What is Nexavir?
During the 1940s, a product called Kutapressin was licensed to treat acne, cold sores, herpes viruses and other inflammatory viruses. In 1983, Kutapressin was trialled on ME/CFS patients. A company called Schwarz Pharma produced Kutapressin until several years ago when this product was discontinued. A separate company called Nexco Pharma recently reintroduced this same product with a virtually identical composition to Kutapressin under the brand name ‘Nexavir.’ The terms Kutapressin and Nexavir will be used interchangeably in this article.
Nexavir is a porcine liver extract that is the residual product from the process of vitamin B12 extraction. It is composed of peptides and amino acids.
Nexavir Studies
Nexavir has been around for almost 70 years however few studies have been performed on it. I will examine the Nexavir studies relevant to ME/CFS. The first such study was a 1996 study titled ‘Potential in vitro activity of Kutapressin against Epstein-Barr virus.’ The abstract of this study can be found here: http://www.ncbi.nlm.nih.gov/pubmed/8797033 This study determined that Kutapressin can inhibit Epstein-Barr virus in vitro.
The second study to assess the efficacy of Kutapressin was published in 1994 and titled ‘Antiviral activity in vitro of Kutapressin against human herpesvirus-6.’ The abstract of this study can be found here: http://www.ncbi.nlm.nih.gov/pubmed/7893985 This study concluded that Kutapressin has potent and previously unexpected antiviral effects. HHV-6 replication was inhibited in vitro by greater than 90%.
A study was published in the 1990 spring CFIDS Chronicle titled ‘The Treatment of CFIDS with Kutapressin.’ This study can be found here: http://www.me-cvs.nl/index.php?pageid=3423&printlink=true&highlight=cfs This study was not peer reviewed and didn’t contain a control group or placebo treatment. Inclusion in this study required patients to fulfil the Holmes et al. criteria with symptoms present for at least four months. Many secondary tests were performed on this cohort to exclude CFS-related conditions. A large portion of those included in this study (59%) had abnormal EBV-EA IgG titer levels. 80% of this study cohort had CFS for greater than 1 year while 18% of the cohort had CFS for a duration exceeding 6 years.
2ml of Kutapressin was administered daily for ten days followed by three times a week. Out of the 270 study participants, 96% of those receiving more than 40 injections reached remission or near remission status (with few residual symptoms.) 71% of patients receiving 11-40 injections reached remission or near remission status (with few residual symptoms.) This positive correlation of number of injections to treatment efficacy was realised post hoc by the study authors hence not all participants had more than 40 injections. High EBV-EA IgG titer levels were the main biomarker indicating a success of Kutapressin treatment, although patients with normal EBV-EA IgG levels also improved with Kutapressin.
The final study that I will examine is titled ‘Subjective Reduction in Symptoms of Chronic Fatigue Syndrome Following Long-Term Treatment with a Porcine Liver Extract: A Phase 1 Trial.’ Some details of this study can be found here: http://www.ncf-net.org/library/kutreat.html This 1994 study was led by the same two study authors as the previously mentioned 1990 study. Consequentially, the same Holmes criteria were used to select participants and a greater than four months CFS duration was a prerequisite for patient inclusion. There was no control group or placebo treatment in this study. The 130 CFS patients in this study were administered 2ml injections of Kutapressin daily for 25 days, then every second day for 50 days followed by three times a week for 105 days. In total, the participants had 95 injections over a period of 180 days. Of the 180 CFS patients, following Kutapressin treatment 43% reached remission status while 42% reached near remission status (with few residual symptoms.) The authors concluded that Kutapressin subjectively decreased the clinical symptoms of the majority of CFS patients.
Nexavir’s Possible Mechanisms of Action on ME/CFS Patients
Nexavir may improve ME/CFS symptoms because it:
- Inhibits EBV
- Inhibit HHV-6
- Is anti-inflammatory
- Is antiviral
- Is an immunomodulator (Nexavir may help shift the immune system away from Th2 dominance.)
