Moreno Guillen Santiago, Losa García Juan Emilio, Berenguer Berenguer Juan, Martínez Sesmero José Manuel, Cenoz Gomis Santiago, Graefenhain Ruth, Lopez Sanchez-Cambronero David, Parrondo Garcia Francisco Javier
Servicio de Enfermedades Infecciosas. Hospital Ramon y Cajal, Madrid.
Sección Infecciosas, Departamento de Medicina Interna, Hospital Universitario Fundación Alcorcón, Madrid..
Farm Hosp. 2017 Sep 1;41(5):601-610. doi: 10.7399/fh.10808.
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.
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.
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.
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.
抗逆转录病毒药物的固定剂量组合是在简化治疗、提高依从性方面向前迈出的重要一步，并提高了治疗效果，降低了病毒载量，改善了患者的生活质量。多替拉韦与阿巴卡韦和拉米夫定的单片制剂（DTG/ABC/3TC）是一种高效且耐受性良好的每日一次治疗方案，用于治疗HIV感染患者。本研究的目的是从西班牙国家卫生系统的角度评估固定剂量组合（DTG/ABC/3TC）与恩曲他滨/替诺福韦/依非韦伦组合（FTC/TDF/EFV）、达芦那韦/r（DRV/r）或拉替拉韦（RAL）与恩曲他滨/替诺福韦（FTC/TDF）或阿巴卡韦/拉米夫定（ABC/3TC）作为初始抗逆转录病毒治疗的增量成本-效用比。
ARAMIS模型采用微观模拟方法，通过疾病描述性健康状态的马尔可夫链模拟每位患者从治疗开始到死亡的个体变化，并将其应用于西班牙。用于比较的替代方案是恩曲他滨/替诺福韦/依非韦伦的固定剂量组合（FTC/TDF/EFV），以及恩曲他滨/替诺福韦（FTC/TDF）或阿巴卡韦/拉米夫定（ABC/3TC）与达芦那韦/r（DRV/r）或拉替拉韦（RAL）的固定剂量组合。模型中纳入的治疗方案实现病毒学抑制的概率来自临床试验SINGLE、SPRING - 2和FLAMINGO，成本以欧元（2015年）表示。该模型采用西班牙国家卫生系统的视角，以终身为期限，成本和效果的贴现率为3%。
与所有对照方案相比，开始使用DTG/ABC/3TC治疗具有优势：与FTC/TDF/EFV相比（-67210.71欧元/质量调整生命年），与DRV/r + FTC/TDF或ABC/3TC相比（-1787341.44欧元/质量调整生命年），与RAL + FTC/TDF或ABC/3TC相比（-1005117.13欧元/质量调整生命年）。所有进行的敏感性分析均显示这些结果具有一致性。
在考虑的前提下，从西班牙卫生系统的角度来看，开始使用DTG/ABC/3TC STR治疗似乎是初治HIV感染患者中最具成本效益的选择。
