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 Treatment regimens –Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r) : 25/150/100 mg QD = 2 tablets –Dasabuvir (DSV) : 250 mg bid  Objective.

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Presentation on theme: " Treatment regimens –Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r) : 25/150/100 mg QD = 2 tablets –Dasabuvir (DSV) : 250 mg bid  Objective."— Presentation transcript:

1  Treatment regimens –Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r) : 25/150/100 mg QD = 2 tablets –Dasabuvir (DSV) : 250 mg bid  Objective –SVR 12 (HCV RNA < 25 IU/ml) TURQUOISE-III Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for genotype 1b with cirrhosis OBV/PTV/r + DSV + RBV Open-label ≥ 18 years HCV genotype 1b HCV RNA > 1,000 IU/ml Naïve or pre-treated No prior therapy with PI Non decompensated cirrhosis* Child-Pugh A * Liver biopsy with Metavir > 3 or Ishak > 4, or Fibroscan > 14.6 kPa N = 60 SVR 12 W12W24  Design Feld JJ. J Hepatol. 2015 Oct 14 [Epub ahead of print] TURQUOISE-III

2 N = 60 Mean age, years60 Female38% Race : black12% Body mass index, mean27.8 IL28B non-CC genotype83% HCV RNA log 10 IU/ml, mean (SD) 6.6 ± 0.6 Fibroscan, kPA, median (range)19 (12.5-67.8) Prior treatment with PEG-IFN + RBV, N (%)33 (55%) SVR 12 100% Baseline characteristics and outcome TURQUOISE-III TURQUOISE-III Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for genotype 1b with cirrhosis Feld JJ. J Hepatol. 2015 Oct 14 [Epub ahead of print]

3 N = 60 Any adverse event46 (77) AE leading to treatment discontinuation0 Serious adverse event1 (2) AE occurring in > 10% Fatigue22% Diarrhea20% Headache18% Arthralgia10% Dizziness10% Insomnia10% Pruritus10% Hemoglobin 8-10 g/dl1 (2) ALT x 5-20 ULN1 (2) AST x 3-5 x ULN1 (2) Adverse events, N (%) TURQUOISE-III TURQUOISE-III Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for genotype 1b with cirrhosis Feld JJ. J Hepatol. 2015 Oct 14 [Epub ahead of print]

4  Summary –OBV/PTV/r FDC + DSV, without the use of RBV, given for 12 weeks achieved SVR 12 of 100% in genotype 1b infected patients with compensated cirrhosis, including treatment-experienced patients –Treatment was very well tolerated, with a low rate of serious adverse events, no premature discontinuations, and infrequent laboratory abnormalities that were not clinically relevant TURQUOISE-III TURQUOISE-III Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for genotype 1b with cirrhosis Feld JJ. J Hepatol. 2015 Oct 14 [Epub ahead of print]

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