Comparison of Metabolic Abnormalities and Clinical Lipodystrophy 48 Weeks After Switching from HAART to Trizivir™ Versus Continued HAART: The Trizal Study

Abstract

Purpose: To analyze the evolution of clinical lipodystrophy (LD) and metabolic abnormalities in patients continuing to receive HAART versus patients switched to Trizivir™ (zidovudine, lamivudine, abacavir) after 48 weeks. Method: Patients treated with HAART >6 months with plasma HIV-1 RNA viral load (VL) <;400 copies/mL and <;50 copies/mL at screening were randomly assigned to continue HAART (103 patients) or to receive Trizivir™ (106 patients). Clinical LD was evaluated using a standardized patient questionnaire only at baseline, weeks 4 and 8, and then every 8 weeks until Week 48. Laboratory evaluation was performed every 4 weeks. Results: The proportion of patients exhibiting ≥1 LD symptom at baseline was 40% in the Trizivir™ arm and 50% in HAART arm (difference not significant). After 48 weeks, the prevalence was 28% and 42% respectively (p = .03), and the median number of LD symptoms per patient was 2 in the Trizivir™ arm and 4 in the continued HAART arm (p = .016). Median decreases in cholesterol levels over the 48-week study period were greater in the Trizivir. arm than in the continued HAART arm (–0.80 vs. –0.44 mmol/L; p < .001). Median triglyceride levels decreased in the Trizivir™ arm but increased in the continued HAART arm (–0.17 and +0.01 mmol/L; p = .006). Suppression of VL was maintained in most patients with no differences between the two arms. Conclusion: A switch from "standard" HAART to Trizivir™ was associated with an improvement in clinical LD and blood lipid abnormalities after 48 weeks.

Keywords:

• lipids
• lipodystrophy
• Trizivir™