AbbVie published the results of the first of six clinical trials Phase III, fully exploring oral, bezinterferonovy 12 -week treatment regimen for hepatitis C ; results demonstrate a 96- percent efficiency (SVR 12) in previously untreated patients with hepatitis C genotype
Published data confirm the results of Phase II clinical trials c comparable virologic response and tolerability
Today it is the largest clinical program investigating fully oral, bezinterferonovy regimen in patients with genotype 1
Terms of basic filing for registration – 2nd quarter 2014, according to the plan
About 160 million people worldwide are infected with chronic hepatitis C, most of them are virus genotype 1 .
NORTH CHICAGO, ILLINOIS , NOVEMBER 18, 2013 – AbbVie (NYSE: ABBV) published the first results of Phase III clinical studies investigating triple antiviral (3D) mode of therapy with direct action in combination with ribavirin in patients with chronic hepatitis C genotype first . The study SAPPHIRE-I included patients (n = 631) , not previously treated for hepatitis C who received triple therapy developed by AbbVie, and 96% of participants in this study was achieved sustained virologic response 12 weeks after the end of treatment (SVR12 ) . Most patients with genotype 1a were considered the most difficult to treat HCV subtype rate of sustained virologic response (SVR12) in patients with genotype 1a and 1b was 95 % and 98 % respectively. Viral recurrence frequency was low and occurred in 1.7 % of patients. Furthermore , the frequency of interrupting treatment due to adverse events were low , did not differ between study and control groups and was 0.6 %.
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 a 1b) – the most common genotype of hepatitis C virus in the world, with a higher prevalence of subtype 1a in the U.S., and subtype 1b – in Europe. SAPPHIRE-I – this is the first of the six studies Phase III, who is studying designed AbbVie triple (3D) regimen for the treatment of patients with hepatitis C genotype 1 st .
“Research SAPPHIRE-I shows that the previously lechivshiesya patients with hepatitis C genotype 1 achieve a high level of virological response to a fully developed AbbVie oral , bezinterferonovom 3D mode of therapy in combination with ribavirin . The results obtained on the frequency of achieving sustained virologic response (SVR) are consistent with the results of our studies Phase II », – said Scott Brun (Scott Brun, MD), vice president of pharmaceutical development company AbbVie. «SAPPHIRE-I – our first study phase III, the results of which have already been obtained , and , taking into account the progress of our clinical program to date, we go according to plan basic filing for registration – in the 2nd quarter of 2014 .”
AbbVie will provide detailed information on the results of the study SAPPHIRE-I at future scientific congresses and publications .
Study Description M11- 646 (SAPPHIRE-I)
SAPPHIRE-I – a global , multicenter , randomized, conducted double-blind studies , placebo-controlled study to evaluate the efficacy and safety of 12 – week course of treatment with ABT- 333 (250 mg) , ribavirin ( body weight ) received daily twice a day , in combination with a fixed combination ABT-450/ritonavir ( 150/100mg ) and ABT- 267 (25 mg) , taken once a day in adult patients infected with HCV genotypes 1a and 1b, without cirrhosis , not previously treated .
The study group consisted of 631 patients previously untreated with genotype 1 and without cirrhosis , of which 473 patients were randomly selected in the 12 weeks of treatment and ribavirin therapy, 3D , and 158 patients (control group) received placebo for the first 12 weeks. Patients initially trapped in the control group and taking a placebo during the first 12 weeks , then received open treatment with 3D mode and ribavirin for 12 weeks.
The study showed that in the treatment group at 12 weeks after completion of therapy 3D mode in combination with ribavirin developed AbbVie, in 96% of patients (N = 455/473 ) was achieved sustained virologic response (SVR12), and patients with missing for any because data is automatically attributed to the group with a negative result of treatment. In the treatment group, 98 % ( 148/151 ) of patients with HCV genotype 1b achieved SVR12, while SVR12 was achieved in 95 % of patients with genotype 1a ( 307/322 ) .
Most designated side effects in the treatment and control groups were fatigue , headache and nausea. Discontinuation of treatment due to adverse events have been reported in 0.6 % of patients treated with 3D mode , and in 0.6 % of patients receiving placebo. Virological relapse or breakthrough was low – at 1.7 % in patients treated with 3D mode .
Additional details about the Phase III, conducted by AbbVie, is available at www.clinicaltrials.gov.
The program for the development of AbbVie therapy for the treatment of viral hepatitis C
Program of clinical trials of our 3D mode includes more than 2,300 patients with genotype 1 in more than 25 countries. Clinical program AbbVie hepatitis C , to improve scientific knowledge and clinical care , fully explores bezinterferonovy oral 3D mode in combination with ribavirin or without the purpose of obtaining sustained virologic response in the largest number of patients, including those who usually responds poorly to treatment , such as not answered earlier in therapy, including interferon, or in patients with advanced fibrosis or cirrhosis. Results of the remaining five Phase III, conducted AbbVie, will be available in the coming months , and will be the basis for the registration dossiers , starting from the second quarter of 2014 .
3D mode includes ritonavir protease inhibitor ABT- 450 , NS5A inhibitor ABT- 267 and a non-nucleoside polymerase inhibitor ABT- 333. Combination of three different mechanisms of action interrupts the replication of hepatitis C virus , and contributes to the achievement of sustained virologic response in different groups of patients. In May 2013 the analyzed 3D mode 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 .
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 concerning safety exist for the purpose 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 scale values Child-Pugh ≥ 6.
Additional information is available in the approved instructions for the drug