The U.S. Department of Health and Human Services (HHS) today announced contract awards for up to 120,000 treatment courses of intravenous (IV) antiviral drugs to help treat hospitalized 2009 H1N1 influenza patients.
Patients hospitalized with 2009 H1N1 influenza are evaluated to determine if antiviral drugs will be useful; some patients are not able to take the drugs that are currently available as pills or liquid and may benefit from intravenous antiviral medications.
To help meet the potential need for IV medications to combat the H1N1 virus, HHS ordered 10,000 treatment courses each from BioCryst, Roche and GlaxoSmithKline, totaling $31.5 million. The contracts allow HHS to place additional orders of up to 30,000 treatment courses with each manufacturer over two years. Roche manufactures Tamiflu; GlaxoSmithKline, Relenza, and BioCryst manufactures Peramivir.
Because there are no Food and Drug Administration (FDA)-approved antiviral medications that can be administered intravenously to treat influenza, the FDA issued an emergency use authorization on Oct. 23 to allow use of intravenous Peramivir, an investigational antiviral drug in the class of drugs known as neuraminidase inhibitors.
The HHS orders for intravenous oseltamivir (Tamiflu) and intravenous zanamivir (Relenza), also neuraminidase inhibitors, are predicated on FDA emergency use authorization for these medications.
FDA has not issued emergency use authorization authorizing the use of intravenous Tamiflu or Relenza. Orders for Tamiflu and Relenza are based on anticipated need of emergency use authorizations for additional IV drugs in the future. Tamiflu and Relenza are FDA-approved in the form of pills or liquid, and studies are ongoing into the use of these two drugs intravenously for hospitalized H1N1 flu patients.