5–7ĭual cART regimens including a PI/r + lamivudine have been tested in randomized studies in treatment-naive patients 8 or as simplification strategies in virologically suppressed patients. 3, 4 Mono-therapies with boosted PIs (PI/r) as simplification strategies have shown interesting results, but their efficacy is not equivalent to standard triple therapy particularly in more advanced patients. 2 Several NRTI-sparing regimens have been studied with conflicting results. In particular, in recent years NRTI-associated toxicities have become a matter of concern. A similar proportion of adverse events occurred in both arms.Ĭonclusions: Treatment simplification to atazanavir/ritonavir + lamivudine showed non-inferior efficacy (superiority on post-hoc analysis) and a comparable safety profile over continuing atazanavir/ritonavir + two NRTIs in virologically suppressed patients.Ĭombination ART (cART) has markedly improved the prognosis of HIV-infected patients 1 however, long-term exposure to antiretroviral drugs has been associated with a potential development of drug toxicity. Virological failure occurred in two (1.5%) patients in the atazanavir/ritonavir + lamivudine arm and six (4.5%) patients in the atazanavir/ritonavir + two NRTIs arm, without resistance selection. After 48 weeks, the primary study outcome was met by 119 of 133 patients (89.5%) in the atazanavir/ritonavir + lamivudine arm and 106 of 133 patients (79.7%) in the atazanavir/ritonavir + two NRTIs arm, demonstrating non-inferiority and superior efficacy of the atazanavir/ritonavir + lamivudine arm.
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Results: Between July 2011 and June 2014, 266 patients were randomized (133 to each arm). This study is registered at, number NCT01599364.
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The primary study outcome was the maintenance of HIV-RNA <50 copies/mL at week 48 of the ITT-exposed (ITT-e) analysis with switch = failure. Patients were randomly assigned 1:1 to either switch to 300 mg of atazanavir/100 mg of ritonavir once daily and 300 mg of lamivudine once daily (atazanavir/ritonavir + lamivudine arm) or to continue the previous regimen (atazanavir/ritonavir + two NRTIs arm). Main exclusion criteria were hepatitis B virus coinfection, past virological failure on or resistance to study drugs, recent AIDS and pregnancy. Methods: We performed an open-label, multicentre, randomized, non-inferiority study, enrolling HIV-infected adults on atazanavir/ritonavir + two NRTIs, with stable HIV-RNA 200 cells/mm 3.
#Roberto arenas atlas de dermatologia pdf trial#
The ATLAS-M trial explored 48 week non-inferior efficacy of simplification to atazanavir/ritonavir + lamivudine versus maintaining three-drug atazanavir/ritonavir-based cART in virologically suppressed patients. Background: Combination ART (cART)-related toxicities and costs have prompted the need for treatment simplification.