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1ISG-023 Economic impact derived from participation on antiretroviral therapy clinical trials in a third-level hospital
  1. S Gutiérrez,
  2. G Miralles Andreu,
  3. N Olcina Forner,
  4. O Guillén Martínez,
  5. C Matoses Chirivella,
  6. A Navarro Ruiz
  1. Hospital General Universitario de Elche, Servicio de Farmacia, Elche, Spain


Background and Importance Antiretroviral therapy (ART) cost is an important expense in the annual Hospital Pharmacy Service (PS) investment. Clinical trials (CT) for ART development represent a high percentage of the CT carried out in a PS, being an opportunity for the hospital in terms of cost savings for these medications.

Aim and Objectives To analyse the avoided cost of ART medications because of patient participation in CT.

Material and Methods Retrospective observational study carried out from January 2021 to March 2023. All patients who were participating in CT against human immunodeficiency virus (HIV) treated with ART were included. Variables collected were: number of patients, investigational drugs, visits and dispensations performed, treatment that the patient would have received if they had not participated in the CT and its cost. Patient’s treatment before enrolling in CT and standard therapies according GESIDA guidelines at the time of inclusion in CT were considered for that purpose. Information was obtained from Fundanet® and OrionClinic.®

Avoided cost was calculated as the difference between the cost of the treatment that the patient would have received if they had not participated in the CT and the CT treatment cost paid by the hospital.

Results 13 CTs were analysed and 89 patients were included with a median age of 44±12 years old and an 87% (77) of male prevalence. The average time participating in the CT was 16 months, having recorded 1,075 clinical visits (12 visits/patient) and 2,997 dispensations (26 dispensations/patient).

ART for intramuscular and oral administration were studied in three and 10 CTs respectively, with a median of two investigational drugs per CT. The alternative therapeutic combinations to CT participation were: dolutegravir+abacavir+lamivudine (32.6%), bictegravir+emtricitabine+tenofovir alafenamide (14.6%), dolutegravir+lamivudine (14.6%), darunavir+cobicistat+emtricitabine+tenofovir alafenamide (13.5%).

The theoretical total cost of treating patients outside of CT would have been €734,432. The hospital provided part of the medication of one CT. Therefore, the total cost avoided was €721,796, being a hospital saving of €333,136.60 annually; €8,110.10 per patient and €3,743.10 per year/patient.

Conclusion and Relevance Patients’ inclusion in HIV CT considerably reduces the pharmaceutical expenses related to ART medications since investigational drugs are provided free of charge by the sponsor. Therefore, CTs represent important economic savings for hospitals, contribute to the Spanish Health System sustainability and allow access to new therapies.

Conflict of Interest No conflict of interest.

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