LIFE IS BEAUTIFUL

AbbVie largest program completed Phase III studies entirely oral, bezinterferonovogo regimen for hepatitis C genotype 1 .

99% SVR SVR12 in combination with ribavirin and without a number of categories of patients
Even in the most difficult to treat patient groups ( with cirrhosis ) achieved SVR12 at 92-96 %
AbbVie expects release of the drug to the U.S. market in 2014
hepatitis C

NORTH CHICAGO , Ill. , Jan. 31, 2014 – AbbVie (NYSE: ABBV) announced the completion of its Phase III clinical program and published the results of four additional studies examining completely oral , bezinterferonovuyu therapy in combination with ribavirin and without patients with chronic hepatitis C genotype 1 (GT1). The results described below confirm previously published data and company AbbVie continue to show a high incidence of sustained virologic response 12 weeks after the end of treatment (SVR12), and tolerability in patients with genotype 1 .
“The results of an extensive research program phase III AbbVie, which included 2,300 patients in 25 countries , demonstrating the action regimen studied in different groups of patients with hepatitis C genotype 1 , including patients with compensated cirrhosis ,” – said Scott Brun (Scott Brun, MD), vice president of pharmaceutical development company AbbVie. ” High frequency of virologic response and tolerability of our regimen in combination with a low frequency interrupt look promising .”

Investigated AbbVie circuit consists of a fixed dose of ABT- 450 / ritonavir ( 150/100 mg) was combined with ABT -267 (25 mg ) administered once a day , and ABT- 333 (250 mg) in combination with ribavirin or without (by weight ) taken twice per day. Combination of three different mechanisms of action interrupts the replication of hepatitis C virus and is used to achieve a high frequency of sustained virologic response in different groups of patients. In May 2013 the scheme studied in combination with ribavirin and without developed by AbbVie for the treatment of hepatitis C genotype 1 , was named by the U.S. to control the quality of products and medicines (FDA) a significant breakthrough . According to the schedule , AbbVie preparing to start supplying the basic documents for the registration of the treatment regimen early in the second quarter of 2014 . Detailed research results AbbVie present at future scientific congresses and publications .

Study Description M13- 389 (PEARL-II)

PEARL-II – international , multicenter , randomized, open-label study to evaluate the efficacy and safety of 12 weeks of treatment regimen developed AbbVie in combination with ribavirin and without it previously treated adult patients with chronic hepatitis C virus genotype 1b, without cirrhosis .

The study group consisted of 179 previously treated patients with hepatitis C genotype 1 b without cirrhosis ; Patients were randomly distributed into 2 groups : 91 patients received therapy without ribavirin for 12 weeks , and 88 patients received therapy with ribavirin for 12 weeks. In the group without ribavirin 100 % (n = 91/91 ) of patients achieved SVR SVR12, whereas in the group with ribavirin virusologicheky sustained response was achieved in 97 % (n = 85/88 ) of patients .

The most common adverse events were fatigue and headache. Discontinuation due to adverse events did not occur in any patient in the group without ribavirin , and it happened in 2 patients (2 % ) in the group with ribavirin. Neither recurrence nor virologic breakthrough was observed in none of the patients in any of the study groups .

Study Description M13- 961 (PEARL-III)

PEARL-III – an international , multicenter , randomized, double-blind, placebo-controlled study on the efficacy and safety of 12 weeks of treatment regimen developed AbbVie in combination with ribavirin and without it had not previously received treatment for adult patients with chronic hepatitis C virus genotype 1b without cirrhosis.

The study included 419 previously untreated patients with hepatitis C genotype 1 b, without cirrhosis . Randomized patients were divided into 2 groups: 209 patients received therapy without ribavirin for 12 weeks , and 210 patients were treated with ribavirin for 12 weeks . After 12 nedelposle end of therapy , 99% received therapy without ribavirin (n = 207/209 ) and 99 % received therapy with ribavirin (n = 209/210 ) demonstrated SVR SVR12.

The most common adverse events were fatigue and headache. Discontinuation of treatment due to adverse events was not none of patsientov.Retsidivy and virological breakthrough was not observed in any of the patients in the group without ribavirin , and in 0.5% of patients treated with ribavirin.

Study Description M14- 002 (PEARL-IV)

PEARL-IV – international , multicenter , randomized, double-blind , placebo-controlled study on the efficacy and safety of 12 weeks of treatment developed AbbVie regimen in combination with ribavirin and without it previously untreated adult patients with chronic hepatitis C virus genotype 1a, without cirrhosis .

