled trials for comparing the efficacy and safety of the triple therapy to the double therapy in HCV genotype 1 untreated patient, using terms: protease inhibitor, hepatitis C, genotype 1. The primary endpoints were composed of the rates of SVR, the rates of relapse, the rates of anemia, and the rates of discontinuation due to severe adverse events, respectively.
  
  
  RESULTS
  Five trials (involving a total of 3200 patients) were included. Data showed the triple therapy with either telaprevir or boceprevir significantly increased the SVR rate and decreased the relapse rate compared with the double therapy [for SVR rate, 65.4% vs. 40.9%, OR=2.92, 95% CI 2.5 to 3.42, P less than 0.01, and for relapse rate, 11.3% vs. 24.8%, OR=0.42, 95% CI 0.26 to 0.68, P less than 0.01], but the triple therapy associated with higher side effects and intolerability [ higher anemia rate, 44.1 % vs. 26.2%, OR=2.25, 95% CI 1.9 to 2.65, P less than 0.01 and higher discontinuation rate owing to severe adverse events, 12.4% vs. 7.7%, OR=1.66, 95% CI 1.19 to 2.32, P less than 0.01]. Subgroup analysis found that the rates of SVR were still higher and the relapse rates were lower in all triple treatment groups [composed by 24 (or 28) -week groups, 48-week groups, and response-guided therapy groups] than that of the double therapy.
  
  
  CONCLUSIONS
  A triple therapy with peginterferon-ribavirin plus either boceprevir or telaprevir significantly increased the rate of sustained virologic response among untreated patients infected with hepatitis C genotype 1. Both the incidence of adverse events and the frequency of discontinuation owing to severe adverse events were higher in patients receiving the triple therapy than those receiving the standard double therapy.
authors.affiliation: Department of Infectious Diseases, the Second Affiliated Hospital, Chongqing Medical University, Chongqing 400010, China.
authors.forename: Xue-lan
authors.initials: XL
authors.lastname: Yuan
authors.forename: Mao-ying
authors.initials: MY
authors.lastname: Li
authors.forename: Da-zhi
authors.initials: DZ
authors.lastname: Zhang
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011480:Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011480:Protease Inhibitors; D011092:Polyethylene Glycols; D012254:Ribavirin