Boehringer Ingelheim has announced that over the course of all clinical trials with Aptivus (tipranavir) capsules in anti-HIV combination treatment, it has received 14 reports of intracranial hemorrhage events, including eight fatalities, in 13 out of 6,840 HIV-1 infected individuals included in the clinical program.
There have been no spontaneous reports of intracranial hemorrhage on marketed Aptivus so far, nor have any of these events been observed in the pediatric or treatment-naive clinical trials of Aptivus.
Boehringer Ingelheim conducted a thorough case-by-case analysis of each of the 14 cases of intracranial hemorrhage. Many of the patients experiencing intracranial hemorrhage had other medical conditions, including central nervous system lesions, head trauma, recent neurosurgery, coagulopathy, hypertension or alcohol abuse, or were receiving concomitant medications that may have contributed to these events.
No pattern of abnormal hematologic or coagulation parameters was observed. Therefore, routine measurement of coagulation parameters is not currently indicated in the management of patients on Aptivus.