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.
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., 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>>, 2017; (n/a): N/A-N/A. [doi:10.3851/IMP3188] [http://hdl.handle.net/10807/111674]
3-Year efficacy and durability of simplification to single tablet regimens: a comparison between co-formulated efavirenz/emtricitabine/tenofovir and rilpivirine/emtricitabine/tenofovir
Gagliardini, RobertaPrimo
;D'Avino, Alessandro;Cauda, Roberto;De Luca, Andrea;Di Giambenedetto, SimonaPenultimo
;Fabbiani, MassimilianoUltimo
2017
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.
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