Date: 2014-11-11
Type of information: Presentation of results at a congress
phase: b
Announcement: presentation of results at The Liver Meeting® 2014
Company: Abbvie (USA - IL)
Product: ABT-450/ritonavir and ombitasvir
Action
mechanism: ABT-450/ritonavir is an inhibitor of the HCV nonstructural 3/4A (NS3/4A) protease administered with the pharmacoenhancer ritonavir. It was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals. Ombitasvir is an HCV NS5A inhibitor.
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On November 11, 2014, AbbVie announced detailed results from its open-label Phase 2b study, PEARL-I, which demonstrated that 100 percent of genotype 4 (GT4) patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49) achieved sustained virologic response rates at 12 weeks post-treatment (SVR12) after taking AbbVie\'s investigational treatment with ribavirin (RBV). Additionally, 90.9 percent of patients who were new to therapy achieved SVR12 (n=40/44) after taking the treatment without RBV. These data will be presented today during a poster session at The Liver Meeting® 2014.
PEARL-I studied AbbVie\'s all-oral, interferon-free investigational treatment combining two direct-acting antivirals (ABT-450/ritonavir and ombitasvir) with and without RBV for 12 weeks in non-cirrhotic adult patients with chronic genotype 1b (GT1b) and GT4 hepatitis C virus (HCV) infection.
There were no discontinuations due to adverse events in PEARL-I. The most commonly reported treatment-emergent adverse events (greater than 15 percent in any group) were headache (29-33 percent), asthenia (weakness) (24-33 percent), fatigue (7-18 percent), nausea (9-17 percent) and insomnia (5-16 percent). One patient had a grade 3 liver function test elevation (AST> five times the upper limit of normal), which was asymptomatic and resolved during continued dosing. Four patients with hemoglobin decreases (anemia) required RBV dose reductions; however, none of these patients required blood transfusions or medication to boost their red blood cell production. In the treatment-naïve group without RBV, on-treatment virologic breakthrough was reported in one patient (2 percent) and two patients (5 percent) experienced post-treatment relapse. There were no virologic failures in the other treatment arms.
