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. |