News

- 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. 

EU Indication
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
Contraindications:
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.

ALT elevations
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.

Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue
and nausea.

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.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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