A Regime for Antiretroviral Treatment of Myalgic Encephalomyelitis

Arztanfragen - Mein Therapieregime für die antiretrovirale Behandlung bei Myalgischer Enzephalomyelitis |date=http://meversuscfs.blogspot.com/2018/06/arztanfragen-mein-therapieregime-fur.html |date=Katharina Voss, Copyright 2018 (Author of a German textbook on ME entitled |date="ME - Myalgische Enzephalomyelitis vs. Chronic Fatigue Syndrom: Fakten Hintergründe Forschung", tredition 2017) |date=Saturday, June 9th, 2018 |date= |date=Doctor Inquiries - My Therapy Regime for Antiretroviral Treatment of Myalgic Encephalomyelitis |date===Introduction== |date=I receive numerous inquiries from doctors at home and abroad who have been made aware of my |date=blog post about the successful antiretroviral therapy (ART) of my ME afflicted daughter by their |date=patients suffering from Myalgic Encephalomyelitis (ME). These physicians are interested in my |date=therapy regime developed by me for my daughter and sometimes also want to clarify further |date=questions about ART for ME. |date=Until now I responded to these questions individually. In order to spare myself this |date=constantly growing (unpaid) work in the future, but above all to also involve patients in this |date=therapeutic concept and make my method comprehensible to them, I have now decided to publish |date=my so far very successful treatment strategy. Unfortunately, I also had to realize that not all doctors |date=who contacted me have been taking my notes on the urgency and frequency of blood and urine |date=testing seriously. My proposals on dosage and accompanying treatments do not seem to always be |date=taken seriously either. By publishing my concept, every patient can now get an idea and decide for |date=oneself whether to accept my suggestions. |date= |date='''As a matter of principle, however, I would like to state in advance that these are by no means |date=medical recommendations or advice, but merely suggestions based on the experience I and other |date=patients have gathered and on my intensive research of literature on the subject. In addition I refer |date=to my disclaimer.''' |date= |date===ART for ME== |date=Treatment with antiretroviral drugs (ARV) for ME is above all based on research by Judy Mikovits |date=et al., who - like several other researchers - found a human gamma-retrovirus (HGRV) in the blood |date=of ME patients (see my blog post). Eligible ARVs for treatment of HGRV infection are AZT, |date=Tenofovir and Raltegravir. The profile of side effects of AZT, however, is much more severe than |date=that of the reverse transcriptase inhibitor Tenofovir. Since the proliferation of infected cells must |date=first be stopped, it is advisable - at least according to Dr. Judy Mikovits and the experience of |date=patients treated with ART - to start treatment with Tenofovir and add the integrase inhibitor |date=Raltegravir later, if required at all. |date=Some patients treated by Dr John Chia also reported successful ART with nucleoside reverse |date=transcriptase inhibitor Lamivudine. In addition, I received reports of patients who have been |date=successfully treated with Truvada, a combination drug containing Tenofovir and used in Pre- |date=exposure Prophylaxis (PrEP). |date= |date=Since retrovirus research in ME is undermined for various reasons (see my book ME - Myalgische Enzephalomyelitis vs. Chronic Fatigue Syndrom - Fakten Hintergründe Forschung), there are unfortunately no tests that could serve as a reliable indicator for ART. One could potentially look |date=for reduced NK cell activity, a defect in antiviral enzyme RNase L, increased HHV-6 titers and |date=proliferation of Anellovirus in plasma. |date=While such tests may facilitate the identification of responders, this is hardly a certain method, as |date=valid examinations are still absent. |date=Even SG-PERT, a testing procedure that quantifies reverse transcriptase activity and can, for |date=example, be performed at the Nationales Referenzzentrum für Retroviren, unfortunately does not |date=indicate whether one is a responder. This was demonstrated by our and other patients' experiences. |date=Perhaps this test does not detect the possibly ultra low-level activity of an HGRV reverse |date=transcriptase enzyme? |date= |date=Even if one is not a supporter of the retrovirus causation hypothesis, Tenofovir could still be |date=contemplated as a treatment option for ME patients, as it has immunomodulatory properties and |date=acts as an anti-inflammatory agent - at least in patients with proven retrovirus infection. |date=However, since experience to date shows that an integrase inhibitor usually needs to be added after |date=a while in order for the patient to continue making