Authors' objectives: GS-6615 is intended for the first line therapy of patients with long QT syndrome (LQTS) type 3. If licensed, GS-6615 will offer the first specific treatment option for patients with this condition. GS-6615 is a sodium channel antagonist and a potent late sodium current inhibitor, which is associated with various genetic and acquired cardiovascular disorders. GS-6615 does not currently have Marketing Authorisation in the EU for any indication. LQTS is a rare hereditary autosomal dominant condition associated with cardiac arrhythmias and sudden cardiac death. It is the most commonly inherited cardiac arrhythmia, with an estimated prevalence ranging from 1 in 2,000 to 1 in 5,000 people. At least seven different types of LQTS have been identified and all forms arise from genetic mutations in cardiac ion channels. LQTS types 1, 2 and 3 account for the majority of mutations identified in patients with LQTS, with the frequency of LQTS type 3 estimated at 5-10%. It is estimated that between 10-15% of sudden infant death syndrome cases may be as a direct result of LQTS. The risk of death is also reported to be highest in the two years post initial cardiac event. In addition to the prevention of triggers such as the avoidance of extreme exercise and several drugs known to prolong the QT interval, treatment options for patients with LQTS include pharmacological therapies, medical devices and surgery. GS-6615 is currently in a phase III clinical trial comparing its effect on mean daytime QT interval against treatment with placebo. The trial is expected to report in early 2018.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/gs-6615-for-long-qt-3-syndrome/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: NIHR Horizon Scanning Research&Intelligence Centre (NIHR HSRIC)