CASL 2015 Abstract A168. Safety and Efficacy of Ombitasvir-ABT-450/R and Dasabuvir ± RBV in HCV Genotype 1-Infected Canadian Patients: Results from Phase 3 Trials

Canadian Association for the Study of the Liver (CASL) 2015 Winter Meeting

CASL 2015 Abstract A168. Safety and Efficacy of Ombitasvir-ABT-450/R and Dasabuvir ± RBV in HCV Genotype 1-Infected Canadian Patients: Results from Phase 3 Trials

J. Feld(1), E. Yoshida(2), A. Ramji(2), E. Tam(3), V. Bain(4), N. Ackad(5), J. Baloukas(5), N. Shulman(6), C. Cooper(7)

1. Toronto Centre for Liver Disease, University of Toronto, Toronto, ON, Canada; 2. University of British Columbia, Vancouver, BC, Canada; 3. LAIR Centre, Vancouver, BC, Canada; 4. University of Alberta, Edmonton, AB, Canada; 5. AbbVie Canada, Saint-Laurent, QC, Canada; 6. AbbVie Inc., North Chicago, IL; 7. University of Ottawa, Ottawa, ON, Canada.

Background: The interferon-free 3 direct-acting antiviral (3D) regimen of co-formulated ombitasvir/ABT-450 (identified by AbbVie and Enanta)/ritonavir and dasabuvir ± ribavirin (RBV) has achieved SVR12 rates >95% in HCV genotype 1-infected patients enrolled in 6 phase 3 studies (n=2053).

Aims: We report the safety and efficacy of 3D±RBV for the subgroup of patients enrolled at Canadian sites of the phase 3 studies.

Methods: Canadian sites participated in 4 of the 6 phase 3 trials. SAPPHIRE-I (GT1 treatment naïve) and SAPPHIRE-II (GT1 HCV treatment-experienced) were both randomized, placebo controlled studies of 3D+RBV for 12 weeks in patients without cirrhosis. PEARL-IV (GT1a treatment naïve) was a randomized study of 3D+RBV or 3D+placebo for 12 weeks in patients without cirrhosis, and TURQUOISE-II (GT1 HCV treatment naïve or experienced patients with cirrhosis) was a randomized, open-label study of 3D+RBV for 12 or 24 weeks. Treatment emergent adverse events (AEs) were reported for any patient receiving at least 1 dose of study drug.

Results: Of the 117 patients who received 3D±RBV at Canadian sites in the phase 3 trials, 72 (62%) were male, 94 (80%) had GT1a infection, 36 (31%) had cirrhosis, and 34 (27%) had failed prior peginterferon/RBV treatment. A total of 97 patients received 3D+RBV and 20 patients received 3D without RBV. The overall SVR12 rate was 97% (114/117). SVR12 rates in patients treated with or without RBV were 98% and 95% respectively, 97% in patients with cirrhosis, and 100% in patients with GT1b infection. Fatigue, headache, nausea, and insomnia were the most commonly reported AEs. Most events were mild and there were no serious AEs. Clinically significant anemia requiring RBV dose modification occurred in only 1 (1%) patient.

Conclusions: Canadian patients enrolled in phase 3 trials of 3D±RBV achieved similar SVR12 rates to the overall study populations.

 

CARE Faculty Canadian Perspective:

This abstract represents all the Canadian sites and patients who participated in the phase-3 program evaluating the Abbvie 3D regimen that has recently received Health Canada approval.  The results reveal excellent SVR-12 rates overall of 97%, including in persons with cirrhosis and prior treatment experienced (Peg-INF + RBV only) patients.  It is notable that the Genotype 1b persons had a 100% SVR.   The regimen was well tolerated with only 1% requiring RBV dose modification.

Overall, the SVR and tolerance of Canadian patients is similar to that of the overall phase 3 program of this regimen.

- CARE Liver Disease Faculty

 

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