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

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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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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

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 -

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