Gilead Sciences gets FDA approval for once-daily single tablet HIV-1 regimen Complera

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the single tablet HIV-1 regimen Complera^® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen. Complera was first approved in 2011 for patients new to therapy and is now one of the most widely-prescribed HIV regimens in the United States.

"Complera is an effective single-pill therapy with a demonstrated safety profile, and has rapidly become an important option for appropriate HIV patients who are initiating antiretroviral treatment," said Calvin J. Cohen, MD, M.Sc., Research Director, Community Research Initiative of New England and an investigator on clinical trials of Complera. "The data supporting today's approval demonstrate Complera has the potential to help a broader range of HIV-infected patients who have achieved virologic control on another regimen."

Complera combines a complete course of three antiretroviral medications into a single, once-daily tablet. The product contains Gilead's Truvada^®, which itself is a fixed-dose combination of two HIV medicines, and Janssen R&D Ireland's rilpivirine (marketed as Edurant^®). Patients switching to Complera should have no history of virologic failure, have suppressed viral load for at least six months, be on their first or second antiretroviral regimen, and have no current or past history of resistance to Complera components. The efficacy of Complera was established in patients who were virologically suppressed (HIV RNA <50 copies/mL) on a stable ritonavir-boosted protease inhibitor-containing regimen.

Today's approval is supported by clinical data from the Phase 3 SPIRIT (Study 106) clinical trial. In this randomized, open-label study, virologically suppressed patients who were taking multi-tablet HIV therapy containing a ritonavir-boosted protease inhibitor (PI) either switched to Complera or remained on their PI-based regimen. The study found that, after 48 weeks of treatment with Complera, 89 percent (n=283/317) of switch patients had viral load less than 50 copies/mL, compared to 90 percent (143/159) of patients who remained on a PI-regimen for 24 weeks. Complera was well tolerated in SPIRIT and there were few treatment discontinuations due to adverse events. The most common side effects in previous clinical studies of Complera were headache, depressive disorders and insomnia (2 percent for all). No new adverse reactions were identified in SPIRIT, but the frequency of adverse reactions increased from 2 percent to 2.4 percent. Complera has a labeled Boxed Warning on the risks of lactic acidosis/severe hepatotoxicity with steatosis and acute exacerbation of hepatitis B; see below for Important Safety Information.

Marketed as Eviplera^® (emtricitabine/rilpivirine/tenofovir disoproxil (as fumarate)) in the European Union, the regimen also was recently granted European regulatory approval for any HIV-infected adult patients without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000 HIV-1 RNA copies/mL.