Changes in Surrogate Laboratory Markers,Clinical Endpoints,and Health-Related Quality of Life in Patients Infected with the Human Immunodeficiency Virus

Abstract

Objective: To evaluate the relationship between laboratory markers of HIV, AIDS- defining events, study discontinuation, and summaryscoresftom theMOS-HWVHealthSurvey. Methods: Secondary analysis of data from a clinical trial of antiretroviral therapies in advanced HIV-infected patients (N = 940). Clinical and health-related quality-of-life data were collected over 48 weeks. Linear regression, logistic regression and survival analyses were performed to evaluate the relationships between MOS-HlVsummary scores, clinical events, and laboratory markers. Results: Each point increase in PHS resulted in a 3.0% decrease in the likelihood of developing an AIDS-defining event (p<.05) and a 2.7% decrease in likelihood of study discontinuation (p<.05). MHS did not significantly predict clinical events, but did predict study discontinuation (p<.05). From the linear regression analyses, the change in CD4 counts was a significant predictor of the change in MHS (p<.01).

Conclusion: The MOS-HIV summary scores predict clinical events and study discontinuation in advanced HIV-infected patients.

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References

Bozzette, S. A. , Hays, R. D. , Berry, S. H. , & Kanouse, D. E. (1994). A perceived health index for use in persons with advanced HIV disease: Derivation, reliability, and validity. Medical Care, 32, 716-731.

Brezinski, D. , Stone, P. H. , Muller, J. , Tofler G. H. , Davis, V. , Parker, C. , Hartley, L. H. , & Braunwald, E. (1991). Prognostic significance of the Karnofsky Performance Status score in patients with acute myocardial infarction: Comparison with the left ventricular ejection fraction and the exercise treadmill test performance. American Heart Journal, 121, 1374-1381.

Burgess, A. , Dayer, M. , Catalan, J. , Hawkins, K. , & Gazzard, B. (1993). The reliability and validity of two HIV-specific health related quality of life measures. AIDS, 7, 1001-1008.

CAESAR Coordinating Committee . (1997). Randomized trial of addition of larnivudine or lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: The CAESAR trial. Lancet, 349, 1413-1421.

Cameron, D. W. , Heath-Chiozzi, M. , Kravcik, S. , Mills, R. , Potthoff, A. , & Henry, D. (1996a, January 28-February 1). Prolongation of life and prevention of AIDS in advanced HIV immunodeficiency with ritonavir. Program and Abstracts of the Third Conference on Retroviruses and Opportunistic Infections, Washington, DC. (Abstract No. LB6a)

Cameron, D. W. , Heath-Chiozzi, M. , Kravcik, S. , Mills, R. , Potthoff, A. , & Henry, D. (1996b, July 7-12). For the Advanced HIV Ritonavir Study Group. Prolongation of life and prevention of AIDS complications in advanced HIV immunodeficiency with ritonavir update. Program and Abstracts of the XI International Conference on AIDS, Vancouver, British Columbia. (Abstract No. MoB411)

Center for Disease Control . (1992). 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. Morbidity and Mortality Weekly Report. 41 (RR17)

Collier, A. C. , Coombs, R. W. , Schoenfeld, D. A. , Bassett, R. L. , Timpone, J. , Baruch, A. , Jones, M. , Facey, K. , Whitacre, C. , McAuliffe, V. J. , Friedman, H. M. , Merigan, T. C. , Reichman, R. C. , Hooper, C. , & Corey, L. (1996). Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine. New England Journal of Medicine, 334, 1011-1017.

DeBoer, J. B. , van Darn, F. S. , Sprangers, M. A. , Frissen, P. H. , & Lange, J. M. (1993). Longitudinal study on the quality of life of symptomatic HIV-infected patients in a trial of zidovudine versus zidovudine and interferon-alpha. AIDS, 7,947-953.

10.

Deeks, S. G. , Smith, M. , Holodniy, M. , & Kahn, J. O. (1997). HIV-1 protease inhibitors: Areview for clinicians. Journal of the American Medical Associations, 277, 145-153.

11.

Earlam, S. , Glover, C. , Fordy, C. , Burke, D. , & Allen-Mersh, T. G. (1996). Relation between tumor size, quality of life, and survival in patients with colorectal liver metastases. Journal of Clinical Oncology, 14, 171-175.

12.

Falkson, G. , Gelman, R. , Leone, L. , & Falkson, C. I. (1990). Survival of premenopausal women with metastatic breast cancer: Long-term follow-up of ECOG and CALGB studies. Cancer, 66, 1621-1629.

13.

Grabowski, C. , Unger, J. , & Potish, R. (1992). Factors predictive of completion of treatment and survival after palliative radiation therapy. Radiology, 184, 329-332.

14.

Hammer, S. M. , Katzenstein, D. A. , Hughes, M. D. , Gundacker, H. , Schooley, R. T. , Haubrich, R. H. , Henry, W. K. , Lederman, M. M. , Phair, J. P. , Niu, M. , Hirsch, M. S. , & Merigan, T C. (1996). A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. New England Journal of Medicine, 335, 1081-1090.

