New real world interim data from the independent AMBER study were presented for AbbVie's VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) with or without ribavirin (RBV) in genotype 1 (GT1) chronic hepatitis C virus (HCV) infected patients. The primary endpoint of the study is the percentage of patients achieving sustained virologic response at 12 weeks post-treatment (SVR12). This study of Polish patients who reached post-treatment at week 12 (n=40 of 186 enrolled to date), demonstrated 98 percent (n=39/40) SVR12.1 These results further help to support the GT1 data shown in AbbVie's Phase 3 clinical trial development program. Interim data from the AMBER study were presented at the Viral Hepatitis Congress in Frankfurt, Germany.
Interim safety analysis of the enrolled 186 patients reported that adverse events experienced were mostly mild, most commonly (>10%) fatigue, nausea and headache. Serious adverse events were infrequent (4%, n=186), which included hepatic decompensation, anemia, kidney insufficiency hepatotoxicity.
The AMBER study is a multicenter, independent investigator-initiated, open-label study that was conducted in Poland. Patients infected with GT1 (n=186) or genotype 4 (n=10) chronic HCV received VIEKIRAX + EXVIERA (co-formulated ombitasvir/paritaprevir/ritonavir (25/150/100 mg QD) ± dasabuvir (250 mg BID) ± RBV) for 12 or 24 weeks according to current product prescribing information. Patient visits were scheduled on day zero, end of treatment and at follow-up week 12. The study population included treatment naïve as well as pegylated-interferon/ribavirin treatment-experienced patients with varying levels of liver fibrosis. Of the 186 enrolled GT1 patients, at baseline, 21 percent of patients were treatment-naïve, 70 percent had been previously treated and 75 percent had levels of liver fibrosis of F3 or F4.
