Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in GT1b TURQUOISE-III

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Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in GT1b TURQUOISE-III Phase 3 Treatment Naïve and Treatment Experienced Compensated Cirrhosis Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in GT1b TURQUOISE-III Feld JJ, et al. J Hepatol. 2016;64:301-7.

OMB-PTV-RTV + DSV in GT1b and Compensated Cirrhosis TURQUOISE-III: Study Design TURQUOISE-III: Features Design: Phase 3, open-label trial evaluating safety and efficacy of ombitasvir- paritaprevir-ritonavir and dasabuvir given for 12 weeks in treatment-naïve and treatment- experienced adults with chronic HCV GT 1b and compensated cirrhosis Setting: 19 sites in United States, Canada, and Belgium Entry Criteria - Chronic HCV infection with genotype 1b - Treatment-naïve or previously treated with peginterferon + ribavirin - Age ≥18 years - Plasma HCV RNA greater than 1,000 IU/mL - Documented cirrhosis Cirrhosis (Metavir >3, Ishak score >4 or Fibroscan ≥12.5 kPa) - Cirrhosis is compensated (Child-Pugh score <7 at screening) - Absence of coinfection with HBV or HIV Primary End-Point: SVR12 Source: Feld JJ, et al. J Hepatol. 2016;64:301-7.

Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir OMB-PTV-RTV + DSV in GT1b and Compensated Cirrhosis TURQUOISE-III: Study Design Week 12 24 GT1b n = 60 Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir SVR12 Drug Dosing Ombitasvir-Paritaprevir-Ritonavir (25/150/100 mg once daily) + Dasabuvir: 250 mg twice daily Source: Feld JJ, et al. J Hepatol. 2016;64:301-7.

OMB-PTV-RTV + DSV in GT1b and Compensated Cirrhosis TURQUOISE-III: Results Virologic Response to Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir 60/60 60/60 60/60 60/60 191/208 165/172 124/140 114/121 67/68 50/51 On Treatment After Treatment Source: Feld JJ, et al. J Hepatol. 2016;64:301-7.

OMB-PTV-RTV + DSV x 12 weeks (n = 60) OMB-PTV-RTV + DSV in GT1b and Compensated Cirrhosis TURQUOISE-III: Adverse Effects Common Adverse Events (≥10% of patients) OMB-PTV-RTV + DSV x 12 weeks (n = 60) Fatigue (%) 13 (21.7) Diarrhea (%) 12 (20.0) Headache (%) 11 (18.3) Arthralgia (%) 6 (10.0) Dizziness (%) Insomnia (%) Pruritis (%) Abbreviations: OMB= Ombitasvir; PTV = Paritaprevir; RTV = Ritonavir; DSV= Dasabuvir Source: Feld JJ, et al. J Hepatol. 2016;64:301-7.

OMB-PTV-RTV + DSV x 12 weeks (n = 60) OMB-PTV-RTV + DSV in GT1b and Compensated Cirrhosis TURQUOISE-III: Adverse Effects Laboratory Abnormalities OMB-PTV-RTV + DSV x 12 weeks (n = 60) Hemoglobin(%) 13 (21.7) Total bilirubin Grade 2 (>1.5-3 x ULN) Grade 3 (>3-10 x ULN) 12 (20.0) 0 Alanine aminotransferase (%) Grade 3 (>5-20 x ULN) 1 (1.7) Aspartate aminotransferase (%) Grade 3 (>5-20 x ULN) Abbreviations: OMB= Ombitasvir; PTV = Paritaprevir; RTV = Ritonavir; DSV= Dasabuvir Source: Feld JJ, et al. J Hepatol. 2016;64:301-7.

OMB-PTV-RTV + DSV in GT1b and Compensated Cirrhosis TURQUOISE-III: Conclusions Conclusions: “The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12 weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population.” Source: Feld JJ, et al. J Hepatol. 2016;64:301-7.