progress, there is some evidence to suggest that |date=the efficacy of Tenofovir in ME patients is due less to its anti-inflammatory and immunomodulatory |date=properties than to inhibition of retrovirus replication. |date= |date===ART for ME: Preconditions== |date=According to the current state of knowledge, it can generally be assumed that only those patients |date=who meet the International Consensus Criteria will benefit from ART (Carruthers et al. 2011, here a |date=short version of the criteria in German). These are patients whose main symptom is not tiredness or |date=generalized fatigue, but a pathological muscle exhaustibility resulting in neuro-immunological |date=exacerbation (PENE) even after slight exertion. (More on ME in my book) |date= |date=In any case, if the attending physician is inexperienced in treatment with ART, cooperation with an |date=HIV specialist is essential in order to better assess potential risks and side effects. |date= |date===Laboratory controls== |date=Before starting any monotherapy with an ARV, it is imperative that both an HIV test and a Hepatitis |date=B test are carried out. This is important not only to prevent the development of drug resistance in |date=the case of actual infection with HIV or Hepatitis B, but also to provide documentation to health |date=insurance if one intends to lay claim to payment of Viread. |date=The following further examinations are necessary before therapy and for follow-up (since I do not |date=guarantee the comprehensiveness of my information and some patients require additional |date=examinations, any necessary examinations should again be discussed with an HIV specialist): |date=*Gamma-GT |date=*GOT |date=*GPT |date=*GFR |date=*creatinine |date=*Large blood count |date=*erythrocytes |date=*leukocytes |date=*thrombocytes |date=*lymphocytes |date=*CD3 cells |date=*CD4 cells |date=*NK cells |date=*potassium |date=*Blood sugar tests |date=*Blood fat levels (total cholesterol and triglycerides, HDL and LDL cholesterol) |date=*Bone metabolism (determination of calcium, phosphate, total protein, albumine in blood) |date=*In order to determine kidney function, a 24-hour urine collection test (+ blood serum) is |date=recommended. |date= |date=All these values must be measured again after 4 weeks of treatment and thereafter be checked at |date=regular intervals, which - in case of known risk - must be carried out either closely or every one to |date=two or three months. |date=When evaluating lab parameters, it must furthermore be taken into account whether and if so |date=which dietary supplements patients are taking. |date= |date===My therapy plan== |date=Now, these are the details of my special treatment concept, which is based on Judy Mikovits', |date=Harvey Alter and Ila Singh's research as well as primarily on my own literature research and |date=considerations. The concept I developed is mainly based on two pillars, on the one hand the |date=unorthodox handling of dosage and on the other hand some very specific additional |date=phytotherapeutic treatments. |date= |date====Dosage=== |date=First, on the unusual handling of dosage, one of the two pillars of my therapy concept. In other |date=retroviral infections, ART is usually started at the full dose that is maintained as long as the patient |date=tolerates the drug well and no resistancies develop. This approach does not seem to work well for |date=severely ill ME patients - according to our experience. The patient who is responding to the drug |date=then does make extremely rapid progress, but also experiences unbearable side effects at the |date=immunological and neurological levels, which eventually force him to discontinue therapy. |date=Subsequently, all progress disappears relatively quickly again, so that the patient is soon as bad as |date=before or - in the case of a progressive course of the disease - increasingly worse again. |date= |date=In contrast to HIV-infected individuals, in which the illness has usually not yet fully broken out |date=when they start treatment, in a severely ill person with ME the full picture of the illness is already |date=apparent. This is probably why these patients are more likely to develop an immune reconstitution |date=syndrome (IRIS) when starting therapy, just like previously untreated HIV-infected patients who |date=have already developed AIDS. In the latter, very low CD4 cell counts, a high viral load prior to |date=commencement of therapy and rapid decrease thereof under treatment seem to be predictors of |date=IRIS. This could be similar in ME patients. |date= |date=IRIS is marked by an aggravation of the infectious or inflammatory process, induced by the start of |date=treatment with ART. Regeneration of the immune system