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Unboosted atazanavir with lamivudine/emtricitabine for patients with long-lasting virological suppression

INTRODUCTION: Unboosted atazanavir (ATV) including regimens have been investigated as a ritonavir-sparing simplification strategy. No data are available on removal of one NRTI in subjects effectively treated with unboosted atazanavir+2NRTIs. We present the 48-week virological efficacy and safety of...

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Autores principales: Carbone, Alessia, Galli, Laura, Bigoloni, Alba, Bossolasco, Simona, Guffanti, Monica, Maillard, Miriam, Carini, Elisabetta, Salpietro, Stefania, Spagnuolo, Vincenzo, Gianotti, Nicola, Lazzarin, Adriano, Castagna, Antonella
Formato: Online Artículo Texto
Lenguaje:English
Publicado: International AIDS Society 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4225246/
https://www.ncbi.nlm.nih.gov/pubmed/25397555
http://dx.doi.org/10.7448/IAS.17.4.19811
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author Carbone, Alessia
Galli, Laura
Bigoloni, Alba
Bossolasco, Simona
Guffanti, Monica
Maillard, Miriam
Carini, Elisabetta
Salpietro, Stefania
Spagnuolo, Vincenzo
Gianotti, Nicola
Lazzarin, Adriano
Castagna, Antonella
author_facet Carbone, Alessia
Galli, Laura
Bigoloni, Alba
Bossolasco, Simona
Guffanti, Monica
Maillard, Miriam
Carini, Elisabetta
Salpietro, Stefania
Spagnuolo, Vincenzo
Gianotti, Nicola
Lazzarin, Adriano
Castagna, Antonella
author_sort Carbone, Alessia
collection PubMed
description INTRODUCTION: Unboosted atazanavir (ATV) including regimens have been investigated as a ritonavir-sparing simplification strategy. No data are available on removal of one NRTI in subjects effectively treated with unboosted atazanavir+2NRTIs. We present the 48-week virological efficacy and safety of unboosted atazanavir plus lamivudine (3TC) or emtricitabine (FTC) (lamivudine/emtricitabine/Reyataz(©), LAREY Study). MATERIALS AND METHODS: Single arm, prospective, pilot study on HIV-treated patients, HBsAg negative, with HIV-RNA<50 cps/mL since at least 2 years, who switched from ATV+2NRTIs to ATV 400 mg QD +3TC or FTC. Virological failure was defined as 2 consecutive values of HIV-RNA>50 cps/ml; viral blip was defined as a single HIV-RNA value>50 cps/ml not subsequently confirmed. Results as median (IQR). Changes between baseline (BL) and week 48 assessed by the Wilcoxon signed rank test. RESULTS: Forty patients enrolled: 75% males, 51 (47–54) years, 14% HCV co-infected, infected with HIV since 16 (9–21) years, on antiretroviral therapy since 13 (5–16) years, with a nadir CD4+ of 254 (157–307) cells/mm(3), virologically suppressed since 4.2 (2.2–5.4) years; 53 patients switched from a tenofovir (TDF)-based regimens; ATV was associated with 3TC in 83% patients. No virological failures or discontinuations were observed; three patients had a single viral blip in the range 50–250 copies/mL; CD4+ increased from 610 (518–829) cells/mm(3) at BL to 697 (579–858) cells/mm(3) at week 48 [48-week change: 39 (−63/+160) cells/mm(3) p=0.081]. Three clinical events were observed (one herpes zoster, one pneumonia, one syphilis) in absence of renal lithiasis, AIDS-defining or drug-related events or death. Overall, significant 48-week amelioration of ALP [BL: 83 (71–107) mg/dL; 48-week change: −15 (−27/−8) mg/dL p<0.0001] and CKD-EPI [BL: 100 (86–108) ml/min/1.73 m(2); 48-week change: 1.5 (−3/+8) ml/min/1.73 m(2), p=0.042] were observed. Patients switching from TDF (Table 1) significantly improved CD4+, lymphocytes, hepatic profile, renal profile and ALP; these patients had also a modest but significant decrease in haemoglobin. CONCLUSIONS: Switch from an unboosted atazanavir-based regimen to ATV+3TC or FTC regimen was effective and safe in this small sample, supporting the hypothesis of a potential two-steps de-intensification (removal of ritonavir and removal of one NRTI) in patients on long-lasting virological suppression.
