TREATMENT DATABASE
Ampligen (poly I:poly C12U) is a mismatched double-stranded RNA (ribonucleic acid) with immodulatory and antiviral properties. Because Ampligen has not yet been approved by the Food and Drug Administration (FDA), its use to date has been experimental.
In 1987 Ampligen was used experimentally in a small group of patients with AIDS (acquired immunodeficiency syndrome). The positive results of this trial seemed to confirm the claim that Ampligen works by enhancing natural killer cell function and influencing the 2-5A synthetase pathway. This pathway is vital in the defense against viral infections. According to Dr. Robert Suhadolnick of Temple University in Philadelphia, there are defects in key components in the antiviral system in some CFS/ME patients, the most notable of which are low latent 2-5A synthetase and upregulated RNase (ribonuclease) L activity (Journal of Interferon and Cytokine Research, 1997). Ampligen is thought to correct both of these defects.
USES IN ME/CFS: In August 1988, Dr. Daniel Peterson was the first physician to use Ampligen on an extremely ill patient with ME/CFS. Because of the severity of the patient's illness, Dr. Peterson was able to obtain permission from the FDA to use Ampligen under compassionate care status. The results were impressive and encouraging. One year into therapy the patient had recovered near-normal function in some areas and demonstrated a 46-point increase in IQ. This justified the next pilot study by Dr. Peterson, as well as several other formal studies conducted independently.
At the 1990 CFIDS Conference in Charlotte, North Carolina, and at the Cambridge Symposium, Dr. Peterson reported positive results after treating 15 patients with Ampligen. At the end of 24 weeks, most of the patients demonstrated increased performance status (using Karnofsky scores) and exercise tolerance (as measured by treadmill testing). Cognitive improvement was demonstrated by improved memory and increased IQ scores. No significant toxicity was reported. Ampligen's antiviral properties were confirmed by evidence that human herpesvirus 6 (HHV-6) reactivation was absent after treatment and abnormal components of the 2-5A pathway returned to normal range. It is of interest that of the two or three patients who did not respond to Ampligen therapy, the only significant pretreatment difference was measurable differences in 2-5A synthetase pathways.
The encouraging results of Dr. Peterson's study paved the way for a larger FDA-approved double-blind study in 1991 involving 92 patients in four U.S. cities. Again the results were encouraging. Many of the participants had been severely disabled before treatment and required assistance for simple daily activities. More than half of those in the study who received Ampligen demonstrated improvement and many were able to carry out daily activities with minimal assistance.
A study in Brussels, Belgium, presented at the 1996 American Association for Chronic Fatigue Syndrome (AACFS) Conference, to evaluate the safety and efficacy of intravenously administered Ampligen also showed encouraging results. Eleven patients with myalgic encephalomyelitis (ME) were given intravenous Ampligen twice a week for 24 weeks. The Belgian physicians reported that at the end of 24 weeks, all 11 experienced some improvement. In addition, no adverse effects to treatment were noted.
No other drug has received more attention from the ME/CFS community than Ampligen. But even in the wake of delays, reversals and lawsuits, many doctors still defend Ampligen as the most effective drug for those patients who have acute viral onset, persistent herpesvirus infections, depressed natural killer cell function, and 2-5A synthesase/RNase L up-regulation.
Dr. Kenny DeMeirleir claims that close to 80% of his patients reported “complete clinical recovery” after taking an extended course of treatment. Patients report improvement in overall function, energy levels, cognitive performance, and some have been able to return to work. Dr. Lapp, who has been using Ampligen since 1998, reports significant improvement in 50% of his severely ill patients. It is important to note that while few doctors claim that Ampligen works for the majority of their patients, it seems to have a very positive effect on a subset of those who are the most seriously ill. Ampligen is currently approved as a treatment for ME/CFS in Argentina.
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