Monday, June 1, 2009

Baltimore Viral conference June 22, 2008

Dr. Jose Montoya gave early results for the Roche Valcyte/CFS trial today, in Baltimore, Sunday June 22, 2008. The timing of the conference was not perfect for the presentations of these results, as Dr. Montoya did not have all his data complete. In a twenty-minute presentation Dr. Montoya went to great care to cite a long list of others who were helpful in this work. He described his and his colleague’s work as a small part of a larger mosaic. He said that his results presented today were not the entire story and that a final presentation would be forthcoming. Dr. Montoya made special reference to the work of Dr. Lerner, who he cited as a pioneer in antiviral work with CFS. After the presentation, in the question period, Dr. Lerner congratulated Dr. Montoya on his work and on the results.

The trial had 30 patients, 20 taking Valcyte and 10 taking a placebo. Valgancyclovir treatment “was well tolerated overall and did not result in clinically significant declines in neutrophil or platelet counts”.

Dr. Montoya explained that there were several objectives to the trial. The first was: Was the benefit real? Among the 19 Valcyte patients (one dropped out for non-Valcyte reasons), a statistical significant improvement was reached in cognitive function after nine months (six months on the drug and three months follow up). On the improvement of fatigue the results were more elliptical. “At three months after discontinuation of treatment (month 9), while the overall MFI-20 (fatigue measurement) general fatigue score did not reach significance, an improvement rate of greater than 10% in the MFI-20 general fatigue subscore was found in a significantly higher proportion of patients in the Valgancyclovir group that in the placebo group.”

The second objective of the trial was to secure biological markers for future treatment. “Test results of assays for different biomarkers are being finalized and analysis is currently underway.”

“Valgancyclovir treatment was not discontinued due to hematologic or hepatic adverse events.”

The conclusion was that with CFS and elevated HHV6 and EBV antibodies, Valgancyclovir therapy results in significantly improved cognitive and physical functioning and appears to be independent of a placebo effect.

The general sense was that this was an important report, although one could sense that there were detractors, or non-believers, present also.

The trial seemed to indicate that the drug is safe when used with CFS patients under the prescribed conditions, that it brings statistical betterment to cognitive function, that physical betterment is less clear under the current conditions of measurement (except when interpreted in subscore manner) and that future identification biomarkers for treatment will be presented later.


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