Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir and Lamivudine for treatment Simplification, AtLaS pilot study)
| Autor: | Alessandro D'Avino, Annalisa Mondi, Antonella Cingolani, Manuela Colafigli, Enrica Tamburrini, Simona Di Giambenedetto, Andrea De Luca, Roberto Cauda, Pierluigi Navarra, Massimiliano Fabbiani, Salvatore Farina, Nicoletta Ciccarelli, Letizia Sidella, Rita Murri |
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| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Male
Pyridines ATAZANAVIR HIV Infections Pilot Projects Neuropsychological Tests Gastroenterology law.invention chemistry.chemical_compound Cognition Randomized controlled trial Pregnancy law Antiretroviral Therapy Highly Active Pharmacology (medical) Treatment Failure Adiposity virus diseases Lamivudine Middle Aged Infectious Diseases Body Composition RNA Viral Reverse Transcriptase Inhibitors Female Oligopeptides Glomerular Filtration Rate medicine.drug Adult Microbiology (medical) safety medicine.medical_specialty Settore BIO/14 - FARMACOLOGIA Endpoint Determination Bilirubin Atazanavir Sulfate Renal function RITONAVIR Settore MED/17 - MALATTIE INFETTIVE Bone and Bones Internal medicine Drug Resistance Viral medicine Humans Adverse effect Pharmacology business.industry simplification HIV HIV Protease Inhibitors Virology Atazanavir Regimen chemistry HIV-1 Quality of Life Patient Compliance Ritonavir business |
| Popis: | OBJECTIVES To explore 48 week safety and efficacy of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients with virological suppression on a stable atazanavir/ritonavir-based standard triple regimen. METHODS This was a single-arm pilot study, enrolling 40 patients on atazanavir/ritonavir + two nucleos(t)ide reverse transcriptase inhibitors (NRTIs), without previous treatment failure, with HIV-RNA 3 months and CD4 >200 cells/mm(3). At baseline, patients were switched to 300/100 mg of atazanavir/ritonavir + 300 mg of lamivudine once daily. Laboratory parameters, atazanavir plasma levels, self-reported adherence, quality of life, neurocognitive performance, bone composition and body fat distribution were monitored. Virological failure was defined as HIV-RNA >50 copies/mL on two consecutive determinations or a single level >1000 copies/mL. RESULTS After 48 weeks, 4/40 (10%) regimen discontinuations occurred: 1 death (brain haemorrhage), 1 study withdrawal (inadequate atazanavir plasma levels), 1 re-induction with two NRTIs due to pregnancy and 1 virological failure without development of resistance. Seven moderate to severe adverse events were recorded (including four renal colics, possibly treatment-related) in six patients. At week 48, increases in total (mean change +17 mg/dL, P = 0.001), high-density lipoprotein (+6 mg/dL, P |
| Databáze: | OpenAIRE |
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