XMRV & Treatments -Update Dr. AzRa MaEl, MD

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GORDON MEDICAL

Innovative Healthcare

3471 Regional Parkway

Santa , CA 95403

Greetings!

This Update on XMRV

is by Dr. AzRa Mael, MD:

What is XMRV (aka Xenotropic

Murine Leukemia Virus-Related

Virus)? Does it cause Chronic

Fatigue Syndrome? What other

illnesses might it be associated

with? How can it be treated?

XMRV is the current name given to this recently

discovered group of retroviruses that infects

humans.

It is a member of the third known family of human

retroviruses, a Human Gamma Retrovirus (HGRV),

and in time these viruses may be renamed HGRV.

Human Immunodeficiency Virus (HIV) and Human

T-Lymphotropic Virus (HTLV) are the other 2 families

of human retroviruses that may be more familiar to

some.

XMRV was first discovered in association with

prostate cancer in 1996. Only recently (2009) was

the virus found to be strongly associated with

Chronic Fatigue Syndrome by a group of collaborating

labs, including Dr. Mikovits's lab at the Whittemore

Institute (WPI).

The presence of other closely related viruses

(murine leukemia virus related-viruses or MLV-related

viruses) was then independently and robustly

confirmed by the Harvard / NIH / FDA collaborative

effort headed by Dr.'s Lo and Alter in 2010.

The family of viruses consists of multiple closely

related viral mutations, which is typical of

retroviruses. In studies, approximately 80-90%

(perhaps more) of people with CFS have XMRV and

closely related viruses, compared to 4-7% of

controls.

The strength of this association has led to the

hypothesis that XMRV causes CFS.

However, it is more complicated than that. In

unpublished studies from Dr. Cheney and

Gordon Medical patients, approximately 40-50% of

healthy family members and close contacts of people

with CFS are infected with XMRV.

XMRV alone may not be sufficient to cause CFS in all

people, but it appears it may be a necessary

contributing factor, possibly in combination with

another undetected retrovirus, another infection, or a

genetic susceptibility to XMRV.

It is possible not everyone infected will develop

disease in response to XMRV. In the case of HTLV,

another human retrovirus, we see a similar pattern in

that only 10% of infected patients develop clinical

illness.

Since the original CFS paper published in Science

magazine in 2009, several research teams have

questioned the research of Mikovits, Lo, and Alter,

perhaps due to concern about the consequences of

the presence of XMRV in the nation's blood supply,

and the high cost of screening our blood banks.

A recent flurry of papers attempted to

debunk the XMRV research using the

issue of possible mouse DNA contamination.

The contamination concerns are generally

valid, but the research done by the group

for the Science paper, and the later paper

by Lo and Alter had already taken steps to

test for such contamination issues.

The contamination arguments, claiming the positive

results are due to mouse DNA, cannot explain why

positive samples show an immune response to

XMRV, or why XMRV can be cultured from samples.

In addition, the samples were tested specifically for

mouse DNA, in order to ensure there would be no

contamination.

The contamination papers are not relavant to the

most important studies indicating the finding of

XMRV in Chronic Fatigue Syndrome, and the

existence of XRMV still stands firm.

As of December 2010, the American Red Cross and

international blood banks began banning blood

donation from people with CFS. The government is

currently working to develop a fast and accurate test

for XMRV in order to protect the blood supply.

In unpublished research XMRV has been found

associated with multiple other illnesses, including

chronic Lyme disease.

It is associated with lymphoma, prostate cancer,

inflammatory breast cancer, fibromyalgia, autism,

Parkinson's, and Multiple Sclerosis, among other

inflammatory conditions.

There is no proof yet that it is causative, but it is

being found in higher numbers than would otherwise

be expected.

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XMRV Testing

Testing for XMRV has not proven easy. The Lo/Alter

paper has shown there are many strains (mutations)

of XMRV and related MLV viruses (such as PMRV).

