Stanford, Calif. January 8, 2007 – A preliminary study suggests there may be hope in the offing for some sufferers of Chronic Fatigue Syndrome with a new therapy being tested by researchers at the Stanford University School of Medicine.
Jose Montoya, MD, associate professor of medicine (infectious diseases), and postdoctoral scholar Andreas Kogelnik, MD, PhD, have used the drug valganciclovir – an antiviral often used in treating diseases caused by human herpes viruses – to treat a small number of CFS patients.
The researchers said they treated 25 patients during the last three years, 21 of whom responded with significant improvement that was sustained even after going off the medication at the end of the treatment regimen, which usually lasts six months. The first patient has now been off the drug for almost three years and has had no relapses. A paper describing the first dozen patients Drs. Montoya and Kogelnik treated with the drug was published in the December issue of the Journal of Clinical Virology.*
"This study is small and preliminary, but potentially very important," said Anthony Komaroff, MD, professor of medicine at Harvard Medical School, who was not involved in the study. "If a randomized trial confirmed the value of this therapy for patients like the ones studied here, it would be an important landmark in the treatment of this illness."
Dr. Montoya has received a $1.3 million grant from Roche Pharmaceutical, which manufactures the drug under the brand name Valcyte®, to conduct a randomized, placebo-controlled, double-blind study set to begin this quarter at Stanford. The study will assess the effectiveness of the drug in treating a subset of CFS patients.
Dr. Montoya [spoke] about his efforts at the International Association for Chronic Fatigue Syndrome Conference in Fort Lauderdale on January 11 and 12.
….Valganciclovir is normally used against diseases caused by viruses in the herpes family, including cytomegalovirus, Epstein-Barr virus and human herpes virus-6. These diseases usually affect patients whose immune systems are severely weakened, such as transplant and cancer patients. Dr. Montoya, who had used the drug in treating such patients for years, decided to try using it on a CFS patient who came to him in early 2004 with extremely high levels of antibodies for three of the herpes family viruses in her blood. At the time, she had been suffering from CFS for five years.
When a virus infects someone, the levels of antibodies cranked out by the immune system in response typically increase until the virus is overcome, then slowly diminish over time. But Dr. Montoya's patient had persistently high antibodies for the three viruses. In addition, the lymph nodes in her neck were significantly enlarged, some up to eight times their normal size, suggesting her immune system was fighting some kind of infection, even though a comprehensive evaluation had failed to point to any infectious cause.
Concerned about the unusual elevations in antibody levels as well as the swelling of her lymph nodes, Montoya decided to prescribe valganciclovir. "I thought by giving an antiviral that was effective against herpes viruses for a relatively long period of time, perhaps we could impact somehow the inflammation that she had in her lymph nodes," said Montoya.
Within four weeks, the patient's lymph nodes began shrinking. Six weeks later she phoned Montoya from her home in South America, describing how she was now exercising, bicycling and going back to work at the company she ran before her illness. "We were really shocked by this," recalled Montoya.
Of the two dozen patients Drs. Montoya and Kogelnik have since treated, the 20 who responded all had developed CFS after an initial flulike illness, while the non-responders had suffered no initial flu.
Some of the patients take the drug for more than six months, such as Michael Manson, whose battle with CFS has lasted more than 18 years. The former triathlete was stricken with a viral infection a year after his marriage. After trying unsuccessfully to overcome what he thought were lingering effects of the flu, he had no choice but to drastically curtail all his activities and eventually stop working.
During his longest period of extreme fatigue, 13-1/2 weeks, Manson said, "My wife literally thought I was passing away. I could hear the emotion in her voice as she tried to wake me, but I couldn't wake up to console her. That was just maddening." Now in his seventh month of treatment, Manson is able to go backpacking with his children with no ill after-effects. Prior to starting the treatment, Manson's three children, ages 9 to 14, had never seen him healthy.
Drs. Montoya and Kogelnik emphasized that even if their new clinical trial validates the use of valganciclovir in treating some CFS patients, the drug may not be effective in all cases. In fact, the trial will assess the effectiveness of the medication among a specific subset of CFS patients; namely, those who have viral-induced dysfunction of the central nervous system.
"This could be a solution for a subset of patients, but that subset could be quite large," said Kristin Loomis, executive director of the HHV-6 Foundation, which has helped fund a significant portion of the preparatory work for the clinical trial. "These viruses have been suspected in CFS for decades, but researchers couldn't prove it because they are so difficult to detect in the blood. If Dr. Montoya's results are confirmed, he will have made a real breakthrough."
"What is desperately needed is the completion of the randomized, double-blind, placebo-controlled clinical trial that we are about to embark on," Dr. Montoya said.
For Patients Interested in Participating
People interested in participating in the clinical trial must live in the San Francisco Bay Area. To find more information about the trial, about the process for applying, and tests that will be required as part of the application, go to the Virus Induced CNS Dysfunction site – created by The HHV-6 Foundation, which is a funder of the project – at http://www.vicd.info/clinicaltrial.html.
Also visit the HHV-6 Foundation’s own site at http://www.hhv-6foundation.org/ for more background on the association of HHV-6 with CFS
* An abstract of the article, “Use of valganciclovir in patients with elevated antibody titers against Human Herpesvirus-6 (HHV-6) and Epstein-Barr Virus (EBV) who were experiencing central nervous system dysfunction including long-standing fatigue,” is featured in this issue. Full text can be downloaded for a fee at http://www.sciencedirect.com/science/journal/13866532
Note: This information is not intended to prevent, diagnose, treat or cure any illness, condition, or disease. It is essential that you never make a change in your health support plan or regime without first researching and reviewing it collaboratively with your professional healthcare team.