Successful simplification of protease inhibitor-based HAART with triple nucleoside regimens in children vertically infected with HIV.
OBJECTIVE
To assess the virological, immunological and metabolic effects of switching from an efficacious first-line protease inhibitor (PI)-based HAART to a simplified triple nucleoside reverse transcriptase inhibitor (NRTI) regimen in children vertically infected with HIV.


METHODS
Prospective, open-label, before-after study of 20 vertically infected children with at least 12 consecutive months of undetectable viral load under a PI-based HAART and no previous history of NRTI treatment.


METHODS
At study entry, HAART was shifted to a triple-NRTI combination.


RESULTS
The children were aged 2 to 18 years (median, 7.9) and were followed for 96 weeks. All were receiving a PI-based regimen for an average duration of 4 years before enrollment. At study entry, 12 patients (60%) switched to abacavir, 5 (25%) to lamivudine; 2 (10%) to zidovudine and 2 to didanosine (10%). All but one patient maintained plasma HIV RNA < 50 copies/ml during the entire follow-up. No immunological failure was observed at week 96. A trend of normalization (P < 0.001) of T cell receptor Vbeta families of the CD8 cell subset was detected in 19/20 (95%), with an increased HIV-specific CD8 T cell response (P < 0.01) in 17/20 (85%). Dyslipidaemia significantly improved during the follow up (P < 0.001). No new cases of lipodystrophy were detected.


CONCLUSIONS
Switching to triple-NRTI regimens in selected HIV-infected children with an extremely low likelihood of harbouring nucleoside-associated mutations maintains viral suppression and immunological function, improving metabolic abnormalities and the effort to take medication for up to 96 weeks.
Palma
Paolo
P
Department of Pediatrics, University of Tor Vergata, Italy. paolo.palma@uniroma2.it
Romiti
Maria Luisa
ML
Cancrini
Caterina
C
Pensieroso
Simone
S
Montesano
Carla
C
Santucci
Marilina B
MB
Bernardi
Stefania
S
Martino
Alessandra M
AM
Rossi
Paolo
P
Castelli-Gattinara
Guido
G
D000293:Adolescent; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D002784:Cholesterol / Q000097:blood; D004812:Epidemiologic Methods; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000635:transmission / Q000821:virology; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D015497:HIV-1; D006801:Humans; D018445:Infectious Disease Transmission, Vertical; D008297:Male; D010349:Patient Compliance; D011446:Prospective Studies; D016693:Receptors, Antigen, T-Cell, alpha-beta / Q000032:analysis; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D017320:HIV Protease Inhibitors; D016693:Receptors, Antigen, T-Cell, alpha-beta; D018894:Reverse Transcriptase Inhibitors; D014280:Triglycerides; D002784:Cholesterol