- Interim results from the independent AMBER study demonstrated 98 percent (n=39/40) SVR(12) rate in patients who completed a 12- or 24-week treatment regimen and 12 weeks follow-up
- Real world interim data presented at the Viral Hepatitis Congress supports findings from previous HCV genotype 1 Phase 3 clinical trials with VIEKIRAX + EXVIERA
NORTH CHICAGO, Illinois, Sept. 11, 2015 /PRNewswire/ -- 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.
"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."
About the AMBER Study
The AMBER study was conducted independently of AbbVie, who provided no financial support or guidance to the investigators.
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.
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.
Important EU Safety Information
VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.
Special warnings and precautions for use:
VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.
Pregnancy and concomitant use with ribavirin
When VIEKIRAX + EXVIERA are used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and 6 months after the treatment. Refer to the Summary of Product Characteristics for ribavirin for additional information.
Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.
Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue
Full summary of product characteristics is available at www.ema.europa.eu.
Globally, prescribing information varies; refer to the individual country product label for complete information.
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1 Flisiak, R. et al, Efficacy and safety of Paritaprevir/r/Ombitasvir/Dasabuvir + Ribavirin in GT1 HCV infected patients treated in real life settings, presented Viral Hepatitis Congress, Frankfurt, September, 10-12, 2015