February 9, 2004
The OPTIMA trial is an ongoing multi-national study of alternative treatment strategies in patients with more advanced HIV disease (CD4 cell counts <300 cells/mm3 and demonstrated resistance to three classes of ARVs). In the current presentation, the effect of both AIDS and non-AIDS diseases on quality of life in such patients, who are taking either ?standard? HAART or mega-HAART, are being evaluated. In speaking with the lead author, Dr. Sheldon Brown of the Bronx VA Hospital, the important question of trying to develop a broader definition of "burden of disease" and its effect on quality of life should be paid more attention to in patients with advanced HIV.
In this study, three groups of patients were identified: those experiencing AID-related events (AREs), non-AIDS-related serious events (non-AIDS SAEs) and a control group not having an event (Non-E). The MOS-HIV quality of life instrument (a well-studied and validated quality of life tool) was used to compare patients' physical and mental health statuses at baseline, pre-event and post-event in these three groups. If an ARE and a non-AIDS SAE occurred at the same time, they were excluded from the analysis.
As of September 2003, 235 patients (median CD4 cell count = 115 cells/mm3) having a median duration of follow-up of 11 months have been enrolled and evaluated. Complete accrual is not expected until December 2005. Six of the eight deaths that have occurred thus far have been due to AIDS. Sixty-six events were able to be evaluated (104 non-AIDS SAEs that occurred in 56 patients and 45 AREs in 35 patients). At baseline, there were no differences between the three groups with respect to either physical health (PHS) or mental health (MHS) scores. Compared to the non-E group, physical health scores declined in the non-SAE group and both physical health and mental health declined in both the non-SAE and ARE groups. Although both physical health and mental health scores declined from pre-event to post-event in the two event groups, there were no differences between them. However, and most interestingly, there was a significant decline in physical health in the non-SAE group and a significant decrease in the mental health in the ARE group.
In summary, non-AIDS related serious adverse events occurred more frequently than did AIDS-related events. In addition, the effect of the particular type of event had differing impacts on quality of life indices between the two event groups.
Well, what does this all mean? In advanced HIV disease, the type of adverse event that occurs is perceived differently by the patient. According to Dr. Brown, the results demonstrated in the analysis thus far suggest that, when confronted with an AIDS-defining event, the impact on quality of life is psychological; this may be due to the fact that the patient is now confronted with the realization that the end may be near. Conversely, when the patient with advanced HIV disease suffers a non-AIDS related serious event (e.g., infection, cardiovascular event, etc.) the impact on quality of life is only physical. This may signify that he/she is only suffering from any serious medical condition that a non-HIV patient sustains and does not indicate a worsening of the HIV/AIDS.
The results of this interim analysis are important in that they help to better define the impact of serious events on patients with more advanced HIV disease. However, this physician remains a bit confused as to how this information relates to the alternative treatment strategies (standard HAART vs. mega-HAART) that are being prospectively evaluated in the OPTIMA study. Information thus far has not been provided regarding whether or not there is a relationship between the two treatment strategies being evaluated and the important quality of life data presented here. Nevertheless, the inclusion of quality of life evaluations in many studies (not only observational cohort studies but clinical treatment trials as well) is now increasing and suggests that it is not only the impact of treatment regimens on "numbers" that is important to be determined but quality of life issues as well. Data from studies such as this one will help us better define what impact various treatments may have (not presented here) on the patient as an individual. This may lead to better interventions when a patient with advancing or advanced HIV disease sustains some type of serious adverse event, whether or not it is AIDS- or non-AIDS related. We should look forward to further updates from this trial that hopefully will also include information that has not been included thus far.
Abstract: The Effect of Non-AIDS Serious Adverse Events Equals or Exceeds That of AIDS Outcomes in Patients With Advanced Multi-Drug Resistant HIV Disease (Poster 874)
Authored by: S. T. Brown, J. Singer, A. Anis, H. Sun, T. C. Kyriakides, B. J. Angus, K. Swanson, W. Cameron, A. Babiker, M. Holodniy, The OPTIMA Study Team
Affiliations: Bronx VA Med. Ctr., NY; Mt. Sinai Sch. Med, New York, NY; HIV Clin. Trials Network, Vancouver, Canada; VA Cooperative Studies Prgm. Coordinating Ctr., West Haven, CT; Univ. of Oxford, Headington, UK; Med. Res. Council Clin. Trials Unit, London, UK; VA Cooperative Studies Prgm., Albuquerque, NM; Ottawa Hosp, Ontario, Canada; VA Palo Alto, CA
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