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Atazanavir—A Once-daily HIV Protease Inhibitor That Does Not Cause Dyslipidemia in Newly Treated Patients: Results from Two Randomized Clinical Trials

Fundación Huésped, Buenos Aires, Argentina

José M. Gatell, MD, PhD

Clinical Institute of Infectious Diseases & Immunology Hospital Clinic, Provencial de Barcelona, Barcelona, Spain

Kathleen Squires, MD

Keck School of Medicine, University of Southern California, Los Angeles, CA

Lisa D. Percival, MD

Pharmaceutical Research Institute, Bristol-Myers Squibb Company, Wallingford, Connecticut, USA

Peter J. Piliero, MD

Clinical Research Initiative, Albany Medical College, Albany, New York, USA

Ian A. Sanne, MD

WHC Infectious Diseases Clinical Trials Unit, Johannesburg, South Africa

Sarah Shelton, BSc

Bristol-Myers Squibb Pharmacueticals, UK

Adriano Lazzarin, MD

IRCCS, San Raffaele Hospital, Milan, Italy

Linda Odeshoo, MS

Thomas D. Kelleher, PhD

Keck School of Medicine, University of Southern California, Los Angeles, CA

Alexandra Thiry, PhD

Pharmaceutical Research Institute, Bristol-Myers Squibb Company, Wallingford, Connecticut, USA

Michael D. Giordano, MD

Pharmaceutical Research Institute, Bristol-Myers Squibb Company, Wallingford, Connecticut, USA

Stephen M. Schnittman, MD

Pharmaceutical Research Institute, Bristol-Myers Squibb Company, Wallingford, Connecticut, USA

Protease inhibitor (PI) treatment can result in dyslipidemia in a significant proportion of patients. Atazanavir (ATV) is a once-daily PI that has not been associated with clinically relevant increases in total cholesterol (TC), fasting low-density lipoprotein cholesterol (LDL-C), or fasting triglyceride (TG) concentrations. The objectives of this paper were to evaluate lipid profiles in untreated patients, and investigate the frequency and severity of dyslipidemia in the same individuals after treatment with ATV or nelfinavir (NFV) for 48 weeks. Two multinational, randomized, active-controlled, blinded trials compared the safety and efficacy of ATV and NFV in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) in antiretroviral (ARV)-naive patients. Serum lipid concentrations were analyzed in patients who had available measurements both at baseline and at week 48. Patients who had missing data at either time point were not included.

Lipid levels remained within baseline ranges at week 48 with ATV treatment, whereas clinically relevant elevations in TC, fasting LDL-C, and fasting TG concentrations occurred with NFV treatment. Mean changes from pre-treatment baseline in fasting LDL-C ranged from -6 percent to +6 percent in the ATV-treatment groups, and from +27 percent to +31 percent in the NFV-treatment groups. After 48 weeks, there was a substantive increase in the proportion of NFV-treated patients who would be recommended for lipid-lowering treatment by National Cholesterol Education Program (NCEP) guidelines, whereas a lesser proportion of ATV-treated patients would be recommended for lipid-lowering treatment.

Atazanavir does not lead to dyslipidemia in ARV-naive patients, and may limit the need for lipid-lowering strategies to reduce the risk of cardiovascular disease.

Key Words: atazanavir • HIV protease inhibitors • hyperlipidemia • hypercholesterolemia • hypertriglyceridemia • nelfinavir

Journal of the International Association of Physicians in AIDS Care (JIAPAC), Vol. 3, No. 3, 92-98 (2004)
DOI: 10.1177/154510970400300304


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