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Single-Tablet HIV Regimen Submitted for FDA Review
A new drug application (NDA) has been submitted to the FDA for an investigational single-tablet regimen that combines dolutegravir, abacavir, and lamivudine (ViiV Healthcare) for the treatment of patients with human immunodeficiency virus-1 (HIV-1) infection.
The NDA submission follows the approval of dolutegravir (Ticivay, ViiV Healthcare) by the FDA in August 2013 for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approximately 88 lbs).
The new submission was based on data from one pivotal phase III study of dolutegravir, supported by three other phase III/IIIb studies that evaluated the safety and efficacy of this regimen. The submission also included pivotal data on the bioequivalence of dolutegravir, abacavir, and lamivudine when taken as a single-tablet regimen compared with the administration of dolutegravir and abacavir/lamivudine as separate components. An additional 48-week phase IIIb/IV study of this single-tablet regimen in treatment-naïve HIV-positive women (the ARIA study) is ongoing.
A combination tablet containing abacavir and lamivudine is available in the U.S. under the brand name Epzicom (ViiV Healthcare).
Source: ViiV Healthcare; October 22, 2013.