reveals latent infections, which often |date=could not be identified or objectivized beforehand, and may cause severe immunological and |date=neurological symptoms. This is especially applicable for the severely ill who begin treatment at full |date=dosage. Slow, low dose introduction of drugs and dietary supplements is recommended for ME |date=anyway, and it is apparent that the severely ill ME patient's organism will also need to gradually get |date=accustomed to ART in order to avoid severe side effects that could lead to discontinuation of |date=therapy. |date=The basis for the idea of an unorthodox approach to dosage was the certainty that date=retroviruses found in the blood of ME patients by some researchers - unlike HI viruses - replicate |date=only very slowly (cf. my book). |date= |date=That is why - these were my thoughts - resistancies cannot develop as quickly. It was |date=probably a hitherto unique experiment which we started, and it was associated with great risk, |date=because no doctor and no scientist could tell us for sure whether a resistance would not in fact |date=develop when starting at a low dose. To my knowledge, none of the few ME patients who undergo |date=ART had tried this before. But our experiment was worth it, because it shas been successful. |date=However, it is important to know that, according to Dr. Mikovits, one can only start with a low dose |date=if there is no acute co-infection, e.g. because of the risk of resistance emergence. If an acute co- |date=infection is present, it is probably advisable to fight it first and/or to enter ART at full dose, whereas |date=however side effects, as explained, can turn out violently in severely ill patients. |date= |date====Dosage details=== |date=Our experience has shown that severely ill ME patients (Bell scale 0) can apparently start safely |date=with an eighth of a Tenofovir tablet - in our case it was Viread, which contains 245mg Tenofovir disoproxil per pill. Of course, I cannot guarantee whether this will apply to all patients; |date=unfortunately, use of this drug is and for the time being remains an experiment that many do not |date=want to forego, because they have their backs to the wall and are heading for a certain end without |date=treatment. |date= |date=According to our findings, one can take a lot of time with the increase in dose and wait in peace |date=until the organism has adapted to every further small increase. In our case, it took seven months to |date=reach full dose. Patience is therefore required, because significant improvements only occur in most |date=responders after reaching full dose. However, after three to four months of daily intake of 245mg, |date=progress should become apparent. (There is, however, also talk of a patient who only experienced |date=significant improvements after 6 months of Truvada application.) If it has not occurred by then, it |date=can be assumed that the drug is not effective in a patient. The improvement in condition is |date=incidentally often wave-like, with ups and downs, but the overall tendency should be an upwards |date=one. |date= |date=Moderately and mildly ill patients can - according to the experiences of other patients |date=described - presumably enter therapy at a higher dose with rapid increase or immediately at the full |date=dose of 245mg. In that case, faster progress is to be expected if the drug is effective. But even in |date=these patients, significant improvements are usually only to be expected after three to four months |date=(cf. p. 3 here). |date= |date=The first small improvements are sometimes noticeable after a shorter period of time - in some |date=patients also at low doses - but mostly concerning physiological processes, such as improved sleep |date=quality and a return to an intact day/night rhythm, improved blood circulation in the limbs, fewer |date=food intolerances, etc., but sometimes also concerning neurosensory symptoms, e.g. a reduction in |date=sensory hypersensitivity. |date= |date====Risks and side effects=== |date=Patients and doctors must inform themselves about the risks and side effects of ART. Relatively |date=little can be said about side effects, since they differ individually in ME patients. The most |date=important side effects can be found listed in the medication's package inserts. All ME patients have |date=to expect side effects, those affected more severely even more so particularly. However, the mildly |date=and moderately ill should also be prepared for side effects. In particular, immunological reactions |date=occur in responders, such as chills, sore throat, neck and limb pains, elevated temperature, |date=headaches, gastrointestinal symptoms. These immune reactions are also an indicator that