Background:  In pre-approval trials, 13 of 6840 patients (0.20%) exposed to tipranavir (TPV) have developed intracranial hemorrhage (ICH) at an incident rate of 0.26/100 person-years of exposure (95%CI 0.09, 0.82). It is unknown whether this rate exceeds that observed with other HAART. We sought to examine the rate of ICH in an HIV-infected population not exposed to TPV in the HAART era.

Methods:  We identified HIV-infected individuals under care in the U.S. Veterans Healthcare System (VA) and California state Medicaid (Medi-Cal) program between October 1997 and December 2003. We used data from the VA national electronic medical record and Medi-Cal claims combined with California hospital discharge abstracts to identify intracranial hemorrhage among subjects presenting for HIV care between October 1997 and December 2003 (ICD-9-CM diagnostic codes 430.xx, 431.xx, 432.xx except 432.0). Prevalence was defined as ICH events occurring from 12 months before to 6 months after date of initial presentation for HIV care. Incidence (per 100 person-years) was defined as events occurring after this time frame.

Results:   Overall 16,573 veterans and 33,037 Medi-Cal recipients presented for HIV care during this observation period. Results are given in the table.

Conclusions:  This analysis presents a range for the incidence of ICH in the setting of HIV infection that appear similar to rates reported in TPV pre-approval trials. The higher rate seen in Medi-Cal may reflect the higher rate of clinical AIDS. In addition, ICH events may be less commonly captured in the VA system because patients with acute ICH may present to non-VA hospitals for their initial care. In both samples, ICH is more common among older individuals and those who have developed AIDS (88% of patients who had an ICH in TPV studies had AIDS; 63% were >40 years).