Please cite this article in press as: Rivero A, et al. Costs and cost-efficacy analysis of the 2017 GESIDA/Spanish National AIDS Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults. Enferm Infecc Microbiol Clin. 2017. http://dx.doi.org/10.1016/j.eimc.2017.04.002 ARTICLE IN PRESS G Model EIMC-1692; No. of Pages 9 Enferm Infecc Microbiol Clin. 2017;xxx(xx):xxx–xxx www.elsevier.es/eimc Original article Costs and cost-efficacy analysis of the 2017 GESIDA/Spanish National AIDS Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults Antonio Rivero a , José Antonio Pérez-Molina b , Antonio Javier Blasco c,∗ , José Ramón Arribas d , Víctor Asensi e , Manuel Crespo f , Pere Domingo g , José Antonio Iribarren h , Pablo Lázaro c , José López-Aldeguer i , Fernando Lozano j , Esteban Martínez k , Santiago Moreno l , Rosario Palacios m , Juan Antonio Pineda j , Federico Pulido n , Rafael Rubio n , Jesús Santos o , Javier de la Torre p , Montserrat Tuset q , Josep M. Gatell k a Unidad de Gestión Clínica de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain b Servicio de Enfermedades Infecciosas, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain c Independent Health Services Researcher, Madrid, Spain d Servicio de Medicina Interna, Unidad de VIH, IdiPAZ, Hospital Universitario La Paz, Madrid, Spain e Unidad de Enfermedades Infecciosas-VIH, Hospital Universitario Central de Asturias, Universidad de Oviedo, Oviedo, Spain f Complexo Hospitalario Universitario de Vigo, Vigo, Spain g Hospitals Universitaris Arnau de Vilanova & Santa María, Universitat de Lleida, Institut de Recerca Biomèdica (IRB) de Lleida, Lleida, Spain h Servicio de Enfermedades Infecciosas, Hospital Universitario Donostia, San Sebastián, Spain i Servicio de Medicina Interna y Unidad de Enfermedades Infecciosas Hospital Universitario La Fe, IISLaFe, Valencia, Spain j Unidad Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valme, Sevilla, Spain k Servicio de Enfermedades Infecciosas, Hospital Clinic-IDIBAPS, Universidad de Barcelona, Barcelona, Spain l Servicio de Enfermedades Infecciosas, Hospital Ramón y Cajal, Universidad de Alcalá de Henares, Instituto de Investigación Sanitaria Ramón y Cajal (IRYCIS), Madrid, Spain m Unidad de Enfermedades Infecciosas, Hospital Virgen de la Victoria, Málaga, Spain n Unidad VIH, i + 12, Hospital Universitario 12 de Octubre, Madrid, Spain o Unidad de Gestión Clínica de Enfermedades Infecciosas, Hospital Universitario Virgen de la Victoria, Málaga. Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain p Grupo de Enfermedades Infecciosas de la Unidad de Medicina Interna, Hospital Costa del Sol, Marbella, Málaga, Spain q Servicio de Farmacia, Hospital Clínic, Barcelona, Spain a r t i c l e i n f o Article history: Received 24 February 2017 Accepted 11 April 2017 Available online xxx Keywords: Costs Efficacy Efficiency HIV AIDS Antiretroviral therapy a b s t r a c t Introduction: GESIDA and the Spanish National AIDS Plan panel of experts have recommended preferred (PR), alternative (AR) and other regimens (OR) for antiretroviral therapy (ART) as initial therapy in HIV- infected patients for 2017. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. Methods: Economic assessment of costs and efficiency (cost-efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50 copies/mL at week 48, in an intention- to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, resistance studies and HLA B*5701 screening. The setting was Spain and the costs correspond to those of 2017. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. Results: In the base case scenario, the cost of initiating treatment ranged from 6882 euro for TFV/FTC/RPV (AR) to 10,904 euros for TFV/FTC + RAL (PR). The efficacy varied from 0.82 for TFV/FTC + DRV/p (AR) to 0.92 for TAF/FTC/EVG/COBI (PR). The efficiency, in terms of cost-efficacy, ranged from 7923 to 12,765 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TFV/FTC + RAL (PR), respectively. Conclusion: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TFV/FTC/RPV (AR) and TAF/FTC/EVG/COBI (PR). © 2017 Elsevier Espa ˜ na, S.L.U. and Sociedad Espa ˜ nola de Enfermedades Infecciosas y Microbiolog´ ıa Cl´ ınica. All rights reserved. ∗ Corresponding author. E-mail address: antoniojblasco@hotmail.com (A.J. Blasco). http://dx.doi.org/10.1016/j.eimc.2017.04.002 0213-005X/© 2017 Elsevier Espa ˜ na, S.L.U. and Sociedad Espa ˜ nola de Enfermedades Infecciosas y Microbiolog´ ıa Cl´ ınica. All rights reserved.