Different strains of the virus can only be detected

using the most sensitive PCR probes and under

exacting conditions, often requiring culturing of the

blood sample for several weeks to increase the viral

numbers to detectable levels.

Testing is also complicated by the fact that XMRV

can be undetectable in the blood, but may be found

instead in organs such as the spleen, lymph nodes,

and others.

Additionally, as in some other chronic infections, not

everyone who is infected with XMRV produces

antibodies, so tests that rely on measuring

antibodies can produce *false negative* results.

Patients who are negative by PCR, may be positive

by culture or serology/antibody, and vice versa.

Dr. Mikovits is currently working on a way to detect

more of the strains of the MLV viruses in the XMRV

family, as well as faster and more sensitive tests for

both antibody and DNA of the entire family of

retroviruses.

Patients who have tested negative for

XMRV should realize that it is still

possible they are infected, but it was

not possible to find the infection in that

sample on that day. Retesting on another

day, or by another type of test, may give

different results.

Samples from Gordon Medical patients who

participated in the XMRV study through WPI are

being used to help in the development of these new

tests.

Dr. Mikovits is continuing to actively test any

negative samples to ensure that any infections are

found if evidence is present in the sample.

When viral evidence is found, WPI is sequencing the

genetics to discover whether it is in this new family

of retroviruses.

