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AbbVie (New york stock exchange: ABBV), a worldwide biopharmaceutical company, today announced high SVR12 rates were achieved with 8 days of treatment using its investigational, once-daily, ribavirin-free, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) in patients with difficult to treat genotype 3 (GT3) chronic hepatitis C virus (HCV) infection. In is a result of the Phase 3 ENDURANCE-3 study, 95 % (n=149/157) of GT3 chronic HCV infected patients without cirrhosis and who’re a new comer to treatment achieved sustained virologic response at 12 days publish-treatment (SVR12) following 8 days of treatment with G/P.1 These new data is going to be featured being an dental presentation today in the Worldwide Liver Congress™ (ILC) 2017 in Amsterdam, Holland.
“GT3 is broadly acknowledged as probably the most difficult to treat genotype, with limited treatments for recently diagnosed patients,” stated Edward Gane, M.D., professor of drugs at College of Auckland, Nz. “When checked out in parallel having a current standard of care, the ENDURANCE-3 study results explore the potential for G/P being an 8 week treatment during these patients without cirrhosis.”
GT3 may be the second most typical genotype globally, comprising 18 percent of patients worldwide and 26 % of patients in Europe.2 Patients with GT3 HCV convey more rapid disease progression, using the greatest rates of connected fibrosis, steatosis (fatty liver), and hepatocellular carcinoma (HCC).3 Treatment guidelines with current standards of care recommend 12 days of treatment in GT3 patients without cirrhosis and who’re a new comer to treatment.4
In addition to evaluating 8 days of treatment with G/P, the ENDURANCE-3 study is built to evaluate whether 12 days of G/P is non-inferior to 12 days of sofosbuvir plus daclatasvir (SOF+DCV), a present standard of take care of GT3 chronic HCV infected patients.1 SVR12 rates of 95 % were observed in both 8 days (n=149/157) and 12 days (n=222/233) of treatment with G/P.1 Furthermore, 12 days of treatment with G/P was shown to become non-inferior to 12 days of treatment with SOF+DCV (97 percent, n=111/115).1
Full is a result of ENDURANCE-3 would be the latest to be sold from registrational studies in AbbVie’s G/P clinical development program, made to investigate a quicker road to virologic cure* for those major HCV genotypes (GT1-6) along with the objective of addressing regions of ongoing unmet need.
Within the ENDURANCE-3 study, no patients who received 8 days of G/P stopped treatment because of adverse occasions (AEs).1 AEs were mostly mild (71 percent) in patients receiving both 8 and 12 days of G/P. The most typical AEs (≥10 percent) in patients receiving 8 days and 12 days of G/P were headache (20 and 26 %), fatigue (13 and 19 percent) and nausea (12 and 14 %), correspondingly with patients receiving 12 days of SOF+DCV treatment (headache 20 %, fatigue 14 % and nausea 13 %).1
Authorization applications for G/P are presently under review by regulatory government bodies all over the world. G/P continues to be granted faster assessment through the European Medicines Agency (EMA), and priority review designations through the U.S. Fda (Food and drug administration) and Japanese Secretary of state for Health, Work and Welfare (MHLW). G/P is definitely an investigational regimen and it is safety and effectiveness haven’t been established.
“These results, together with many other ILC presentations from your G/P clinical development program, investigate the potential for our regimen in patients with specific treatment challenges and explore an 8 week virologic cure for almost all patients across all major genotypes,” stated Michael Severino, M.D., executive v . p ., development and research and chief scientific officer, AbbVie. “Evidence collected in the ENDURANCE-3 study thus remains a vital a part of our G/P clinical development program, underscoring our dedication to the HCV community by investigating a pan-genotypic treatment option.”
The ENDURANCE-3 study is going to be featured within the official ILC press conference on Friday, April 21 from 11:30 a.m. – 12:30 p.m. local time.