Hyperlipidemia led to treatment withdrawal in 1 patient in the PI-continuation arm.
At week 28, the LSM reduction in triglycerides was significantly greater in the abacavir-switch arm than the PI-continuation arm (-134 vs -36 mg/dL, P = 0.019).
Of 104 patients enrolled in the study, 52 were randomized to the abacavir-switch arm and 52 to the PI-continuation arm.
Cumulative coronary artery risk factors in the PI-continuation arm: 0 factors = 26; 1 factor = 12; 2 factors = 13; and 3 factors = 1.
The LSM LDL-cholesterol level at week 28 was 133 mg/dL in the abacavir-switch arm and 153 mg/dL in the PI-continuation arm (P = 0.016).
New adverse events in the PI-continuation arm were not expected as patients had been stabilized on this treatment for >3 months.
In the ITT analysis, the abacavir-switch arm experienced greater reductions in total cholesterol and LDL-cholesterol than the PI-continuation arm over the entire study period, with differences between treatment arms being statistically significant from week 8 onward.
A higher proportion of patients in the abacavir-switch arm had decreases in the triglyceride toxicity grade as compared to the PI-continuation arm, whereas a lower proportion in the abacavir-switch arm had increases in triglyceride toxicity grade.
In the SF-36, the week 28 QOL scores did not differ between treatment arms for most domains, except Vitality (in favor of the PI-continuation arm; P = 0.042) and Health (in favor of the abacavir-switch arm; P = 0.013).
At week 28, the abacavir-switch arm had significantly greater least square mean reduction from baseline in total cholesterol (-42 vs -10 mg/dL, P < 0.001), LDL-cholesterol (-14 vs +5 mg/dL, P = 0.016), and triglycerides (-134 vs -36 mg/dL, P = 0.019) than the PI-continuation arm, with no differences in HDL-cholesterol (+0.2 vs +1.3 mg/dL, P = 0.583).
