“One pill, once daily”: what clinicians need to know about Atripla™

Abstract

As the number of persons chronically prescribed antiretrovirals has grown and the realization that antiretrovirals are required to be continued for life, pharmaceutical manufacturers have developed new classes of agents, improved the pharmacokinetics of marketed products through dosing reformulations, and in an effort to maximize success with respect to adherence, compiled into a single dosing unit all necessary elements for an antiretroviral regimen. Atripla™ represents the first ever fixed-dose combination antiretroviral available. This article reviews currently available data on this agent, the impact of resistance on clinical use and implementation, as well as extensive descriptions of the pharmacokinetics, adverse effects and drug-interactions warranting consideration. Whether beginning in a naïve patient or switching from other regimens for tolerability issues, Atripla™ represents a viable option. Its demonstrated advantages with respect to lipid and hematologic parameters and equivalent incidence of renal toxicity are tempered by the findings of bone mineral density decreases, however. Combining multiple mechanisms of action in a single dosing unit appears to improve efficacy, increase the likelihood for adherence and maintain viral suppression compared to administering these agents independently. It is suggested other pharmaceutical companies assess the potential to replicate this for the remaining antiretrovirals.

Simplification of HAART therapy on ambulatory HIV patients in Malaysia: a randomized controlled trial

“…CD4 counts were observed to increase in both the FDC and FRC groups from baseline to six months. However, the increase in the FDC group was found to be significantly higher than that seen in the FRC group 35. Adherence to antiretroviral therapy is essential for providing immunologic and virologic benefits to patients with HIV.…”

Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature

“…Drug combination is considered by many authors as a re-launch strategy and is a recurring theme in repositioning of drugs ( 24 , 27 ). The combination can be approved for use in a different (such as Bidil ® ) ( 5 ) or in the same indication granted for the individual components (such as Atripla ® ) ( 14 ).…”

Highly active antiretroviral therapy dysregulates proliferation and differentiation of human pre-adipocytes

“…The following drug concentrations were used in all the experiments: EFV, 20 μmol/L; FTC, 15 μmol/L; TDF, 1 μmol/L; ATV, 10 μmol/L; RTV, 2 μmol/L. These concentrations are in the range of those observed in the plasma of patients treated with the specific antiretroviral combination regimens[ 10 - 12 ]. The effects of antiretroviral medications were compared with control samples in which preadipocytes were cultured and stimulated to differentiate in the absence of antiretroviral medications.…”