AB0827 IS DENOSUMAB SAFE IN HIV PATIENTS?
Authors: Isabel de la Morena, Sara Vela, Juan Alberto Paz Solarte, Diego Bedoya, M Jose Galindo
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> The survival of the infected patients by the human immunodeficiency virus (HIV) has increased in the last years, increasing the incidental comorbilities, being osteoporosis (OP) one of them, caused by traditional risk factors, by the ones associated to the infection itself and due to the specific treatments used. The denosumab is a human monoclonal antibody that acts against the link of the receptor that activates the nuclear kappa B (RANK-L), and among its secondary effects most commonly described, there are the infections, reason why its indication in HIV patients requires special caution. <h3>Objectives</h3> To analize efficacy, security and compliance to denosumab in HIV patients. <h3>Methods</h3> Retrospective longitudinal observational study. There were included all HIV patients with OP diagnosed by bone mineral density measured by dual-energy X-ray densitometry (DEXA) or fragility fractures treated with denosumab at Infectious Diseases Unit of our Hospital from August 2014 until December 2018. There were collected clinical data, immunological status, antiretroviral therapies, fragility fractures and duration, adverse events, tolerance and compliance to denosumab treatment. <h3>Results</h3> There were included 14 patients, 8 females and 6 males, with a mean age of 58.35 (50-73) years old, and a mean HIV evolution of 23,78 (± 9.56) years, with a mean denosumab treatment duration of 27.07 (9-58) months. They presented a DEXA mean T-score values of -2.39 for femoral neck and -2.96 for spine. There were collected a patient with múltiple vertebral fractures, and an other patient with a single vertebral fractures before started denosumab treatment and 1 distal radius fracture 9 months on denosumab treatment. There were reported adverse events in 5 of the 14 patients: 2 mild infections of the upper respiratory track, 1 injection site rash that lead to the interruption of the treatment, and 2 exitus but none of them with a direct relationship with denosumab treatment: a patient with refractory small cell lung cancer history, deceased of pneumonia, and a 77 year old woman with Alzheimer disease deceased of respiratory infection. Compliance was not met in three patients, 1 because lost of follow-up, 1 caused by bad general compliance and another because indication of odontological surgery, these two last ones are waiting for re-introduction. There have not been collected jaw osteonecrosis neither atypical fractures cases. There have not been collected viral loads or CD4 changes during the follow-up period that involved a switch for the OP treatment. The antiretroviral treatment changes have been caused by intolerances to previous treatments and treatment simplifications in order to improve the compliance, but never because denosumab concomitant therapy. <h3>Conclusion</h3> Denosumab treatment in the HIV patients of our series is well tolerated, has adequate adherence and seems safe although perhaps it should be used with greater caution in patients with comorbidities. <h3>Disclosure of Interests</h3> Isabel de la Morena Speakers bureau: Abbvie, Celgene, Pfzier, UCB, Ghebro, Roche, Sanofi, Janssen., Sara Vela: None declared, Juan Alberto Paz Solarte Employee of: He is working at UCB since December 2018, when the patient recruitment ended., Speakers bureau: Abbvie, Roche, Pfzier, Novartis, Celgene, Amgen, MSD, Janssen, Diego Bedoya: None declared, M Jose Galindo: None declared