Welcome to Prestigio Registry platform
Purposes of the PRESTIGIO Registry
of the long-term efficacy of different antiretroviral regimens in people with HIV infection resistant to 4 drug classes (4DCR PLWH)
of genotypic and phenotypic resistance testing in 4DCR PLWH with virological failure
of ART adherence and patient-related outcomes
of 4DCR PLWH in terms of immunological, virological and inflammatory parameters
of the incidence of AIDS-defining conditions and associated non-AIDS clinical events
pharmacoeconomic analyses to support management of this vulnerable population.
What we do
The PRESTIGIO Registry is the first cohort to include people with 4-drug-class-resistant HIV (4DCR-PWH).
It is an ongoing Italian, observational, prospective, multicenter cohort collecting biological samples and data on clinical, laboratory, treatment, and virological characteristics of 4DCR-PWH.
The Registry was established in December 2017 and currently has 39 participating Infectious Diseases centers, located in 15 different Italian regions.
The PRESTIGIO Registry includes PWH who are:
Four-class drug resistance is defined as intermediate or high-level resistance to ≥1 NRTI, ≥1 NNRTI, ≥1 PI, and ≥1 INSTI, according to the Stanford algorithm (version 9.5, https://hivdb.stanford.edu/) and considering cumulative data from all the RNA-based genotypic resistance tests performed for each person; in case of unavailability of any integrase genotype, a documented virological failure (2 consecutive HIV-1 RNA detections ≥50 copies/mL, or 1 detection ≥1000 copies/mL) to an INSTI-containing regimen is accepted as an inclusion criterion.
Currently more than 230 individuals are included in the Registry and more than 10 scientific papers have been accepted for publication on peer-reviewed journals. Open Multicenter National Registry.
infectious diseases
centers
patients
enrolled
Research Activities
Why the PRESTIGIO Registry
The availability of combination antiretroviral therapies has significantly increased the life expectancy of people living with HIV (PLWH) 1,2.
However, a subgroup of PLWH defined as heavily treatment- experienced (HTE-PLWH) have a history of multiple virological failures on different antiretroviral regimens and limited treatment options due to drug resistance mutations and/or drug intolerance 3,4.
According to various definitions, HTE individuals have two or fewer classes of antiretroviral drugs available and a reduced number of drugs that can be used within each class 5, and thus represent a group of PLWH at high risk of clinical progression.
The management of HTE patients is further complicated by the presence of concomitant factors such as severe immunosuppression and multiple comorbidities, including opportunistic infections, which require specific drug therapies 6-9.
Thus, in this population, the already limited therapeutic options may be further reduced by the addition of adverse drug events and pharmacokinetic interactions 10.
Finally, HTE-PLWH usually require complex and inconvenient regimens (combinations of drugs taken once or more than once a day, or combinations of drugs administered orally, subcutaneously, or intravenously) that are often burdened by a high number of tablets to be taken each day.
All these factors can lead to suboptimal adherence, increasing the risk of virological failure 11 and worsening the prognosis of HTE- PLWH 12.
Within this population with limited therapeutic options, those with a history of resistance to four drug classes - nucleoside (NRTIs) and non-nucleoside (NNRTIs) reverse transcriptase inhibitors, protease inhibitors (PIs) and integrase inhibitors (INSTIs) - represent a subgroup of HTE-PLWH with a significant disease burden and very few therapeutic options 7.
To better characterize this vulnerable population, the PRESTIGIO registry was established at the end of 2017.
Bibliografia
Steering Committee
PRESTIGIO Centres
At the moment the PRESTIGIO Registry involves more than 35 centers scattered throughout the national territory.
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