Valcyte (Valganciclovir)

Valcyte (valganciclovir) is…

 an antiviral drug designed to inhibit viral DNA synthesis. It is federally approved to treat the symptoms of the cytomegalovirus infection in AIDS patients. Cytomegalovirus is a herpes virus.

Valcyte May Work in Chronic Fatigue Syndrome (ME/CFS) Because…

it treats a type of infection (herpesvirus) known to occur in some patients. Possible herpesvirus infections include HHV-6/7, Epstein-Barr Virus and Cytomegalovirus.

Chronic Fatigue Syndrome (ME/CFS) Physicians Report…

Dr. Guyer believes Valcyte is a ‘significant step forward’ in the treatment of patients with a documented viral infection. He reports mostly ‘encouraging results’ from a small set of patients he has treated. Dr. Holtof reports Valcyte is effective in patients with infectious onset, evidence of viral reactivation (elevated IgG/Ea for EBV, HHV-6, CMV), high RNase L activity, low NK cell activity, and other immune findings. Dr. Peterson warns that 3 months may be too short a trial period and cites many patients with no benefits at three months who have had significant benefits at six months. Dr. Enlander reports its effects range from highly dramatic to minimal.

Dr. Podell suggests, however, that patients with a ‘decent quality of life’ refrain from taking Valcyte given it’s potentially serious side effects.

Chronic Fatigue Syndrome (ME/CFS) Studies

In a preliminary study Dr. Montoya reported that 21/25 ME/CFS patients with documented EBV/HHV-6 infection, several of which were severely disabled, improved dramatically with many returning to work or full time activities after 6 months treatment with Valcyte. `Side effects were low and there were no relapses after the treatment was ended.

Dr. Anthony Komaroff, MD, professor of medicine at Harvard Medical School reported “This study is small and preliminary, but potentially very important. If a randomized trial confirmed the value of this therapy for patients like the ones studied here, it would be an important landmark in the treatment of this illness.”

A randomized, placebo-controlled, double-blinded treatment trial sponsored by Roche Pharmaceuticals began in spring, 2007. The study results were not nearly as impressive and as of 2012 had not been published.

Dose

(From Dr. Lerner’s ME/CFS Treatment Guide). Dr. Lerner recommends “valganciclovir (Valcyte) one 450-mg capsule daily for three days, followed by two 450-mg capsules in the morning daily. Liver function tests are studied very carefully. If  there is any abnormality, one alters the dosage. Given the patient’s ability to safely tolerate two 450-mg capsules, dosing can be increased to two, 450-mg capsules in the morning and a one additional 450-mg capsule twelve hours later. Liver function tests, again, must be studied carefully and frequently.

Both valacyclovir and valganciclovir are absorbed with a 20% increment if there is food in the stomach.”

Side Effects

the list of potential side effects is long and includes liver toxicity, anemia, reduced white blood cell counts (granulocytopenia), reduced blood platelets (thrombocytopenia), reduced bone marrow levels and reduced fertility. Valcyte may also be carcinogenic. These can increase the risk of infection, anemia and bleeding. It can cause life-threatening side effects. This drug is counter-indicated in patients with low white blood cells, platelets or hemoglobin counts.

Patients are usually tightly monitored (up to twice weekly in the early stages) for liver toxicity and the dosage is lowered or stopped if side effects occur. Side effects have not been a problem in either Montoya study.

Cost

Dr. Peterson cited costs of about $2,000 a month.

The Phoenix Rising website is compiled by a layman. It is not a substitute for a physician and is for informational uses only. It does not present complete information on this drug or any treatment. Please discuss any treatments in these pages with your physician.

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Dr Holtorf on Valcyte in Chronic Fatigue Syndrome

Kogelnik AM, Loomis K, Hoegh-Petersen M, Rosso F, Hischier C, Montoya JG.
Use of valganciclovir in patients with elevated antibody titers against Human Herpesvirus-6 (HHV-6) and Epstein-Barr Virus (EBV) who were experiencing central nervous system dysfunction including long-standing fatigue. J Clin Virol. 2006 Dec;37 Suppl 1:S33-8.

Dr. Podell On Valcyte: Chronic Fatigue Syndrome HHV-6-Possible Cure?

RxList: the Internet Drug Index: Valcyte

Virus Induced Central Nervous System Dysfunction Association

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