3-Year efficacy and durability of simplification to single tablet regimens: a comparison between co-formulated efavirenz/emtricitabine/tenofovir and rilpivirine/emtricitabine/tenofovir

Roberta Gagliardini; Alessandra Bandera; Mauro Zaccarelli; Gaetana Sterrantino; Alessandra Latini; Alessandro D'Avino; Giuseppe Lapadula; Andrea Antinori; Roberto Cauda; Andrea De Luca; Andrea Gori; Simona Di Giambenedetto; Massimiliano Fabbiani

doi:10.3851/IMP3188

3-Year efficacy and durability of simplification to single tablet regimens: a comparison between co-formulated efavirenz/emtricitabine/tenofovir and rilpivirine/emtricitabine/tenofovir

Roberta Gagliardini, Alessandra Bandera, Mauro Zaccarelli, Gaetana Sterrantino, Alessandra Latini, Alessandro D'Avino, Giuseppe Lapadula, Andrea Antinori, Roberto Cauda, Andrea De Luca, Andrea Gori, Simona Di Giambenedetto, Massimiliano Fabbiani

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND: Few data are available about efficacy and durability of simplification from multi-tablet antiretroviral regimens to co-formulated efavirenz (EFV)/emtricitabine (FTC)/tenofovir (TDF) versus rilpivirine (RPV)/FTC/TDF in virologically suppressed HIV-1-infected patients.

METHODS: We retrospectively analysed HIV-infected patients with HIV RNA <50 copies/ml switching to co-formulated EFV/FTC/TDF or RPV/FTC/TDF at five Italian centres. Patients were followed from time of switch until regimen discontinuation or a maximum of 3-years follow-up. Time to treatment discontinuation (TD) and virological failure (VF; defined as two consecutive HIV RNA >50 copies/ml or a single determination >1,000 copies/ml) and their predictors were investigated.

RESULTS: 1,560 patients were reviewed of which 1,097 (70%) switched to EFV/FTC/TDF and 463 (30%) to RPV/FTC/TDF. During follow-up, VF and TD occurred in 44 (4%) and 242 (22%) patients in EFV/FTC/TDF and in 29 (6%) and 50 (11%) patients in RPV/FTC/TDF, respectively. The 3-year estimated probability of remaining free from VF was 96.2% with EFV/FTC/TDF versus 92.7% with RPV/FTC/TDF (P=0.003). At multivariate analysis, regimen type (EFV/FTC/TDF versus RPV/FTC/TDF aHR 0.24; P=0.004) and time of virological suppression (aHR 0.85; P=0.048) were the only independent predictors of VF. The estimated 3-year probability of remaining free from TD was 77.4% with EFV/FTC/TDF versus 88.4% with RPV/FTC/TDF (P=0.001). Predictors of TD were female sex, switching from PI-based regimens, older age, shorter time of virological suppression and regimen type (EFV/FTC/TDF versus RPV/FTC/TDF aHR 2.48; P<0.001). RPV/FTC/TDF showed a safer lipid profile and a greater increase in creatinine.

CONCLUSIONS: Both regimens showed good safety and efficacy in this real-life setting, although switch to RPV/FTC/TDF seemed better tolerated while EFV/FTC/TDF was associated with a lower probability of VF.

Original language	English
Journal	Antiviral Therapy
DOIs	https://doi.org/10.3851/IMP3188
Publication status	E-pub ahead of print - Aug 11 2017

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Journal Article

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10.3851/IMP3188

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Gagliardini, R., Bandera, A., Zaccarelli, M., Sterrantino, G., Latini, A., D'Avino, A., Lapadula, G., Antinori, A., Cauda, R., De Luca, A., Gori, A., Di Giambenedetto, S., & Fabbiani, M. (2017). 3-Year efficacy and durability of simplification to single tablet regimens: a comparison between co-formulated efavirenz/emtricitabine/tenofovir and rilpivirine/emtricitabine/tenofovir. Antiviral Therapy. https://doi.org/10.3851/IMP3188

3-Year efficacy and durability of simplification to single tablet regimens : a comparison between co-formulated efavirenz/emtricitabine/tenofovir and rilpivirine/emtricitabine/tenofovir. / Gagliardini, Roberta; Bandera, Alessandra; Zaccarelli, Mauro; Sterrantino, Gaetana; Latini, Alessandra; D'Avino, Alessandro; Lapadula, Giuseppe; Antinori, Andrea; Cauda, Roberto; De Luca, Andrea; Gori, Andrea; Di Giambenedetto, Simona; Fabbiani, Massimiliano.

In: Antiviral Therapy, 11.08.2017.

