Original articleCost–effectiveness of initial antiretroviral treatment administered as single vs. multiple tablet regimens with the same or different componentsCoste-efectividad del tratamiento inicial antirretroviral de comprimido único vs. tratamiento con regímenes de múltiples comprimidos con los mismos o diferentes componentes☆
Introduction
Fixed-dose single tablet regimens (STR) are generally preferred by patients and physicians. As long as they include drugs of choice, co-formulated drugs are specifically recommended by antiretroviral treatment (ART) guidelines, unless dose-adjustments are required.1, 2, 3, 4 They represent a significant advance in the simplification of ART, facilitating adherence to complex and chronic treatments, and contributing to a quantifiable improvement in patient's quality of life.5 STRs reduce the risk of treatment error, are associated with lower risks of hospitalization, can lessen the possibility of covert monotherapy if selective noncompliance, reduce the risk of developing HIV-1 resistance, and can impact treatment costs as well.6, 7, 8, 9, 10, 11, 12, 13 One study found that STR led to a 17% reduction in overall healthcare costs.7 However, most of these studies have baseline prescription bias and no randomized clinical trials using drugs as they are prescribed in an unblinded way have demonstrated these potential benefits of STR so far. Moreover, efficiency of STR has never been compared with a MTR with same components.
We hypothesized that despite having a possible higher direct cost, the efficiency (cost–effectiveness) of STR might be better when compared with a multi-tablet regimen (MTR) with the same or different components in antiretroviral-naïve subjects.
Section snippets
Methods
This was an observational open clinical study undertaken in a prospectively collected cohort data. All antiretroviral naïve HIV-infected patients from 6 reference centers (4 from Barcelona, Spain; 1 from Madrid, Spain; 1 from Paris, France) who initiated ART with the STR-Atripla®, with their exact components administered separately (Tenofovir disoproxil fumarate [DF] + Lamivudine/Emtricitabine + Efavirenz, or with Truvada® + Efavirenz; MTR-SC) or with a MTR with different components (MTR-Other)
Baseline characteristics
A total of 2773 patients (759 (27%) STR-Atripla®, 483 (17%) MTR-SC, and 1531 (55%) MTR-Other) were included. There were significant differences among centers and between Spanish and French centers in the type of regimens prescribed, suggesting differences in local practices for ART prescription. Baseline characteristics are illustrated in the Supplemental Table 1. The most commonly prescribed MTR-Other regimens are listed in the Supplemental Table 2. The STR-Atripla® arm had a significantly
Discussion
In this prospective multicenter study we did not found significant differences in the 48-week response rates, the median duration of assigned regimen, the rates of patients completing at least one year of follow-up, and the rates of interruptions for tolerance problems among subjects receiving their initial ART as STR-Atripla® or MTR-SC. However, the rates of virological failure were significantly lower with STR-Atripla®. The cost per responder (efficiency) at 48 weeks was lower for MTR-SC
Funding
Supported in part by an unrestricted grant from Gilead Sciences.
Conflicts of interest
Josep M. Llibre has been a member of the speakers’ bureaus and received fees from lectures or for participating in advisory boards from Janssen-Cilag, Merck Sharp & Dohme, ViiV Healthcare, Gilead Sciences and Bristol Myers Squibb.
Arkaitz Imaz has received financial compensation for lectures, consultancies, or educational activities from Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck Sharp & Dome, and ViiV Healthcare.
Daniel Podzamczer has received research grants and/or honoraria
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Presented in part at: 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention, 19–22 July 2015, Vancouver, Canada. Abstract TUBEB264.