A new study published in the New England Journal of Medicine and presented at the International Liver Congress highlights the use of a multitargeted therapy that combines the drug ABT-450 with ritonavir, ombitasvir, and dasabuyir in patients diagnosed with cirrhosis and genotype 1 hepatitis virus C (HCV) co-infection.
Findings of the study involving the NS3/4A protease inhibitor ABT-450 with ritonavir 100 mg (ABT-450/r); the NS5A inhibitor ombitasvir (formerly ABT-267); and NS5B RNA polymerase inhibitor dasabuvir (formerly ABT-333) — all three of which are manufactured by AbbVi — were presented by Dr. Fred Poordad of the Texas Liver Institute and the University of Texas Health Science Center in San Antonio.
The analysis included the study of 208 patients with the genotype 1 form of the disease who also had compensated cirrhosis. They were assigned to the three drug regimen plus ribavirin for 12 weeks, and observed by investigators for 48 weeks. One select group of 172 patients were treated with the same regimen for 24 weeks and observed for 48 weeks.
The primary outcome measure in the study was to ascertain the sustained virology response at 12 weeks (SVR12). According to Dr. Poordad’s presentation, “The non-inferiority threshold for this endpoint was 43%, and the superiority threshold was 54%.”
SVR12 data was reached by 91.8% of patients after 12 weeks of the multitargeted treatment, and 95.9% of patients after the 24-week period of treatment. “Our results showed no statistical difference between the 12- and 24-week arms” Poordad said.
Patients with genotype 1a achieved an SVR12 rate of 88.6% when treated for 12 weeks, and 94% when treated for 24 weeks. “For genotype 1b disease, almost everyone achieved SVR,” Poordad said. “When measured by surrogates of portal hypertension and hepatic function, high SVR rates were achieved with no appreciable difference between either arm.”
Finally, it was concluded that the phase 3 trials of the drug combination resulted in high rates of sustained virology response to the interferon free regimen evaluated exclusively in patients with HCV genotype 1 infection and cirrhosis.