Biomaterial Database

Cost-utility analysis of the fixed-dose combination of dolutegravir/abacavir/lamivudine as initial treatment of HIV+ patients in Spain. 2017

Santiago Moreno Guillen, and Juan Emilio Losa García, and Juan Berenguer Berenguer, and José Manuel Martínez Sesmero, and Santiago Cenoz Gomis, and Ruth Graefenhain, and David Lopez Sanchez-Cambronero, and Francisco Javier Parrondo Garcia

Servicio de Enfermedades Infecciosas. Hospital Ramon y Cajal, Madrid. smguillen@salud.madrid.org.

OBJECTIVE Fixed-dose combinations of antiretroviral drugs have meant an important step forward in simplifying treatment and improving compliance and has led to an increased effectiveness of therapy, a viral load decrease and improving the quality of life of patients. The single-table formulation of dolutegravir with abacavir and lamivudine (DTG/ABC/3TC) is a highly efficacious and well-tolerated once-daily regimen for HIV-infected patients. The objective of the study was to assess the incremental cost-utility ratio of the fixed-dose combination of (DTG/ABC/3TC) versus the combinations emtricitabine/tenofovir/efavirenz (FTC/TDF/EFV), and darunavir/r (DRV/r) or raltegravir (RAL) with emtricitabine/tenofovir (FTC/TDF) or abacavir/lamivudine (ABC/3TC) as initial antiretroviral therapy in patients infected with HIV-1 from the perspective of the Spanish National Health System. METHODS The ARAMIS model, which uses a microsimulation approach to simulate the individual changes in each patient from the start of treatment to death through a Markov chain of descriptive health states of the disease, was adapted to Spain. The alternatives used for comparison were the fixed-dose combination of emtricitabine/tenofovir/efavirenz (FTC/TDF/EFV), and the fixed- dose combinations of emtricitabine/tenofovir (FTC/TDF) or abacavir/lamivudine (ABC/3TC) with darunavir/r (DRV/r) or raltegravir (RAL). The probability of achieving virological suppression by the treatments included in the model was obtained from clinical trials SINGLE, SPRING-2 and FLAMINGO and the costs were expressed in € (2015). The model use the perspective of the Spanish National Health System, with a lifetime horizon and a discount rate of 3% was applied to cost and effectiveness. RESULTS Treatment initiation with DTG/ABC/3TC was dominant when it was compared with treatment initiation with all the comparators: vs. FTC/TDF/EFV (-67 210.71€/QALY), vs. DRV/r + FTC/TDF or ABC/3TC (-1 787 341.44€/QALY), and vs. RAL + FTC/TDF or ABC/3TC (-1 005 117.13€/QALY). All the sensitivity analyses performed showed the consistency of these findings. CONCLUSIONS With the premises considered, treatment initiation with DTG/ABC/3TC STR appears to be the most cost-effective option in ARTnaïve HIV infected patients from the Spanish Health System perspective.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D010078	Oxazines	Six-membered heterocycles containing an oxygen and a nitrogen.
D010879	Piperazines	Compounds that are derived from PIPERAZINE.
D011728	Pyridones	Pyridine derivatives with one or more keto groups on the ring.	Pyridinones
D003362	Cost-Benefit Analysis	A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. In contrast a cost effectiveness in general compares cost with qualitative outcomes.	Cost and Benefit,Cost-Benefit Data,Benefits and Costs,Cost Benefit,Cost Benefit Analysis,Cost-Utility Analysis,Costs and Benefits,Economic Evaluation,Marginal Analysis,Analyses, Cost Benefit,Analysis, Cost Benefit,Analysis, Cost-Benefit,Analysis, Cost-Utility,Analysis, Marginal,Benefit and Cost,Cost Benefit Analyses,Cost Benefit Data,Cost Utility Analysis,Cost-Benefit Analyses,Cost-Utility Analyses,Data, Cost-Benefit,Economic Evaluations,Evaluation, Economic,Marginal Analyses
D004338	Drug Combinations	Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.	Drug Combination,Combination, Drug,Combinations, Drug
D004339	Drug Compounding	The preparation, mixing, and assembly of a drug. (From Remington, The Science and Practice of Pharmacy, 19th ed, p1814).	Drug Formulation,Drug Preparation,Drug Microencapsulation,Pharmaceutical Formulation,Compounding, Drug,Formulation, Drug,Formulation, Pharmaceutical,Microencapsulation, Drug,Preparation, Drug
D005260	Female		Females
D006575	Heterocyclic Compounds, 3-Ring	A class of heterocyclic compounds that include a three-ring fused structure. Both aromatic or non-aromatic ring structures are included in this category.	Fused Heterocyclic Compounds, Three-Ring,Heterocyclic Cpds, 3 Ring,Three Ring Heterocyclic Compounds,3-Ring Heterocyclic Compounds,Fused Heterocyclic Compounds, Three Ring,Heterocyclic Compounds, 3 Ring
D006679	HIV Seropositivity	Development of neutralizing antibodies in individuals who have been exposed to the human immunodeficiency virus (HIV/HTLV-III/LAV).	AIDS Seroconversion,AIDS Seropositivity,Anti-HIV Positivity,HIV Antibody Positivity,HIV Seroconversion,HTLV-III Seroconversion,HTLV-III Seropositivity,AIDS Seroconversions,AIDS Seropositivities,Anti HIV Positivity,Anti-HIV Positivities,Antibody Positivities, HIV,Antibody Positivity, HIV,HIV Antibody Positivities,HIV Seroconversions,HIV Seropositivities,HTLV III Seroconversion,HTLV III Seropositivity,HTLV-III Seroconversions,HTLV-III Seropositivities,Positivities, Anti-HIV,Positivities, HIV Antibody,Positivity, Anti-HIV,Positivity, HIV Antibody,Seroconversion, AIDS,Seroconversion, HIV,Seroconversion, HTLV-III,Seroconversions, AIDS,Seroconversions, HIV,Seroconversions, HTLV-III,Seropositivities, AIDS,Seropositivities, HIV,Seropositivities, HTLV-III,Seropositivity, AIDS,Seropositivity, HIV,Seropositivity, HTLV-III