15.

Haubrich, R. , Burger, H. U. , Beattie, D. , Donatacci, L. , Salgo, M. P. , & the NV14256 Study Team . (1996). Saquinavir + zalcitabine vs. Saquinavir or zalcitabine monotherapy in HIV-infected patients discontinuing or intolerant to zidovudine: Results of a randomized double-blind trial [Abstract]. AIDS, 10(Suppl. 2), S17-S17.

16.

Holmes, W. C. , & Shea, J. A. (1997). Performance of a new, HIV/AIDS-targeted quality of life (HAT-QoL) instrument in asymptomatic seropositive individuals. Quality of Life Research, 6, 561-568.

17.

Justice, A. C. , Aiken, L. H. , Smith, H. L. , & Turner, B. J. (1996). The role of functional status in predicting inpatient mortality with AIDS: A comparison with current predictors. Journal of Clinical Epidemiology, 49, 193-201.

18.

Kaplan, R. M. , Patterson, T. L. , Kerner, D. N. , Hampton Atkinson, J. , Heaton, R. K. , Grant, I. , & the HNRC Group . (1997). The Quality of Well-Being scale in asymptomatic HIV-infected patients. Quality of Life Research, 6, 507-514.

19.

Karnofsky, D. A. , & Burchenal, J. H. (1949). The clinical evaluation of chemotherapeutic agents in cancer. In C. M. MacLeod (Ed.), Evaluation of chemotherapeutic agents in cancer (pp. 191-205). New York: Columbia University Press.

20.

Katzenstein, D. A. , Hammer, S. M. , Hughes, M. D. , Gundacker, H. , Jackson, J. B. , Ficus, S. , Rasheed, S. , Elbeik, T. , Reichman, R. , Japour, A. , Merigan, T. C. , & Hirsch, M.S. for the AIDS Clinical Trials Group Study 175 Virology Study Team . (1996). The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 cd4 cells per cubic millimeter. New England Journal of Medicine, 335, 1091-1098.

21.

Lalezari, J. , Haubrich, R. , Burger, H. U. , Beattie, D. , Donatacci, L. , & Salgo, M. P. (1996, July 7-12). Improved survival and decreased progression of HIV in patients treated with saquinavir (Invirase, SQV) plus HIVID (zalcitabine, ddC). Program and Abstracts of the XI International Conference on AIDS, Vancouver British Columbia. (Abstract No. LB.B.6033)

22.

Lenderking, W. R. , Gelber, R. D. , Cotton, D. J. , Cole, B. F. , Goldhirsch, A. , Volberding, P. A. , & Testa, M. A. (1994). Evaluation of the quality of life associated with zidovudine treatment in asymptomatic human immunodeficiency virus infection. New England Journal of Medicine, 330,738-743.

23.

Lenderking, W. R. , Testa, M. A. , Katzenstein, D. , & Hammer, S. (1997). Measuring quality of life in early HIV-disease: The modular approach. Quality of Life Research, 6, 515-525.

24.

25.

Lenderking, W. R. , Testa, M. A. , Katzenstein, D. , & Hammer, S. (1997). Measuring quality of life in early HIV-disease: The modular approach. Quality of Life Research, 6, 515-525.

26.

Leplege, A. P. , Rude, N. , Ecosse, E. , Ceinos, R. , Dohin, E. , & Pouchot, J. (1997). Measuring quality of life from the point of view of HIV-positive subjects: The HIV-QL3 1. Quality of Life Research, 6, 585-594.

27.

Lubeck, D. P. , & Fries, J. F. (1997). Assessment of quality of life in early stage HIV-infected persons: Data from the AIDS Time-Oriented Health Outcome Study (ATHOS). Quality of Life Research, 6, 494-506.

28.

McClellan, W. , Anson, C. , Birkeli, K. , & Tuttle, E. (1991). Functional status and quality of life: Predictors of early mortality among patients entering treatment for end stage renal disease. Journal of Clinical Epidemiology, 44, 83-89.

29.

Nabulsi, A. , Maurath, C. , Revicki, D. A. , Conway, D. , Sarocco, P. , & Leonard, J. (1996). Improvement in quality of life due to the use of ritonavir in AIDS patients [Abstract]. AIDS, 10(Suppl. 5), P54-P54.

30.

Nunnally, J. C. (1978). Psychometric theory (2nd ed.). New York: McGraw-Hill.

31.

O'Brien, W. A. , Hartigan, P. M. , Martin, D. , Esinhart, J. , Hill, A. , Benoit, S. , Rubin, M. , Simberkoff, M. S. , & Hamilton, J. D. (1996). Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. New England Journal of Medicine, 334,426-431.

32.

Peterman, A. H. , Cella, D. , Mo, F. , & McCain, N. (1997). Psychometric validation of the revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument. Quality of Life Research, 6, 572-584.

33.

