Research from the US and Europe has found that patients taking a single-tablet, fixed-dose combination (FDC) regime for HIV had a ‘modestly’ lower risk of virological failure compared to those taking a multiple-tablet regime containing two or three different drugs.
The research, led by Professor Heiner Bucher at the Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Switzerland, aimed to contribute to debates around potential procurement cost savings, and focused on the effectiveness of different antiretroviral treatment (ART) regimes. But concerns exist regarding adherence patterns and pill burden which could affect virological (and wider health and well-being) outcomes, outweighing any potential cost-saving benefits.
Antiretroviral drugs (ARVs) used in single-tablet treatments are often available separately in generic form, but are under patent when packaged together with other drugs in a one-tablet formulation. This means replacing single-tablet drugs with generic, multiple-tablet drugs could lead to substantial savings for health systems in the US and UK where the cost of ARVs accounts for more than half the total cost of HIV care.
The study looked at just under 12,000 people starting ART in Europe and Northern America between 2006 and 2012 to ascertain whether the single-dose treatment of the ARVs efavirenz, emtricitabine and tenofovir might be as effective and cost less if taken as two- or three-a-day pill regimes.
Researchers found that taking this treatment in a single tablet was associated with a modest decrease in the risk of virological failure compared to the multiple-pill formulations. After the first month, two pills rather than one was associated with an increase in the risk of developing Aids or dying from an Aids-related illness. However, three pills rather than two did not appreciably add to that increase.
From the data, researchers calculated that 77 people would need to be exposed to a one-pill regime, rather than a three-pill regime, for one year to avoid one additional person developing Aids or dying from an Aids-related illness.
The findings do not necessarily imply that a single-tablet treatment regime should be used over a multiple-tablet formulation of the same regime using generic drugs. Rather, the data can be used to see if single-tablet regimes are cost-effective compared to other public health data.
The authors note: “If undiagnosed HIV infection is the limiting factor in the cascade of HIV care, then saving money on drug costs could fund prevention and detection programmes leading to better public health outcomes.”
However, the authors also note that these results are not applicable for lower resource settings, where treatment access is an issue. Single-dose treatments are more likely to successfully make it to the patient over multiple pill options, because of bottle-necks in the supply chain and drug procurement in these contexts.
Abstract
Objectives: Treatment guidelines recommend single-tablet regimens for patients with HIV infection starting antiretroviral therapy. These regimens might be as effective and cost less if taken as separate drugs. We assessed whether the one pill once a day combination of efavirenz, emtricitabine and tenofovir reduces the risk of disease progression compared with multiple-pill formulations of the same regimen.
Methods: We selected treatment-naïve patients starting one-, two- or three-pill formulations of this regimen in data from the Antiretroviral Therapy Cohort Collaboration. These patients were followed until an AIDS event or death or until they modified their regimen. We analysed these data using Cox regression models, then used our models to predict the potential consequences of exposing a future population to either a one-pill regimen or a three-pill regimen.
Results: Among 11 739 treatment-naïve patients starting the regimen, there were 386 AIDS events and 87 deaths. Follow-up often ended when patients switched to the same regimen with fewer pills. After the first month, two pills rather than one was associated with an increase in the risk of AIDS or death [hazard ratio (HR) 1.39; 95% confidence interval (CI) 1.01-1.91], but three pills rather than two did not appreciably add to that increase (HR 1.19; 95% CI 0.84-1.68). We estimate that 77 patients would need to be exposed to a one-pill regimen rather than a three-pill regimen for 1 year to avoid one additional AIDS event or death.
Conclusions: This particular single-tablet regimen is associated with a modest decrease in the risk of AIDS or death relative to multiple-pill formulations.
Authors
J Young, C Smith, R Teira, P Reiss, I Jarrín Vera, H Crane, JM Miro, A D'Arminio Monforte, M Saag, R Zangerle, HC Bucher
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[link url="http://onlinelibrary.wiley.com/doi/10.1111/hiv.12562/full"]HIV Medicine abstract[/link]