CHICAGO — Treatment-naive chronic hepatitis C virus genotype 1-infected patients achieved sustainable virologic response at 12 weeks after therapy with three direct-acting antivirals and ribavirin, according to research presented at Digestive Disease Week.
In the SAPPHIRE I, phase 3 trial, Kris V. Kowdley, MD, of the Digestive Disease Institute, Virginia Mason Medical Center, Seattle, and colleagues conducted a double blind, placebo-controlled study with 631 treatment-naive patients (mean age, 52 years; 57.3% men) with chronic hepatitis C virus genotype 1 (GT-1) infection for 12 weeks. Patients with cirrhosis were excluded.
Kris V. Kowdley
Patients were randomly assigned 150 mg ABT-450/100 mg ritonavir (AbbVie/Enanta) and 25 mg ABT-267 daily with 250 mg ABT-333 (AbbVie; 3D) twice daily, and weight-based ribavirin (RBV; 1,000 mg or 1,200 mg) twice a day, or placebos. Arm A patients (n=473) received 3D+RBV, and Arm B included 158 patients assigned placebos.
Among treated patients, 96.2% achieved sustained virologic response at 12 weeks (SVR12). Of those infected with HCV GT-1a (n=322), 95.3% reached SVR12, and 98% of HCV GT-1b-infected patients (n=151) attained SVR12. Seven treated patients experienced post-treatment relapse and one had on-treatment virologic failure.
Less than 1% of all patients discontinued treatment because of adverse events (AE). The most common AE were fatigue and headache, and there was no significant difference in the frequency of AE in either study arm.
“High rates of SVR12 were observed in the study regardless of HCV subtype,” Kowdley said at the conference. “This regimen was well-tolerated with a low rate of study drug discontinuation due to adverse events.”
For more information:
Kowdley KV. #475. Presented at: Digestive Disease Week 2014; May 3-6; Chicago.
Disclosure: The researchers report numerous financial disclosures.