Efficacy and safety of switching to dolutegravir plus emtricitabine/tenofovir disoproxil fumarate (TDF) or elvitegravir/cobicistat/emtricitabine/TDF in virologically suppressed HIV-infected patients in clinical practice: results from a multicentre, observational study

被引:17
作者
Baldin, G. [1 ]
Ciccullo, A. [1 ]
Capetti, A. [2 ]
Rusconi, S. [3 ]
Sterrantino, G. [4 ]
Cossu, M. V. [2 ]
Giacomelli, A. [3 ]
Lagi, F. [4 ]
Latini, A. [5 ]
Bagella, P. [6 ]
De Luca, A. [7 ]
Di Giambenedetto, S. [1 ]
Madeddu, G. [6 ]
机构
[1] Univ Cattolica Sacro Cuore, IRCCS, Fdn Policlin Univ A Gemelli, Inst Clin Infect Dis, Rome, Italy
[2] Luigi Sacco Univ Hosp, Div Infect Dis, Dept Infect Dis, Milan, Italy
[3] Univ Milan, Infect Dis Unit, DIBIC Luigi Sacco, Milan, Italy
[4] Careggi Hosp, Div Trop & Infect Dis, Florence, Italy
[5] IRCCS, IFO S Gallicano Inst, Infect Dermatol & Allergol Unit, Rome, Italy
[6] Univ Sassari, Dept Clin & Expt Med, Sassari, Italy
[7] Siena Univ Hosp, Univ Div Infect Dis, Siena, Italy
关键词
dolutegravir; efficacy; elvitegravir/cobicistat/tenofovir/emtricitabine; safety; tenofovir/emtricitabine; ANTIRETROVIRAL-NAIVE ADULTS; ONCE-DAILY DOLUTEGRAVIR; NON-INFERIORITY; OPEN-LABEL; DOUBLE-BLIND; COFORMULATED ELVITEGRAVIR; PHASE; 3B; RALTEGRAVIR; TOLERABILITY; COBICISTAT;
D O I
10.1111/hiv.12688
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
Objectives The aim of the study was to compare the efficacy and tolerability of switching antiretroviral therapy to dolutegravir + emtricitabine/tenofovir disoproxil fumarate (TDF) with those of switching to elvitegravir/cobicistat/emtricitabine/TDF in clinical practice. Methods In a multicentre real-life observational study, we analysed data for HIV-infected patients on antiretroviral treatment with viral load < 50 HIV-1 RNA copies/mL switching to dolutegravir + emtricitabine/TDF (dolutegravir group) or elvitegravir/cobicistat/emtricitabine/TDF (elvitegravir group). Follow-up was censored at 48 weeks. Results The 48-week estimated proportion maintaining virological efficacy was 96.1% with dolutegravir (n = 123) and 95.4% with elvitegravir (n = 186; P = 0.941). Patients in the dolutegravir group showed more treatment discontinuations, but these were mainly as a result of simplification. The elvitegravir group showed more discontinuations because of renal adverse events (2.7% versus 0% with dolutegravir). Interestingly, no difference was observed between the two regimens in central nervous system toxicity-related discontinuations. Switching to dolutegravir was associated with a better blood lipid profile. Conclusions Switching to dolutegravir + emtricitabine/TDF was associated with similar efficacy and tolerability to switching to elvitegravir/cobicistat/emtricitabine/TDF in virologically suppressed patients in clinical practice, although reasons for discontinuation showed differences between regimens. These results should be interpreted with caution, as this is a nonrandomized comparison.
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收藏
页码:164 / 168
页数:5
相关论文
共 17 条
[1]  
Arribas JR, 2017, JAIDS-J ACQ IMM DEF, V75, P211, DOI [10.1097/QAI.0000000000001350, 10.1097/qai.0000000000001350]
[2]   Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results of a randomised, open-label, phase 3b, non-inferiority trial [J].
Arribas, Jose R. ;
Pialoux, Gilles ;
Gathe, Joseph ;
Di Perri, Giovanni ;
Reynes, Jacques ;
Tebas, Pablo ;
Thai Nguyen ;
Ebrahimi, Ramin ;
White, Kirsten ;
Piontkowsky, David .
LANCET INFECTIOUS DISEASES, 2014, 14 (07) :581-589
[3]   Discontinuation of treatment and adverse events in an Italian cohort of patients on dolutegravir [J].
