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

Frank Andersohn; Anne-Kathrin Claes; Werner Kulp; Jörg Mahlich; Jürgen Kurt Rockstroh

doi:10.1186/s12879-015-1311-3

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 patients^a	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 %
Study C212	2011–2013	Multi-national	Yes	Single-arm	yes	85 %	All other patients: 48 weeks	1000 mg / 1200 mg (w.a.)	N = 106	47 years	85 %	13 %
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 %
Chung 2004 [12]	2000–2002	US	Yes	RCT (not blinded)	no	82 %	Patients with response in week 24: 48 weeks	600 mg (week 1–4); 800 mg (week 5–8); 1000 mg (week >8)	N = 51	45 years	82 %	10 %
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
Fuster 2006 [14]	2001–2002	Spain	Yes	RCT (not blinded)	no	75 %	Patients without EVR in week 12: 48 weeks or 72 weeks (randomized)	800 mg	N = 51	39 years	75 %	39 %^b
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 %
Mandorfer 2014 [22]	n.r.	Austria	Yes	Single-arm	no	73 %	Patients without RVR in week 4: 72 weeks	1000 mg to 1200 mg for 12 weeks; 800 mg thereafter	N = 28	37 years	73 %	42 %
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 weeks^d	Treatment group 1: 800 mg	N = 135 (group 1)	45 years	80 %	12 %
Rodriguez-Torres 2012 [21]	2006–2009	US, Spain, Portugal	Yes	RCT (blinded)	no	89 %	48 weeks^d	Treatment group 2: 1000 mg / 1200 mg (w.a.)	N = 275 (group 2)	45 years	80 %	12 %
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.

^aOnly patients with HCV-1 infection
^bBridging fibrosis or fibrosis
^cFibrosis stage F3 or F4
^dNo early stopping rules according to study protocol, but within the discretion of the study physician
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)

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