Substitution of nevirapine or efavirenz for protease inhibitor versus lipid-lowering therapy for the management of dyslipidaemia.
OBJECTIVE
To evaluate simplified protease inhibitor (PI)-sparing antiretroviral treatment versus lipid-lowering therapy for the management of highly active antiretroviral therapy (HAART)-induced hyperlipidaemia.


METHODS
Randomized, open-label clinical trial assessing the efficacy on hyperlipidaemia of a switching therapy from PI to non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine or efavirenz versus a hypolipidaemic treatment (with pravastatin or bezafibrate) added to current, unchanged antiretroviral combination.


METHODS
All HIV-infected patients on their first HAART regimen, with stable immuno-virological features, naive to all NNRTIs, and with mixed hyperlipidaemia, were randomized to replace PI with nevirapine (arm A) or efavirenz (arm B), or to receive pravastatin (arm C) or bezafibrate (arm D) with unchanged HAART regimen, and were followed-up for 12 months.


RESULTS
One hundred and thirty patients were evaluated: 29 patients were randomized to arm A, 34 to arm B, 36 to arm C, and 31 to arm D. At the end of the 12-month follow-up, a reduction of 25.2, 9.4, 41.2 and 46.6% in mean triglyceridaemia versus respective baseline values was reported in groups A, B, C and D, respectively, with statistically significant difference between arms A-B and C-D (P < 0.01). Similar results were reported for total and low-density lipoprotein cholesterol levels. Viro-immunological efficacy and tolerability profile were comparable in all considered arms.


CONCLUSIONS
Pravastatin and bezafibrate proved significantly more effective in the management of HAART-related hyperlipidaemia than the switching therapy from PI to nevirapine or efavirenz.
Calza
Leonardo
L
Department of Clinical and Experimental Medicine, Division of Infectious Diseases, "Alma Mater Studiorum" University of Bologna, S. Orsola Hospital, Bologna, Italy. calza@med.unibo.it
Manfredi
Roberto
R
Colangeli
Vincenzo
V
Tampellini
Livia
L
Sebastiani
Teresa
T
Pocaterra
Daria
D
Chiodo
Francesco
F
D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D048588:Benzoxazines; D001629:Bezafibrate / Q000627:therapeutic use; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D006949:Hyperlipidemias / Q000139:chemically induced / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008297:Male; D019829:Nevirapine / Q000627:therapeutic use; D010078:Oxazines / Q000627:therapeutic use; D017035:Pravastatin / Q000627:therapeutic use; D011480:Protease Inhibitors / Q000627:therapeutic use*; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D016896:Treatment Outcome
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D000960:Hypolipidemic Agents; D010078:Oxazines; D011480:Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; C098320:efavirenz; D017035:Pravastatin; D001629:Bezafibrate