Bonfanti, Paolo ;
Madeddu, Giordano ;
Gulminetti, Roberto ;
Squillace, Nicola ;
Orofino, Giancarlo ;
Vitiello, Paola ;
Rusconi, Stefano ;
Celesia, Benedetto M. ;
Maggi, Paolo ;
Ricci, Elena .
AIDS, 2017, 31 (03) :455-457
[4]   Virological control and metabolic improvement in HIV-infected, virologically suppressed patients switching to lamivudine/dolutegravir dual therapy [J].
Borghetti, A. ;
Baldin, G. ;
Ciccullo, A. ;
Gagliardini, R. ;
D'Avino, A. ;
Mondi, A. ;
Ciccarelli, N. ;
Lamonica, S. ;
Fanti, I. ;
Trecarichi, E. ;
Fabbiani, M. ;
Cauda, R. ;
De Luca, A. ;
Di Giambenedetto, S. .
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 2016, 71 (08) :2359-2361
[5]   Efficacy and tolerability of dolutegravir and two nucleos(t) ide reverse transcriptase inhibitors in HIV-1-positive, virologically suppressed patients [J].
Borghetti, Alberto ;
Baldin, Gianmaria ;
Capetti, Amedeo ;
Sterrantino, Gaetana ;
Rusconi, Stefano ;
Latini, Alessandra ;
Giacometti, Andrea ;
Madeddu, Giordano ;
Picarelli, Chiara ;
De Marco, Ramona ;
Cossu, Maria V. ;
Lagi, Filippo ;
Cauda, Roberto ;
De Luca, Andrea ;
Di Giambenedetto, Simona .
AIDS, 2017, 31 (03) :457-459
[6]   Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study [J].
Clotet, Bonaventura ;
Feinberg, Judith ;
van Lunzen, Jan ;
Khuong-Josses, Marie-Aude ;
Antinori, Andrea ;
Dumitru, Irina ;
Pokrovskiy, Vadim ;
Fehr, Jan ;
Ortiz, Roberto ;
Saag, Michael ;
Harris, Julia ;
Brennan, Clare ;
Fujiwara, Tamio ;
Min, Sherene .
LANCET, 2014, 383 (9936) :2222-2231
[7]   Intolerance of dolutegravir-containing combination antiretroviral therapy regimens in real-life clinical practice [J].
de Boer, Mark G. J. ;
van den Berk, Guido E. L. ;
van Holten, Natasja ;
Oryszcyn, Josephine E. ;
Dorama, Willemien ;
Moha, Daoud Ait ;
Brinkman, Kees .
AIDS, 2016, 30 (18) :2831-2834
[8]   Muscle symptoms and creatine phosphokinase elevations in patients receiving raltegravir in clinical practice: Results from the SCOLTA project long-term surveillance [J].
Madeddu, Giordano ;
De Socio, Giuseppe V. L. ;
Ricci, Elena ;
Quirino, Tiziana ;
Orofino, Giancarlo ;
Carenzi, Laura ;
Franzetti, Marco ;
Parruti, Giustino ;
Martinelli, Canio ;
Vichi, Francesca ;
Penco, Giovanni ;
Dentone, Chiara ;
Celesia, Benedetto Maurizio ;
Maggi, Paolo ;
Liberton, Raffaella ;
Bagella, Paola ;
Di Biagio, Antonio ;
Bonfanti, Paolo .
INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS, 2015, 45 (03) :289-294
[9]   Raltegravir central nervous system tolerability in clinical practice: results from a multicenter observational study [J].
Madeddu, Giordano ;
Menzaghi, Barbara ;
Ricci, Elena ;
Carenzi, Laura ;
Martinelli, Canio ;
Di Biagio, Antonio ;
Parruti, Giustino ;
Orofino, Giancarlo ;
Mura, Maria S. ;
Bonfanti, Paolo .
AIDS, 2012, 26 (18) :2412-2415
[10]   Neuropsychiatric adverse effects on dolutegravir: an emerging concern in Europe [J].
Menard, Amelie ;
Montagnac, Clementine ;
Solas, Caroline ;
Meddeb, Line ;
Dhiver, Catherine ;
Tomei, Christelle ;
Ravaux, Isabelle ;
Tissot-Dupont, Herve ;
Mokhtari, Saadia ;
Colson, Philippe ;
Stein, Andreas .
AIDS, 2017, 31 (08) :1201-1203