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

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 and immunological factors predictive of clinical outcome and treatment efficacy, especially through analysis of plasma and cell samples.
Future Plans: The registry can provide new knowledge on how to implement an integrated approach to study PLWH with documented resistance to the four main antiretroviral classes, a population with a limited number of individuals characterised by a high degree of frailty and complexity in therapeutic management. Given the scheduled annual updates of PLWH data, the researchers who collaborate in the registry can send study proposals at any time to the steering committee of the registry, which evaluates every 3 months whether the research studies can be conducted on data and biosamples from the registry and whether they are aimed at a better understanding of a specific health condition, the emergence of comorbidities or the effect of potential treatments or experimental drugs that may have an impact on disease progression and quality of life. Finally, the research studies should aim to be inclusive, innovative and in touch with the communities and society as a whole.
Trial Registration Number: NCT04098315.
Competing Interests: Competing interests: RG reports payments to her institution from Gilead Sciences; personal fees for speaker panels and educational material from ViiV Healthcare, Merck Sharp and Dohme and Gilead Sciences and advisory boards from Theratechnologies, Janssen-Cilag and Gilead Sciences. FL reports personal fees for speaker panels from ViiV Healthcare, Janssen-Cilag and Merck Sharp and Dohme; travel grants from Gilead Sciences, ViiV Healthcare and Janssen-Cilag and advisory boards from ViiV Healthcare and Janssen-Cilag. EF reports personal fees for consultancy from Merck Sharp and Dohme, ViiV Healthcare, Gilead Sciences and Swedish Orphan Biovitrum; speaker panels and educational material from ViiV Healthcare and Gilead Sciences and advisory boards from ViiV Healthcare, Gilead Sciences and Merck Sharp and Dohme. ADB reports personal fees for speaker panels and educational material from ViiV Healthcare and Gilead Sciences and travel grants from ViiV Healthcare. AdCe reports personal fees for speaker panels from ViiV Healthcare. FM reports personal fees for consultancy and advisory boards from Merck Sharp and Dohme, ViiV Healthcare and Gilead Sciences. GM reports personal fees for speaker panels and educational material from Gilead Sciences; travel grants from Janssen-Cilag, Gilead Sciences and ViiV Healthcare and advisory boards from Gilead Sciences, ViiV Healthcare and Angelini Pharma. GC reports personal fees for speaker panels and educational material from Gilead Sciences, ViiV Healthcare and AbbVie and travel grants from Gilead Sciences. SR reports payments to his institution from Gilead Sciences, Janssen-Cilag and ViiV Healthcare; personal fees for travel grants from Gilead Sciences, Janssen-Cilag and ViiV Healthcare and advisory boards from Gilead Sciences, Janssen-Cilag, ViiV Healthcare and Merck Sharp and Dohme. MZ reports personal fees for consultancy and speaker panels and educational material from Gilead Sciences, ViiV Healthcare and Merck Sharp and Dohme. MMS reports personal fees for speaker panels and educational material from ViiV Healthcare, Merck Sharp and Dohme and Janssen-Cilag and advisory boards from ViiV Healthcare and Theratechnlogies. VS reports grants from Gilead Sciences and personal fees for speaker panels from Gilead Sciences, ViiV Healthcare and Merck Sharp & Dohme. AnCa reports personal fees for advisory boards, speaker panels and educational materials from Gilead Sciences, ViiV Healthcare, Janssen-Cilag, Merck Sharp & Dohme and Theratechnlogies. PRESTIGIO Registry received funding from Gilead Sciences, ViiV Healthcare, Merck Sharp & Dohme, and Theratechnologies.All other authors: no potential conflicts.
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