Valacyclovir treatment in Epstein-Barr virus subset chronic fatigue syndrome: thirty-six months follow-up, Lerner 2007

Evergreen

Evergreen

Senior Member (Voting Rights)
Randomized Controlled Trial
In Vivo2007 Sep-Oct;21(5):707-13.

Valacyclovir treatment in Epstein-Barr virus subset chronic fatigue syndrome: thirty-six months follow-up​

A Martin Lerner, Safedin H Beqaj, Robert G Deeter, James T Fitzgerald

Abstract​

We hypothesized that subset classification of Epstein-Barr virus (EBV) in chronic fatigue syndrome (CFS) is required. At first, a blinded-random placebo-controlled trial of valacyclovir in EBV CFS subset was performed (Group 1), and this EBV subset was followed for thirty-six months (Group 2).

Patients were given valacyclovir at 14.3 mg/kg every 6 hours. The validated Energy Index (EI) point score assessing physical functional capacity, Holter monitor, multigated (radionuclide) MUGA rest/stress ventriculographic examination, EBV serum IgM viral capsid antibodies (VCA), and EBV early antigen diffuse (EA) were followed.

After six-months, Group 1 CFS patients receiving valacyclovir experienced an increased mean least square EI point score +1.12 units (122 kcal/day), while the placebo cohort increased +0.42 EI units (65 kcal/day).

EI point scores at Group 2 increased progressively. Sinus tachycardias decreased and abnormal cardiac wall motion improved. Serum antibody titers to EBV VCA IgM decreased. Patients resumed normal activities.

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The upper graph shows how the Energy Index (see previous post) changed during and after the trial:
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Some patients are getting back to work over time, but I don't see any evidence that that had anything to do with antiviral therapy.

What do others think?
 
Here's what Richman et al. 2019 (including Klimas) wrote about the trial [gaps added for ease of reading]:

a 2007 study on valacyclovir, which is metabolized into acyclovir upon administration, found significant improvements in physical activity among 27 ME/CFS patients with elevated Epstein Barr virus (EBV) antibodies14. However, treatment methods were altered significantly in those that were not responding to valacyclovir treatment alone, complicating the interpretation of results.

Additional drugs, including cimetidine and probenecid, were added to the treatment course in patients not responding within three months of treatment. Furthermore, three patients who suffered side-effects of valacyclovir were placed on a different guanosine analog, famciclovir14.

In addition administration of these drugs was also not performed at consistent intervals, as treatment was withheld when symptoms appeared to improve over a month and only re-administered if patients began to relapse14. These confounding variables leave the effectiveness of valacyclovir/acyclovir in question.
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