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Successful simplification of protease inhibitor-based HAART with triple nucleoside regimens in children vertically infected with HIV

Palma, Paoloa,c; Romiti, Maria Luisaa; Cancrini, Caterinaa,c; Pensieroso, Simonea; Montesano, Carlab; Santucci, Marilina Bb; Bernardi, Stefaniac; Martino, Alessandra Mc; Rossi, Paoloa,c; Castelli-Gattinara, Guidoc

doi: 10.1097/QAD.0b013e3282f1560b
Clinical Science

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.

Design: 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 Vβ 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.

From the aDepartment of Pediatrics, Italy

bDepartment of Biology, University of Tor Vergata, Italy

cDivision of Immunology and Infectious Diseases, Children's Hospital Bambino Gesù, Rome, Italy.

Received 12 June, 2007

Revised 15 August, 2007

Accepted 20 August, 2007

Correspondence to Dr P. Palma, Division of Immunology and Infectious Diseases, Children's Hospital Bambino Gesù, P.zza S.Onofrio 4-00165 Rome, Italy. E-mail: paolo.palma@uniroma2.it

© 2007 Lippincott Williams & Wilkins, Inc.