Ampligen

There is no known cure for CFS, but there is hope for an effective treatment – Ampligen®

Ampligen is an experimental anti-viral and immune modulatory drug manufactured by Hemispherx Biopharma of Philadelphia. In a double blind placebo controlled study performed from 1990-1992, approximately 80% of the 45 CFS subjects improved on the drug, and 50% of subjects improved significantly. Many were able to return to work again after a few months of treatment! A similar study conducted in Belgium reported results that parallel the 1990-1992 U.S. study. Several hundred subjects with CFS have been treated so far with Ampligen, and thousands of doses of the drug have been administered safely.

Does it Work?

The Medical Director of Hemispherx Biopharma presented preliminary data on Ampligen to an international group of scientists (7th Annual AACFS Research and Clinical Symposium, Madison, Wisconsin, October 2004). In summary,

”Dr. Strayer reported on a Phase III randomized, double blind placebo controlled crossover study of 234 subjects treated with parenteral Ampligen 400 mg twice weekly for 40 weeks. Demographics were similar in both groups. The dropout rate was slightly increased (24 v 16) as were the Serious Adverse Events (16 v 8) in the treatment group compared to placebo, but the differences were not statistically significant (p > 0.10).

Exercise duration in the treatment group was 16.1% greater than placebo (in completers) and 15.2% greater than placebo in all participants (intent to treat analysis, p<0.05). These increases in exercise duration were over twice the minimum considered medically significant (6.5%). Maximum oxygen utilization was markedly improved in treated (6.07) versus placebo (0.58) subjects.

There were no significant adverse events or significant abnormalities in laboratory parameters. Ampligen treatment in this debilitated population of CFS patients resulted in a medically and statistically significant improvement in the primary endpoint, exercise treadmill duration, compared to placebo. Ampligen may be the first drug to demonstrate safety and effectiveness in the treatment of CFS.”

Availability

As of March 19, 1997, Dr. Lapp received FDA approval to administer Ampligen on a "cost recovery basis," which means that the patient must bear the cost of the drug, safety monitoring and administration. So far, 26 persons with CFS (PWCs)  have taken Ampligen as part of this cost recovery program, 12 of whom had significant improvement and another 6 demonstrated some improvement.

The Treatment

Ampligen is only available as an intravenous drug. Typically 400mg is administered twice weekly over the course of about one hour. Most subjects experience mild flu-like feelings for several hours after the infusion. While research demonstrates that 6 months of therapy can produce a significant response, we generally recommend at least 12 months of therapy. Persons who have been ill for a long time are well advised to consider 18 months of therapy. In our cohort of subjects we have seen obvious improvement in as little as 24 weeks, but the average treatment period was about 70 weeks.

Restrictions

There are several restrictions that apply to subjects receiving Ampligen treatment. The subject must be 18 to 60 years old and very ill. Female subjects with child-bearing potential are required to use regular birth control. While most medications may be continued, subjects may not use immune modulating drugs (such as gamma globulin, steroids, interferon, etc.), anti-viral drugs (like Zovirax, Famvir or Valtrex), non-steroidal anti-inflammatory drugs (such as aspirin, Advil, Naprosyn, etc.), or any other experimental medication. Other restrictions may apply, and each subject is considered individually.

It is highly recommended that persons receiving Ampligen transfer residence to Charlotte temporarily, in order to minimize travel. We have found that more than an hour of traveling to and from the office is difficult for most subjects, and can “undo” the benefit of Ampligen. Our staff can recommend rental apartments nearby.

Costs

The cost of Ampligen is about $150 per dose, or $1200 per month. Infusion costs, medical visits, and laboratory add approximately $1000 monthly, thus the total cost may exceed two thousand dollars per month. Some insurers will reimburse medical visits, lab, and infusion costs; and an occasional insurer will reimburse the cost of Ampligen. Medicare does not cover any expenses for investigational therapies.

More information

Ampligen has been available on a cost recovery basis in the USA, Belgium, and Canada, but only a three US clinics currently provide this drug worldwide. Hunter-Hopkins was the first to offer such a program in the USA, and has been continuously providing Ampligen therapy since FDA approval in 1997.

Dr. Lapp has been treating patients with Ampligen since 1988, through FDA sanctioned research protocols.

Interested individuals should contact our General Manager at (704) 543 9692 for more information or to register for treatment. You may also wish to consult the manufacturer’s website at http://www.hemispherx.net/ .

Updated March 2008