HIV

FDA Approves Once-Daily HIV Drug, New Option for Asthma

Genvoya – HIV

The FDA has approved  Genvoya (fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection.1

Genvoya is approved for use in HIV-infected adults and children 12 years and older who are treatment-naïve and in adults with suppressed HIV infection.
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The drug’s safety and efficacy were evaluated in 4 studies involving a total of 3171 participants who were randomly assigned to either Genvoya or another HIV treatment. Overall, Genvoya effectively reduced viral loads and was comparable to other approved treatments.

The combination drug contains a form of tenofovir previously unapproved by the FDA that delivers lower levels of the drug into the bloodstream but higher levels directly into cells in which HIV replicates.

The drug carries a boxed warning of possible buildup of lactic acid in the blood and severe liver problems.

The most common side effect is nausea, although kidney problems, decreased bone mineral density, fat redistribution, and immune system changes can occur.

Nucala – Severe Asthma

The FDA has approved Nucala (mepolizumab) for use in combination with other asthma medications for the maintenance of severe asthma in patients 12 years and older.2

Nucala, a humanized interleukin-5 antagonist monoclonal antibody, is administered by a health care professional every 4 weeks as a subcutaneous injection in the upper arm, thigh, or abdomen.

The safety and efficacy of the drug were evaluated in 3 double-blind, randomized, placebo-controlled trials of patients with severe asthma who were already taking other drugs to control their symptoms. Patients received either Nucala or placebo every 4 weeks as an add-on treatment. Overall, those taking Nucala had fewer exacerbations requiring hospitalization or emergency room visits and longer time before the first exacerbation than those taking placebo.

The most common side effects include headache, back pain, and weakness.

—Michael Potts

References:

  1. FDA. FDA approves new treatment for HIV [press release]. November 5, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm471300.htm.
  2. FDA. FDA approves Nucala to treat severe asthma [press release]. November 4, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm471031.htm.