Table 29: Pivotal Phase III trials76 Design arms, treatment of duration Placebo controlled, no cirrhosis Multicentre, genotype 1 631 Viekira 72 randomised (a and b) Pak+RBV double M11-646 Treatment (12 blind naïve Placebo without cirrhosis Multicentre, genotype 1 394 Viekira 72 randomised (a and b) Pak+RBV double M13-098 Treatment (12 weeks) Placebo without cirrhosis Viekira Pak-RBV versus VIEKIRA-Pak, no cirrhosis PEARL-II Multicentre, genotype 186 Viekira 60 1b, Pak+RBV M13-389 , open label Treatment ( 12 weeks) without Viekira Pak (12 cirrhosis PEARL-III Multicentre, genotype 419 Viekira 60 1b, Pak+RBV M13-961 double Treatment ( 12 blind naïve without Viekira Pak (12 cirrhosis PEARL-IV Multicentre, genotype 305 Viekira 60 1a Pak+RBV M14-002 double Treatment ( 12 weeks) naïve without Viekira Pak (12 cirrhosis weeks) Viekira Pak-RBV, cirrhosis
Table 29: Pivotal Phase III trials76 Design of arms, treatment duration Placebo controlled, no cirrhosis M11-646 Multicentre, double blind genotype 1 (a and b) Treatment naïve without cirrhosis 631 Viekira Pak+RBV (12 Placebo 72 M13-098 Multicentre, double genotype 1 (a and b) Treatment without cirrhosis 394 Viekira Pak+RBV (12 weeks) Placebo 72 Viekira Pak-RBV versus VIEKIRA-Pak, no cirrhosis PEARL-II M13-389 Multicentre, open label genotype 1b, Treatment without cirrhosis 186 Viekira Pak+RBV ( 12 weeks) Viekira Pak (12 60 PEARL-III M13-961 Multicentre, double blind genotype 1b, Treatment naïve without cirrhosis 419 Viekira Pak+RBV ( 12 Viekira Pak (12 60 PEARL-IV M14-002 Multicentre, double genotype 1a Treatment naïve without cirrhosis 305 Viekira Pak+RBV ( 12 weeks) Viekira Pak (12 weeks) 60 Viekira Pak-RBV, cirrhosis randomised randomised ,
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