F8/3 - FAVOURABLE INCREASES IN HIGH-DENSITY LIPOPROTEIN CHOLESTEROL (HDL-C) CONCENTRATIONS IN CHRONIC HIV-INFECTED THERAPY NAÏVE SUBJECTS RECEIVING 908/R QD IN THE SOLO STUDY

9^TH EUROPEAN AIDS CONFERENCE (EACS)
1^st EACS RESISTANCE & PHARMACOLOGY WORKSHOP

October 25 - 29, 2003 Warsaw, Poland

9.2 Disturbances in Lipid and Glucose Metabolism

F8/3 - FAVOURABLE INCREASES IN HIGH-DENSITY LIPOPROTEIN CHOLESTEROL (HDL-C) CONCENTRATIONS IN CHRONIC HIV-INFECTED THERAPY NAÏVE SUBJECTS RECEIVING 908/R QD IN THE SOLO STUDY

Horban A.¹, Staszewski S.², Walmsley S.³, Pierone G.⁴, Sexton A.⁵, Stark T.⁶

(1) Hospital of Infectious Disease, Warsaw, Poland,² University Clinic Frankfurt/M, Germany,³ University Health Network - Toronto General Hospital, Canada,⁴ Treasure Coast Infectious Disease Consultants, Florida, USA,⁵ GlaxoSmithKline R&D RTP, USA,⁶ GlaxoSmithKline R&D, Greenford, UK

Background: Chronic HIV infection is associated with decreases in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and HDL-C. In HIV negative subjects, low HDL-C (<40mg/dL) and high TC/HDL-C ratios are associated with an increased risk for cardiovascular disease. Currently available protease inhibitors (PI) have often been associated with increases in TC and LDL-C but little change in HDL-C.

Method: In SOLO, a 48-week randomised study, 322 subjects received 908/r QD (NFV: 327). Serum samples were collected in fasting state. Dyslipidemia was defined according to the US National Cholesterol Education Programme cut-offs.

Results: At baseline (BL), the mean HDL-C level was 38mg/dL (NFV: 37mg/dL). After starting 908/r QD, mean HDL-C increased over 48 weeks to 46mg/dL (+ 29%; NFV: +27%). TC increased by 38% (NFV: +37%), but with minimal changes in TC/HDL-C ratio (mean +0.39; NFV: +0.34) observed.

	908/r QD (N=232)	908/r QD	NFV BID (N=245)	NFV BID
Observed Analysis	BL	Wk 48	BL	Wk 48
% with HDL-C <40mg/dL	60	25	68	31
% with HDL-C >40mg/dL and < 60mg/dL	36	61	28	51
% with HDL-C >60mg/dL	4	15	4	18
% with TC/HDL-C ratio >6.5	15	18	9	14

Conclusion: In this chronically HIV infected ART-naïve population with low BL HDL-C, substantial increases in HDL-C combined with minimal changes in the TC/HDL-C ratio were observed following treatment with 908/r QD and NFV for 48-weeks. Similar observations were previously reported with NNRTIs.

Presenting Author: Dr. Andrzej Horban, Hospital of Infectious Disease - AIDS Diagnosis and Therapy Center, 37, Wolska Str., PL - 01-, Warsaw, Poland, Phone: ++48-22-6320611

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