658   Indinavir, not Nelfinavir, Is Associated with Systemic Hypertension When Compared to No Protease Inhibitor Therapy.

R. G. Hewitt*, W. M. Thompson IV, A. Chu, F. Hernandez, and M. J. Shelton.
State Univ. of New York at Buffalo.

Background:Case reports have linked development of systemic hypertension to indinavir use. The objective of this study is to compare the incidence of systemic hypertension (HTN) of HIV⁺outpatients taking either indinavir or nelfinavir to HIV⁺patients who never received a protease inhibitor (PI).

Methods:A retrospective study consisting of 445 HIV-positive patients from a large HIV practice in an academic medical center treated between 1996—99. All patients were normotensive at baseline, without a history of HTN. There were 3 study groups: 104 patients receiving anti-retroviral therapy who were protease inhibitor naive (PIN), 163 patients on nelfinavir (NFV) as first PI, and 178 patients on indinavir (IDV) as first PI. Classification of blood pressure was by the Sixth Report of the Joint National Committee on Hypertension. 67% of the subjects were male, 44% Caucasian, 41% African-American, and 14% Hispanic, and the median age was 37 years. Median baseline CD4 count was 257 cells/mm³and median HIV RNA was 29,300. Median baseline blood pressure was 120/76. Median duration on study was 486 days. Time to Stage I HTN (BP >140/90) is the time from start of treatment to the first of the two consecutive Stage I HTN qualifying visits. Kaplan-Meier estimates of the percentage of subjects who continued to have Stage I HTN at days 200, 400, 600 and 800 were derived.

Results:PIN patients had an incidence of HTN of 17.8%, 28.2%, 33.5% and 38.4%, respectively. Patients receiving NFV had 18.5%, 32.4%, 35.5%, and 35.5%, respectively. However, patients receiving IDV had an incidence of 31.8%, 40.9%, 53.5%, and 61.8%, respectively. P-values (log-rank test) for pair-wise comparison of K—M curves are IDV vs. PIN 0.0022, NFV vs. PIN 0.4707, and IDV vs. NFV 0.0404. Multivariate Cox regression analysis is in progress.

Conclusions:Patients receiving IDV experienced a statistically significant increase in systemic hypertension when compared to PIN and NFV patients. Hypertension due to antiretroviral therapy with IDV appears to be a newly described clinical adverse effect, joining other metabolic complications such as hyperlipidemia, insulin resistance and fat redistribution.