96 week follow-up of HIV-infected patients in rescue with raltegravir plus optimized backbone regimens

A multicentre Italian experience

Amedeo Capetti, Simona Landonio, Paola Meraviglia, Antonio Di Biagio, Sergio Lo Caputo, Gaetana Sterrantino, Adriana Ammassari, Barbara Menzaghi, Marco Franzetti, Giuseppe Vittorio de Socio, Giovanni Pellicanò, Elena Mazzotta, Alessandro Soria, Marianna Meschiari, Michele Trezzi, Lolita Sasset, Benedetto Maurizio Celesia, Patrizia Zucchi, Sara Melzi, Elena Ricci & 1 others Giuliano Rizzardini

Research output: Contribution to journalArticle

14 Citations (Scopus)

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 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.

Original languageEnglish
Article numbere39222
JournalPLoS One
Volume7
Issue number7
DOIs
Publication statusPublished - Jul 11 2012

Fingerprint

HIV
Salvaging
T-cells
Human immunodeficiency virus 1
HIV-1
T-lymphocytes
Cholesterol
cholesterol
Patient treatment
T-Lymphocytes
Salvage Therapy
durability
viral load
Viral Load
Liver
Triglycerides
Durability
triacylglycerols
Raltegravir Potassium
RNA

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

Capetti, A., Landonio, S., Meraviglia, P., Di Biagio, A., Lo Caputo, S., Sterrantino, G., ... Rizzardini, G. (2012). 96 week follow-up of HIV-infected patients in rescue with raltegravir plus optimized backbone regimens: A multicentre Italian experience. PLoS One, 7(7), [e39222]. https://doi.org/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. / Capetti, Amedeo; Landonio, Simona; Meraviglia, Paola; Di Biagio, Antonio; Lo Caputo, Sergio; Sterrantino, Gaetana; Ammassari, Adriana; Menzaghi, Barbara; Franzetti, Marco; de Socio, Giuseppe Vittorio; Pellicanò, Giovanni; Mazzotta, Elena; Soria, Alessandro; Meschiari, Marianna; Trezzi, Michele; Sasset, Lolita; Celesia, Benedetto Maurizio; Zucchi, Patrizia; Melzi, Sara; Ricci, Elena; Rizzardini, Giuliano.

In: PLoS One, Vol. 7, No. 7, e39222, 11.07.2012.

Research output: Contribution to journalArticle

Capetti, A, Landonio, S, Meraviglia, P, Di Biagio, A, Lo Caputo, S, Sterrantino, G, Ammassari, A, Menzaghi, B, Franzetti, M, de Socio, GV, Pellicanò, G, Mazzotta, E, Soria, A, Meschiari, M, Trezzi, M, Sasset, L, Celesia, BM, Zucchi, P, Melzi, S, Ricci, E & Rizzardini, G 2012, '96 week follow-up of HIV-infected patients in rescue with raltegravir plus optimized backbone regimens: A multicentre Italian experience', PLoS One, vol. 7, no. 7, e39222. https://doi.org/10.1371/journal.pone.0039222
Capetti, Amedeo ; Landonio, Simona ; Meraviglia, Paola ; Di Biagio, Antonio ; Lo Caputo, Sergio ; Sterrantino, Gaetana ; Ammassari, Adriana ; Menzaghi, Barbara ; Franzetti, Marco ; de Socio, Giuseppe Vittorio ; Pellicanò, Giovanni ; Mazzotta, Elena ; Soria, Alessandro ; Meschiari, Marianna ; Trezzi, Michele ; Sasset, Lolita ; Celesia, Benedetto Maurizio ; Zucchi, Patrizia ; Melzi, Sara ; Ricci, Elena ; Rizzardini, Giuliano. / 96 week follow-up of HIV-infected patients in rescue with raltegravir plus optimized backbone regimens : A multicentre Italian experience. In: PLoS One. 2012 ; Vol. 7, No. 7.
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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 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.",
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T2 - A multicentre Italian experience

AU - Capetti, Amedeo

AU - Landonio, Simona

AU - Meraviglia, Paola

AU - Di Biagio, Antonio

AU - Lo Caputo, Sergio

AU - Sterrantino, Gaetana

AU - Ammassari, Adriana

AU - Menzaghi, Barbara

AU - Franzetti, Marco

AU - de Socio, Giuseppe Vittorio

AU - Pellicanò, Giovanni

AU - Mazzotta, Elena

AU - Soria, Alessandro

AU - Meschiari, Marianna

AU - Trezzi, Michele

AU - Sasset, Lolita

AU - Celesia, Benedetto Maurizio

AU - Zucchi, Patrizia

AU - Melzi, Sara

AU - Ricci, Elena

AU - Rizzardini, Giuliano

PY - 2012/7/11

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N2 - 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 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.

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