CHICAGO — A regimen of three direct-acting antivirals demonstrated high rates of sustained virologic response in hepatitis C virus genotype 1b-infected patients who previously failed treatment with pegylated interferon and ribavirin, according to results from the PEARL-II study, presented here at Digestive Disease Week.
The 12-week regimen of ABT 450 with ritonavir, co-formulated with ombitasvir and dasabuvir (all from AbbVie), yielded a 12-week sustained virologic response (SVR12) of 96.6% in non-cirrhotic patients, without the need for ribavirin.
“The regimen was generally well-tolerated, as evidenced by the low rate of treatment discontinuation and serious adverse events,” Pietro Andreone, MD, of the University of Bologna in Italy, said during the presentation. “The regimen, without ribavirin, was associated with lower rates of laboratory abnormalities, including bilirubin elevation and hemoglobin decrease.”
The phase 3, open-label study included 187 patients with genotype 1b HCV. They were randomly assigned to the combination regimen, with or without ribavirin, for 12 weeks. The researchers compared the SVR12 rates in both arms to a historical rate for treatment with telaprevir (Incivek, Vertex) plus pegylated interferon and ribavirin.
The SVR12 rates were 96.6% for the treatment without ribavirin and 100% for treatment with ribavirin. High SVR12 rates were found in null-responders, partial responders and in relapsers, and zero patients experienced virologic failure. The most common adverse effects were fatigue, headache and nausea.
“In these patients, the treatment regimen of ABT-450, ombitasvir and dasabuvir, without ribavirin, achieves optimal treatment efficacy, regardless of prior treatment response,” Andreone said.
For more information:
Andreone P. #5220. Presented at: Digestive Disease Week 2014; May 3-6, 2014; Chicago.
Disclosure: Andreone is on the advisory committee or review panel for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen Cilag and Merck Sharp & Dohme.