11th International Workshop on Adverse Drug

Reactions & Co-Morbidities in HIV

26–28 October 2009, Philadelphia, PA, USA

BOTH ONCE-DAILY SAQUINAVIR/RITONAVIR AND ATAZANAVIR/RITONAVIR, WHEN

COMBINED WITH TENOFOVIR/EMTRICITABINE CONSERVE ADIPOSE TISSUE, ONLY
MODESTLY AFFECT LIPIDS AND EXHIBIT SIMILAR MILD REDUCTION IN
GLOMERULAR FILTRATION OVER 48 WEEKS: THE BASIC TRIAL

Antiviral Therapy 2009; 14(Suppl. 2):A27 (abstract no. P-05)

SME Vrouenraets1,2, E Fernandez Garcia2, A Jackson3, F Raffi4, DT Jayaweera5, C Katlama6, M

Fisher7, L Slama8, D Hardy9, S Mauss10, E DeJesus11, A van Eeden12, D Prelutsky13, FWNM Wit1,2, G
Moyle3 and P Reiss1,2 for the BASIC Study Group
1Academic Medical Center, Amsterdam, the Netherlands; 2IATEC, Amsterdam, the Netherlands; 3Chelsea and Westminster Hospital,
London, UK; 4CHU Hôtel Dieu, Nantes, France; 5University of Miami School of Medicine, Miami, FL, USA; 6Hôpital Pitié-Salpêtrière,
Paris, France; 7Royal Sussex County Hospital, Brighton, UK; 8Hôpital Tenon, Paris, France; 9Cedars-Sinai Medical Centre, Los
Angeles, CA, USA; 10Gemeinschaftspraxis Mauss, Düsseldorf, Germany; 11Orlando Immunology Center, Orlando, FL, USA; 12St MC
Jan van Goyen, Amsterdam, the Netherlands; 13Central West Clinical Research, St Louis, MO, USA

OBJECTIVES: To compare the effects on lipids, body composition and renal function of once-daily
ritonavirboosted saquinavir or atazanavir in combination with tenofovir/emtricitabine over 48 weeks.

METHODS: BASIC is a 48-week randomized multinational trial comparing saquinavir/r 2,000/100 mg

and atazanavir/r 300/100 mg, each once-daily with tenofovir/ emtricitabine in treatment-naïve HIV-1-
infected patients. Changes in fasting lipids, glucose/insulin, body composition by DEXA and abdominal
CT (in subset), and estimated glomerular filtration rate (eGFR) by Cockcroft–Gault and MDRD were
compared by ITT analysis, including all 118/123 randomized patients who had received at least one dose
of trial drug.

RESULTS: Patients were comparable at baseline. Changes in lipids were similar and modest, without
increases in triglycerides and similar reductions in TC/HDL. No significant changes in insulin sensitivity
were observed. Patients on atazanavir gained statistically significantly more subcutaneous adipose
tissue. A lesser decrease in eGFR by Cockcroft–Gault but not MDRD was seen on atazanavir (Table 1).
Loss of virologic response (TLOVR) was seen in 25% (saquinavir) and 21% (atazanavir), respectively
(P=0.68). Mean CD4 increase was 190 (saquinavir) versus 161 cells/mm3 (atazanavir; P=0.19).
Table 1.

Saquinavir (n=057) Atazanavir (n=061) Difference from BL-W48

between atazanavir-
BL W48 change BL W48 change saquinavir (95% CI) P-value

n 54 59

TC, mmol/l 4.0 ±0.1 0.2 ±0.1a 4.0 ±0.1 0.2 ±0.1a 0.02 (-0.3–0.3) 0.887

HDL-c, mmol/l 1.0 ±0.04 0.2 ±0.04a 1.0 ±0.03 0.1 ±0.04a 0.1 (0.002–0.2) 0.046

TC/HDL-c 4.3 ±0.2 -0.5 ±0.1a 4.3 ±0.2 -0.2 ±0.1 -0.3 (-0.6–0.1) 0.189
LDL-c, mmol/l 2.5 ±0.1 -0.05 ±0.08 2.4 ±0.1 0.1 ±0.08 -0.2 (-0.4–0.04) 0.102
TG, mmol/l 1.3 ±0.2 0.02 ±0.1 1.4 ±0.1 0.02 ±0.1 -0.001 (-0.4–0.4) 0.996
ApoA1, g/l 1.2 ±0.03 0.1 ±0.03a 1.2 ±0.03 0.1 ±0.03a 0.03 (-0.06–0.1) 0.532
ApoB, g/l 0.9 ±0.03 0.003 ±0.02 0.9 ±0.03 0.04 ±0.02 -0.03 (-0.1–0.04) 0.340

n 54 59

Glucose, mmol/l 4.6 ±0.1 0.00 ±0.09 4.6 ± 0.08 0.2 ±0.09a -0.2 (-0.5–0.04) 0.094
Insulin, pmol/l 8.5 ±1.8 -0.5 ±1.2 6.9 ±0.6 2.0 ±1.2 -2.6 (-5.9–0.8) 0.132
HOMA 1.8 ±0.4 -0.1 ±0.3 1.5 ±0.1 0.5 ±0.3 -0.6 (-1.4–0.2) 0.121

n 41 45

Total body mass, g 69,090 ±2,234 927 ±712 74,468 ±2,073 3,003 ±679a -2,076 (-4,032– -119) 0.038

Lean body mass, g 50,486 ±1,602 260 ±370 54,668 ±1,407 1,035 ±353a -775 (-1,793–243) 0.134

Limb fat, g 7,037 ±633 336 ±218 7,593 ±910 993 ±208a -656 (-1,255– -58) 0.032

SAT, cm2 176.0 ±14.2 8.0 ±6.2 182.0 ±20.9 26.3 ±5.9a -18.3 (-35.4– -1.2) 0.037

VAT, cm2 86.8 ±8.2 2.6 ±4.3 79.4 ±6.6 10.8 ±4.1a -8.2 (-20.0–3.5) 0.169

eGFR, ml/min/1.73m2 55 58

Cockcroft–Gault 118 ±5 -9 ±2a 124 ±6 -1 ±2 -9 (-15– -2) 0.009

MDRD-4 92 ±2 -10 ±1a 88 ±2 -7 ±1a -3 (-7–1) 0.098

Estimated means ±sem unless stated otherwise. aSignificant change within arm. BL, baseline; eGFR, estimated glomerular filtration
rate; W, week.

CONCLUSIONS: Combined with tenofovir/emtricitabine, saquinavir/r 2,000/100 mg and atazanavir/r

300/100 mg were virologically effective once-daily regimens. Each had comparable modest and
potentially favourable effects on lipids, did not affect glucose metabolism, conserved adipose tissue and
similarly reduced GFR. The difference in total and lean body mass changes may explain the discrepancy
between GFR estimations.

2009-10-26
P-05

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