Four years data of raltegravir-based salvage therapy in HIV-1-infected, treatment-experienced patients: The SALIR-E Study

Autor: Benedetto Maurizio Celesia, Simona Landonio, Antonio Di Biagio, Barbara Menzaghi, Marianna Meschiari, Sara Melzi, Paola Meraviglia, Amedeo Capetti, Giovanni Francesco Pellicanò, Alessandro Soria, Giuliano Rizzardini, Sergio Lo Caputo, Elena Mazzotta, Laura Carenzi, Giuseppe Vittorio De Socio, Michele Trezzi, Lolita Sasset, Gaetana Sterrantino, Adriana Ammassari, Marco Franzetti, Elena Ricci
Jazyk: angličtina
Rok vydání: 2014
Předmět:
Popis: 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.
Databáze: OpenAIRE