Dr. Mikovits stated that she expects to have a new,

commercially viable test available by June of 2011.

``````

Treatment Possibilities

for the New Human

Retroviruses

Are there treatments for XMRV? Will they

help people with CFS, cancer, or other

illnesses?

This is the hot topic that is still under investigation.

Doctors at Gordon Medical, the Whittemore-

Institute, and a handful of other centers across the

world are actively looking at possibilities.

At the time of writing, we know of approximately 65

CFS patients with XMRV who have tried various

combinations of three anti-retroviral (ARV)

medications originally designed for HIV: tenofovir,

zidovudine and raltegravir.

Each drug has been proven to inhibit XMRV viral

replication in in vitro (test tube) studies, and they

are synergistic when any two drugs are combined.

Dr. ph Brewer is one of the primary clinicians

doing trials with these medications. Dr. Brewer and

other CFS doctors report that after 6 months of use,

approximately 20-30% of patients on ARV's have

noticed mild to moderate improvements.

Though these medications help some people, they

are clearly not a complete solution for CFS and

XMRV.

There is still a lot to learn about what doses, what

combinations, and what supportive therapies might

make them more useful for more patients.

Gordon Medical doctors, along with

several other centers around the world

are now looking at working with

immunomodulating treatments such as

Gc-MAF, stem cells, Peptide T and others

that boost immune system function against

viruses and cancers.

Dr. Cheney is one of the pioneers of umbilical

cord stem cells in the treatment of CFS and XMRV.

Based on 18 - 24 months of his experience with just

over 30 patients, it is clear that stem cells produce

dramatic improvements in most people under the age

of 36, moderate results in the 36 - 60 year age group

and mild improvements in those over 60 years of

age.

Unfortunately, the good results are only temporary,

lasting approximately 6 - 18 months before patients

regress partially or completely.

Doctors at GMA are now investigating a technology

related to stem cells called Platelet Poor Particle

Rich Plasma that has proven beneficial to several

hundred patients, some with conditions related to

CFS, and will hopefully will have longer lasting

effects than umbilical cord stem cells.

Another promising immune therapy

is Gc-MAF (Gc protein-Macrophage

Activating Factor).

Gc-MAF activates macrophages, which

are immune system cells that are

important in eliminating infection and

cancer.

Unfortunately, many cancers and viruses cause the

secretion of an enzyme called nagalase that digests

naturally occurring MAF in our bodies.

Gc-MAF has a similar effect to that of our naturally

occurring MAF, but Gc-MAF is not degraded by

nagalase.

Administration of Gc-MAF via intra-muscular injection

results in the reactivation of previously suppressed

macrophages.

Gc-MAF was first used by Dr. Yamamoto in the

treatment of HIV and cancer. Recently,

approximately 80 XMRV positive CFS patients in

Belgium and the U.S. have received Gc-MAF with very

promising initial results.

Patients who are considering this therapy can be

tested for nagalase levels as well as vitamin D

receptor mutations, which may influence the outcome

of Gc-MAF treatment.

Dr. Mikovits warns that it may be important

to use an anti-viral strategy in addition to

immunologic treatments that could

potentially activate a reservoir in the body

to express more virus. In addition to ARV

pharmaceuticals, agents such as artesunate,

nexavir and others have antiviral and anti-

inflammatory properties that retard the

growth of viruses.

Other factors that studies show may inhibit XMRV

replication are restoring healthy glutathione levels,

reducing oxidative stress, reducing inflammation, and

normalizing methylation.

Few people realize that our body can naturally

silence viral infections, including retroviruses such as

HIV and XMRV, through methylating viral DNA.

Conversely, if viral DNA is not properly methylated,

viruses will continue to reproduce and grow in our

bodies.

We know that almost everyone with

CFS has a methylation cycle abnormality

that can be improved by taking methylation

enhancing nutritional supplements.

The study that proved this concept was co-written by

GMA's very own Neil , MD. Most people with

CFS have mild to moderate improvement in

symptoms when on methylating factors.

Some very sensitive patients find that starting

methylation supplements can exacerbate symptoms,

so as with all treatments, it is important to do these

in close consultation with your physician.

Viruses replicate more quickly in environments of

oxidative stress and inflammation. They also grow

more easily in low-glutathione environments.

As an adaptive mechanism viruses actually cause

oxidative stress, inflammation, and low glutathione

levels in our bodies that favors their survival.

By replenishing glutathione levels and reducing

oxidative stress and inflammation, we may inhibit

viral growth.

Many natural compounds have

anti-inflammatory properties. One

group of compounds that has proven

to inhibit both the herpes viruses and

the NF-kB inflammatory pathway is

artesunate and related artemisinin

derivatives.

Dr. Mikovits and the doctors at Gordon Medical

believe it will be important to diagnose and treat

co-infections in patients infected with XMRV, just as

it is with HIV.

In the Gordon Medical cohort so far approximately

half of the patients who are positive for XMRV also

have Lyme disease. Many also have EBV, HHV-6 and

CMV, and other infections.

Some patients who are diagnosed with *CFS*

respond partially or completely after treating the

Lyme disease.

Other patients experience benefits by taking valtrex,

valcyte or other antiviral medications active against

herpes-viruses. Though valtrex and valcyte do not

usually cure CFS, they can help people feel better by

reducing the immune system load imparted by viral

co-infections.

Studies have shown that hormones

such as cortisol, testosterone and

estrogen can promote XMRV replication.

Each of these hormones performs critical functions in

our body, so some amount is needed, but in excess,

or out of balance, they may be harmful.

Cortisol is produced in response to stress, and

most people with CFS are familiar with how

stress impacts their symptoms.

Estrogen, progesterone, testosterone

and DHEA are often low or out-of-balance

in CFS. Some patients feel better on

low-level supplementation of these

hormones, but some worsen. It is

important to pay close attention how

one's body responds to hormonal shifts

in order to stay in balance.

The good news is that with every passing year, our

understanding of CFS is getting better and better.

Though CFS is still a challenging illness to treat,

recently discovered treatments have resulted in

marked improvements in a growing percentage of

patients with CFS, which represents a significant

advance compared to years past.

It is important to remember

that each of the therapies

mentioned in this newsletter

are experimental.

There are no published

clinical trials yet, only informal

observations made by groups

of astute doctors and patients.

The practitioners and staff at GMA thank you for your

time and interest.We will continue to collaborate

with the Whittemore- Institute and share

the latest advances in CFS and XMRV research.

We would also like to extend our appreciation and

gratitude to the courageous patients dealing with

CFS, XMRV, chronic Lyme disease and related

illnesses who have maintained hope, raised

awareness and pushed us forward.