Research output: Contribution to journal › Article › peer-review

Gagliardini, R, Bandera, A, Zaccarelli, M, Sterrantino, G, Latini, A, D'Avino, A, Lapadula, G, Antinori, A, Cauda, R, De Luca, A, Gori, A, Di Giambenedetto, S & Fabbiani, M 2017, '3-Year efficacy and durability of simplification to single tablet regimens: a comparison between co-formulated efavirenz/emtricitabine/tenofovir and rilpivirine/emtricitabine/tenofovir', Antiviral Therapy. https://doi.org/10.3851/IMP3188

Gagliardini, Roberta ; Bandera, Alessandra ; Zaccarelli, Mauro ; Sterrantino, Gaetana ; Latini, Alessandra ; D'Avino, Alessandro ; Lapadula, Giuseppe ; Antinori, Andrea ; Cauda, Roberto ; De Luca, Andrea ; Gori, Andrea ; Di Giambenedetto, Simona ; Fabbiani, Massimiliano. / 3-Year efficacy and durability of simplification to single tablet regimens : a comparison between co-formulated efavirenz/emtricitabine/tenofovir and rilpivirine/emtricitabine/tenofovir. In: Antiviral Therapy. 2017.

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title = "3-Year efficacy and durability of simplification to single tablet regimens: a comparison between co-formulated efavirenz/emtricitabine/tenofovir and rilpivirine/emtricitabine/tenofovir",

abstract = "BACKGROUND: Few data are available about efficacy and durability of simplification from multi-tablet antiretroviral regimens to co-formulated efavirenz (EFV)/emtricitabine (FTC)/tenofovir (TDF) versus rilpivirine (RPV)/FTC/TDF in virologically suppressed HIV-1-infected patients.METHODS: We retrospectively analysed HIV-infected patients with HIV RNA <50 copies/ml switching to co-formulated EFV/FTC/TDF or RPV/FTC/TDF at five Italian centres. Patients were followed from time of switch until regimen discontinuation or a maximum of 3-years follow-up. Time to treatment discontinuation (TD) and virological failure (VF; defined as two consecutive HIV RNA >50 copies/ml or a single determination >1,000 copies/ml) and their predictors were investigated.RESULTS: 1,560 patients were reviewed of which 1,097 (70%) switched to EFV/FTC/TDF and 463 (30%) to RPV/FTC/TDF. During follow-up, VF and TD occurred in 44 (4%) and 242 (22%) patients in EFV/FTC/TDF and in 29 (6%) and 50 (11%) patients in RPV/FTC/TDF, respectively. The 3-year estimated probability of remaining free from VF was 96.2% with EFV/FTC/TDF versus 92.7% with RPV/FTC/TDF (P=0.003). At multivariate analysis, regimen type (EFV/FTC/TDF versus RPV/FTC/TDF aHR 0.24; P=0.004) and time of virological suppression (aHR 0.85; P=0.048) were the only independent predictors of VF. The estimated 3-year probability of remaining free from TD was 77.4% with EFV/FTC/TDF versus 88.4% with RPV/FTC/TDF (P=0.001). Predictors of TD were female sex, switching from PI-based regimens, older age, shorter time of virological suppression and regimen type (EFV/FTC/TDF versus RPV/FTC/TDF aHR 2.48; P<0.001). RPV/FTC/TDF showed a safer lipid profile and a greater increase in creatinine.CONCLUSIONS: Both regimens showed good safety and efficacy in this real-life setting, although switch to RPV/FTC/TDF seemed better tolerated while EFV/FTC/TDF was associated with a lower probability of VF.",

keywords = "Journal Article",

author = "Roberta Gagliardini and Alessandra Bandera and Mauro Zaccarelli and Gaetana Sterrantino and Alessandra Latini and Alessandro D'Avino and Giuseppe Lapadula and Andrea Antinori and Roberto Cauda and {De Luca}, Andrea and Andrea Gori and {Di Giambenedetto}, Simona and Massimiliano Fabbiani",

year = "2017",

month = aug,

day = "11",

doi = "10.3851/IMP3188",

language = "English",

journal = "Antiviral Therapy",

issn = "1359-6535",

publisher = "International Medical Press Ltd",

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TY - JOUR

T1 - 3-Year efficacy and durability of simplification to single tablet regimens

T2 - a comparison between co-formulated efavirenz/emtricitabine/tenofovir and rilpivirine/emtricitabine/tenofovir

