Peterson Reports Antiviral Effective in Treating “Severely Ill CFS Patients with HHV6 or CMV”

[Ember]

“These results show objective endpoints, subset selection, and recovery. There were complete responders and partial responders among severely ill CFS patients with HHV6 or CMV. These are encouraging results for this subset and further well-designed trials should be pursued to confirm them.” Dr. Dan Peterson

By Cort Johnson
April 9, 2013

At the HHV6 Conference in Paris, France today Dr. Peterson reported on the results of a retrospective study following 65 severely ill chronic fatigue syndrome patients given a course of Vistide from 2005-2012 for HHV6 and/or HCMV infections. Despite the interest in pathogens in ME/CFS, antiviral studies are rare and this is the first one reported for this drug.

Vistide (Cidofovir) gets a lot less press than other antivirals and immunomodulators (Ampligen, Rituximab, Valcyte, Valtrex) used in this disorder probably because the drug requires a complex infusion protocol, frequent blood tests because of the rare but real possibility of serious kidney side effects and is expensive (although it can be covered by insurance).

This combination – infusions, frequent blood tests and expense – requires close physician follow-up. With Dr. Peterson’s specialized focus on patients with dysfunctional natural killer cells, however, he may be most consistent about testing for herpesviruses, which are known to be active in ME/CFS patients.

After three decades of focusing on immunologically challenged ME/CFS patients, Peterson may be more experienced at pathogen detection and treatment than any other practitioner in the field, and so it’s not surprising to find the first Vistide study coming from his office. In an interview, a former patient of his said, ‘he leaves no stones unturned’; when he finds something he goes after it ‘aggressively’.

In his presentation he stated almost 30% of his patients test positive for HHV-6 or human cytomegalovirus (HCMV) (PCR, rapid culture, antigenemia), and a whopping 50% test positive for Epstein-Barr virus (EBNA).

Serious Drug For A Serious Illness

Vistide (Cidofovir) is FDA approved for the treatment of cytomegalovirus (CMV) in patients with AIDS. (Cytomegalovirus is a member of the herpesvirus family.) and it’s been used off-label to treat human papillomavirus, BHK virus, herpes simplex virus, vaccinia virus infections. The Black Box warning on Vistide speaks for itself:

’Cases of acute renal failure resulting in dialysis and/or contributing to death have occurred with few as one or two doses of Vistide. The “recommended dose, rate, frequency of Vistide injections must not be exceeded.”

[...]

Wrap Up

In a retrospective study Vistide proved to be effective in treating severely ill ME/CFS patients with HHV6 and HCMV infections. Dr. Peterson called for double-blinded, placebo-controlled studies to further study Vistide’s efficacy and mechanism of effect. The CFI’s pathogen discovery studies due out this year should shed light on what percentage of ME/CFS patients could benefit from Vistide.

A Vistide analogue under development called CMX001 which does not require infusions and does not effect the kidneys could be boon for ME/CFS patients with herpesvirus infections if it is approved by the FDA. CMX001 was given fast-track status by the FDA earlier this year.

More: http://simmaronresearch.com/2013/04...mecfs-patients-with-hhv6-and-hcmv-infections/

 

[vli]

May I use this opportunity to ask if ANYONE on vistide on this forum is willing to talk??? I was doing ampligen 2012, only saw partial success/couldn't afford to keep staying in NYC with that result not to mention that not being American, I had to move there from Asia to see dr Enlander for it, and left the US because my lease was up and I was in too big of a mess to move somewhere cheaper at the time. Before I left I desperately asked around for ANYONE who got vistide in the US but everyone I heard from was from Dr Peterson's--there was absolutely NO ONE else it seemed in the US who would give it. So I hope members will understand if I try to ask again whether there is anyone here who is also on vistide or knows someone who is--there is now a big possibility that I will return to the US but I would really like to hear more testimonies before making such a big move.

Thank you.

 

[Sushi]

vli

It is interesting that Peterson said that cmx001 is being fast-tracked for approval. That would make this class of drug much more available. Really hope it is approved.

Sushi

 

[heapsreal]

vli

It is interesting that Peterson said that cmx001 is being fast-tracked for approval. That would make this class of drug much more available. Really hope it is approved.

Sushi

probably off label for us, so probably expensive. Be good if its approved directly for cfs/me with viral reactivation.

 

[snowathlete]

vli

It is interesting that Peterson said that cmx001 is being fast-tracked for approval. That would make this class of drug much more available. Really hope it is approved.

