36. Incidence of Grade IV Events, AIDS, and Mortality in a Large Multicenter Cohort Receiving HAART

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Session 7 Oral Abstract Session
Opportunistic Infections and Complications of Antiretroviral Therapy
Session Time: Monday, 10 am - 12:30 pm
Room 6E

11:15 36.

Incidence of Grade IV Events, AIDS, and Mortality in a Large Multicenter Cohort Receiving HAART
R. Reisler*¹, C. Han², W. Burman³, E. Tedaldi⁴, and J. Neaton²
¹ NIAID,NIH, Bethesda, MD; ²Univ. of Minnesota, Minneapolis; ³Denver Publ. Hlth., CO; and ⁴Temple Univ., Philadelphia, PA

Background: Use of highly active antiretroviral therapy (HAART) for HIV has made a dramatic impact upon survival. Yet, there is a paucity of data regarding the incidence of life threatening events in the era of HAART. We therefore sought to quantify the incidence of grade IV events and mortality in a multicenter HIV cohort, comparing it to the incidence of AIDS.
Methods: We retrospectively analyzed 5 large Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) trials, which enrolled 3050 patients, naďve and treatment experienced, over the 57-month period December 1996-August 2001. During follow-up, patients were prescribed HAART. Data collection for grade IV events, AIDS event, and death were uniform for all 5 trials. Cumulative event rates were estimated with the Kaplan-Meier method. The mortality risk associated with the development of AIDS and grade IV events was estimated with use of time-varying covariates in a Cox model with the following baseline covariates: age, gender, race, injecting drug use, body mass index, CD4+ cell count, prior AIDS, and use of ART.
Results: At baseline, mean CD4 count was 244 cells/mm³; 38% had a prior AIDS diagnosis; and 45% were ART naďve. Median follow-up was 17.4 months; 642 patients were followed for at least 30 months. Cumulative percentage of patients with any grade IV event at 30 months was 27%; while, the 30-month rate for developing an AIDS-defining illness was 13.4%, and the 30-month mortality rate was 10.6%. The 10 most common grade IV events considering 30-month cumulative rates were: liver-related 6.1%; neutropenia 3.9%; pancreatitis 2.2%; anemia 2.1%; psychiatric 2.1%; cardiac-related 1.6%; cardiovascular 1.6%; kidney-related 1.5%; thrombocytopenia 1.2; and hemorrhage 0.9%. The risk of death associated with disease progression, yielded a HR = 6.84 (p = 0.0001); while, the risk of death associated with any grade IV adverse event, yielded a HR = 5.77 (P = 0.0001).
Conclusions: In this large U.S. HIV cohort treated with HAART, the rate of grade IV events is higher than the rate of AIDS; and the risk of death associated with a grade IV event and the risk of death associated with AIDS were similarly high. There remains a great need for randomized HIV strategy trials with sufficient sample size and study duration to reliably estimate clinical event rates- both AIDS and grade IV events--as well as mortality to assess the risks and benefits of therapy.

Š2002 9^th Conference on Retroviruses and Opportunistic Infections