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December 16, 2013

Gilead obtains FDA approval for expanded indication of single tablet HIV-1 regimen Complera

Gilead Sciences has received approval from the US Food and Drug Administration (FDA) for its once-daily single tablet HIV-1 regimen Complera, for use in certain virologically suppressed adult patients on a stable antiretroviral regimen to replace their existing antiretroviral treatment regimen.

HIV

Gilead Sciences has received approval from the US Food and Drug Administration (FDA) for its once-daily single tablet HIV-1 regimen Complera, for use in certain virologically suppressed adult patients on a stable antiretroviral regimen to replace their existing antiretroviral treatment regimen.

Complera is a combination of three antiretroviral medications including Gilead’s Truvada, which is a fixed-dose combination of two HIV medicines, and Janssen R&D Ireland’s rilpivirine (marketed as Edurant).

The company said that 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.

Efficacy of Complera was recognised in patients who were virologically suppressed on a stable ritonavir-boosted protease inhibitor-containing regimen.

Community Research Initiative of New England research director Calvin Cohen said Complera is an effective single-pill therapy with a demonstrated safety profile, and has become a major option for HIV patients who are initiating antiretroviral treatment.

"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," Cohen said.

The FDA approval of Complera is based on data secured from the randomised, open-label Phase III SPIRIT (Study 106) clinical trial.

"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."

In the 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 trial showed that 89% of the switch patients treated for 48 weeks with Complera had viral load less than 50 copies/mL, compared with 90% of patients who remained on a PI-regimen for 24 weeks.

Most common side effects observed in previous clinical trials of Complera were headache, depressive disorders and insomnia, while the SPIRIT study has shown no new adverse reactions, but the frequency of adverse reactions increased from 2% to 2.4%.

In the US Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) was first approved in 2011 for patients new to therapy and is currently the most widely-prescribed HIV regimens in the region.

Marketed as Eviplera in the European Union (EU), Complera also recently secured European regulatory approval for use in any HIV-infected adult patients without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor class, tenofovir or emtricitabine, and with a viral load = 100,000 HIV-1 RNA copies/mL.


Image: HIV is a member of the genus Lentivirus, which causes acquired immunodeficiency syndrome. Photo: courtesy of freedigitalphotos.net.

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