Cohort profile: PRESTIGIO, an Italian prospective registry-based cohort of people with HIV-1 resistant to reverse transcriptase, protease and integrase inhibitors

作者：Tommaso Clemente, Laura Galli, Riccardo Lolatto, Roberta Gagliardini, Filippo Lagi, Sergio Ferrara, Anna Maria Cattelan, Emanuele Focà, Antonio Di Biagio, Adriana Cervo, Leonardo Calza, Franco Maggiolo, Giulia Marchetti, Giovanni Cenderello, Stefano Rusconi, Maurizio Zazzi, Maria Mercedes Santoro, Vincenzo Spagnuolo, Antonella Castagna · 发表于：BMJ Open · 年份：2024 · DOI：10.1136/bmjopen-2023-080606 · 被引用次数：21 · 研究领域：HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions、HIV-related health complications and treatments

PURPOSE: The PRESTIGIO Registry was established in 2017 to collect clinical, virological and immunological monitoring data from people living with HIV (PLWH) with documented four-class drug resistance (4DR). Key research purposes include the evaluation of residual susceptibility to specific antiretrovirals and the validation of treatment and monitoring strategies in this population. PARTICIPANTS: The PRESTIGIO Registry collects annual plasma and peripheral blood mononuclear cell samples and demographic, clinical, virological, treatment and laboratory data from PLWH followed at 39 Italian clinical centres and characterised by intermediate-to-high genotypic resistance to ≥1 nucleoside reverse transcriptase inhibitors, ≥1 non-nucleoside reverse transcriptase inhibitors, ≥1 protease inhibitors, plus either intermediate-to-high genotypic resistance to ≥1 integrase strand transfer inhibitors (INSTIs) or history of virological failure to an INSTI-containing regimen. To date, 229 people have been recorded in the cohort. Most of the data are collected from the date of the first evidence of 4DR (baseline), with some prebaseline information obtained retrospectively. Samples are collected from the date of enrollment in the registry. FINDINGS TO DATE: The open-ended cohort has been used to assess (1) prognosis in terms of survival or development of AIDS-related or non-AIDS-related clinical events; (2) long-term efficacy and safety of different antiretroviral regimens and (3) virological a...