Bayer announced findings from an analysis of the PROTECT VIII extension study. This study found that long-term safety and efficacy was consistent with previous data analysis in severe hemophilia A patients who received treatment with Jivi® for five years. The announcement was made at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA, December 1-4, 2018.
The PROTECT VIII main study was a partially randomized, open-label trial of 134 males aged 12–65 years with severe hemophilia A. Following the completion, patients could enter an optional extension of the study. Of the 126 patients who completed the main study, 121 entered the extension and 107 continued treatment with Jivi. The data presented was from 33 patients who have completed five years of treatment with Jivi at the time of this analysis.
According to the Bayer press release, there were few drug-related adverse events and no serious drug-related adverse events. In addition, no patients confirmed FVIII inhibitors and that one-third of those patients on Jivi in the last year of the extension study did not experience any bleeding episodes.
"These findings provide insight into the long-term efficacy and safety of Jivi in previously treated hemophilia A patients 12 years and older," said Mark Reding, MD, associate professor of medicine at the University of Minnesota and lead investigator of the PROTECT VIII study. "This additional information can be instrumental for clinical decision-making and disease management regarding the long-term treatment of hemophilia A."
Source: Bayer press release dated December 4, 2018