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

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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 ; Giuliano Rizzardini
  • Publisher: Public Library of Science (PLoS)
  • Journal: PLoS ONE, volume 7, issue 7 (issn: 1932-6203, eissn: 1932-6203)
  • Related identifiers: doi: 10.1371/journal.pone.0039222, pmc: PMC3394760
  • Subject: Antivirals | Research Article | Biology | HIV diagnosis and management | Immune Physiology | Infectious diseases | Microbiology | Immune Cells | Medicine | Drug Research and Development | Anatomy and Physiology | Viral diseases | Immunodeficiency Viruses | Q | R | Drugs and Devices | HIV | Virology | Science

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/mm(3); 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/mm(3), 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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