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spelling pubmed-42252462014-11-12 Unboosted atazanavir with lamivudine/emtricitabine for patients with long-lasting virological suppression Carbone, Alessia Galli, Laura Bigoloni, Alba Bossolasco, Simona Guffanti, Monica Maillard, Miriam Carini, Elisabetta Salpietro, Stefania Spagnuolo, Vincenzo Gianotti, Nicola Lazzarin, Adriano Castagna, Antonella J Int AIDS Soc Poster Sessions – Abstract P279 INTRODUCTION: Unboosted atazanavir (ATV) including regimens have been investigated as a ritonavir-sparing simplification strategy. No data are available on removal of one NRTI in subjects effectively treated with unboosted atazanavir+2NRTIs. We present the 48-week virological efficacy and safety of unboosted atazanavir plus lamivudine (3TC) or emtricitabine (FTC) (lamivudine/emtricitabine/Reyataz(©), LAREY Study). MATERIALS AND METHODS: Single arm, prospective, pilot study on HIV-treated patients, HBsAg negative, with HIV-RNA<50 cps/mL since at least 2 years, who switched from ATV+2NRTIs to ATV 400 mg QD +3TC or FTC. Virological failure was defined as 2 consecutive values of HIV-RNA>50 cps/ml; viral blip was defined as a single HIV-RNA value>50 cps/ml not subsequently confirmed. Results as median (IQR). Changes between baseline (BL) and week 48 assessed by the Wilcoxon signed rank test. RESULTS: Forty patients enrolled: 75% males, 51 (47–54) years, 14% HCV co-infected, infected with HIV since 16 (9–21) years, on antiretroviral therapy since 13 (5–16) years, with a nadir CD4+ of 254 (157–307) cells/mm(3), virologically suppressed since 4.2 (2.2–5.4) years; 53 patients switched from a tenofovir (TDF)-based regimens; ATV was associated with 3TC in 83% patients. No virological failures or discontinuations were observed; three patients had a single viral blip in the range 50–250 copies/mL; CD4+ increased from 610 (518–829) cells/mm(3) at BL to 697 (579–858) cells/mm(3) at week 48 [48-week change: 39 (−63/+160) cells/mm(3) p=0.081]. Three clinical events were observed (one herpes zoster, one pneumonia, one syphilis) in absence of renal lithiasis, AIDS-defining or drug-related events or death. Overall, significant 48-week amelioration of ALP [BL: 83 (71–107) mg/dL; 48-week change: −15 (−27/−8) mg/dL p<0.0001] and CKD-EPI [BL: 100 (86–108) ml/min/1.73 m(2); 48-week change: 1.5 (−3/+8) ml/min/1.73 m(2), p=0.042] were observed. Patients switching from TDF (Table 1) significantly improved CD4+, lymphocytes, hepatic profile, renal profile and ALP; these patients had also a modest but significant decrease in haemoglobin. CONCLUSIONS: Switch from an unboosted atazanavir-based regimen to ATV+3TC or FTC regimen was effective and safe in this small sample, supporting the hypothesis of a potential two-steps de-intensification (removal of ritonavir and removal of one NRTI) in patients on long-lasting virological suppression. International AIDS Society 2014-11-02 /pmc/articles/PMC4225246/ /pubmed/25397555 http://dx.doi.org/10.7448/IAS.17.4.19811 Text en © 2014 Carbone A et al; licensee International AIDS Society http://creativecommons.org/licenses/by/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Poster Sessions – Abstract P279
Carbone, Alessia
Galli, Laura
Bigoloni, Alba
Bossolasco, Simona
Guffanti, Monica
Maillard, Miriam
Carini, Elisabetta
Salpietro, Stefania
Spagnuolo, Vincenzo
Gianotti, Nicola
Lazzarin, Adriano
Castagna, Antonella
Unboosted atazanavir with lamivudine/emtricitabine for patients with long-lasting virological suppression
title Unboosted atazanavir with lamivudine/emtricitabine for patients with long-lasting virological suppression
title_full Unboosted atazanavir with lamivudine/emtricitabine for patients with long-lasting virological suppression
title_fullStr Unboosted atazanavir with lamivudine/emtricitabine for patients with long-lasting virological suppression
title_full_unstemmed Unboosted atazanavir with lamivudine/emtricitabine for patients with long-lasting virological suppression
title_short Unboosted atazanavir with lamivudine/emtricitabine for patients with long-lasting virological suppression
title_sort unboosted atazanavir with lamivudine/emtricitabine for patients with long-lasting virological suppression
topic Poster Sessions – Abstract P279
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4225246/
https://www.ncbi.nlm.nih.gov/pubmed/25397555
http://dx.doi.org/10.7448/IAS.17.4.19811
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