Profilaxis preexposición al VIH en España: situación política y administrativa / HIV pre-exposure prophylaxis (PrEP) in Spain: political and administrative situation

Este estudio se ha centrado en las actuaciones a nivel político y administrativo que se han realizado en España en relación con la implementación de la profilaxis preexposición (PrEP) al VIH. Se ha analizado todo tipo de iniciativas formales por parte de los actores políticos y administrativos implicados. Las fuentes utilizadas son las fuentes oficiales públicas. Hasta febrero de 2018, la PrEP no ha sido implementada. La decisión depende de los niveles estatal y autonómico. El Ministerio de Sanidad y algunas Comunidades Autónomas trabajan en diversas intervenciones sin establecer un calendario de implementación. Los partidos políticos por su parte han promovido escasas iniciativas relacionadas con la implementación de la PrEP. En el terreno jurídico, se han producido vaivenes legales relacionados con la extensión de la patente. El papel de los órganos intergubernamentales e interdepartamentales es vital para la implementación de la PrEP

This study focuses on actions at the political and administrative level in Spain in relation to the implementation of pre-exposure prophylaxis (PrEP). We analysed a whole range of different formal initiatives taken by the political and administrative actors involved. The information was obtained from official public data sources. As of February 2018, PrEP had not been implemented. The decision is dependent on both state and regional governments. The Ministry of Health and some Autonomous Regions are working on different interventions, but without providing an implementation timetable. The political parties have kept a very low profile in terms of initiatives related to the implementation of PrEP. From a legal point of view, proceedings are passing back and forth with the extension of the patent. The role of intergovernmental and interdepartmental institutions is very important for the implementation of PrEP in Spain

Cost-effectiveness of DTG + ABC/3TC versus EFV/TDF/FTC for first-line treatment of HIV-1 in the United States.

OBJECTIVE: Data from the SINGLE trial demonstrated that 88% of treatment-naïve HIV-1 patients treated with dolutegravir and abacavir/lamivudine (DTG + ABC/3TC) achieved viral suppression at 48 weeks compared with 81% of patients treated with efavirenz/tenofovir disoproxil fumarate/emtricitabine (EFV/TDF/FTC). It is unclear how this difference in short-term efficacy impacts long-term cost-effectiveness of these regimens. This study sought to evaluate long-term cost-effectiveness of DTG + ABC/3TC vs EFV/TDF/FTC from a US payer perspective. METHODS: This study is an individual discrete-event simulation which tracked the disease status and treatment pathway of HIV-1 patients. The model simulated treatment over a lifetime horizon by tracking change in patients' CD4 count, clinical events occurrence (opportunistic infections, cancer, and cardiovascular events), treatment switch, and death. The model included up to four lines of treatment. Baseline patient characteristics, efficacy, and safety of DTG + ABC/3TC and EFV/TDF/FTC were informed by data from the SINGLE trial. The efficacy of subsequent treatment lines, clinical event risks, mortality, cost, and utility inputs were based on literature and expert opinion. Outcomes were lifetime discounted medical costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). RESULTS: Compared with EFV/TDF/FTC, DTG + ABC/3TC increased lifetime costs by $19,153 and per person survival by 0.12 QALYs, resulting in an ICER of $158,890/QALY. ICERs comparing DTG + ABC/3TC to EFV/TDF/FTC remained above the traditional, US willingness-to-pay threshold of $50,000/QALY gained in all scenarios, and above $100,000 or $150,000/QALY gained in most scenarios. LIMITATIONS: Due to data limitations, the treatment patterns, CD4 count during viral rebound and treatment switch, viral rebound after trial end, and long-term adverse event-related treatment discontinuation were based on assumptions, presented to and approved by clinical experts. CONCLUSIONS: Compared with EFV/TDF/FTC, DTG + ABC/3TC resulted in higher cost and only slightly increased QALYs over a lifetime, with an ICER that exceeded the standard cost-effectiveness threshold. This indicates that the incremental benefit in effectiveness associated with DTG + ABC/3TC may not be worth the incremental increase in costs.