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SAPPHIRE-II: Interferon-free treatment combo a success for genotype 1 HCV
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CHICAGO — A combination treatment of three direct-acting antivirals demonstrated significant efficacy against patients with hepatitis C genotype 1, suggesting that an interferon-free treatment is soon on the horizon for this group of patients.
High rates of SVR12 were seen across all patient groups, regardless of HCV subtype and prior treatment response, including a 95% SVR rate seen in prior null responders, according to results from the phase-3 SAPPHIRE-II study, presented here at Digestive Disease Week 2014.
“These two points represent a leveling of the playing field that we were worried about with the earlier antiviral regimens a few years ago, when we saw that genotype 1b patients might have an advantage, and interferon non-responders, typically null responders, might be at a disadvantage,” Ira M. Jacobson, MD, chief of the division of gastroenterology and hepatology at Weill Medical College of Cornell University and co-chief medical editor of HCV Next, said during his presentation.
Ira M. Jacobson
The treatment regimen included a coformulation of ABT-450 (AbbVie); an NS3/4A protease inhibitor, ombitasvir (AbbVie); a NS5A inhibitor; and dasabuvir (AbbVie), a non-nucleoside NS5B polymerase inhibitor given twice-daily. Patients were randomly assigned to the combination treatment plus ribavirin (n=297), or placebo (n=97) for 12 weeks. After 12 weeks, patients who received placebo also were treated with the combination treatment plus ribavirin for 12 weeks.
The overall intention-to-treat SVR12 rate was 96.3% (95% CI, 94.2-98.4), which was non-inferior and superior to a historical control SVR12 rate of 65%. In genotype 1a patients, the SVR12 rate was 96% and in genotype 1b patients, the SVR12 rate was 96.7%. When analyzed according to prior treatment response, the SVR12 rate among prior relapse patients was 95.3%. Among prior partial response patients, the SVR12 rate was 100% and among prior null responders, the SVR12 rate was 95.2%.
Seven patients relapsed after receiving the experimental treatment: One was a prior relapse and six were prior null responders. Five of these patients had resistance-associated variants present at the time of virologic failure. There were no significant differences in laboratory abnormalities between the patients, and the only adverse event that was more common among patients in the experimental treatment was pruritus.
Disclosures: The researchers report numerous financial disclosures.
For more information:
Jacobson I. Abstract #235. Presented at: Digestive Disease Week 2014; May 3-6; Chicago.