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

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 co...

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Published in:BMC infectious diseases Vol. 12; no. 1; p. 179
Main Authors: Rusconi, Stefano, Giacomet, Vania, Mameli, Chiara, Viganò, Alessandra, Viganò, Ottavia, Adorni, Fulvio, Galli, Massimo, Zuccotti, Gian Vincenzo
Format: Journal Article
Language:English
Published: London BioMed Central 06.08.2012
BioMed Central Ltd
Springer Nature B.V
BMC
Subjects:
Adolescent
Adolescents
Anti-HIV Agents - administration & dosage
Antiretroviral agents
Antiretroviral drugs
Antiretroviral Therapy, Highly Active - methods
Atazanavir
Atazanavir Sulfate
Bilirubin
Blood cholesterol
Carbamates - administration & dosage
Care and treatment
CD4 Lymphocyte Count
Child
Children
Cholesterol
DNA polymerases
Dosage and administration
Drug therapy
Female
Fosamprenavir
Highly active antiretroviral therapy
HIV
HIV (Viruses)
HIV and co-infections
HIV infection
HIV Infections - drug therapy
HIV Protease Inhibitors - administration & dosage
Human immunodeficiency virus
Humans
Hypercholesterolemia
Infection
Infectious Diseases
Insulin resistance
Internal Medicine
Lipids - blood
Male
Medical Microbiology
Medical research
Medicine
Medicine & Public Health
Medicine, Experimental
Mutation
Nucleosides
Oligopeptides - administration & dosage
Organophosphates - administration & dosage
Parasitology
Pediatrics
Protease inhibitors
Proteases
Proteinase inhibitors
Pyridines - administration & dosage
Research Article
Ritonavir
Ritonavir - administration & dosage
RNA
RNA, Viral - blood
Salvage Therapy - methods
Sulfonamides - administration & dosage
Treatment Outcome
Tropical Medicine
Viral Load
Italy
Atazanavir
Darunavir
Ritonavir
Nucleoside Reverse Transcriptase Inhibitor
Virological Failure
ISSN:1471-2334, 1471-2334
Online Access:Get full text
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Summary: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 >97 th cent.le for the males and 94 th 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.
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ISSN:1471-2334
1471-2334
DOI:10.1186/1471-2334-12-179