Cobicistat-boosted elvitegravir-based fixed-dose combination antiretroviral therapy for HIV infection

A fixed-dose co-formulated antiretroviral drug containing elvitegravir, a new integrase strand transfer inhibitor, boosted by a novel pharmacokinetic enhancer cobicistat, and further containing the nucleoside pair of tenofovir and emtricitabine was recently approved by the U.S. Food and Drug Administration as a single-tablet, once-a-day treatment of HIV-1 infection in antiretroviral therapy-naive adults. This drug was found to be noninferior to two currently preferred antiretroviral regimens in clinical practice in two large, 48-week, phase III studies. Renal adverse effects limit its use to those with creatinine clearance > 70 mL/min; its considerable drug interaction potential requires care and attention when used. Nevertheless, the availability of this fixed-dose combination product is an important progress in the management of HIV infection for a number of reasons: It provides a third option for a one-pill, once-a-day antiretroviral regimen; it is the first such regimen that is not based on a non-nucleoside reverse transcriptase inhibitor; and it provides an alternative to ritonavir for the pharmaco-enhancement of other antiretroviral drugs.