AEGiS-9CROI: Incidence of Grade IV Events, AIDS, and Mortality in a Large Multicenter Cohort Receiving HAART

9th Conference on Retroviruses and Opportunistic Infections


Seattle, Washington - February 24 -February 28, 2002

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

Conf Retroviruses Opportunistic Infect 2002 Feb 24-28;9:abstract no. 36
Reisler R, Han C, Burman W, Tedaldi E, Neaton J; NIAID,NIH, Bethesda, MD

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, naïve 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 naïve. 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.

Keywords: AEGiS, Incidence, Antiretroviral Therapy, Highly Active, Acquired Immunodeficiency Syndrome, CD4 Lymphocyte Count, HIV Infections, Proportional Hazards Models, Disease Progression, Survival Rate, United States, Human, mortality, epidemiologyKWDaegis,incidence,antiretroviraltherapy,highlyactive,acquiredimmunodeficiencysyndrome,cd4lymphocytecount,hivinfections,proportionalhazardsmodels,diseaseprogression,survivalrate,unitedstates,human,mortality,epidemiology

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Copyright © 2002 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.