- Enhances blood flow in the brain (as measured by a SPECT scan.) This increased rate of blood flow may be a consequence of the Bradykinin effect which involves dilation of the blood vessels.
Side Effects
Nexavir has been used to treat a variety of conditions for almost 70 years and is widely regarded as safe. Some physicians that are reluctant to prescribe antivirals such as Valtrex and Famvir due to possible side effects instead prescribe Nexavir as a safer alternative.
The 1990 study titled ‘The Treatment of CFIDS with Kutapressin’ contained 270 CFS patients and involved the administration of 8,900 injections of Kutapressin. This study only noted one adverse reaction to Kutapressin in which the patient believed that they had new symptoms and observed a deterioration of functioning immediately following injections.
The 1994 study titled ‘Subjective Reduction in Symptoms of Chronic Fatigue Syndrome Following Long-Term Treatment with a Porcine Liver Extract: A Phase 1 Trial’ also examined the side effects of Kutapressin injections. Out of the 130 CFS patients, only 21 had minor side effects. Out of the 21 patients experiencing mild side effects, 16 reached a remission or near remission of their CFS.
Nexavir is contraindicated in those with an intolerance or hypersensitivity to liver or pork products. Nexavir contains tyramine and therefore cannot be used by patients taking MAO inhibitors. The tyramine may also cause migraines in a small portion of patients. Nexavir also contains phenol which may cause an allergic reaction in some users. Like with all injections; rashes, swelling, pain and stinging may occur at the injection site. Anecdotal reports online indicate that many users of Nexavir experience bruising at the injection site and therefore must vary the specific injection location.
ME/CFS specialists’ opinions on Nexavir
I will now present what an eclectic range of ME/CFS specialists’ thoughts are regarding Nexavir as an ME/CFS treatment. I have attempted to gather the most up-to-date viewpoints of these specialists however due to the perpetually evolving nature of ME/CFS treatments, some of these opinions may now be outdated.
Dr. De Meirleir
Dr. De Meirleir performed a study involving the administration of Nexavir or a placebo to ME/CFS patients. 63% of those ME/CFS patients in the treatment group responded to Nexavir while only 17% of those ME/CFS patients in the placebo group responded. Dr. De Meirleir finds that approximately 50% of his patients are pain free after 2-3 months of Nexavir injections. His patients generally experience a normalisation of sleep within 3 days of commencing Nexavir. Approximately 70% of Dr. De Meirleir’s patients experience a 20+ point increase (based on the Karnovsky scale) as a consequence of taking Nexavir
Dr. Cheney
Dr Cheney formerly recommended Kutapressin as a treatment for ME/CFS. He stated that it is analogous to a weaker form of Ampligen. In the past Dr Cheney used Kutapressin/Nexavir injections however at some staged preferred using the gel form of Nexavir. He has also stated that his patients generally experience a 20-80% improvement as a consequence of taking Nexavir gel and secondary treatments. ‘ECHO terrain maps’ now mainly influence Dr Cheney’s ME/CFS protocol and he has consequentially stopped prescribing Nexavir. He now uses his own mix of five cell signalling factors instead of Nexavir. These are; porcine brain, bison liver, bison heart, bison kidney and bison pancreas.
Dr. Enlander
Dr. Enlander used Kutapressin for approximately 12 years until Schwarz Pharma ceased producing it. He then originally tried Nexavir on his patients however due to the preservatives within Nexavir, he trialled his patients on Hepapressin. Hepapressin is similar to Nexavir however it is an Argentinean bovine liver extract, as opposed to porcine liver extract. Dr. Enlander recommends that his patients take other substances in tandem with Hepapressin to increase its effectiveness. 67% of his patients have shown an improvement as a consequence of weekly Hepapressin injections in combination with other treatments. Recently, Dr. Enlander commenced a study alongside Dr. De Meirleir that examined alternative ways to administer Nexavir/Hepapressin.
