May 2, 2014
New FDA HIV Treatment Guidelines Account for Cost
Issuing an update to the February 2013 Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents, the U.S. Food and Drug Administration (FDA) has for the first time added a section on cost considerations as related to treatment. Following the lead of the HIV Medicine Association of the Infectious Diseases Society of America, the FDA also recommended testing CD4 counts less frequently for those who are doing well on antiretroviral (ARV) therapy.
The new section on cost considerations takes into account the availability of generic ARVs and provides an overview of the cost of therapy as it relates to adherence to HIV meds; it also looks into cost-sharing issues and prior authorization of therapies. The section examines how cost may be contained without ultimately dragging on the effectiveness of treatment.
The FDA recommends that those who have been taking ARVs for two years or more and who have consistently had an undetectable viral load should receive a CD4 screen once a year if they have between 300 and 500 CD4s. For those with greater than 500 CD4s, screening is optional. More frequent CD4 testing is advised for those who experience virologic rebound, who develop symptoms related to HIV disease, or who develop other symptoms or begin a new drug regimen that might cause CD4s to drop.
To read the guidelines, click here.
Search: U.S. Food and Drug Administration, FDA, Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents, cost considerations, CD4 screening.
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