AU - Gagliardini, Roberta

AU - Bandera, Alessandra

AU - Zaccarelli, Mauro

AU - Sterrantino, Gaetana

AU - Latini, Alessandra

AU - D'Avino, Alessandro

AU - Lapadula, Giuseppe

AU - Antinori, Andrea

AU - Cauda, Roberto

AU - De Luca, Andrea

AU - Gori, Andrea

AU - Di Giambenedetto, Simona

AU - Fabbiani, Massimiliano

PY - 2017/8/11

Y1 - 2017/8/11

N2 - BACKGROUND: Few data are available about efficacy and durability of simplification from multi-tablet antiretroviral regimens to co-formulated efavirenz (EFV)/emtricitabine (FTC)/tenofovir (TDF) versus rilpivirine (RPV)/FTC/TDF in virologically suppressed HIV-1-infected patients.METHODS: We retrospectively analysed HIV-infected patients with HIV RNA <50 copies/ml switching to co-formulated EFV/FTC/TDF or RPV/FTC/TDF at five Italian centres. Patients were followed from time of switch until regimen discontinuation or a maximum of 3-years follow-up. Time to treatment discontinuation (TD) and virological failure (VF; defined as two consecutive HIV RNA >50 copies/ml or a single determination >1,000 copies/ml) and their predictors were investigated.RESULTS: 1,560 patients were reviewed of which 1,097 (70%) switched to EFV/FTC/TDF and 463 (30%) to RPV/FTC/TDF. During follow-up, VF and TD occurred in 44 (4%) and 242 (22%) patients in EFV/FTC/TDF and in 29 (6%) and 50 (11%) patients in RPV/FTC/TDF, respectively. The 3-year estimated probability of remaining free from VF was 96.2% with EFV/FTC/TDF versus 92.7% with RPV/FTC/TDF (P=0.003). At multivariate analysis, regimen type (EFV/FTC/TDF versus RPV/FTC/TDF aHR 0.24; P=0.004) and time of virological suppression (aHR 0.85; P=0.048) were the only independent predictors of VF. The estimated 3-year probability of remaining free from TD was 77.4% with EFV/FTC/TDF versus 88.4% with RPV/FTC/TDF (P=0.001). Predictors of TD were female sex, switching from PI-based regimens, older age, shorter time of virological suppression and regimen type (EFV/FTC/TDF versus RPV/FTC/TDF aHR 2.48; P<0.001). RPV/FTC/TDF showed a safer lipid profile and a greater increase in creatinine.CONCLUSIONS: Both regimens showed good safety and efficacy in this real-life setting, although switch to RPV/FTC/TDF seemed better tolerated while EFV/FTC/TDF was associated with a lower probability of VF.

AB - BACKGROUND: Few data are available about efficacy and durability of simplification from multi-tablet antiretroviral regimens to co-formulated efavirenz (EFV)/emtricitabine (FTC)/tenofovir (TDF) versus rilpivirine (RPV)/FTC/TDF in virologically suppressed HIV-1-infected patients.METHODS: We retrospectively analysed HIV-infected patients with HIV RNA <50 copies/ml switching to co-formulated EFV/FTC/TDF or RPV/FTC/TDF at five Italian centres. Patients were followed from time of switch until regimen discontinuation or a maximum of 3-years follow-up. Time to treatment discontinuation (TD) and virological failure (VF; defined as two consecutive HIV RNA >50 copies/ml or a single determination >1,000 copies/ml) and their predictors were investigated.RESULTS: 1,560 patients were reviewed of which 1,097 (70%) switched to EFV/FTC/TDF and 463 (30%) to RPV/FTC/TDF. During follow-up, VF and TD occurred in 44 (4%) and 242 (22%) patients in EFV/FTC/TDF and in 29 (6%) and 50 (11%) patients in RPV/FTC/TDF, respectively. The 3-year estimated probability of remaining free from VF was 96.2% with EFV/FTC/TDF versus 92.7% with RPV/FTC/TDF (P=0.003). At multivariate analysis, regimen type (EFV/FTC/TDF versus RPV/FTC/TDF aHR 0.24; P=0.004) and time of virological suppression (aHR 0.85; P=0.048) were the only independent predictors of VF. The estimated 3-year probability of remaining free from TD was 77.4% with EFV/FTC/TDF versus 88.4% with RPV/FTC/TDF (P=0.001). Predictors of TD were female sex, switching from PI-based regimens, older age, shorter time of virological suppression and regimen type (EFV/FTC/TDF versus RPV/FTC/TDF aHR 2.48; P<0.001). RPV/FTC/TDF showed a safer lipid profile and a greater increase in creatinine.CONCLUSIONS: Both regimens showed good safety and efficacy in this real-life setting, although switch to RPV/FTC/TDF seemed better tolerated while EFV/FTC/TDF was associated with a lower probability of VF.

KW - Journal Article

U2 - 10.3851/IMP3188

DO - 10.3851/IMP3188

M3 - Article

C2 - 28799920

JO - Antiviral Therapy

JF - Antiviral Therapy

SN - 1359-6535

ER -