A Preliminary 6 Month Trial of Valacyclovir (VAL) in Chronic Fatigue Syndrome (CFS) Using the Epstein-Barr Virus (EBV), Cytomegalovirus (HCMV) Paradigm

A. M. Lerner*, R.G. Deeter, H. J. Dworkin, M. Zervos, C.-H. Chang and T. Fitzgerald, William Beaumont Hospital, Royal Oak, MI; Glaxo Wellcome Inc., RTP, N.C., Wayne State Univ., Detroit, MI. and Univ. of Michigan, Ann Arbor, MI.

Previous therapeutic trials in CFS suffer from not narrowly defining the disease. The objective of this study was to determine the efficacy and safety of VAL in CFS using 4 strict entry criteria; 19 patients met the entry criteria. Ten (10) patients with (1) recently (< 1 yr) diagnosed CFS, (2) CDC-defined CFS who had, (3) abnormal oscillating T-waves, (4) elevated viral capsid antigen IgM and/or elevated total early antigen titers in sera and also no HCMV antibodies, were studied. A control group of 9 CFS patients (using the 4 strict criteria) and who had high titers of IgG to HCMV antibodies were also studied. Patients underwent clinical and lab testing and were treated with VAL 1-1.5 gm q 6 h po for 6 months.

The CFS specific validated Energy Index (EI) was used to assess patient functional capacity at baseline and at 1, 3 and 6 months. There were no demographic differences between the CFS with EBV patients and the control group. Overall, the mean age was 41 years; 94% were women; patients had CFS for 9 2.2 months prior to treatment. For CFS with EBV patients, the mean EI scores increased from 4.1 at baseline to 5.3, 6.6 and 7.0 at 1, 3, and 6 months (p<.0001). Control CFS patients mean EI scores did not change from baseline, 1, 3, and 6 months: scores of 4.1, 4.7, 3.9 and 4.6 (p >.05), respectively. No major adverse events occurred. Valacyclovir improves CFS patients with permissive EBV, But does not improve control CFS patients (EBV with HCMV). These inclusion criteria appear to improve the chance of showing that a therapeutic intervention can be achieved in CFS.