Several cohort studies have recently shown a significant increase in the mean age of PLWH ( People Living With HIV) and in the prevalence of people in advanced age in the various cohorts, as a result of the marked increase in the mean life expectancy of these people achieved by modern antiretroviral combination therapies.
However, the high prevalence of comorbidities exposes PLWH in old age to the need to take multiple drug treatments in addition to antiretroviral therapy, with the gradually increasing risk of unfavorable pharmacokinetic interactions between antiretroviral drugs and drugs taken to treat the comorbidities.
This project consists of an observational, cohort, retrospective, single-center study and aims to evaluate the variation in the number and type of clinically significant drug interactions between antiretroviral therapy and concomitant therapies in PLWH aged \>60 years on stable antiretroviral therapy who, for any reason at the Clinician's discretion, have made a switch from ongoing antiretroviral therapy to the bictegravir/emtricitabine/tenofovir alafenamide regimen.
Age > 60 years
Non-infectious comorbidities receiving drug therapy
Receiving BIC/TAF/FTC therapy at the time of of enrollment
Genotypic resistance testing that present or past evidence of viral resistance to the integrase inhibitor class, to emtricitabine or to tenofovir
Severe acute infectious disease
The study involves the enrollment of 50 patients (number calculated on the basis of the patient's medical history with the main characteristics for the purpose of enrollment in the clinical trial) who will be seen at the outpatient clinics of the Infectious Diseases Operative Unit of the IRCCS, Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola, during the period from January 1, 2021 to December 31, 2022.
Cohort
Retrospective
Not listed
Evaluation of the change in the total number of clinically significant drug-drug interactions (DDIs)
Evaluation of the change in the total number of clinically significant drug-drug interactions (DDIs) between antiretroviral drugs and concomitant drugs following therapeutic switch to bictegravir/emtricitabine/tenofovir alafenamide.
Evaluation of the change in the number of clinically significant DDIs between antiretroviral drugs and drugs of specific therapeutic classes
Evaluation of the change in the number of clinically significant DDIs between antiretroviral drugs and drugs of specific therapeutic classes (cardiovascular, hypolipidemic, hypoglycemic, neurological/psychiatric, etc.) following therapeutic switch to bictegravir/emtricitabine/tenofovir alafenamide
Evaluation of viro-immunological parameters and incidence of clinical adverse events and treatment discontinuations
Evaluation of viro-immunological parameters and incidence of clinical adverse events and treatment discontinuations during the follow-up period.
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead sponsor
Gilead Sciences
Collaborator
