RESUMO
OBJECTIVE: Cabotegravir long-acting (CAB-LA) administered every 2 months was approved in the USA as pre-exposure prophylaxis (PrEP) for individuals at risk of acquiring human immunodeficiency virus (HIV)-1 infection based on the HIV Prevention Trials Network (HPTN) 083 and HPTN 084 clinical trials, which demonstrated superior reduction in HIV-1 acquisition compared with daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in men who have sex with men (MSM), transgender women (TGW), and cisgender women. A decision-analytic model was developed to assess the lifetime cost-effectiveness of initiating CAB-LA versus generic oral FTC/TDF for HIV PrEP in the USA from a healthcare sector perspective. METHODS: PrEP-eligible adults entered the Markov model receiving CAB-LA or FTC/TDF and could continue initial PrEP, transition to a second PrEP option, or discontinue PrEP over time. Efficacy was taken from the HPTN 083 and HPTN 084 clinical trials. Individuals who acquired HIV-1 infection incurred lifetime HIV-related costs, could transmit HIV onwards, and could develop PrEP-related resistance mutations. Input parameter values were obtained from public and published sources. Model outcomes were discounted at 3%. RESULTS: The model estimated that the CAB-LA pathway prevented 4.5 more primary and secondary HIV-1 infections per 100 PrEP users than the oral PrEP pathway, which yielded 0.2 fewer quality-adjusted life-years (QALYs) lost per person. Additional per-person lifetime costs were $9476 (2022 US dollars), resulting in an incremental cost-effectiveness ratio of $46,843 per QALY gained. Results remained consistent in sensitivity and scenario analyses, including in underserved populations with low oral PrEP usage. CONCLUSIONS: Our analysis suggests that initiating CAB-LA for PrEP is cost-effective versus generic daily oral FTC/TDF for individuals at risk of acquiring HIV-1 infection.
Assuntos
Fármacos Anti-HIV , Dicetopiperazinas , Infecções por HIV , Profilaxia Pré-Exposição , Piridonas , Minorias Sexuais e de Gênero , Masculino , Adulto , Humanos , Feminino , Estados Unidos , Fármacos Anti-HIV/uso terapêutico , Homossexualidade Masculina , Análise Custo-Benefício , Infecções por HIV/prevenção & controleRESUMO
INTRODUCCIÓN: Las guías GESIDA proponen pautas preferentes de inicio de tratamiento antirretroviral en pacientes infectados por el VIH. El objetivo de este análisis es comparar los costes y la eficacia de darunavir/r QD frente a otros inhibidores de la proteasa (IP) potenciados recomendados por GESIDA en pacientes naďve. MÉTODOS: Mediante un modelo de coste-eficacia se compararon los IP/r recomendados como pautas preferentes o alternativas en pacientes naďve, junto con un tratamiento de base con 2 ITIAN. La eficacia se midió mediante la respuesta virológica (carga viral < 50 copias/ml) a las 48 semanas ajustada por los niveles basales de carga viral y recuentos de CD4. Para generar la «frontera de eficiencia» y ratios de coste-eficacia se utilizaron los costes espańoles y las tasas de eficacia a las 48 semanas. RESULTADOS: El modelo estimó que el inicio del tratamiento en naďve con darunavir/r QD se mostró como la opción preferente basada en un IP/r más coste-eficaz. El coste medio del TARGA por paciente respondedor era menor para darunavir/r (13.420 €) que para atazanavir/r (14.000 €) o lopinavir/r (13.815 €). Se estimó que darunavir/r sería el IP preferente más eficiente, mientras que atazanavir/r QD y lopinavir/r BID resultarían opciones «dominadas», situándose fuera de la frontera de la eficiencia. Partiendo de un presupuesto fijo de 10 millones de €, se estimó que la pauta de inicio con darunavir/r QD conseguiría un mayor número de pacientes respondedores (745) que con atazanavir/r QD (714) o lopinavir/r BID (724). Al mismo tiempo, darunavir/r QD reduciría el número de pacientes que fracasarían al tratamiento (150) en comparación con atazanavir/r QD (172) o lopinavir/r (286). CONCLUSIONES: Según este modelo, darunavir/r QD es el IP/r preferente más coste-efectivo para el tratamiento de la infección por el VIH-1 basado en IP/r en pacientes naďve en Espańa
INTRODUCTION: GESIDA (AIDS Study Group) has proposed preferred regimens of antiretroviral treatment as initial therapy in HIV infected patients. The objective of this analysis is to compare the costs and effectiveness of darunavir/r QD and other ritonavir-boosted (/r) protease inhibitors (PIs) currently recommended in GESIDA guidelines for treatment-naďve patients. METHODS: A cost-efficacy model compared the boosted PIs recommended as preferred or alternative treatment choices, each used with a nucleoside reverse transcriptase inhibitor backbone. Efficacy was measured by 48-week virological response (viral load < 50 copies/mL) adjusted by baseline viral load and CD4 cell count. To generate efficiency frontiers and cost-efficacy ratios, one-year antiretroviral therapy costs in Spain, and 48-week efficacy values were used. Results The model estimated that starting treatment with darunavir/r QD was the most cost-effective choice compared with the other preferred PI/r based therapies. The average cost per patient with a virological response was lower for darunavir/r QD (13,420€) than for atazanavir/r QD (14,000€), or lopinavir/r BID (13,815€). Among the preferred PI/r-based therapies, darunavir/r QD also was estimated to be the most efficient option for treatment-naďve patients. Atazanavir/r QD and lopinavir/r BID were found to be «dominated» by darunavir/r) and, consequently, were outside the efficiency frontier of PI/r-based first-line treatment. Given a fixed budget of 10 million euros for PI/r-based first-line therapy, the model estimated that darunavir/r QD would yield more responders (745) than atazanavir/r QD (714), or lopinavir/r BID (724). At the same time, darunavir/r QD would reduce the number of individuals failing treatment (150) compared with atazanavir/r QD (172) and lopinavir/r BID (286). CONCLUSIONS: In this model, darunavir/r QD was found to be the most cost-effective choice, among the preferred PI/r-based therapies recommended in the Spanish guidelines for treatment-naïve patients