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 < 50 copies/mL for > 3 months and CD4 > 200 cells/mm3. 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=0.001) and low-density lipoprotein (+8 mg/dL, P=0.052) cholesterol were observed. The glomerular filtration rate improved (+7 mL/min/1.73 m2, P <0.001), as did scores exploring self-reported physical and mental health (+11, P=0.009 and +13, P,0.001 on a 0-100 scale), neuropsychological performance (21 pathological task, P=0.002) and total bone mineral density (+0.03 g/cm2, P=0.026). There were no significant changes in CD4 cell count, bilirubin, atazanavir plasma levels, adherence and body fat distribution over time. Conclusions: Simplification to atazanavir/ritonavir+lamivudine was apparently safe and associated with rare virological failure, without resistance selection. This strategy deserves further investigation in a randomized trial. ©The Author 2013.
Safety and feasibility of treatment simplification to atazanavir/ ritonavir1lamivudine in hiv-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors1atazanavir/ ritonavir with virological suppression (atazanavir and lamivudine for treatment simplification, atlas pilot study)
Ciccarelli N.;
2013-01-01
Abstract
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 < 50 copies/mL for > 3 months and CD4 > 200 cells/mm3. 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=0.001) and low-density lipoprotein (+8 mg/dL, P=0.052) cholesterol were observed. The glomerular filtration rate improved (+7 mL/min/1.73 m2, P <0.001), as did scores exploring self-reported physical and mental health (+11, P=0.009 and +13, P,0.001 on a 0-100 scale), neuropsychological performance (21 pathological task, P=0.002) and total bone mineral density (+0.03 g/cm2, P=0.026). There were no significant changes in CD4 cell count, bilirubin, atazanavir plasma levels, adherence and body fat distribution over time. Conclusions: Simplification to atazanavir/ritonavir+lamivudine was apparently safe and associated with rare virological failure, without resistance selection. This strategy deserves further investigation in a randomized trial. ©The Author 2013.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
