Metabolic effects of protease inhibitor-sparing antiretroviral regimens given as initial treatment of HIV-1 Infection (AIDS Clinical Trials Group Study A5095).

TitleMetabolic effects of protease inhibitor-sparing antiretroviral regimens given as initial treatment of HIV-1 Infection (AIDS Clinical Trials Group Study A5095).
Publication TypeJournal Article
Year of Publication2007
AuthorsShikuma CM, Yang Y, Glesby MJ, Meyer WA, Tashima KT, Ribaudo HJ, Webb N, Bastow B, Kuritzkes DR, Gulick RM
JournalJ Acquir Immune Defic Syndr
Volume44
Issue5
Pagination540-50
Date Published2007 Apr 15
ISSN1525-4135
KeywordsAdult, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Benzoxazines, Blood Glucose, Body Composition, Dideoxynucleosides, Double-Blind Method, Female, HIV Infections, HIV-1, Humans, Insulin Resistance, Lactic Acid, Lamivudine, Lipids, Male, Reverse Transcriptase Inhibitors, Zidovudine
Abstract

OBJECTIVE: To assess metabolic changes after initiation of protease inhibitor (PI)-sparing regimens in antiretroviral-naive patients.

METHODS: Metabolic changes were analyzed within the triple-nucleoside (zidovudine [ZDV]/lamivudine [3TC]/abacavir [ABC])-containing, 3-drug efavirenz (EFV) [ZDV/3TC + EFV]-containing, and 4-drug EFV [ZDV/3TC/ABC + EFV]-containing arms of the AIDS Clinical Trials Group multicenter trial A5095. Metabolic values were compared with published US general population norms.

RESULTS: From week 0 to week 24, all arms exhibited similar mild median increases in glucose and decreases in insulin sensitivity, whereas changes in lipids were greater in the ZDV/3TC + EFV and ZDV/3TC/ABC + EFV arms than in the ZDV/3TC/ABC arm: triglyceride (TG; 7, 18, and -1 mg/dL, respectively), total cholesterol (TC; 23, 28, and 5 mg/dL, respectively), low-density lipoprotein cholesterol (LDL-C; 9, 14, and 1 mg/dL, respectively), and high-density lipoprotein cholesterol (HDL-C; 10, 10, and 5 mg/dL, respectively). Adjusted mean study lipid values of all study participants at week 0 and week 96 compared with those of the National Health and Nutrition Examination Survey (NHANES) 1999 through 2002 values were: TG (148, 187, and 123 mg/dL, respectively), TC (164, 195, and 203 mg/dL, respectively), HDL-C (35, 47, and 51 mg/dL, respectively), and LDL-C (101, 117, and 123 mg/dL, respectively) (P < or = 0.005 for each value vs. NHANES values).

CONCLUSIONS: Similar mild increases in glucose and decreases in insulin sensitivity were observed in all regimens, whereas lipids were modestly higher in the EFV-containing arms. Compared with general population norms, the metabolic dysfunctions of concern after these PI-sparing therapies were increasingly abnormal TC and lower (but improved relative to baseline) HDL-C levels.

DOI10.1097/QAI.0b013e318031d5a0
Alternate JournalJ. Acquir. Immune Defic. Syndr.
PubMed ID17245230
Grant ListAI 10781 / AI / NIAID NIH HHS / United States
AI 25859 / AI / NIAID NIH HHS / United States
AI 25868 / AI / NIAID NIH HHS / United States
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