the patient |date=is a responder. But as soon as the body has adapted to the dose increase, those symptoms disappear |date=again. |date= |date====Alternative to Viread=== |date=A good alternative to Viread is the proprietary drug Vemlidy (TAF = Tenofovir alafenamid), which has a much better side effect profile, although it is supposed to be equally as potent as Viread. |date=Vemlidy can be taken at its full dose straightaway. It is possible to start out with a smaller dose, too, |date=but it is better to reach full dosage soon to prevent the development of resistance. This is because it |date=contains far less Tenofovir than Viread. |date= |date=Because of its better tolerability, especially with regard to kidney function and bone density, |date=Vemlidy is probably also better suited for older patients. The only catch on Vemlidy - besides the |date=fact that, unlike Viread, it is not yet available as a generic drug - is that it is still relatively new on |date=the market, studies on which integrase inhibitors it can be combined with are still missing and only |date=very few ME patients have had experience with it so far. The interaction between Vemlidy and, for |date=example, the integrase inhibitor Raltegravir, which, as mentioned at the beginning, has to be added |date=at some point, has not yet been investigated, but none is expected. |date= |date====Additional phytotherapeutic treatments=== |date=The other pillar of my treatment concept is the additional administration of antiretrovirally active |date=phytotherapeutics. This has enabled us to successfully prevent the use of a synthetic integrase |date=inhibitor such as Raltegravir and also avoid protease inhibitors required in regular anti-HIV |date=combination therapy. This not only saves a lot of money, but also a range of possible side effects |date=and long-term damage. Furthermore, the risk of resistance development with these phytotherapeutic |date=agents is relatively low. |date= |date=First and foremost Cistus Incanus. Cistus shows broad antiviral activity in vitro with a low risk of |date=virus resistance. It is in a way effective as an entry inhibitor in HIV (Rebensburg et al. 2016) and |date=contains several anti-HIV components. |date= |date=It works at the entry level already, which means that treatment with Cistus blocks the entrance of |date=the virus into the host cell at a very early stage and prevents the docking of virus particles onto |date=cells. This effect provides maximum protection of host cells against virus attack. Many other, |date=synthetic entry inhibitors - according to the study - only take effect at a later stage of the entrance |date=procedure. Cistus, however, already acts as a so-called attachment inhibitor, similar to Pelargonium |date=sidoides, a medicinal plant from South Africa. (Helfer et al. 2014) Cistus is also said to have an |date=advantage over synthetic integrase inhibitors, as it is effective against more HIV genotypes than, for |date=example, Raltegravir. (Cf. also e.g. Depatureaux et al. 2015) |date= |date=On the side, Cistus also effectively fights upper respiratory tract infections, possesses antibacterial, |date=antiviral and antifungal properties and thus also attacks the so numerous but mostly occult |date=infections present in ME patients. It has also shown in vitro growth-inhibiting activity against |date=Borrelia, with which ME patients are often co-infected. |date= |date=In our case, a total of 2100mg of Cistus in capsule form distributed throughout the day has proven |date=to be an effective dose. It is imperative that Cistus be taken with a time gap of at least two hours |date=between it and Viread/Vemlidy. According to our experience, it is probably a good idea to start with |date=Cistus before beginning ART, so that co-infections can be treated in advance. Moreover, this way |date=the organism does not have to get used to two new drugs at the same time. Cistus Incanus is |date=available in capsules and lozenges, for example, the latter can also be used for immunological |date=reactions such as sore throat or fungal infections in the mouth and throat. With all the intolerances |date=that are so common in ME patients, it is probably better to start treatment with Cistus slowly, too |date=and then gradually increase the dose. |date= |date=Reishi (Ganoderma lucidum), recommended to us by Dr. Mikovits, strengthens and activates the |date=immune system and has a number of other interesting properties, especially for ME patients, |date=because Reishi also inhibits EBV activation. In addition, according to my literature research, it is |date=effective against HIV-1 and inhibits HIV-1 protease. That is why we use it as a protease inhibitor; |date=one capsule (500mg) per