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Ribavirin unnecessary addition to 3-drug combination for HCV treatment
BOSTON — Sustained virologic response rates of nearly 100% were reported in a multiple-drug combination with or without ribavirin, according to findings presented here at the 2014 Conference on Retroviruses and Opportunistic Infections.
Researchers with the PEARL-III study investigated three drugs from AbbVie with or without ribavirin for non-cirrhotic, treatment-naive hepatitis C virus genotype 1b disease: the protease inhibitor ABT-450/r, which is dosed with ritonavir 100 mg; the NS5A inhibitor ABT-267; and the non-nucleoside polymerase inhibitor ABT-333.
Previous results indicated that 12 weeks of this regimen with or without ribavirin was associated with a 100% sustained virologic response (SVR) rate.
In the current phase 3, double blind, controlled trial, the treatment regimens included 150 mg ABT-450, 100 mg ritonavir and 25 mg ABT-267 once daily and 250 mg ABT-333 twice daily. Patients in the weight-based ribavirin arm received 1,000 mg or 1,200 mg daily divided into a twice-daily regimen, and those in the other group received placebo for ribavirin.
There were 419 patients included in the analysis.
Twelve-week SVR rates, as measured on an intention-to-treat basis, were 99.5% for the ribavirin arm and 99% for the placebo arm.
The treatment regimen without ribavirin was associated with no on-treatment virologic failures or post-treatment relapses.
A hemoglobin decrease to less than 10 g/dL occurred in 19 patients in the ribavirin arm and zero patients in the placebo arm (P<.001).
Headache occurred in 24.3% of patients in the ribavirin arm and 23.4% of those in the placebo arm. Fatigue was reported in 21.4% of the treatment arm and 23% of the placebo arm. There were no discontinuations due to adverse events.
“Both regimens were noninferior compared to the historical rate for telaprevir (Incivek, Vertex Pharmaceuticals) plus pegylated interferon and ribavirin,” K. Rajender Reddy, MD, professor of medicine, director of hepatology and medical director of liver transplantation at the Hospital of the University of Pennsylvania, said during a presentation. “The addition of ribavirin in this population did not provide additional clinical benefit. The three direct-acting antiviral regimen without ribavirin is recommended in these patients.”
For more information:
Ferenci P. Abstract #29LB. Presented at: CROI 2014; March 3-6, 2014; Boston.
Disclosure: Reddy has financial relationships with AbbVie, Bionor, BMS, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech-Roche, Genfit, Gilead, Janssen, Jürgen K. Rockstroh, Merck and Vertex.