In a large trial, AbbVie’s “3-D” combination therapy cured 92 percent to 96 percent of cirrhotic study participants with genotype 1 of hepatitis C virus (HCV), MedPage Today reports. Results from the SAPPHIRE study were presented at the 49th annual meeting of the European Association for the Study of the Liver (EASL) in London and published in The New England Journal of Medicine.
The 3-D regimen consists of 12 weeks of a daily dose of the fixed-dose combination of the protease inhibitor ABT-450 and ritonavir coformulated with the NS5A inhibitor ombitasvir (ABT-267), as well as a twice-daily dose of non-nucleoside polymerase inhibitor dasabuvir (ABT-333). Everyone also took twice-daily doses of ribavirin.
Out of 380 participants, all of whom had Child-Pugh class A cirrhosis, 208 were randomized to receive 12 weeks of therapy and 172 were randomized to receive 24 weeks of treatment.
A total of 91.8 percent (191/208) of those in the 12-week arm achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), compared with 95.9 percent (165/172) of those in the 24-week arm.
The only subpopulation that faired more poorly was those with genotype 1a who took 12 weeks of therapy: Just 80 percent (40/50) were cured, compared with 92.9 percent (39/42) of those with genotype 1a who took 24 weeks of treatment.
A total of 2.1 percent of the study participants dropped out of the study because of adverse side effects.
To read the MedPage Today story, click here.
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