Dear Janet
I assume from what you say that you do not have a copy of the MEA purple book
So I enclose the section on the background to the use of antiviral drug treatment in ME/CFS below, which you should find helpful
There is also a long section on immunomodulatory treatments (including immunoglobulin) if you need an up to date summary of clinical trial information relating to immune system treatments in ME/CFS
I also assume that you may not be aware that the NICE guideline on ME/CFS does NOT recommend the use of antiviral or immunomodulatory treatments - so this is not a form of treatment that is likely to be prescribed on the NHS, unless there are very good reasons for doing so
I have had a meeting with the UK pharmaceutical company (Roche) that makes valganciclovir to see if there was any interest in setting up a UK clinical trial to run in parallel with the work that is being done by Montoya et al in the US - but without any success
7.4.6 Antiviral drugs
Although viral infections commonly trigger ME/CFS, there is very little scientific evidence to indicate that a persisting viral infection is involved in perpetuating ME/CFS. The first antiviral drug to be assessed in a clinical trial was acyclovir (Straus et al 1988a). No benefits were found. Intravenous ganciclovir was found to be of benefit in a subset of patients with abnormal aberrant T-waves in a small pilot trial (Lerner et al 1997).
Valganciclovir (VGCV), which is active against human herpes virus type-6 infection, is currently being assessed in the USA following a report that it could be of benefit in ME/CFS patients with evidence of persisting EBV infection (Kogelnik et al 2006).
A more recent study investigated whether antibody titres against HHV-6 and EBV were associated with a clinical response to valganciclovir in a subset of ME/CFS patients (Watt et al 2012). Antibody titres were considered high if HHV-6 IgG was > 1:320, EBV capsid antigen IgG was > 1:640 and EBV early antigen IgG was > 1:160. Treatment with valganciclovir, independent of baseline antibody titres, was associated with self-rated improvement in physical and cognitive functioning in those who had positive HHV-6 and/or EBV serologies.
Montoya et al (2013) randomised (2:1) 30 ME/CFS patients with elevated IgG antibody titres against HHV-6 and EBV to receive valganciclovir or placebo for six months in a double-blind, placebo-controlled trial. Statistically significant differences between groups were observed in mental fatigue sub-scores and cognitive function. The VGCV patients experienced improvements within the first three months and maintained that benefit for the remaining nine months. In the VGCV arm, monocyte counts decreased, neutrophil counts increased and cytokines were more likely to evolve towards a Th-1 profile.
NICE does not recommend the use of antiviral treatment in ME/CFS (National Institute for Health and Care Excellence 2007b), and this has had a very negative impact on any interest here in the UK regarding a clinical trial that would aim to replicate these very interesting findings. The MEA has met with a representative from the pharmaceutical company that manufactures Valcyte (one of the brand names of VGCV) to discuss the possibility of a UK clinical trial.
Dr Charles Shepherd
Hon Medical Adviser, MEA