Journal Article

Preevaluation of Clinical Trial Data: The Case of Preemptive Cytomegalovirus Therapy in Patients with Human Immunodeficiency Virus

A. David Paltiel, Sue J. Goldie, Elena Losina, Milton C. Weinstein, George R. Seage, April D. Kimmel, Hong Zhang and Kenneth A. Freedberg

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 32, issue 5, pages 783-793
Published in print March 2001 | ISSN: 1058-4838
Published online March 2001 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/319223
Preevaluation of Clinical Trial Data: The Case of Preemptive Cytomegalovirus Therapy in Patients with Human Immunodeficiency Virus

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We developed a mathematical simulation model to anticipate outcomes from an upcoming trial of targeted, preemptive cytomegalovirus (CMV) therapy in high-risk, human immunodeficiency virus (HIV)-infected patients identified by means of CMV polymerase chain reaction screening. We estimated the costs and consequences of CMV prophylaxis in patients with CD4+ counts ⩽100 cells/µL under various assumptions regarding disease progression, complication rates, drug effects, and costs. Without CMV preemptive therapy, lifetime costs average $44,600 with expected duration of survival of 19.16 quality-adjusted life-months and 213 CMV cases per 1000 patients. Targeted preemptive therapy with orally administered valganciclovir increases costs and duration of survival to $46,900 and 19.63 quality-adjusted life-months, respectively. CMV cases decrease to 174 per 1000 patients. The cost per quality-adjusted life-year gained is $59,000. This result compares favorably with other strategies in end-stage HIV disease but hinges on valganciclovir cost and efficacy assumptions and the absence of minimally effective salvage antiretroviral therapy for HIV. The upcoming trial should resolve the clinical uncertainty surrounding some of these assumptions.

Journal Article.  7237 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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