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Study reports high sustained viral response with Viekirax + Exviera in GT1 HCV
11 September 2015 • Author: Victoria White
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% SVR12. These results further help to support the GT1 data shown in AbbVie’s Phase 3 clinical trial development programme.
Viral cure rates high even in treatment experienced patients
“These interim results from the AMBER study help to support the results that we saw with the Viekirax + Exviera regimen in clinical trials,” said Professor Robert Flisiak, AMBER study author, head of Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Poland. “Importantly, viral cure rates were high even though most patients were treatment experienced and had advanced liver disease, characteristics that are usually more difficult to treat.”
The AMBER study, conducted independently of AbbVie, took place in Poland. Patients infected with GT1 or genotype 4 chronic HCV received Viekirax + Exviera for 12 or 24 weeks. 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% of patients were treatment-naïve, 70% had been previously treated and 75% had levels of liver fibrosis of F3 or F4.
In the EU, Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
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