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Table 1 Characteristics of included studies

From: Simeprevir with pegylated interferon alfa 2a plus ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a meta-analysis and historical comparison

Study Study period Study region Multi-center study? Study design Relapser/Non-responder included? Patients on HIV therapy Planned duration of treatment Ribavirin dose per day Number of patientsa Mean/median age (years) Males (%) Patients with liver cirrhosis (%)
Study C212 2011–2013 Multi-national Yes Single-arm yes 85 % Treatment-naïve patients + relapsers with EVR at week 4/12: 24 weeks 1000 mg / 1200 mg (w.a.) N = 106 47 years 85 % 13 %
All other patients: 48 weeks
Chung 2004 [12] 2000–2002 US Yes RCT (not blinded) no 82 % Patients without response in week 24: 24 weeks 600 mg (week 1–4); 800 mg (week 5–8); 1000 mg (week >8) N = 51 45 years 82 % 10 %
Patients with response in week 24: 48 weeks
Dahari 2010 [13] n.r. Brazil No Single-arm n.r. 88 % 48 weeks 11 mg/kg body weight N = 13 41 years 88 % 15 %
Fuster 2006 [14] 2001–2002 Spain Yes RCT (not blinded) no 75 % Patients with EVR in week 12: 48 weeks 800 mg N = 51 39 years 75 % 39 %b
Patients without EVR in week 12: 48 weeks or 72 weeks (randomized)
Mandorfer 2014 [22] n.r. Austria Yes Single-arm no 73 % Patients with RVR in week 4: 48 weeks 1000 mg to 1200 mg for 12 weeks; 800 mg thereafter N = 28 37 years 73 % 42 %
Patients without RVR in week 4: 72 weeks
Murphy 2011 [15] 2004–2007 US No RCT (not blinded) n.r. 90 % 48 weeks 1000 mg / 1200 mg (w.a.) N = 10 48 years 90 % n.r.
Nunez 2007 [16] 2003–2006 Spain Yes Non-randomized study no 78 % Patients without EVR in week 12: 12 weeks 1000 mg / 1200 mg (w.a.) N = 191 39 years 77 % 11 %
Patients with detectable HCV in week 24: 24 weeks
All other patients: 48 weeks (since August 2004: 72 weeks)
Rivero-Juarez 2014 [17] n.r. Spain Yes Non-randomized study no 92 % Treatment according to 2009 AASLD guidelines (48 weeks; patients with delayed virologic response: 72 weeks) 1000 mg / 1200 mg (w.a.) N = 192 42 years 82 % 51 %c
Rodriguez-Torres 2012 [21] 2006–2009 US, Spain, Portugal Yes RCT (blinded) no 89 % 48 weeksd Treatment group 1: 800 mg N = 135 (group 1) 45 years 80 % 12 %
Treatment group 2: 1000 mg / 1200 mg (w.a.) N = 275 (group 2)
Torres-Cornejo 2014 [18] 2004–2011 Spain No Non-randomized study no 85 % 48 weeks 1000 mg / 1200 mg (w.a.) N = 135 41 years 85 % 39 %
Torriani 2004 [19] 2000–2003 Multi-national Yes RCT (blinded) no 84 % 48 weeks 800 mg N = 176 40 years 80 % 15 %
Tural 2008 [20] 2003–2005 Spain Yes Non-randomized study n.r. n.r. 48 weeks 1000 mg / 1200 mg (w.a.) N = 55 40 years 67 % n.r.
  1. aOnly patients with HCV-1 infection
  2. bBridging fibrosis or fibrosis
  3. cFibrosis stage F3 or F4
  4. dNo early stopping rules according to study protocol, but within the discretion of the study physician
  5. EVR early virologic response, RVR rapid virologic response, n.r. not reported, w.a. weight-adapted (1000 mg for body weight <75 kg; 1200 mg for body weight ≥75 kg)