Therapy AbbVie shows 96% sustained virologic response (SVR12) in Phase III trials in previously treated patients with hepatitis C genotype first
Published data confirm the results of Phase II clinical trials c comparable virologic response and tolerability
SAPPHIRE-II – the second of the six studies phase III, studying triple (3D) regimen
Expected new information on clinical trials AbbVie, studying 3D mode in combination with ribavirin and without it, including on the treatment of hepatitis C in patients with cirrhosis
NORTH CHICAGO, ILLINOIS , December 10, 2013 – AbbVie (NYSE: ABBV) published the results of a Phase III clinical studies investigating the triple (3D) mode antiviral therapy with direct action in combination with ribavirin in patients with chronic hepatitis C genotype first (GT1) . The study SAPPHIRE-II sustained virologic response at the end of the 12th week of treatment (SVR12) was achieved in 96% of 394 patients who previously did not report on the clinical success of therapy with pegylated interferon and ribavirin , including about 49% of those who have completely missed the answer a previous therapy. The majority of patients were genotype 1a , which is considered the most difficult to treat hepatitis C virus subtype rate of sustained virologic response (SVR12) in patients with genotype 1a and 1b was 96 % and 97 %, respectively. Virological relapse or breakthrough occurred in 2% of patients treated with 3D mode in combination with ribavirin . Moreover, the frequency of treatment interruption due to side effects was 1%.
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 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-II study shows that previously lechivshiesya patients with hepatitis C genotype 1 achieved high virological response to a fully developed AbbVie oral , bezinterferonovom 3D mode of therapy in combination with ribavirin ,” – said Scott Brun (Scott Brun, MD), Vice – president of pharmaceutical development company AbbVie. “Completion of two placebo – controlled studies SAPPHIRE – an important step in the clinical trial program of AbbVie in hepatitis C. We look forward to the results of studies investigating designed AbbVie 3D mode in combination with ribavirin and without in different groups of patients , as well as data from our special study of patients with cirrhosis . ”
Study Description M13- 098 (SAPPHIRE-II)
Following SAPPHIRE-I, SAPPHIRE-II – the second placebo-controlled study , and the second of the six studies phase III, supporting AbbVie 3D mode developed for the treatment of patients with hepatitis C genotype first . AbbVie will provide detailed information on the results of the study SAPPHIRE-II at future scientific congresses and publications .
SAPPHIRE-II – 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 have not reached the clinical effect on pegylated interferon plus ribavirin .
The study group included 394 patients previously treated with genotype 1 and without cirrhosis , of which 297 patients were randomly selected , for 12 weeks were treated with 3D therapy with ribavirin , and 97 patients in the control group received placebo during 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. Previously, 49 % of patients – study participants showed no response to treatment with pegylated interferon and ribavirin ; These patients are generally considered the most difficult to successfully treat group.
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 = 286/297 ) 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. SVR SVR12 showed 96% ( 166/173 ) of patients with hepatitis C virus genotype 1a and 97 % (119 /123) of patients with genotype 1b. One patient had hepatitis genotype 1 , and has reached SVR12, but to determine its genotype subtype failed.
Most designated side effects in the treatment and control groups were headache , fatigue and nausea. Discontinuation of treatment due to adverse events have been reported in three ( 1%) patients treated with 3D mode , and none of the patients receiving placebo . Virological relapse or breakthrough was at 2% in patients treated with 3D mode in combination with ribavirin .
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 or without ribavirin in order to achieve high values of sustained virologic response in the largest number of patients, including those who usually responds poorly to treatment , for example, did not respond to earlier therapy, including interferon or in patients with advanced fibrosis or cirrhosis. Results of the remaining four studies Phase III, conducted AbbVie, will be available in the coming months and will be the basis for registration dossiers , starting from the second quarter of 2014 .