Healthcare Industry News:  NS5A 

Biopharmaceuticals Regulatory

 News Release - July 25, 2016

CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX(R) (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A)

NORTH CHICAGO, Ill., July 25, 2016 -- (Healthcare Sales & Marketing Network) -- AbbVie (ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the use of 12 weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin (RBV) in genotype 4 (GT4) chronic hepatitis C virus (HCV) infected adult patients with compensated cirrhosis (Child-Pugh A). VIEKIRAX with RBV is currently approved in the European Union for GT4 patients with compensated cirrhosis for 24 weeks.

"Through optimizing the use of VIEKIRAX, AbbVie strives to meet the needs of patients and physicians, including a shortened treatment duration," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone is progress toward an approval that would allow us to provide the opportunity for a cure with just 12 weeks of our regimen to genotype 4 patients with or without compensated cirrhosis in Europe."

Chronic HCV affects more than 160 million people worldwide,4 with 34 million people living with GT4 HCV infection.3 In Europe, where nine million people are infected with HCV,2 GT4 is becoming increasingly prevalent in several countries including Italy, France, Greece and Spain, where prevalence rates from 10 to 24 percent have been reported.3

The CHMP positive opinion is supported by data from a dedicated Phase 3 AGATE-I study of GT4 HCV infected patients with compensated cirrhosis. The randomized, open-label study evaluated the safety and efficacy of VIEKIRAX and RBV for 12 and 16 weeks. Results from the study showed that with 12 weeks of treatment with VIEKIRAX and RBV, 97 percent (n=57/59) of patients achieved sustained virologic response at 12 weeks post-treatment (SVR12 ).1

"Until recently people living with genotype 4 chronic hepatitis C had limited treatment options," said Tarik Asselah, M.D., lead study author and professor at Université Paris Diderot. "If approved, this 12-week treatment would mark another step forward in the cure for GT4 patients, allowing difficult-to-cure patients with compensated cirrhosis to be treated in half the time with VIEKIRAX, representing a significant benefit for both them and their physicians."

Results from the AGATE-I study also showed that patients treated with 16 weeks of VIEKIRAX and RBV achieved 98 percent (n=60/61) SVR12 rates. The most commonly reported adverse events (=20 percent) in the 12-week arm were asthenia, fatigue and headache (18 percent, 17 percent and 23 percent respectively); and for the 16 week arm were fatigue, asthenia, headache, anemia, nausea, and pruritus (33 percent, 32 percent, 23 percent, 23 percent and 20 percent respectively).1 One patient in the 12-week group experienced virologic breakthrough and one discontinued prematurely after the first day of treatment. One patient missed the post-treatment week 12 visit in the 16-week group.1 The full study results were published online in The Lancet in June 2016.

About VIEKIRAX®

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.

Currently, in GT4 HCV infected patients VIEKIRAX with RBV is taken for 12 weeks, except in patients with compensated cirrhosis (Child-Pugh A), who should take it for 24 weeks.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (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.

Important EU Safety Information

Contraindications

VIEKIRAX is 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. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A4 substrates or strong inhibitors of CYP3A4. Do not give VIEKIRAX with strong or moderate enzyme inducers.


Source: AbbVie

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