AbbVie Announces High SVR Rates with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) Regardless of the Presence of Resistance-Associated Variants Prior to Treatment in Genotype 1 Chronic Hepatitis C Patients

BARCELONA, Spain, April 14, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced data showing that patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection who received the recommended regimen of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets), with or without ribavirin (RBV), achieved high sustained virologic response rates at 12 weeks post-treatment (SVR₁₂), regardless of the presence of baseline resistance-associated variants (RAVs).¹ These late-breaking data from a post-hoc analysis of five completed Phase 3 clinical trials will be presented today at The International Liver Congress™ (ILC) 2016 in Barcelona, Spain.

The study found that no matter whether certain RAVs, called NS5A, were present, 100 percent (n=148/148) of patients with genotype 1b (GT1b) chronic HCV infection, who received VIEKIRAX + EXVIERA without RBV for 12 weeks, achieved SVR₁₂.¹ Results also showed 97 percent of patients with genotype 1a (GT1a) chronic HCV infection with or without baseline NS5A RAVs (n=57/59 and n=351/361 respectively) achieved SVR₁₂ when receiving the recommended regimen of VIEKIRAX + EXVIERA with RBV.¹ These findings included both patients new to therapy and pegylated interferon/ribavirin (pegIFN/RBV) treatment-experienced, as well as those with compensated cirrhosis.¹

"These results show that high virologic cure rates were achieved in HCV genotype 1a and 1b infected patients no matter their NS5A RAV status when treated with VIEKIRAX plus EXVIERA with and without ribavirin as recommended, a regimen which contains the NS5A inhibitor ombitasvir," said Christoph Sarrazin, M.D., professor of medicine at J.W. Goethe University Hospital in Frankfurt, Germany.  

As the hepatitis C virus replicates, variants of the viral NS5A protein are produced.² The impact of these variants on treatment response, including the possibility of becoming resistant to therapy or achieving SVR, has yet to be fully determined.³

"It's important that we understand emerging issues in treating people with chronic HCV, including RAVs, so that we can meet the needs of patients and physicians," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie. "As we learn more about the role of resistance to direct-acting antiviral regimens, it is vital to further investigate treatment options that are not affected by baseline RAVs."

To understand more about the impact of variants on treatment response, next-generation sequencing was used to assess baseline samples for variants in NS5A, which were detected in 11 percent of GT1a patients and 19 percent of GT1b patients, with a detection threshold of 15 percent, consistent with the limits of detection for variants by population sequencing.¹ The post-hoc analysis was performed on data from five completed Phase 3 studies:¹ PEARL-IV (GT1a treatment-naïve, n=90), SAPPHIRE-II (GT1a pegIFN/RBV treatment-experienced, n=214), TURQUOISE-II (GT1a compensated cirrhosis – 24 week treatment arm, n=118), PEARL-II (GT1b pegIFN/RBV treatment-experienced, n=89) and TURQUOISE-III (GT1b compensated cirrhosis, n=59). Patients who did not achieve SVR for reasons other than virologic failure (such as early treatment discontinuations or SVR₁₂ data unavailable) were excluded from the analysis.

About VIEKIRAX® + EXVIERA® 
VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.

VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.

Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.

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 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. 

Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
VIEKIRAX and EXVIERA are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis should be monitored for signs and symptoms of hepatic decompensation, including hepatic laboratory testing at baseline and during treatment.

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.

Pregnancy and concomitant use with ribavirin
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when VIEKIRAX with or without EXVIERA is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.

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.

¹ Sarrazin C, et al. Effect of Baseline Resistance-Associated Variants on SVR With the 3D Regimen Plus RBV. Late Breaker Poster #LBP503; presented at the International Liver Congress^TM (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, April 13-17, 2016.  
² Schneider MD, et al. Antiviral therapy of hepatitis C in 2014: Do we need resistance testing? Antiviral Res. 2014 May;105:64-71.
³ American Association for the Study of Liver Diseases. Monitoring patients who are starting hepatitis C treatment, are on treatment, or have completed therapy, February 24, 2016, http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have. Accessed March 15, 2016. 

SOURCE AbbVie

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