The study group consisted of 305 previously untreated patients with hepatitis C genotype 1a , without cirrhosis ; Patients were randomly divided into 2 groups : 205 patients received therapy without ribavirin for 12 weeks , and 100 patients were treated with ribavirin for 12 weeks . After 12 weeks after completion of therapy , 90% of patients treated with ribavirin without (n = 185/205 ) and 97 % received therapy with ribavirin (n = 97/100 ) demonstrated SVR SVR12.

The most common adverse events were fatigue , headache and nausea. Cancel therapy due to adverse events occurred in two (1%) patients treated without ribavirin , and no odnogoiz patients treated with ribavirin. Virologic breakthrough or relapse was observed in 8% of patients treated without ribavirin , and in 2% of patients treated with ribavirin.

Study Description M13- 099 (TURQUOISE-II)

TURQUOISE-II – the first study phase III, fully studied oral, bezinterferonovy AbbVie regimen in patients with hepatitis C genotype 1 exclusively with liver cirrhosis. TURQUOISE-II – international , multicenter , randomized, open-label study to evaluate the efficacy and safety of 12 or 24 weeks of treatment rezhimaterapii AbbVie in combination with ribavirin in untreated and previously treated adult patients with hepatitis C virus genotypes 1a and 1b and cirrhosis.

The study group consisted of 380 patients with hepatitis C virus genotypes 1a and 1b ikompensirovannym cirrhosis ka treated and had not previously received antiviral treatment . Patients were randomly divided into 2 groups : 208 patients received therapy with ribavirin for 12 weeks , and 172 patients were treated with ribavirin for 24 weeks . After 12 weeks of treatment , 92% of patients (n = 191/208 ) of the first group showed SVR SVR12. At the end of 24 weeks of treatment, 96 % (n = 165/172 ) achieved SVR SVR12.

The most common adverse events were fatigue , headache and nausea. Treatment withdrawal due to adverse events was observed in four ( 2 %) patients treated with ribavirin for 12 weeks , and four (2 %) patients treated with ribavirin for 24 weeks . Virologic breakthrough relapse was observed in 6% of patients treated for 12 weeks , and 2% of patients treated for 24 weeks .

Additional details about the Phase III, conducted by AbbVie, is available at www.clinicaltrials.gov.

About 160 million people worldwide are infected with chronic hepatitis C virus . International Programme AbbVie in hepatitis C is by far the most extensive program of clinical trials in patients with hepatitis C genotype 1, which is studied completely oral regimen containing no interferon . Genotype 1 ( subtypes 1a and from 1b) – the most frequent genotype of hepatitis C in the world .

The program for the development of AbbVie therapy for the treatment of viral hepatitis C

Clinical program AbbVie hepatitis C , to improve scientific knowledge and clinical care , explores bezinterferonovy completely oral regimen in combination with or without ribavirin in order to achieve high frequency of sustained virological response in a wide range of patients, including those who usually responds poorly to treatment , including non-responders to previous therapy, including interferon, or in patients with advanced fibrosis or cirrhosis.

ABT- 450 was discovered in the course of the ongoing cooperation between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA), aimed at the development of protease inhibitors of hepatitis C virus , as well as schemes involving protease inhibitors . ABT- 450 is intended for use in combination with other drugs for the treatment of hepatitis C researched AbbVie.

Ribavirin and ritonavir : Safety Information

Ribavirin and ritonavir are not ” study medication ” in the above studies , and no conclusions can or should be done with respect to their safety and efficacy for these purposes.

Specific recommendations relating to safety exist in the appointment of these drugs for the approved indications .

Ritonavir should not be used in combination with certain medications because of significant drug-drug interactions , as well as in patients with a known hypersensitivity to ritonavir or any of its components.

Ribavirin monotherapy is not effective treatment for chronic hepatitis C and should not be used for these purposes. Ribavirin has significant teratogenic effects and should not be used in pregnant or lactating women and in men whose female partners are pregnant. Ribavirin should not be used in patients with a history of previously identified serious heart disease , severe hepatic dysfunction or decompensated cirrhosis , autoimmune hepatitis, a hemoglobin disorder , or in combination with peginterferon alfa-2a in co-infected with HCV / HIV patients with cirrhosis and the value on the scale Child-Pugh ≥ 6.

Additional information is available in the approved instructions for the drug .

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