Sushi

Here is a thing about the fast-tracking

And here is the abstract about Peterson's study:


"Therapeutic potential of cidofovir (HPMPC, VISTIDE) for the treatment
of HHV-6 and/or CMV infections in severely ill patients diagnosed with
chronic fatigue syndrome/myalgic encephalomyelitis"

Gunnar Gottschalk1, Isabel Barao2, Daniel Peterson1
1Sierra Internal Medicine, Incline Village, NV, USA
2University of Nevada, Reno, NV, USA

Objective:
Herpesvirus infections and natural killer (NK) cell
dysfunction may be important in the pathogenesis of Chronic Fatigue
Syndrome/Myalgic Encephalomyelitis (CFS/ME) in a subset of patients.
Cidofovir has broadspectrum activity against many DNA viruses
including the Beta-herpesviruses human herpesvirus 6 (HHV-6) and human
cytomegalovirus (HCMV). In this study, we proposed:
1) to determine the effect of cidofovir treatment on physical and cognitive
functioning and NK cell function in CFS/ME patients with laboratory
results suggestive of HHV-6 and HCMV infections; and
2) to evaluate the tolerability and safety of Cidofovir treatment.

Methods:
From January 2005 to December 2012, we prospectively
evaluated 65 severely ill CFS/ME patients who underwent Cidofovir
treatment (intravenous; 5mg/Kg, every other week) in our clinic.

Patients were tested for exercise tolerance (time on treadmill and
oxygen consumption – VO2 Max) and signs of possible herpesvirus
infection in blood via polymerase chain reaction (PCR) and antigenemia
assays, before and after treatment.
NK cell function was determined by a NK cell lytic unit (LU30) assay.
The tolerability of Cidofovir was assessed by standard blood chemistry tests.

Results:
46/65 (70%) patients had a partial or full response to
treatment. Of this group 27/46 (56%) presented with a full response to
treatment and were able to return to work and/or daily activities.
Increases in VO2 and in NK cell function were observed. There were
6/65 (9%) patients who stopped taking the drug due to adverse events,
5/65 (8%) patients who were “lost to follow up,” and 8/65 individuals
(12%) who were non-responders to the drug. In general, Cidofovir was
well tolerated.

Conclusions:
An expanded study is indicated to confirm these initial
results and explore new combination therapies for the treatment of
this subset of patients diagnosed with CFS/ME.

Sounds promising, particularly because the drug has quite a broad spectrum.

 

[Ember]

And here is the abstract about Peterson's study:

Thanks! Where is this published?

 

[maryb]

Does it say anywhere how long each patient was on the drug? Not 7yrs surely.

 

[vli]

Does it say anywhere how long each patient was on the drug? Not 7yrs surely.

Yes this would be extremely helpful information.

 

[Ember]

Does it say anywhere how long each patient was on the drug? Not 7yrs surely.

Sample Cases:

• A 27 year old college graduate unable to work because of constant flu-like symptoms, weakness and marked cognitive decline (math!) presented with low NK functioning, low VO2 max and HHV6 and cytomegalovirus infection. He was able to return to work after 24 weeks of bi-weekly infusions. His VO2 max on the exercise test went up went up 23%, his NK cells a remarkable 400% and he tested negative for both viruses at the end of treatment. He had had ME/CFS for three years.

• A 54 year-old former high school teacher unable to work due to extreme fatigue, flu-like symptoms and cognitive problems severe enough to keep him from being able to grade his students papers presented with active HHV6 and cytomegalovirus infections and low NK cell functioning and VO2 max. He was able to return to work after 24 weeks of bi-weekly infusions. His VO2 max increased 47%, his NK function test went up 20% and he tested negative for both viruses. He had had ME/CFS for five years.

• The third patient had classic, acute onset ME/CFS which progressed to seizures. Both serum and cerebral spinal fluid tested positive for HHV6. At the end of the Cifodovir trial the viral load in his cerebral spinal fluid dropped from 3670 copies/ml to undetectable levels. Serum HHV6 was dramatically reduced (47,000 copies/ml to 3,000 copies/ml). Still symptomatic and experiencing cognitive problems, he was nonetheless able to return to work. (emphasis added)

 

[snowathlete]

Thanks! Where is this published?

not sure if it was published in a proper journal, or just in the HHV6 conference booklet, which is where i got the abstract from.

 

[vli]

thx Ember for that but I'm not sure that's entirely representative though. Since he cited the time periods for two patients, I can also cite two Peterson patients who told me they had to be on Vis for MUCH longer than 24 wks, in one case twice as long, in another even longer. If two patients told me directly that they had to be on vistide longer than the above cases, I think that balances out the impression that "24 weeks does it".

 

[Tristen]

I don't know all the stats about others on Vistide and in that study, but my impression was that not everyone was on the drug for the same length of time.....it's somewhere between 6 months and 1 year, depending on several factors of which I'm not fully privy. I was on it for a full year, which I'm pretty sure was the max.