day. |date= |date=In addition, one can take green tea capsules. Some green tea plant extracts have, according to my |date=research, an inhibitory effect on the activity of the Rauscher mouse leukemia virus, which is related |date=to HGRV in some ways, and also on HIV reverse transcriptase. Green tea contains epigallocatechin- |date=3 gallate, a powerful antioxidant, which thereby also inhibits the replication of HI viruses and could |date=thus potentially be used as an additional therapy for HIV-1 infection. According to Dr. Mikovits, in |date=a way it draws retroviruses from the tissue. We take one 250mg green tea capsule daily. |date= |date=Whether our successful, to my knowledge until now unique experiment with a synthetic reverse |date=transcriptase inhibitor in combination with phytotherapeutic entry, protease and reverse |date=transcriptase inhibitors (unique at least with regard to the - high-dose - use of Cistus Incanus as |date=entry inhibitor and which I consider the most important and effective additional treatment) is |date=applicable to other patients will only become apparent over the course of time. If this does not work |date=for others, chemical integrase inhibitor Raltegravir would most likely have to be added after some |date=time, usually at the latest after one year, namely when progress stagnates or even decline sets in |date=again. |date= |date=Since the research team of the internationally renowned Helmholtz Association of German Research |date=Centres in Munich, which discovered the infection-blocking effect of Cistus against the HI |date=retrovirus, assumes that the antiviral activity of Cistus Incanus will allow for a dose reduction in |date=anti-HIV combination therapies and thus to curb side effects and toxicity risk, it does not seem so |date=far-fetched if I postulate the same infection blocking effect of Cistus against HGRV, which may |date=cause the ME disease. The Helmholtz scientists have, by the way, already filed a world patent |date=application. |date= |date====Raltegravir=== |date=Raltegravir is so far the chemical integrase inhibitor of choice for ME patients. As long as the |date=patient continues to make progress, however, experience to date suggests that it is not necessary to |date=take it. Only when no more progress is being achieved would Raltegravir have to be added. |date=With regard to the dosage of Raltegravir for ME, there are only testimonials from patients, which I |date=can solely reproduce here, as we ourselves - thanks to Cistus Incanus - have not yet gathered any |date=experience with the drug. Raltegravir is described by patients who take it as a very strong drug. It |date=might therefore be advisable to start out with a lower dosage, e.g. half the original dose as well. |date=That would be 200mg in the morning and 200mg in the evening. By the time a patient starts |date=treatment with Raltegravir, one should already be doing reasonably well overall, not least because |date=of possible side effects. |date= |date====Mitochondria=== |date=Most often mitochondrial function is being doctored with all possible means in ME patients - not |date=seldom with the result that the patient is subsequently even worse off. But what if strengthening of |date=the mitochondria leads to cells infected with a possible retrovirus also being strengthened and thus |date=able to multiply even faster? |date= |date=Therefore, it is in my opinion important to first of all gain control over the possible retrovirus and |date=all other, mostly occult viruses and bacterial infections. By the way, mitochondrial function, which |date=is reduced by disease, repairs all by itself through ART - at least this is our experience. |date= |date=That is why strengthening the mitochondrial function while taking synthetic ARV is primarily about |date=buffering potentially harmful effects of the drugs. Time-displaced to Viread/Vemlidy intake, N- |date=acetylcysteine (NAC, caution in case of histamine intolerance!), glutathione or Niacinamide |date=(vitamin B3 flush-free) is suitable for this purpose. |date= |date=Actually, it has been proven in vitro that NAC and glutathione also suppress the replication of HIV- |date=1 and are therefore antiretrovirally active in addition to their mitochdria-strengthening properties. |date=Especially in HIV patients with advanced immunodeficiency, a short-term, high-dose combination |date=treatment with NAC and vitamin C seems to be of therapeutic value. Glutathione deficiency is also |date=common in HIV-infected individuals and therefore administration of NAC seems to be a useful |date=supplementary therapy, not only to increase protection against oxidative stress and improve immune |date=system functionality, but also to promote the detoxification