Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir

sq_drugsAs there seems to be a lot happening around ombitasvir / paritaprevir / ritonavir and dasabuvir (known in Canada as Holkira Pak and Viekira Pak in the USA), with CADTH seeking patient group input reports and PHCN putting out a call for patient input and survey participants, the Hepatitis C Treatment Information Project has put together the following treatment summary:

OMBITASVIR / PARITAPREVIR / RITONAVIR & DASABUVIR (HOLKIRA PAK)
Maker: AbbVie

3 DAA Co-formulated Drugs for Genotype 1:

  • Ombitasvir / paritaprevir / ritonavir +
  • Dasabuvir +/-
  • Ribavirin (RBV)

Adult Daily Doses:  4 pills per day +/- ribavirin

  • Ombitasvir / paritaprevir / ritonavir: 2 pills in the morning
  • Dasabuvir: 1 pill in the morning and 1 pill in the evening
  • Ribavirin (RBV): 1 pill in the morning and 1 pill in the evening

Length of Treatment:

12 or 24 weeks

Summary of Phase III Clinical Trial Results:

Clinical Trial Patients Treatment Regimen SVR12*
PEARL-II(12 weeks) Genotype 1bTreatment-experienced AbbVie regimen + RBV 97%(85/88)
AbbVie regimen only 100%(91/91)
PEARL-III(12 weeks) Genotype 1bTreatment-naive AbbVie regimen + RBV 99%(209/210)
AbbVie regimen only 99%(207/209)
PEARL-IV(12 weeks) Genotype 1aTreatment-naive AbbVie regimen + RBV 97%(97/100)
AbbVie regimen only 90%(185/205)
TURQUOISE-II(12 & 24 weeks) Genotype 1Treatment-naive & treatment-experienced with

compensated cirrhosis

AbbVie regimen + RBV, 12 weeks 92% (191/208)
AbbVie regimen + RBV, 24 weeks 96%(165/172)
SAPPHIRE-I(12 weeks) Genotype 1Treatment-naive AbbVie regimen + RBV 96%(455/473)
SAPPHIRE-II(12 weeks) Genotype 1 treatment-experienced AbbVie regimen + RBV 96%(286/297)

*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped. SVR12 or SVR24 means that the treatments can achieve this response after 12 or 24 weeks of therapy.

Side Effects:

During the clinical trials, some reported side effects including headaches, fatigue, itchy skin, nausea, insomnia, and/or diarrhea. Headaches and fatigue were reported similarly by those taking the AbbVie regimen without ribavirin (RBV) and those taking it with ribavirin (RBV).

PHCN’s Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir Survey

Please email hepctip@pacifichepc.org for more information about the survey or visit PHCN’s Hepatitis C Treatment Information Project for more information about ombitasvir / paritaprevir / ritonavir and dasabuvir and the different hep C treatments within the drug approval process.