Our experience with antiretrovirals

Two months shy of three years, I discontinued antiretrovirals, began after receiving reports of positive XMRV cultures from VIP Dx in January 2010. Ali and I started AZT and Isentress in March 2010, added Viread in May 2010, discontinued AZT in Feb 2011. I discontinued Isentress in August 2011 and remained on Viread monotherapy until two weeks ago. Ali continues on Viread and Isentress. We also tried the protease inhibitor Lexiva, and I tried it a second time, but didn’t tolerate it.

We both improved for the first year, but it wasn’t a clean experiment, as I’ve said all along. We did other things concurrently. When we started, I thought we’d ride on the coattails of HIV and have viral load measures in a year or two. We sent lots of blood to the WPI and Dr. Mikovits was studying us, but the specific results were never shared with me and are now lost, with the rest of Dr. Mikovits’ data.

We stopped AZT after 11 months, with no way to monitor, to prevent long term toxicity. Neither of us noticed much of anything coming off of it. By the summer of 2011, I knew there would be no help with monitoring and came off Isentress in anticipation of our both stopping the drugs. I wanted to see what happened to me first, before Ali came off. I tried to stop Viread shortly after. Nothing noticeable happened when I stopped Isentress, but I felt worse after a few days of stopping Viread, better when I went back on. I did that two other times by the first part of 2012, with the same results.

Meanwhile, Ali continued to go uphill. Me not so much. In hindsight, I wish I had not stopped Isentress, since Ali continued to improve and I didn’t. I functioned fairly well, with lots of travel and stress, through my last trip to Hawaii in October, but then crashed pretty hard. By Christmas I was feeling very poorly. I always say, when things go south, stop the drugs, so I did. Since then, I am feeling a little better. I am having less nausea than I was having on Viread, but my nausea predated arv’s by several years and when I went on arv’s, I didn’t think it was worse. I am now on only Cozaar, baby aspirin and hormones. As I got sicker, I my tolerance for Deplin lessened, interestingly, and I am now taking an OTC dose of Folapro 800mcg once per day. I have increased nutriceutical and nutritional support, am doing biofeedback, and am about at my October baseline, I’d say.

Here’s an interesting paper about raltegravir, though reactivated Herpesviruses are not a part of our clinical picture: A Drug Against AIDS Could Be Effective Against The Herpesvirus and here’s the paper: Structure and inhibition of herpesvirus DNA packaging terminase nuclease domain. It isn’t new, but I hadn’t seen it before. Here’s a new one: Biochemical, inhibition and inhibitor resistance studies of xenotropic murine leukemia virus-related virus reverse transcriptase:

We demonstrated that XMRV RT mutants K103R and Q190M, which are equivalent to HIV-1 mutants that are resistant to tenofovir (K65R) and AZT (Q151M), are also resistant to the respective drugs, suggesting that XMRV can acquire resistance to these compounds through the decreased incorporation mechanism reported in HIV-1.

So there are still scientists working on this really creepy virus that was created in a lab and infects human cells, but fortunately, not particularly well, though the statement below is not very comforting. Severe Restriction of Xenotropic Murine Leukemia Virus-Related Virus Replication and Spread in Cultured Human Peripheral Blood Mononuclear Cells:

In summary, our results show that XMRV replication and spread is severely restricted in PBMCs, but these cells can serve as a reservoir for generation of infectious virus that can potentially spread to cells that express low levels of these restriction factors.

It’s good for us that they are still studying it, because, although we don’t have XMRV, we still may have something very much like it. I still find the extreme resistance to trying HIV drugs for something besides HIV to be completely bizarre. AIDS drugs have been noted to be useful on occasion for Sjogren’s, MS and HTLV, but then generally nobody follows up even so. Here is the latest reference on clinical trials for HTLV associated leukemia: Clinical Trials and Treatment of ATL. I aways find it disheartening to read about HTLV, because it has been neglected for so long, even though it was isolated by Bernard Poiesz, Francis Ruscetti and their co-workers in Gallo’s lab over 30 years ago.

Speaking of dishearteningly slow progress, look at this paper from 2005: Association of human endogenous retroviruses with multiple sclerosis and possible interactions with herpes viruses. From the abstract: “Gammaretroviral HERV sequences are found in reverse transcriptase-positive virions produced by cultured mononuclear cells from MS patients, and they have been isolated from MS samples of plasma, serum and CSF, and characterised to some extent at the nucleotide, protein/enzyme, virion and immunogenic level.” And this one from 2010: The human endogenous retrovirus link between genes and environment in multiple sclerosis and in multifactorial diseases associating neuroinflammation. “In particular, certain viruses transactivate promoters from endogenous retroviral family type W (HERV-W). HERV-W RNA was first isolated in circulating viral particles (Multiple Sclerosis-associated RetroViral element, MSRV) that have been associated with the evolution and prognosis of multiple sclerosis. HERV-W elements encode a powerful immunopathogenic envelope protein (ENV) that activates a pro-inflammatory and autoimmune cascade through interaction with Toll-like receptor 4 on immune cells. This ENV protein has repeatedly been detected in MS brain lesions and may be involved in other diseases.” But nobody wants to try antiretrovirals on these patients?

