PEARL-II GT1b, 186 Viekira 60 weeks Treatment Pak+RBV M13-389 ( 12 open weeks) without cirrhosis Viekira Pak (12 weeks) PEARL-III GT1b, 419 Viekira 60 weeks Treatment Pak+RBV M13-961 ( 12 double without weeks) blind cirrhosis Viekira Pak (12 weeks) PEARL-IV GT1a 305 Viekira 60 weeks Treatment Pak+RBV M14-002 naïve ( 12 double without weeks) blind cirrhosis Viekira Pak (12 weeks) Viekira Pak-RBV, cirrhosis TURQUOISE GT1 (a 380 Viekira 72 weeks M13-099 and b) Pak+RBV Treatment ( 12 open weeks) label and Viekira treatment Pak+RBV naïve with cirrhosis (24 M11-646, SAPPHIRE-I Genotype 1, treatment naïve. This was a Phase III, multicentre, randomised, double blind, placebo controlled safety and efficacy study of paritaprevir/ritonavir/ ombitasvir and dasabuvir co-administered with ribavirin (3DAA + RBV) in treatment naïve non-cirrhotic adults with genotype 1 chronic HCV infection. It was conducted at 79 centres in 13 countries. The primary efficacy objective was to show the non-inferiority in SVR12 rates after 12 weeks of treatment with 3DAA + RBV, compared with the historical SVR rate for telaprevir plus pegIFN/RBV. Approximately 600 patients were randomised to one of two arms in a 3:1 ratio to receive 3DAA + RBV for 12 weeks (Group A), or placebo 3DAA + RBV for 12 weeks followed by 3DAA + RBV for 12 weeks (Group B). In the double blind treatment period, randomisation was stratified according to HCV subtype (1a and non-1a) and IL28B genotype (CC and non- The duration of the study was 72 weeks consisting of a double blind treatment period, an open label treatment period (for patients randomised to placebo) and a post dosing period. All patients who received active study drugs were followed for 48 weeks post
PEARL-II M13-389 open GT1b, Treatment without cirrhosis 186 Viekira Pak+RBV ( 12 weeks) Viekira Pak (12 weeks) 60 weeks PEARL-III M13-961 double blind GT1b, Treatment without cirrhosis 419 Viekira Pak+RBV ( 12 weeks) Viekira Pak (12 weeks) 60 weeks PEARL-IV M14-002 double blind GT1a Treatment naïve without cirrhosis 305 Viekira Pak+RBV ( 12 weeks) Viekira Pak (12 weeks) 60 weeks Viekira Pak-RBV, cirrhosis M13-099 open label GT1 (a and b) Treatment and treatment naïve with cirrhosis 380 Viekira Pak+RBV ( 12 weeks) Viekira Pak+RBV (24 72 weeks M11-646, SAPPHIRE-I Genotype 1, treatment naïve. This was a Phase III, multicentre, randomised, double blind, placebo controlled safety and efficacy study of paritaprevir/ritonavir/ ombitasvir and dasabuvir co-administered with ribavirin (3DAA + RBV) in treatment naïve non-cirrhotic adults with genotype 1 chronic HCV infection. It was conducted at 79 centres in 13 countries. The primary efficacy objective was to show the non-inferiority in SVR12 rates after 12 weeks of treatment with 3DAA + RBV, compared with the historical SVR rate for telaprevir plus pegIFN/RBV. Approximately 600 patients were randomised to one of two arms in a 3:1 ratio to receive 3DAA + RBV for 12 weeks (Group A), or placebo 3DAA + RBV for 12 weeks followed by 3DAA + RBV for 12 weeks (Group B). In the double blind treatment period, randomisation was stratified according to HCV subtype (1a and non-1a) and IL28B genotype (CC and The duration of the study was 72 weeks consisting of a double blind treatment period, an open label treatment period (for patients randomised to placebo) and a post dosing period. All patients who received active study drugs were followed for 48 weeks post TURQUOISE non-
auspar-paritaprevir-ritonavir-ombitasvir-dasabuvir-as-sodium-salt-and-ribavirin-170324.docx