Thursday, August 22, 2013

subset of patients with CFS improve within the first 3 months of valganciclovir use

@ pubmed
 2013 Aug 19. doi: 10.1002/jmv.23713. [Epub ahead of print]

Randomized clinical trial to evaluate the efficacy and safety of valganciclovir in a subset of patients with chronic fatigue syndrome.


Department of Medicine, Stanford University School of Medicine, Stanford, California; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California.


There is no known treatment for chronic fatigue syndrome (CFS). Little is known about its pathogenesis. Human herpesvirus 6 (HHV-6) and Epstein-Barr virus (EBV) have been proposed as infectious triggers. Thirty CFS patients with elevated IgG antibody titers against HHV-6 and EBV were randomized 2:1 to receive valganciclovir (VGCV) or placebo for 6 months in a double-blind, placebo-controlled trial. Clinical endpoints aimed at measuring physical and mental fatigue included the Multidimensional Fatigue Inventory (MFI-20) and Fatigue Severity Scale (FSS) scores, self-reported cognitive function, and physician-determined responder status. Biological endpoints included monocyte and neutrophil counts and cytokine levels. VGCV patients experienced a greater improvement by MFI-20 at 9 months from baseline compared to placebo patients but this difference was not statistically significant. However, statistically significant differences in trajectories between groups were observed in MFI-20 mental fatigue subscore (P = 0.039), FSS score (P = 0.006), and cognitive function (P = 0.025). VGCV patients experienced these improvements within the first 3 months and maintained that benefit over the remaining 9 months. Patients in the VGCV arm were 7.4 times more likely to be classified as responders (P = 0.029). In the VGCV arm, monocyte counts decreased (P < 0.001), neutrophil counts increased (P = 0.037) and cytokines were more likely to evolve towards a Th1-profile (P < 0.001). Viral IgG antibody titers did not differ between arms. VGCV may have clinical benefit in a subset of CFS patients independent of placebo effect, possibly mediated by immunomodulation and/or antiviral effect. Further investigation with longer treatment duration and a larger sample size is warranted. J. Med. Virol. 9999:1-9, 2013. © 2013 Wiley Periodicals, Inc.
© 2013 Wiley Periodicals, Inc.


Epstein-Barr virus, chronic fatigue syndrome, human herpesvirus 6, randomized clinical trial, valganciclovir
[PubMed - as supplied by publisher]


David Doherty said...

I Investigated Valgancyclovir treatment privately as my precursor misdiagnosed disease to severe ME/FM that caused my bilateral Ramsay Hunt Syndrome types1and2 (1 in 4 million) was caused by Varicella Zoster (Herpes Zoster) but unfortunately offlabel treatment using this antiviral would cost over 4000AUD per 7 day course with no guarantee....shame more research funding is not being dedicated to this approach so one day valgancyclovir may be available on PBS or NHS benefits for more severe ME/FM sufferers with Herpes Zoster precursor viral infections. Thank You for yet another great journal article Dr Speedy:-)

Sasha said...

Dr Speedy, what do you think is the exact mechanism is that is stopping antivirals and immunomodulators being tried in the NHS for people with ME by those consultants in immunology, infectious disease, and so on, who are convinced that ME is an immune system issue?

As a patient who has had ME for decades, I don't understand why these specialists don't experiment: how it can seem better to them to do nothing than to try something with patients who have been ill for years and are now facing old age completely untreated and who are willing to take a risk.

Is it a budgetary issue? Is it a medico-legal issue? Is it the NICE guidelines? Is it an attitude towards risk?

In the absence of strong RCTs on many immune treatments for ME, what should we be asking those doctors for? Who (their professional bodies?) should we be pressuring? Who should they be pressuring? What can we do to move things forward?

I'd be very interested on your take on this, as a doctor with experience of how the NHS works. As patients, I don't think we understand the clinician's side of this.

Dr Speedy said...

Thx David Doherty !!

Dr Speedy said...

"Sasha said...
Dr Speedy, what do you think is the exact mechanism is that is stopping antivirals and immunomodulators being tried in the NHS for people with ME"



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