UNITY 2: Fixed-dose combination with BMS-791325 yields SVR12 in treatment-naive, experienced patients

BOSTON — A fixed-dose combination involving the novel compound BMS-791325 was associated with SVR12 rates of around 90% in treatment-naive and experienced patients, according to findings from the UNITY trials series presented here.

“Current treatments for treatment experienced patients with cirrhosis require 24 weeks,” Andrew J. Muir, MD, of the Duke Clinical Research Institute at the Duke University School of Medicine in North Carolina, told Healio.com Hepatology. “This study demonstrates that a 12-week regimen can cure this patient group with high SVR rates. Ribavirin was important for the genotype 1a patients to maximize chance of cure.”

Andrew J. Muir

Muir presented findings from UNITY 2, which investigated the fixed-dose combination of daclatasvir (Bristol-Myers Squibb) 30 mg, asunaprevir (Bristol-Myers Squibb) 200 mg and beclabuvir (formerly BMS-791325, Bristol-Myers Squibb) 75 mg with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 1 disease and compensated cirrhosis.

Among 57 treatment-naïve patients who received the regimen without ribavirin, the SVR12 rate was 93%. For the 54 treatment-naïve, but cirrhotic patients who were treated with the regimen with ribavirin, the SVR12 rate was 98%. Among treatment-experienced cirrhotics, the SVR12 rates were 87% among 45 patients treated without ribavirin and 93% among 45 patients treated with ribavirin.

For the genotype 1a subgroup, SVR12 rates were 90% among those treated without ribavirin and 97% for those treated with ribavirin. For treatment-experienced patients with genotype 1a disease, the rates were 86% in the non-ribavirin arm and 91% in the ribavirin arm.

In the genotype 1b group, SVR12 rates were 100% regardless of the presence or absence of ribavirin for treatment-naive patients, 90% for those in the non-ribavirin group and 100% for those in the ribavirin group.

“There was no difference in response when we stratified the patients by platelet counts,” Muir said. “There were 13 virologic failures.”

Two serious adverse events occurred in the non-ribavirin group, and seven occurred in patients treated with ribavirin. Muir reported 13 virologic failures and two discontinuations of ribavirin due to anemia.

“In summary, high SVR12 rates were achieved with the fixed-dose combination of daclatasvir, asunaprevir and beclabuvir,” Muir said. “The addition of ribavirin decreased relapse frequency in genotype 1a patients.”

For more information:

Muir. LB-2. Presented at: The Liver Meeting; Nov. 7-11, 2014; Boston.

Disclosure: Muir reports no relevant financial disclosures.