TURQUOISE-III

TURQUOISE-III Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for genotype 1b with cirrhosis
Safety and Efficacy of 12-Week Ribavirin-Free Treatment for Patients with HCV Genotype 1B and Cirrhosis
Feld JJ. J Hepatol 2016; 64:301-7

Anti-HCV
Ombitasvir
Paritaprevir/ritonavir
Dasabuvir
Ribavirin
Genotype
1b
Treatment history
Naive
IFN-Experienced
Cirrhosis
Yes

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Design


* Liver biopsy with Metavir > 3 or Ishak > 4, or Fibroscan > 14.6 kPa

Treatment regimens

  • Co-formulated ombitasvir (OBV)/ paritaprevir (PTV)/ rironavir (r) : 25/150/100 mg QD = 2 tablets
  • Dasabuvir (DSV) : 250 mg bid

Objective

  • SVR12 (HCV RNA < 25 IU/ml)

Baseline characteristics and outcome

Adverse events, N (%)

Summary

  • OBV/PTV/r FDC + DSV, without the use of RBV, given for 12 weeks achieved SVR12 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