Why is it such a stretch that the concepts learned from the AIDS epidemic could have vast utility beyond the treatment of that one well funded infection. Where are the drug companies??? We don’t have specific drugs and we don’t have any way to monitor the effects of the drugs we do have. So we are effectively stopped from studying something promising. A good percentage of the people who tried antiretrovirals experienced mild to moderate improvement for a period of time. Very little harm happened, even though it was a completely random and uncontrolled experiment. The drugs are not scary compared to many drugs that are given to ME/CFS patients every day. I can tell you there is a lot more possibility of harm from the SSRI’s, pain and sleep meds which are routinely offered, with no chance of positively impacting the disease process.

So, we as a community paid VIP Dx a bunch of money to tell lots of us we had XMRV. They are lucky the damages were only financial and not large enough individually for anybody to spend the effort to recover. Several people have sent me this: Transcribed  and posted on MECFS forums from Mass CFIDS/ME & FM Association’s Fall 2012 Lecture: (YouTube video of lecture by Dr. Byron Hyde)

Byron Hyde: The other thing he [Lombardi] says is that he studied under Dr. Suhadolnik at Temple University. So I picked up the phone and I [Hyde] phoned Robert [Suhadolnik] – who is a wonderful wonderful researcher man – and I said: ‘Tell me about Lombardi – who studied Chronic fatigue Syndrome under you and did research with you’.

He [Suhadolnik] said: ‘He never did’.

I said: ‘Oh ? What do you mean he never did ?’

[Suhaldolnik:] ‘Well, he came here for a few days and I got rid of him because he was a nuisance and he didn’t knew what he was doing and that was it.’

…one minute later:

Byron Hyde: I figure they (WPI) made somewhere between two and three million dollars on that [XMRV-test]. People all over Europe, people all over Canada, the United States, were sending their blood in. The other thing which is interesting is the Whittemore-Peterson advertises as a charitable institute. It is not a charitable institute. It’s got a Cameo institute on the floor below which is for fee for service. And they are there to make money.

Here is the WPI version: Date: January 6, 2013 (link)

Vincent C. Lombardi, Ph.D., Director of Research (…) He later continued to work in CFS-related research in the laboratory of Dr. Robert Suhadolnik at Temple University, studying the interferon regulated RNase L antiviral pathway and its involvement in CFS. (…)

The bio then goes on to give Lombardi credit for Dr. Mikovits’ ideas. Of course they also give him credit for the collaboration with Silverman. You’d think he wouldn’t be so quick to take credit for that. So let’s see what is left. He got a PhD at University of Nevada, Reno in 2005 and then invested in Redlabs and went to work running tests on humans. What was his dissertation about? When did the training happen that qualified him to be culturing retroviruses from humans? What prior experience did he have running a clinical lab? It would appear that anything he learned after finishing school must have been from Dr. Mikovits. Actually he was already trying to take credit for her ideas when I was there. He took me to breakfast in December 2010 and told me that it was really his discovery. He was rewriting history already, a dishonest post-doc, trying to discredit his mentor to a new colleague.

Please read Larry’s comments after the last blog (link). We were robbed and the WPI is still sucking up all the money. I expected a federal investigation of the lab, holding them accountable for the money they made on the tests, but it hasn’t happened. There seems to be no critical thinking on the part of the government agencies in question. So they have the grants, which will run their multi-year courses, irrespective of whether the money is producing anything meaningful or not. Nevermind that it is a very significant chunk of all the government money available to study our disease and it might be much better used. Why not give that money to Dr. Ruscetti or Dr. Lipkin? Or give it back to Dr. Mikovits, so she can get on with her work, as should have happened in the first place.

Posted last night on Facebook by Joan McParland:


As most patients are aware, Dr. Judy Mikovits has been forced into bankruptcy due to recent unfortunate events. A number of members discussed this issue at our monthly meeting last night and have made a decision to send some financial help to Dr. Mikovits.

The main reason for this action by some members of the support group is to show our support and also in an attempt to return the unreported kind acts and dedication shown to us by Dr. Mikovits on her numerous visits to N. Ireland.

Many more patients, worldwide, who have contacted me recently have also witnessed and benefited from the caring nature of the human being behind the scientist.

As from today, Dr. Mikovits is now free to return to work, we wish her well and hopefully she will be able to continue her dedication to helping find the answers we all so desperately need and deserve.

The entire situation has already been well summed up by Ian Lipkin’s quote below..

“I feel very badly for Mikovits, [her co-author] Ruscetti and Harvey Alter [a hematologist at the NIH Clinical Center in Bethesda, Maryland, who led one of the CFS studies]. Mikovits in particular — she has lost everything. She can be wrong but she’s not a criminal. She has been honest in a respectful, forceful way and said that we have to conclude that we were wrong. You can imagine how difficult it must be, and I think she should be applauded. Lots of people wouldn’t have the balls to do that. She has come across as a scientist who really believes in the importance of truth.”

On a much happier note, Michael Snyderman is still stable on full HAART. Stable cancer for 31 months. No chemo brain. And still no interest from the scientific or medical communities??? It is a travesty.

Dr. Snyderman’s update…

My study so far shows:

1. The combination of AZT+raltegravir has activity but is not sufficient to maintain the response.

2. Tenofovir has activity but is not sufficient to maintain the response.

3. Lopinavir has activity which so far is longer than previous responses. More data is necessary to know how long this drug will work.

4. A trial with more cancer patients is indicated.  We need to know what are the predictors for response and what is the optimal drug combination.  What is learned from cancer patients would potentially be valuable to patients with CFS.

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Tonight’s song: Slip Sliding Away by Simon and Garfunkel