Journal of IiME Volume 2 Issue 1 www.investinme.org PROFILES of PRESENTERS at the IiME INTERNATIONAL ME/CFS CONFERENCE (Continued from page 13) The validated Energy Index (EI) point score (1-10) was calculated for each CFS patient every 3 months at physician visits. A CFS patient has an EI < 5. A CFS patient with an EI of 0 is bedridden; a CFS diagnosis is no longer present at an EI > 5. The EI effect size is 0.25, a medium effect size is 0.5. A large effect size is > 0.8. Administrations of antiviral drugs were given within a defined pharmacokinetic therapeutic window. Eighteen CFS patients with elevated serum IgG serum antibody titers to cytomegalovirus (HCMV) were treated with intravenous ganciclovir 5mg/Kg q 12 h for 30 days. At evaluations, 24 weeks later, 13 patients (72%) returned to their premorbid healthy states (Infectious Diseases in Clinical Practice, 1997:6;110-117). In a second study, 25 CFS patients with elevated serum antibody titers to Epstein-Barr virus (EBV), Early Antigen (Diffuse) and/or EBV, viral capsid antigen (VCA, IgM) were treated with valacyclovir (14.6 mg/Kg po q 6 h) for 6 months. This valacyclovir dose achieved serum acyclovir Cmax > 7µm and high antiviral activity versus EBV (ID50, 4.4 – 13.3µm), but no antiviral activity versus HCMV. The CFS patients EI functional capacity as well as EBV and HCMV serum antibody titers were again assessed after 1, 3 and 6 months of valacyclovir. We concluded that the 16 CFS patients with EBV persistent infection (EBV single-virus subset) improved after 6 months, but 9 CFS patients with elevated serum antibody titers to “both” EBV and HCMV did not benefit from valacyclovir (Drugs of Today, 2002:38;549-561). With this guidance, a randomized double blinded controlled 6 month study of EBV subset single virus (no HCMV serum antibody) showed an EI rise after 6 months of +1.12 units (122 Kcal/day), in the valacyclovir group while the placebo group improved +0.42 units (65 Kcal/day), Invivo 2007:21;707-714. The current inclusive CFS data (May 1, 2001—December 31, 2007) regardless of duration of CFS illness from this treatment center of 201 CFS patients reveal demographic and epidemiologic data, 156 (77.6%) female; 45 (22.4%) male. The mean age of CFS patients is 45.2 years, BMI 26.4 Kg/m2. These 201 CFS patients are two distinct groups with similar demographics; (A) CFS Herpesvirus Illness (EBV, HHV6, HCMV) with no co-infections, and Group (B) CFS Herpesvirus Illness (EBV, HCMV,HHV6) “with” mimicking, coinfections, both A group and B group meeting international criteria for diagnosis of CFS. (Fukuda, Ann Intern Med. 1994:121;953-9). The major co-infections of Group B are Lyme Disease, Babesiosis and Adult Rheumatic Fever. The subsequent data here are those of CFS Group A who were ill an average of 5.2 years before receiving antiviral therapy. Data for CFS Group B are not included. There are 138 group A CFS patients, 104 females (75.4%) and 34 males (24.6%). The mean age is 46.4 years, BMI 26.7 Kg/m2. Patients were further identified by the presence of elevated serum antibody titers to EBV, HCMV, or HHV6. CFS patients (>95%) had abnormal oscillating flat or inverted T-waves at 24Hr ECG monitor and abnormal cardiac wall motion at rest (11.5%) and stress (24.1%). Cardiac biopsies from CFS patients seen in 1997 showed a noninflammatory cardiomyopathy with myofiber disarray, myofiber drop out, apoptosis, and cardiac replacement fibrosis. Among the 138 Group A herpesvirus CFS patients there were single virus infections, EBV patients (27.5%); HCMV (13.8%); and HHV6 (1.4%). However, more commonly, each CFS patient was infected with several herpesviruses simultaneously: (79 patients with multiple herpesvirus infections (57.2%)). There were EBV/HCMV co-infections (28.3%); EBV/HHV6 co-infections (10.9%); HCMV/HHV6 co-infections (5.1%); and EBV/HCMV/HHV6 co-infections (13.0%). Specific long-term pharmacokinetic therapy was administered to each patient until the EI point score reached 8, at which time, antiviral medicines were tapered, stopped, or continued, as appropriate with no change in the EI point score. The EI point score at 3 month intervals for the 6 years of the study was recorded. There were a mean of 46 EI patients at each 3 month time interval and 25 time intervals over the 6 year longitudinal study. The mean EI for the 138 CFS patients at baseline was 4.5. The mean final EI point score was 6.0, an increase of 1.5 EI units and, therefore, a large EI effect size change (Spearman’s p nonparametric correlation test, Spearman’s p=0.562, p=0.0019). These data indicate that specific long-term anti-herpesvirus pharmacokinetic administration of valacyclovir/valganciclovir provides long-term significant benefit to Group A CFS patients. (Continued on page 15) Invest in ME (Charity Nr 1114035) Page 14
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