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9th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV19-21 July 2007, Sydney, Australia |
METABOLIC CHANGES IN A THAI TREATMENT-NAÏVE POPULATION STARTING DOUBLE-BOOSTED PROTEASE INHIBITOR THERAPY
Antiviral Therapy 2007; 12(Suppl. 2):L7 (abstract no. O-06)
J van der Lugt1,2, K Ruxrungtham1,3, S Autar1,2, S Ubolyam1, J Lange1,2,4, D Cooper5, P Phanuphak1,3, D Burger6, F Wit2,4 and P Reiss2,4
1HIV Netherlands Australia Thailand (HIV-NAT) Research Collaboration, Thai Red Cross AIDS Research Center Bangkok; 2International Antiretroviral Therapy Evaluation Center, Amsterdam, The Netherlands; 3Department of Medicine, Faculty of Medicine,
Chulalongkorn University, Thailand; 4Department of Internal medicine, Academic Medical Center, University of Amsterdam, The Netherlands; 5National Center in HIV Epidemiology and Clinical Research, University of New South Wales; 6Radboud University Medical Center,
Nijmegen, The Netherlands
OBJECTIVE: To assess changes in body fat distribution, lipid and glucose metabolism, after initiation of therapy with ritonavir-boosted lopinavir (LPV/r) plus (hard gel) saquinavir (SQV) in treatment-naïve patients.
METHODS: Forty-eight treatment-naïve patients were randomized to LPV/r 400/100 mg + SQV 1,000 mg twice daily (bid) (Group A), LPV/r 400/100 mg + SQV 600 mg bid (Group B), LPV/r 266/66 mg + SQV 1,000 mg bid (Group C) or LPV/r 266/66 mg + SQV 600 mg bid BL, baseline value; slope, change from baseline at week 24; P-value A versus rest, comparison of slope from group A with each of the other groups. (Group D) and followed for 24 weeks. Fasting high-density lipoprotein (HDL), directly measured low-density lipoprotein (LDL-c), total cholesterol (TC), triglycerides (TG), insulin and glucose levels were measured at week 0, 4, 12 and 24. DEXA and abdominal CT at L4 were done at week 0, 12 and 24. Data were analysed using repeated- measures linear regression.
| Table 1. (Abstract O-06) | |||||
| BL | Slope | P-value slope |
P-value A versus rest |
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| TC, mg/dl | |||||
| A | 166 | +57 | <0.0001 | – | |
| B | 157 | +45 | <0.0001 | 0.35 | |
| C | 166 | +21 | 0.032 | 0.0041 | |
| D | 196 | +34 | 0.0001 | 0.052 | |
| LDL-c, mg/dl | |||||
| A | 88 | +30 | <0.0001 | – | |
| B | 82 | +24 | 0.0002 | 0.46 | |
| C | 91 | +10 | 0.11 | 0.015 | |
| D | 112 | +16 | 0.007 | 0.054 | |
| Weight, kg | |||||
| A | 56 | +6.0 | <0.0001 | – | |
| B | 53 | +0.0 | 0.97 | 0.0018 | |
| C | 58 | +0.0 | 0.96 | 0.0025 | |
| D | 56 | -0.4 | 0.80 | 0.0008 | |
| Limb fat, kg | |||||
| A | 6.9 | +0.59 | 0.0038 | – | |
| B | 6.0 | +0.38 | 0.078 | 0.44 | |
| C | 7.5 | +0.42 | 0.063 | 0.54 | |
| D | 6.6 | +0.38 | 0.062 | 0.42 | |
| HDL-c, mg/dl | |||||
| A | 46 | +15 | <0.0001 | – | |
| B | 52 | +7 | 0.014 | 0.040 | |
| C | 52 | +6 | 0.046 | 0.014 | |
| D | 53 | +6 | 0.017 | 0.011 | |
| TG, mg/dl | |||||
| A | 124 | +100 | 0.0003 | – | |
| B | 104 | +81 | 0.0085 | 0.63 | |
| C | 108 | +75 | 0.014 | 0.53 | |
| D | 113 | +75 | 0.0055 | 0.49 | |
| Trunk fat, kg | |||||
| A | 6.2 | +0.72 | 0.0024 | – | |
| B | 4.8 | +0.20 | 0.40 | 0.10 | |
| C | 5.4 | +0.38 | 0.14 | 0.29 | |
| D | 5.4 | -0.07 | 0.74 | 0.0098 | |
| Abdominal fat, cm2 | |||||
| A | 54 | +7.6 | 0.023 | – | |
| B | 33 | +3.6 | 0.31 | 0.40 | |
| C | 33 | -3.9 | 0.28 | 0.015 | |
| D | 40 | -3.4 | 0.35 | 0.020 | |
RESULTS: Six patients were excluded from the DEXA/CT analysis because they had no scans performed. Another patient was lost to follow up after 1 week. Baseline values did not differ significantly among groups. HIV RNA and CD4 change at week 24 did not differ significant by ITT analysis. TC, HDL-c, LDL-c and TG, but not glucose and insulin, increased significantly in all arms. Increases in TC, HDL-c and LDL-c, but not TG, were significantly greater in group A than in groups C and D. Body weight, and trunk, total limb, and intra-abdominal fat increased significantly in group A only. Changes were less marked in the other groups.
CONCLUSION: Therapy-naïve patients treated with LPV/r + SQV only, at least in the first 6 months, did not show evidence of limb fat loss, but rather overall fat gain in both peripheral and central compartments and dyslipidaemia, particularly in the highest dose group. The latter suggests that metabolic and body composition changes on this PI combination may be exposure-related.
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2007-07-24
O-06
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