Background: Long term efficacy of raltegravir (RAL)-including regimens in highly pre-treated HIV-1-infected patients has been demonstrated in registration trials. However, few studies have assessed durability in routine clinical settings. Methods: Antiretroviral treatment-experienced patients initiating a RAL-containing salvage regimen were enrolled. Routine clinical and laboratory follow-up was performed at baseline, week 4, 12, and every 12 weeks thereafter. Data were censored at week 96. Results: Out of 320 patients enrolled, 292 (91.25%) subjects maintained their initial regimen for 96 weeks; 28 discontinued prematurely for various reasons: death (11), viral failure (8), adverse events (5), loss to follow-up (3), consent withdrawal (1). Eight among these 28 subjects maintained RAL but changed the accompanying drugs. The mean CD4+ T-cell increase at week 96 was 227/mm3; 273 out of 300 patients (91%), who were still receiving RAL at week 96, achieved viral suppression (HIV-1 RNA <50 copies/mL). When analyzing the immuno-virologic outcome according to the number of drugs used in the regimen, 2 (n = 45), 3 (n = 111), 4 (n = 124), or >4 (n = 40), CD4+ T-cell gain was similar across strata: +270, +214, +216, and +240 cells/mm3, respectively, as was the proportion of subjects with undetectable viral load. Laboratory abnormalities (elevation of liver enzymes, total cholesterol and triglycerides) were rare, ranging from 0.9 to 3.1%. The mean 96-week total cholesterol increase was 23.6 mg/dL. Conclusions: In a routine clinical setting, a RAL-based regimen allowed most patients in salvage therapy to achieve optimal viral suppression for at least 96 weeks, with relevant immunologic gain and very few adverse events. © 2012 Capetti et al.

96 week follow-up of HIV-infected patients in rescue with raltegravir plus optimized backbone regimens: A multicentre Italian experience / Capetti, A.; Landonio, S.; Meraviglia, P.; Di Biagio, A.; Lo Caputo, S.; Sterrantino, G.; Ammassari, A.; Menzaghi, B.; Franzetti, M.; de Socio, G. V.; Pellicano, G.; Mazzotta, E.; Soria, A.; Meschiari, M.; Trezzi, M.; Sasset, L.; Celesia, B. M.; Zucchi, P.; Melzi, S.; Ricci, E.; Rizzardini, G.. - In: PLOS ONE. - ISSN 1932-6203. - 7:7(2012), pp. e39222-e39222. [10.1371/journal.pone.0039222]

96 week follow-up of HIV-infected patients in rescue with raltegravir plus optimized backbone regimens: A multicentre Italian experience

Meschiari M.;
2012

Abstract

Background: Long term efficacy of raltegravir (RAL)-including regimens in highly pre-treated HIV-1-infected patients has been demonstrated in registration trials. However, few studies have assessed durability in routine clinical settings. Methods: Antiretroviral treatment-experienced patients initiating a RAL-containing salvage regimen were enrolled. Routine clinical and laboratory follow-up was performed at baseline, week 4, 12, and every 12 weeks thereafter. Data were censored at week 96. Results: Out of 320 patients enrolled, 292 (91.25%) subjects maintained their initial regimen for 96 weeks; 28 discontinued prematurely for various reasons: death (11), viral failure (8), adverse events (5), loss to follow-up (3), consent withdrawal (1). Eight among these 28 subjects maintained RAL but changed the accompanying drugs. The mean CD4+ T-cell increase at week 96 was 227/mm3; 273 out of 300 patients (91%), who were still receiving RAL at week 96, achieved viral suppression (HIV-1 RNA <50 copies/mL). When analyzing the immuno-virologic outcome according to the number of drugs used in the regimen, 2 (n = 45), 3 (n = 111), 4 (n = 124), or >4 (n = 40), CD4+ T-cell gain was similar across strata: +270, +214, +216, and +240 cells/mm3, respectively, as was the proportion of subjects with undetectable viral load. Laboratory abnormalities (elevation of liver enzymes, total cholesterol and triglycerides) were rare, ranging from 0.9 to 3.1%. The mean 96-week total cholesterol increase was 23.6 mg/dL. Conclusions: In a routine clinical setting, a RAL-based regimen allowed most patients in salvage therapy to achieve optimal viral suppression for at least 96 weeks, with relevant immunologic gain and very few adverse events. © 2012 Capetti et al.
2012
7
7
e39222
e39222
96 week follow-up of HIV-infected patients in rescue with raltegravir plus optimized backbone regimens: A multicentre Italian experience / Capetti, A.; Landonio, S.; Meraviglia, P.; Di Biagio, A.; Lo Caputo, S.; Sterrantino, G.; Ammassari, A.; Menzaghi, B.; Franzetti, M.; de Socio, G. V.; Pellicano, G.; Mazzotta, E.; Soria, A.; Meschiari, M.; Trezzi, M.; Sasset, L.; Celesia, B. M.; Zucchi, P.; Melzi, S.; Ricci, E.; Rizzardini, G.. - In: PLOS ONE. - ISSN 1932-6203. - 7:7(2012), pp. e39222-e39222. [10.1371/journal.pone.0039222]
Capetti, A.; Landonio, S.; Meraviglia, P.; Di Biagio, A.; Lo Caputo, S.; Sterrantino, G.; Ammassari, A.; Menzaghi, B.; Franzetti, M.; de Socio, G. V.; Pellicano, G.; Mazzotta, E.; Soria, A.; Meschiari, M.; Trezzi, M.; Sasset, L.; Celesia, B. M.; Zucchi, P.; Melzi, S.; Ricci, E.; Rizzardini, G.
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