title: Four years data of raltegravir-based salvage therapy in HIV-1-infected, treatment-experienced patients: the SALIR-E Study.
abstract: Apart from the BENCHMRK study, there are no large observational experiences describing the long-term efficacy and safety of rescue regimens for human immunodeficiency virus type 1 (HIV-1) infection. Antiretroviral-experienced patients with detectable viraemia starting a raltegravir (RAL)-based regimen between March 2007 and June 2009 were consecutively enrolled and followed for ≥4 years. Data were censored at Week 206 for homogeneity. Of 333 patients, 258 (77.5%) were still on RAL-based therapy at Week 206, and 241 had undetectable HIV-1 RNA (73% in intention-to-treat analysis). Of the 75 subjects who discontinued RAL therapy, 36 were lost to follow-up, 15 changed their regimen due to virological failure, 2 simplified their regimen stopping RAL, 9 stopped all antiretrovirals and 13 died. Overall, 100 subjects (30.0%) had at least one detectable viraemia, but only 32 (9.6%) had true viral failure. Seventeen patients continued their failing regimen. 'Blips' were experienced by 53 patients (15.9%), whilst 15 (4.5%) had confirmed viral rebound due to adherence issues and were re-suppressed upon treatment re-introduction. In a multivariate analysis of predictors of interruption or failure, each baseline HIV-1 RNA log10 increase was associated with an adjusted hazard ratio for failure of 1.6; having more than 13 previous treatment courses also emerged as a predictor. Overall, adverse events were rare (n=64), with 13 deaths. Tumours were mainly early events, often fatal (7/15), mainly non-Hodgkin's lymphomas (8), followed by hepatocarcinoma (2). RAL proved effective and well tolerated in this cohort, and few patients experienced viral failure after 4 years.
authors: 1st Division of Infectious Diseases, 'Luigi Sacco' Hospital, via GB Grassi 74, Milan 20157, Italy. Electronic address: capetti.amedeo@hsacco.it.
authors: Amedeo
authors: A
authors: Capetti
authors: 1st Division of Infectious Diseases, 'Luigi Sacco' Hospital, via GB Grassi 74, Milan 20157, Italy.
authors: Paola
authors: P
authors: Meraviglia
authors: 1st Division of Infectious Diseases, 'Luigi Sacco' Hospital, via GB Grassi 74, Milan 20157, Italy.
authors: Simona
authors: S
authors: Landonio
authors: Division of Infectious Diseases, 'Careggi' Hospital, Florence, Italy.
authors: Gaetana
authors: G
authors: Sterrantino
authors: Infectious Diseases Clinic, 'San Martino' Hospital, Genoa, Italy.
authors: Antonio
authors: A
authors: Di Biagio
authors: Infectious Diseases Clinic, 'Santa Maria Annunziata' Hospital, Florence, Italy.
authors: Sergio
authors: S
authors: Lo Caputo
authors: 3rd Division of Infectious Diseases, Istituto Nazionale di Malattie Infettive 'Lazzaro Spallanzani', Rome, Italy.
authors: Adriana
authors: A
authors: Ammassari
authors: Division of Infectious Diseases, 'Ospedale di Circolo', Busto Arsizio, Italy.
authors: Barbara
authors: B
authors: Menzaghi
authors: Division of Infectious Diseases, 'Santa Maria della Misericordia' Hospital, Perugia, Italy.
authors: Giuseppe Vittorio
authors: GV
authors: De Socio
authors: Infectious Diseases Clinic, 'Luigi Sacco' Hospital, Milan, Italy.
authors: Marco
authors: M
authors: Franzetti
authors: Infectious Diseases Clinic, 'San Gerardo de' Tintori' Hospital, Monza, Italy.
authors: Alessandro
authors: A
authors: Soria
authors: Infectious Diseases Clinic, Azienda Ospedaliera Universitaria Policlinico, Modena, Italy.
authors: Marianna
authors: M
authors: Meschiari
authors: Division of Infectious Diseases, 'Santa Maria della Misericordia' Hospital, Rovigo, Italy.
authors: Lolita
authors: L
authors: Sasset
authors: Division of Infectious Diseases, 'Policlinico G. Martino', Messina, Italy.
authors: Giovanni
authors: G
authors: Pellicanò
authors: Division of Infectious Diseases, 'Santo Spirito' Hospital, Pescara, Italy.
authors: Elena
authors: E
authors: Mazzotta
authors: Division of Infectious Diseases, 'Santa Maria della Misericordia' Hospital, Grosseto, Italy.
authors: Michele
authors: M
authors: Trezzi
authors: Infectious Diseases Unit, University of Catania, ARNAS Garibaldi, Catania, Italy.
authors: Benedetto Maurizio
authors: BM
authors: Celesia
authors: 2nd Division of Internal Medicine, Azienda Ospedaliera di Desio e Vimercate Hospital, Vimercate, Italy.
authors: Sara
authors: S
authors: Melzi
authors: 1st Division of Infectious Diseases, 'Luigi Sacco' Hospital, via GB Grassi 74, Milan 20157, Italy.
authors: Laura
authors: L
authors: Carenzi
authors: 1st Division of Infectious Diseases, 'Luigi Sacco' Hospital, via GB Grassi 74, Milan 20157, Italy.
authors: Elena
authors: E
authors: Ricci
authors: 1st Division of Infectious Diseases, 'Luigi Sacco' Hospital, via GB Grassi 74, Milan 20157, Italy.
authors: Giuliano
authors: G
authors: Rizzardini
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D008297:Male; D011760:Pyrrolidinones / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D000068898:Raltegravir Potassium; D016879:Salvage Therapy / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D011760:Pyrrolidinones; D012367:RNA, Viral; D000068898:Raltegravir Potassium
keywords: Experienced; HIV; Raltegravir; Resistance; Salvage