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Open Access Research article

Efficacy and safety of a dual boosted protease inhibitor-based regimen, atazanavir and fosamprenavir/ritonavir, against HIV: experience in a pediatric population

Stefano Rusconi14*, Vania Giacomet2, Chiara Mameli2, Alessandra Viganò2, Ottavia Viganò1, Fulvio Adorni3, Massimo Galli1 and Gian Vincenzo Zuccotti2

Author Affiliations

1 Department of Biomedical and Clinical Science “Luigi Sacco”, Infectious Diseases, University of Milan, Milan, Italy

2 Department of Biomedical and Clinical Science “Luigi Sacco”, Pediatrics, University of Milan, Milan, Italy

3 ITB-CNR, Segrate, Milan, Italy

4 Sezione di Malattie Infettive, Dipartimento di Scienze Biomediche e Cliniche (DIBIC) "Luigi Sacco", Universita' degli Studi di Milano, via G.B. Grassi 74, Milano, 20157, Italy

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BMC Infectious Diseases 2012, 12:179  doi:10.1186/1471-2334-12-179

Published: 6 August 2012

Abstract

Background

Although dual-boosted protease inhibitors regimen is not recommended in children with HIV infection, such a strategy could be useful in subjects with a complex resistance profile. This study was aimed at assessing the long term efficacy and safety of a double-boosted protease inhibitor combination, fosamprenavir (fAVP) and atazanavir/ritonavir (ATV/r) in a cohort of HIV-infected children and adolescents who had failed with nucleoside reverse transcriptase inhibitors.

Methods

Seven vertically infected children and adolescents who had previously failed highly active antiretroviral therapy and were resistant to nucleoside reverse transcriptase inhibitors, received a dual protease inhibitor (PI) regimen including fAVP plus ATV/r for 42 months. The patients were assessed at baseline, every month for the first 24 weeks of therapy and every 3 months until month 32. Physical examination, CD4+ cell count, HIV-RNA viral load, lipid profile and hepatic function were assessed throughout the follow up.

Results

During the study no serious adverse events were reported. CD4 absolute number increased over-time in all subjects. At baseline the median HIV-RNA was 6562 cp/mL (ranging 1048 -102772 cp/mL) and rapidly decreased below the limit of detection (50 cp/mL) after 2 months of the new treatment and remained undetectable in all cases through the entire study period. At the beginning of the study all cases showed a normal lipid profile. During the study period, 4/7 subjects showed total cholesterol, low density lipoprotein and triglyceride levels >97th cent.le for the males and 94th cent.le for the females. HDL cholesterol showed protective values. Hepatic enzymes remained stable during the entire observation, whereas total bilirubin showed toxicity II/III grade in 6/7 subjects. No change in fat redistribution and insulin resistance was observed.

Conclusion

Dual-boosted protease inhibitor therapy was virologically and immunologically effective and it could be considered as a possible alternative to a rescue regimen in children and adolescents. However, hypercholesterolemia and hypertriglyceridemia need close follow-up and may limit the use of this therapeutic option.