Objectives: AtLaS was a single-arm pilot study that demonstrated promising efficacy and safety of treatment simplification to a dual regimen with atazanavir/ritonavir+lamivudine in virologically suppressed HIV-positive patients. Here, we report data from the 144 week follow-up. Methods: At baseline, patients treated with a three-drug atazanavir/ritonavir-based regimen were switched to 300/100 mg of atazanavir/ritonavir plus 300 mg of lamivudine once daily. Major clinical events, laboratory parameters, neurocognitive performance, bone composition and body fat distribution were monitored. Treatment failure was defined as a discontinuation/switch of the regimen or virological failure (HIV-RNA .50 copies/mL in two consecutive determinations or a single level above 1000 copies/mL). Results: After 144 weeks, 9/40 (22.5%) treatment failures occurred, including two virological failures (Weeks 48 and 53, without resistance). A significant increase in the CD4 count was observed at Week 96 (+124 cells/mm3; P1/40.002) and Week 144 (+94 cells/mm3; P1/40.008). After 144 weeks, a significant increase in total cholesterol (+25 mg/dL; P1/40.001), HDL cholesterol (+6 mg/dL; P1/40.024) and LDL cholesterol (+12 mg/dL; P1/40.008) was observed, without any change in triglyceride levels, total cholesterol/HDL ratio or LDL/HDL ratio. A significant increase in the estimated glomerular filtration rate (+25 mL/min/1.73 m2; P,0.001) and lumbar spine T-score and Z-score (+0.2, P1/40.011; and +0.35, P1/40.001, respectively) and a decrease in trunk fat (21.898 g; P1/40.005) were also observed. Neurocognitive function did not decline over time. Concerning safety, 10 moderate to severe adverse events were recorded in eight patients; overall seven cases of renal colic (possibly treatment related) were observed, leading to a discontinuation of treatment in two patients. Conclusions: Data from the 144 week follow-up suggested good long-term efficacy of the simplification strategy that was investigated, with rare virological failure and a potential for improvement of the CD4 count, renal function and bone mineral density. This strategy warrants further investigation in a randomized trial. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved.

Mondi, A., Fabbiani, M., Ciccarelli, N., Colafigli, M., D'Avino, A., Borghetti, A., et al. (2015). Efficacy and safety of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients with virological suppression: 144 week follow-up of the AtLaS pilot study. JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 70(6), 1843-1849 [10.1093/jac/dkv037].

Efficacy and safety of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients with virological suppression: 144 week follow-up of the AtLaS pilot study

FABBIANI M;DE LUCA, ANDREA
;
2015-01-01

Abstract

Objectives: AtLaS was a single-arm pilot study that demonstrated promising efficacy and safety of treatment simplification to a dual regimen with atazanavir/ritonavir+lamivudine in virologically suppressed HIV-positive patients. Here, we report data from the 144 week follow-up. Methods: At baseline, patients treated with a three-drug atazanavir/ritonavir-based regimen were switched to 300/100 mg of atazanavir/ritonavir plus 300 mg of lamivudine once daily. Major clinical events, laboratory parameters, neurocognitive performance, bone composition and body fat distribution were monitored. Treatment failure was defined as a discontinuation/switch of the regimen or virological failure (HIV-RNA .50 copies/mL in two consecutive determinations or a single level above 1000 copies/mL). Results: After 144 weeks, 9/40 (22.5%) treatment failures occurred, including two virological failures (Weeks 48 and 53, without resistance). A significant increase in the CD4 count was observed at Week 96 (+124 cells/mm3; P1/40.002) and Week 144 (+94 cells/mm3; P1/40.008). After 144 weeks, a significant increase in total cholesterol (+25 mg/dL; P1/40.001), HDL cholesterol (+6 mg/dL; P1/40.024) and LDL cholesterol (+12 mg/dL; P1/40.008) was observed, without any change in triglyceride levels, total cholesterol/HDL ratio or LDL/HDL ratio. A significant increase in the estimated glomerular filtration rate (+25 mL/min/1.73 m2; P,0.001) and lumbar spine T-score and Z-score (+0.2, P1/40.011; and +0.35, P1/40.001, respectively) and a decrease in trunk fat (21.898 g; P1/40.005) were also observed. Neurocognitive function did not decline over time. Concerning safety, 10 moderate to severe adverse events were recorded in eight patients; overall seven cases of renal colic (possibly treatment related) were observed, leading to a discontinuation of treatment in two patients. Conclusions: Data from the 144 week follow-up suggested good long-term efficacy of the simplification strategy that was investigated, with rare virological failure and a potential for improvement of the CD4 count, renal function and bone mineral density. This strategy warrants further investigation in a randomized trial. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved.
2015
Mondi, A., Fabbiani, M., Ciccarelli, N., Colafigli, M., D'Avino, A., Borghetti, A., et al. (2015). Efficacy and safety of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients with virological suppression: 144 week follow-up of the AtLaS pilot study. JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 70(6), 1843-1849 [10.1093/jac/dkv037].
File in questo prodotto:
File Dimensione Formato  
Efficacy and safety of treatment simplification-Mondi-2015.pdf

non disponibili

Tipologia: PDF editoriale
Licenza: NON PUBBLICO - Accesso privato/ristretto
Dimensione 212.15 kB
Formato Adobe PDF
212.15 kB Adobe PDF   Visualizza/Apri   Richiedi una copia

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11365/1011870