Dr Teitelbaum
Dr. Teitelbaum has noticed a dramatic improvement in some of his CFS patients as a consequence of taking Nexavir regularly. He has found that those patients who took Nexavir three times a week didn’t gain much benefit as daily injections are a necessity. Dr. Teitelbaum has also observed that some of his patients’ CFS symptoms returned after discontinuing Nexavir.
Dr. Lapp
Dr. Lapp provided almost every ME/CFS patient that made an appointment with him, the opportunity to try Kutapressin. He has labelled it as a “wonderful alternative.” Dr. Lapp has stated that Nexavir was handmade for CFS patients with the main arguments against taking it being the cost and the necessary frequency of the ‘painful’ injections.
Combining Nexavir with Other Treatments
Many specialists combine Nexavir with other treatments to either increase the efficacy of Nexavir itself or through the means of multiple treatments increasing the chances of a successful treatment.
- Dr. De Meirleir often uses Nexavir in combination with vitamin B12 injections. He recommends 10mgs of B12 (either methylcobalamin or hydroxocobalamin) be administered twice a week.
- Dr. Enlander combines Hepapressin injections with injectable; magnesium sulphate, folic acid, B12, calphosan, glutathione and trace elements.
- Dr. Cheney (who no longer recommends Nexavir) formerly found combining Nexavir gel with Hawthorn leaf and flower an effective treatment.
- Some anecdotal reports indicate that combining Nexavir with other, more traditional prescription antivirals may increase the efficacy of Nexavir or one of the other antivirals.
How to take Nexavir?
Nexavir is to be administered by either subcutaneous or intramuscular injection. Different ME/CFS specialists have various protocols regarding dosage and frequency of Nexavir injection however the most commonly recommended dosage is 2ml administered daily. Some patients may experience a herxheimer type reaction on a 2ml starting dose hence it may be wise to work up to a 2ml dose. Dr Cheney (when he prescribed Nexavir) recommended that the dose be varied between 1 and 4 cc a day. Nexavir should be taken for at least 6 months to determine whether it may be an effective treatment.
Other Details
A prescription is required to purchase the injectable form of Nexavir. The only company that manufactures Nexavir is a Texan company called Nexco Pharma. A Texas pharmacy called Village Compounding produces Nexavir compounded as a transdermal gel. A prescription is also required for this Nexavir gel. Nexavir should not be confused with ‘Nexavar,’ a drug that treats certain cancers.
Negatives of taking Nexavir
The main negative of taking Nexavir is the cost. At 2ml a day (the standard dose), Nexavir will cost approximately US$450 a month. As the minimum recommended treatment period of Nexavir is 6 months (barring side effects), the total cost of a Nexavir trial is approximately US $2,700. This is not including the cost of shipping, syringes or needles. Some insurance companies may partially cover the cost of Nexavir.
Another negative of taking Nexavir involves the cumbersome daily injections. These have been described by some Nexavir uses as “painful.” The final potential negative of using Nexavir as an ME/CFS treatment involves the possible side effects (mentioned in an earlier section.) While the likelihood of experiencing these side effects seems to be minimal, the possibility exists.
My Nexavir Protocol
I will begin Nexavir injections in the coming week. I will start at a 2ml daily dose and keep this dose static for 1-2 months. Depending on whether Nexavir has any effect on my ME/CFS symptoms, I may then begin to pulse the Nexavir dose. I may also attempt to combine Nexavir with other treatments to increase its efficacy. I will update this blog to detail any effects Nexavir has on my illness.
Conclusion
Nexavir/Kutapressin boast some of the most successful study results of CFS treatments. Although the heterogeneity of CFS makes transposing CFS study results often problematic. The efficacy of Nexavir in tandem with the low possibility of side effects makes Nexavir (or one of its related derivatives) one of the primary ME/CFS treatments utilised by a multitude of specialists.
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