Be glad when the cmx001 is out because the Vistide tx is not only dangerous, but also very involved. For me, it was worth it.

http://simmaronresearch.com/2013/04...mecfs-patients-with-hhv6-and-hcmv-infections/

 

[vli]

In light of what presented in Paris, could anyone (in particular any Dr Peterson patients???) comment on this? http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm340094.htm

I have called up Gilead and they said they could not tell me either IF or WHEN they would have it again. By "if", I meant that I tried to extract some statement from them as to whether they'd resume making vistide in the future, however far off that may be. The fact that they refuse to even state that they would make it again is rather worrying to me as it means they want to preserve the possibility that they would never make it again. Otherwise, why should there be any doubt in their response as to whether they'd supply it again?

 

[snowathlete]

In light of what presented in Paris, could anyone (in particular any Dr Peterson patients???) comment on this? http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm340094.htm

I have called up Gilead and they said they could not tell me either IF or WHEN they would have it again. By "if", I meant that I tried to extract some statement from them as to whether they'd resume making vistide in the future, however far off that may be. The fact that they refuse to even state that they would make it again is rather worrying to me as it means they want to preserve the possibility that they would never make it again. Otherwise, why should there be any doubt in their response as to whether they'd supply it again?

Sounds like only a specific batch has been recalled? Perhaps the latest lot? In which case you would expect them to just fix the manufacturing problem and resume making it. Must be something else going on.

 

[maryb]

Thanks for the info ember.

 

[heapsreal]

does drP prescribe valcyte much anymore though? but now leaning towards the visi as is getting better results.
Are these nk function tests improving purely from visi reducing viral infections?? or is dr P using something else for immune system, i think he is a fan of gamaglobulin?

 

[vli]

yes heaps on that cfsalert video that right nowi don't have the link to, we saw that a vis patient of his describing getting gamma...and calling it a "gift". but i have to re-read his findings carefully, because when you're studying the effect of one thing like that surely you can't introduce other things or else how do u know what's doing what??

 

[Tristen]

does drP prescribe valcyte much anymore though? but now leaning towards the visi as is getting better results.
Are these nk function tests improving purely from visi reducing viral infections?? or is dr P using something else for immune system, i think he is a fan of gamaglobulin?

Hiya Heaps,

My NK function went from 1 before then up to 28 after the Vistide (still low, but improved), but then with follow up maybe like 6 months later off Tx, it was back down to 4. Yet, I didn't relapse the progress made symptomatically, or with other immune parameters (ie, IL 6,8, elastace, TNF, RnaseL, etc, were all absurdly high before Tx, and also remain closer to normal now). Looking at my immune labs, the NK function does not seem connected to symptom severity, at least not immediately. I haven't done another one in over a year now.....prolly do one when I see him next month.

I didn't get the gamma, or any other tx along with the Vistide, except for IV amino acids (AA), also for that entire year. I felt relief after each AA infusion too. He said I needed the AA's to assist with brain healing.

No idea how much he uses Valcyte. My impression is that it doesn't work as well as Vistide, at least for CMV which is what I was being treated for. I have remained negative for the HHV6 &7 all along. The CMV was very high.

 

[patient.journey]

http://simmaronresearch.com/2013/04...mecfs-patients-with-hhv6-and-hcmv-infections/

These results show objective endpoints, subset selection, and recovery. There were complete responders and partial responders among severely ill CFS patients with HHV6 or CMV. These are encouraging results for this subset and further well-designed trials should be pursued to confirm them.” Dr. Dan Peterson​

At the HHV6 Conference in Paris, France today Dr. Peterson reported on the results of a retrospective study following 65 severely ill chronic fatigue syndrome patients given a course of Vistide from 2005-2012 for HHV6 and/or HCMV infections. Despite the interest in pathogens in ME/CFS, antiviral studies are rare and this is the first one reported for this drug.

 

[vli]

Sounds like only a specific batch has been recalled? Perhaps the latest lot? In which case you would expect them to just fix the manufacturing problem and resume making it. Must be something else going on.

I can confirm to anyone outside US: no Vistide until further notice.

I've just spent the last hour reeling from a call I made to my sourcing company that says the six mos' supply they said had for me was in fact non-existent. The recall was 15/2/13, it's now the end of april. I don't expect to be able to get any vistide at all in the near future.

I cannot put into words the despair I am feeling, as I'd been counting on this for three months while also trying valcyte and doing terrible on it. I was already bedridden at half tabs every three or four days, so it's just dawning on me now that I'll have to go back to being bedbound until God knows whenever vistide again becomes available.