Complera Approval Completed

Gilead Sciences announces the FDA approval of new HIV drug Complera

(RxWiki News) Gilead Sciences announces Complera, a new daily pill for HIV-1 infected adults with no prior antiretroviral therapies, has been approved by the FDA.

Complera combines three antiretroviral medications in one daily tablet: Truvada, already containing two antiretroviral therapies and Edurant.

"New daily ART pill is available for HIV-infected adults."

Anthony Mills, M.D., participating investigator in ongoing Complera studies reports that in the 30 years since the first AIDS cases were reported, incredible strides have been made in the treatment of HIV. A single-tablet regimen is a welcome addition to currently available therapies and has been a goal in HIV drug development.

Complera, with its safety, convenience and efficacy, will prove to be an exciting treatment option for the appropriate patient population.

John C. Martin, Ph.D., Chairman and Chief Executive Officer, Gilead Sciences reports that Complera is the second single-tablet regimen that Gilead has presented. The first was Atripla. This is a collaborative effort combining the resources of both Gilead Sciences and Tibotec. Martin reports that Gilead Sciences will continue to explore treatment options for this patient population.

Complera does not cure HIV-1 infection or help prevent the transmission of HIV to others. Complera has Boxed Warnings including enlarged liver due to fat deposits and extreme exacerbation of hepatitis B. The following treatment outcomes should also be noted:

  • More patients treated with rilpivirine (Edurant) with HIV-1 RNA greater than 100,000 copies/mL at the beginning of Complera therapy experienced virologic failure compared to patients with HIV-1 RNA less than 100,000 copies/mL at the start of therapy.
  • The observed virologic failure rate in patients treated with Edurant had a higher rate of overall treatment resistance and cross-resistance  compared to efavirenz (Sustiva, Stocrin)
  • More subjects treated with Edurant developed lamivudine (Epivir) or emtricitabine (Emtriva) associated resistance compared to Sustiva or Stocrin.

Complera is not approved for children and adolescents.

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Review Date: 
August 11, 2011