In 2009 and again in 2013, the FDA rejected Ampligen as a ME/CFS treatment. It would have been the first approved treatment for this condition as well as providing Ampligen’s entrance into the marketplace. In spite of these failures, the manufacturer continues to move ahead to get this drug approved.
How It Works
Ampligen is believed to work by jump-starting your body’s natural anti-viral pathway and regulating levels of RNase L (a substance in your cells that attacks viruses), which can be high in people with ME/CFS. It’s also been shown to inhibit tumor cell growth.
Ampligen doesn’t appear to suppress the immune system. Instead, it’s believed to change the way your immune system works.
Ampligen for CFS
In clinical trials, Ampligen has been shown to improve cognition, exercise tolerance, neuropsychological health and overall function in people with ME/CFS; decrease the activity of HHV-6 (a virus believed to be linked to ME/CFS), and decrease RNase L activity.
According to Ampligen’s manufacturer, Hemispherx Biopharma Inc., more than 40,000 doses of Ampligen were given to about 500 patients in clinical trials at more than 20 U.S. clinics. One of those clinics, the Hunter-Hopkins Center, says 80% of its patients improved on Ampligen, and 50% improved significantly.
Because Ampligen isn’t currently approved for any use in the U.S., only clinics with special permission can prescribe Ampligen. It’s also incredibly expensive—as in more than $40,000 a year! And no, your insurance won’t cover it, because it’s experimental.
Ampligen also remains unapproved in the European Union, but some patients there may be able to get it through what’s called an “early access program.”
Dosage
Ampligen is administered intravenously (I.V.). In trials and under conditional permits by the FDA, patients typically have received 400mg of the drug twice a week. Hunter-Hopkins recommends at least 12 months of therapy and 18 months for the severely ill.
Side Effects
Like any drug, Ampligen can cause unwanted side effects. Possible side effects include:
Mild flushingTightness of the chestRapid heartbeatAnxietyShortness of breathFeeling hotSweatingNauseaLiver enzyme level changesDiarrheaItchingLow blood pressureRashArrhythmiasLow white blood cell countDizzinessConfusion
Some patients have flu-like symptoms for a few hours after receiving a dose of the drug. The manufacturer says these effects typically went away after several months of treatment.