of drugs. |date= |date=Treatment with NAC could therefore also be useful for other diseases in which glutathione |date=deficiency or oxidative stress plays a role (such as ME!) - according to the results of a study on |date=HIV. |date= |date=Niacinamide (vitamin B3), especially nicotinamide riboside, has proven to be a promising treatment |date=strategy for mitochondrial myopathy in animal models. It has beneficial effects on energy |date=metabolism and neuroprotection. |date= |date=But what could be even more crucial: Niacinamide seems to be effective against multi-resistant |date=germs, which even healthy people, but especially ME patients, are often abundantly populated with. |date=A population which a healthy person can usually cope with well could possibly have a devastating |date=effect on weakened ME patients combined with viral loads. With niacinamide flush-free 500mg |date=daily, a dose still below the tolerable upper intake level set by the European Food Safety Authority, |date=a low-cost option for controlling these hospital germs is available. |date= |date====General remarks=== |date=Good vitamin and mineral supplementation during antiretroviral therapy is also important, the usual |date=things to take with ME. Before doing blood tests, various dietary supplements should be |date=discontinued in order not to falsify results. The intake of dietary supplements should always be |date=time-displaced with respect to ARVs. Attention must also be paid to any interactions and whether |date=contraindications are present. Milk thistle (silybum marianum) for liver detoxification is - if |date=tolerated - certainly not wrong either. Besides, patients undergoing treatment with ARV should |date=drink plenty, ideally water, and eat as healthy a diet as possible. Often this is not feasible at the |date=beginning of ART for many ME patients because of the numerous food intolerances present, but |date=those disappear - just like fragrance intolerances - under therapy by themselves - thus our |date=experience at least. |date= |date===Outlooks== |date=Based on the few experiences available so far worldwide, it must be assumed that ART will be a |date=permanent medication. This is also supported by our experiences to date. So there is no talk of a |date=cure, just as little as for HIV patients who are treated with ART. In the case of successful ART, |date=however, even as an ME patient one can expect to be able to lead a reasonably, ideally even quite |date=normal life - at least as long as one tolerates the strong drugs well and does not suffer from too |date=pronounced persistent side effects. |date=Abortion of therapy can lead to a relatively rapid return of the full-blown clinical picture of the |date=disease. Attempts to establish a two-day break every week in order to keep the toxicity risk as low |date=as possible were not effective in our case because a significant deterioration of the condition would |date=occur at the latest on the second day and symptoms would flare up again. |date=Even with very successful ART, a few but not always restrictive symptoms can persist for quite a |date=while. Whether a completely symptom-free life under ART is possible, we are not yet able to say at |date=this time. |date= |date=During recovery, mood swings and a temporary increase in irritability, i.e. a certain overall mood |date=instability, may become apparent. The same has been reported from those recovering from previous |date=epidemics. (Cf. Lancet 1956) Interestingly, these symptoms do not occur at all or only very rarely in |date=many severely ill patients during the illness. Whether they are pathologically caused or only come |date=to light through the attainment of full consciousness about the extent of losses suffered due to |date=disease, which the severely ill cannot fully realize, has not yet been researched. |date=Another hurdle during gradual regeneration is the difficulty of regaining confidence in one's own |date=body. If one has for many years made the experience that any form of stress leads to a deterioration |date=in the condition, adapting is not always easy. But over time, confidence returns, namely when one |date=has often enough experienced that one no longer has to "pay" for physical, mental and emotional |date=efforts with Post-Exertional Neuroimmune Exhaustion (PENE). |date=But one thing you should know before deciding on ART: ARVs aren't candy! We therefore hope that |date=in the not too distant future there will be treatment options that will make the use of synthetic ARVs |date=obsolete. And I already have an idea... |date= |date=This blog entry is dedicated to Dr. Judy Mikovits. |date= |date=Katharina Voss, Copyright 2018 |date= |date=translated with deepl.com by ys |date=