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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Vydáno v:	BMC infectious diseases Ročník 12; číslo 1; s. 179
Hlavní autoři:	Rusconi, Stefano, Giacomet, Vania, Mameli, Chiara, Viganò, Alessandra, Viganò, Ottavia, Adorni, Fulvio, Galli, Massimo, Zuccotti, Gian Vincenzo
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	London BioMed Central 06.08.2012 BioMed Central Ltd Springer Nature B.V BMC
Témata:	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
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Popis
Shrnutí:	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.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23
ISSN:	1471-2334 1471-2334
DOI:	10.1186/1471-2334-12-179