Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HIV Infections, Drug Interaction, Elderly Infection, Comorbidities and Coexisting Conditions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older on Stable Antiretroviral Therapy Making a Switch to Bictegravir/Tenofovir Alafenamide/Emtricitabine
Overview
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.
Detailed description
The introduction of integrase inhibitors into clinical practice has greatly improved the efficacy and tolerability of modern antiretroviral combination therapies for the treatment of patients with HIV-1 infection. Indeed, these drugs have shown in registration studies high antiviral potency associated with a negligible incidence of short- and long-term adverse events, so much so that they are consistently included in the drug regimens recommended by all international guidelines for the treatment of HIV-positive patients naive to antiretroviral therapy.
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.
PLWH in advanced age, however, have a high prevalence of noninfectious comorbidities (cardiovascular disease, metabolic abnormalities, chronic renal failure, osteopenia-osteoporosis, neoplastic diseases, etc.), brought about by age-related aging but also by their accelerated biological aging caused by HIV infection and associated chronic inflammation and immunoactivation.
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.
The effect of such interactions can be either a reduction in plasma concentrations with reduced efficacy of antiretroviral drugs or an increase in plasma levels of concomitant drugs and the risk of toxicity induced by them.
The availability of integrase inbitors such as bictegravir, i.e., antiretroviral drugs characterized by a very low risk of drug interactions (because they are generally not metabolized by hepatic cytochrome P450 3A4 isoenzymes), has made it possible to significantly reduce the risk of interactions between antiretroviral therapy and concomitant therapy, especially in people of advanced age, while providing high viro-immunologic efficacy and a favorable effect on the cardio-metabolic profile.
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.
Primary outcome measures
- Evaluation of the change in the total number of clinically significant drug-drug interactions (DDIs) [Time frame: 12 Months]
- Evaluation of the change in the number of clinically significant DDIs between antiretroviral drugs and drugs of specific therapeutic classes [Time frame: 12 Months]
Secondary outcome measures (1)
- Evaluation of viro-immunological parameters and incidence of clinical adverse events and treatment discontinuations [Time frame: 12 Months]
Eligibility criteria
Inclusion criteria
- Age > 60 years
- Non-infectious comorbidities receiving drug therapy
- Receiving BIC/TAF/FTC therapy at the time of of enrollment
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Publications
- McIntosh RC, Ironson G, Antoni M, Kumar M, Fletcher MA, Schneiderman N. Alexithymia is linked to neurocognitive, psychological, neuroendocrine, and immune dysfunction in persons living with HIV. Brain Behav Immun. 2014 Feb;36:165-75. doi: 10.1016/j.bbi.2013.10.024. Epub 2013 Nov 1. PMID 24184475
- Pompili M, Pennica A, Serafini G, Battuello M, Innamorati M, Teti E, Girardi N, Amore M, Lamis DA, Aceti A, Girardi P. Depression and affective temperaments are associated with poor health-related quality of life in patients with HIV infection. J Psychiatr Pract. 2013 Mar;19(2):109-17. doi: 10.1097/01.pra.0000428557.56211.cf. PMID 23507812
- Parruti G, Vadini F, Sozio F, Mazzott E, Ursini T, Polill E, Di Stefano P, Tontodonati M, Verrocchio MC, Fulcheri M, Calella G, Santilli F, Manzoli L. Psychological factors, including alexithymia, in the prediction of cardiovascular risk in HIV infected patients: results of a cohort study. PLoS One. 2013;8(1):e54555. doi: 10.1371/journal.pone.0054555. Epub 2013 Jan 22. PMID 23349927
- Leyro TM, Vujanovic AA, Bonn-Miller MO. Examining associations between cognitive-affective vulnerability and HIV symptom severity, perceived barriers to treatment adherence, and viral load among HIV-positive adults. Int J Behav Med. 2015 Feb;22(1):139-48. doi: 10.1007/s12529-014-9404-8. PMID 24643444
- McIntosh RC, Ironson G, Antoni M, Fletcher MA, Schneiderman N. Alexithymia, Assertiveness and Psychosocial Functioning in HIV: Implications for Medication Adherence and Disease Severity. AIDS Behav. 2016 Feb;20(2):325-38. doi: 10.1007/s10461-015-1126-7. PMID 26143246
Identifiers
NCT: NCT06717581 · BICTER