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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...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
International AIDS Society
2014
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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. |
format | Online Article Text |
id | pubmed-4225246 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | International AIDS Society |
record_format | MEDLINE/PubMed |
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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