The Ministry of Health has updated the pharmacoclinic protocols and financing criteria to allow access to car-t therapies to people with HIV infection that present undetectable viral load. This measure is a fundamental step in the elimination of discriminatory barriers and the improvement of equity in the National Health System (SNS), aligned with the principles of the Social Pact for non -discrimination and equal treatment associated with HIV.
The CAR-T (Chimeric Antigen Receiver T-Cell) is a type of cell and gene therapy in which the patient becomes his own donor. It consists of modifying the patient’s T lymphocytes so that they have the ability to attack tumor cells. Through apheresis, a technique that allows the separation of the blood components, the T lymphocytes are obtained and genetically reprogrammed so that, when they are transfused again to the patient, they can specifically recognize tumor cells and attack them.
Currently, there are seven authorized car-t therapy drugs in Spain, five industrial manufacturing: Axicabtagen Ciloleuce (YESCCTA), Bexucabtagen (tecartus), illitacabtagen (Carvykti), Tizaleuce (KYRIAH) and his decabtagé glleuce (Abecma), and two of industrialist. To date, HIV people were excluded from access protocols for these therapies due to the lack of clinical data that will endorse their safety and efficiency in this group, a direct consequence of the systematic exclusion of these people in clinical trials.
Protocol and financing update
In March 2024, he joined the Idecabtagén Vicleucel pharmaceutical benefit (Abecma). As an exclusion criterion, its use in patients with active infection with the human immunodeficiency virus (HIV), the hepatitis B (HBV) or the hepatitis C (HPC) virus, including patients with controlled infection.
-In March 2025, the Pharmacoclinic Protocols of the medications Axicabtagén Ciloleuce (YESCARTA) and BREXUCABTAGÉN AUTOLEUCEL (Tecartus) have been updatedallowing people with HIV infection with undetectable viral load to start treatment. Also, in April 2025, Ciltacabtagén Autoleuce (Carvykti) has been included in the pharmaceutical benefit of the SNS under the same criteria.
These medications are now available in the Bifimed Medication Financing Searchwith criteria that allow access to patients with prior history of HIV infection, hepatitis B or C, provided they have undetectable viral load.
A shared achievement
This update has been possible thanks to the joint work of the Ministry of Health with entities such as the HIV and AIDS State Coordinator (Cesida)that since 2021 has denounced this situation of inequality. Cooperation with health professionals, scientific societies, patient organizations and the pharmaceutical industry has been key to technically substantiate this decision.
With this advance, the Ministry reinforces its inclusion policy and its commitment to the rights of people with HIVcontributing and improving health equity in our country.
