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HIV/AIDS

Immunologic Benefits of Enfuvirtide in Patients Enrolled in a Drug Assistance Program

Clinical Pharmacist, Department of Family and Community Medicine, University of California at San Francisco, San Francisco, CA

Nikolai H Caswell, MA

Independent Analyst, San Francisco

Cristina I Gruta, PharmD

Clinical Pharmacist, Department of Family and Community Medicine, University of California at San Francisco

Jason N Tokumoto, MD

Assistant Clinical Professor, Department of Family and Community Medicine, University of California at San Francisco

Betty J Dong, PharmD FCCP

Professor of Clinical Pharmacy, Departments of Clinical Pharmacy and Family and Community Medicine, University of California at San Francisco

Reprints: Dr. Saberi, San Francisco General Hospital, UCSF Box 1365, San Francisco, CA 94143, fax 415/476-3454, Parya.saberi{at}ucsf.edu

BACKGROUND:Randomized clinical trials have demonstrated that enfuvirtide plus an optimized background regimen can cause a significant increase in CD4+ cell counts and a reduction in HIV RNA levels.

OBJECTIVE:To describe and analyze CD4+ cell count and HIV RNA changes in HIV-infected patients receiving enfuvirtide and a prescribed background regimen (PBR) in a primarily clinical setting.

METHODS:A retrospective review from September 1998 through August 2005 of CD4+ cell counts and HIV RNA changes from baseline was conducted in patients receiving enfuvirtide. Data were stratified and analyzed according to baseline CD4+ cell count and HIV RNA.

RESULTS:A mean CD4+ cell count increase of approximately 102 cells/mm³was observed, regardless of baseline CD4+ cell count, in 187 patients receiving enfuvirtide during a mean of 19.4 months of follow-up. During 3 years of follow-up, patients initiating enfuvirtide at CD4+ cell counts less than 100 cells/mm³never achieved absolute CD4+ cell counts comparable to the counts in patients starting enfuvirtide at CD4+ cell counts of 100 cells/mm³or more. In 38.3% of patients achieving an undetectable HIV RNA level, a mean CD4+ cell count increase of 185 cells/mm³was observed. An unexpected finding was that a mean CD4+ cell count increase of 76 cells/mm³occurred in 61.7% of patients not achieving complete viral suppression.

CONCLUSIONS:Immunologic benefits were observed in subjects continuing enfuvirtide plus a PBR irrespective of baseline CD4+ cell count, complete viral suppression, or antiretroviral susceptibility data. Data suggest that initiation of enfuvirtide at CD4+ cell counts greater than 100 cells/mm³may be immunologically advantageous and independent of complete virologic response.

Key Words: CD4+ cell count, enfuvirtide, viremia

Published Online, April 15, 2008. www.theannals.com, DOI 10.1345/aph.1K572