Revicki, D. A. , Brown, R. E. , Henry, D. H. , McNeill, M. V. , Rios, A. , & Watson, T. (1994). Recombinant human erythropoietin and health-related quality of life of AIDS patients with anemia. Journal of Acquired Immune Deficiency Syndrome, 7,474-484.

34.

Revicki, D. A. , Sorensen, S. , & Wu, A. W. (in press). Reliability and validity of physical and mental health summary scores from the MOS-HIV health survey. Medical Care.

35.

Revicki, D. A. , Swartz, C. , Wu, A. W. , Haubrich, R. , & Collier, A. C. (1997) Quality of life outcomes of saquinavir, zalcitabine and combination saquinavir-zalcitabine therapy for advanced HPV-infected adults with CD4 counts between 50 and 300 per cubic millimeter [Report]. Bethesda, MD: MEDTAP International.

36.

Revicki, D. A. , Wu, A. W. , & Murray, M. I. (1995). Change in clinical status, health status, and health utility outcomes in HIV-infected patients. Medical Care, 23, AS173-AS182.

37.

Shumaker, S. A. , Ellis, S. , & Naughton, M. (1997). Assessing health-related quality of life in HIV disease: Key measurement issues. Quality of Life Research, 6, 475-480.

38.

Smith, K. W. , Avis, N. E. , Mayer, K. N. , & Swisiow, L. (1997). Use of the MQoL-HIV with asymptomatic HIV-positive patients. Quality of Life Research, 6, 555-560.

39.

Stanton, D. L. , Wu, A. W. , Moore, R. D. , Rucker, S. C. , Piazza, M. P. , Abrams, J. E. , & Chaisson, R. E. (1994). Functional status of persons with HIV infection in an ambulatory setting. Journal of Acquired Immune Deficiency Syndrome, 7, 1050-1056.

40.

Stucki, G. , Daltroy, L. , Katz, J. N. , Johannesson, M. , & Liang, M. H. (1996). Interpretation of change scores in ordinal clinical scales and health status measures: The whole may not equal the sum of the parts. Journal of Clinical Epidemiology, 49, 711-717.

41.

Testa, M. A. , & Lenderking W. R. (1995). Quality of life considerations in clinical trials of persons with HIV infection. In D. Finkelstein & D. Schoenfeld (Eds.), AIDS clinical trials (pp. 213-241). New York: Wiley-Liss.

42.

Wachtel, T. , Piette, J. , Mor, V. , Stein, M. , Fleishman, J. , & Carpenter, C. (1992). Quality of life in persons with human immunodeficiency virus infection: Measurement by the Medical Outcomes Study instrument. Annals of Internal Medicine, 116, 129-137.

43.

Ware, J. E. , Snow, K. K. , Kosinski, M. , & Gandek, B. (1993). SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Center.

44.

Wisloff, F , & Hjorth, M. (1997). Health-related quality of life assessed before and during chemotherapy predicts for survival in multiple myeloma. Nordic Myeloma Study Group. British Journal of Haematology, 97, 29-37.

45.

Wu, A. W. , Hays, R. D. , Kelly, S. , Malitz, F. , & Bozzette, S. A. (1997). Applications of the Medical Outcomes Study health-related quality of life measures in HIV-AIDS. Quality of Life Research, 6, 531-543.

46.

Wu, A. W. , Jacobson, D. , Clark, B. , & Brookmeyer, R. (1997). Quality of life associated with valcyclovir vs. high and low dose acyclovir for prophylaxis against cytomegalovirus in AIDS. Programs and Abstracts of the 4th Conference on Retroviruses and Opportunistic Infections, Washington, DC. (Abstract No. 297)

47.

Wu, A. W. , Jacobson, D. , Grant, D. , & Scott-Lennox, J. (1997, January 22-26). Quality of life scores predict clinical trial attrition and mortality. Programs and Abstracts of the 4th Conference on Retroviruses and Opportunistic Infections, Washington, DC. (Abstract No. 298)

48.

Wu, A. W. , Revicki, D. A. , Jacobson, D. , & Malitz, F. E. (1997). Evidence for reliability, validity, and usefulness of the Medical Outcomes Study HIV health survey (MOS-HIV). Quality of Life Research, 6, 481-493.

49.

Wu, A. W. , Rubin, H. R. , Mathews, W. C. , Brysk, L. M. , Bozzette, S. A. , Hardy, W. D. , Atkinson, J. H. , Grant, I. , Spector, S. A. , & McCutchan, J. A. (1993). Functional status and well-being in a placebo-controlled trial of zidovudine in early symptomatic HIV infection. Journal of Acquired Immune Deficiency Syndrome, 6, 452-458.

50.

Wu, A. W. , Rubin, H. R. , Mathews, W. C. , Ware, J. E. , Brysk, L. T. , Hardy, W. D. , Bozzette, S. A. , Spector, S. A. , & Richman, D. D. (1991). A health status questionnaire using 30 items from the Medical Outcomes Study: Preliminary validation in persons with early HIV infection. Medical Care, 29, 786-798.