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| Experimental & Alternative treatments: Alternative therapies: Kutapressin, Kutapressin is a drug which consists of processed extract from porcine livers that contain peptides. Nexco Pharmaceuticals has introduced a generic form of kutapressin, called Nexavir, which is based on the original formula. Kutapressin has demonstrated efficacy against HHV-6 in a 1994 in-vitro study (Ablashi, Berneman et al. 1994) as it inhibited replication by over 90% and has also been used in the treatment of patients with herpes zoster. Results of uncontrolled studies have indicated that treatment with kutapressin results in the abatement of symptoms among many patients with CFS. Kutapressin has also improved the NK cell function in CFS patients. Ampligen,is a mismatched double-stranded RNA with broad antiviral and immunomodulatory properties produced by Hemispherx Biopharma, Inc. Hemispherx recently completed Phase III trials for Ampligen as a treatment for CFS and is currently pursuing FDA approval of the product. In a 1994 study, Ampligen was found to inhibit replication of HHV-6A in in-vitro testing at concentrations of 100 and 200 pg/ml (Ablashi, Berneman et al 1994). When the Ampligen was removed from the virus-infected cell culture, HHV-6 infection reappeared slowly but never reached the same level as before. No toxicity of the cells was noted. In a 1995 randomized, double-blinded placebo controlled study (Strayer et al) of CFS patients, patients on Ampligen had improved Karnofsky performance scores, increased capacity for daily living (ADL), reduced cognitive impairment and improved work on the treadmill. Patients on Ampligen also required less medication to control their symptoms. In 1994, Sudaholnik evaluated the 2-5A and RNAase L levels in 15 CFS patients before and after Ampligen treatment compared to healthy controls. Patients had lower levels of 2-5A and increased levels of RNAase L activity. Therapy with Ampligen resulted in significant downregulation of the 2-5A/RNAase L pathway. Also the levels of HHV-6 replication in PBMCs significantly decreased after treatment. For additional information regarding Ampligen, please refer to: http://www.hemispherx.net/content/rnd/drug_candidates.htm Whey protein ImmunoPro(which enhances glutathione production) was found to inhibit HHV-6 in testing done at Advanced Biotechnologies (Ablashi et al. unpublished data). Further, it was found to reduce the toxicity of foscarnet and potentiate the foscarnet (thus reducing the amount of dose administered) when the two were tested together. Of course, clinical trials are necessary to determine if there is any clinical benefit. Isoprinosine Isoprinosine is a synthetic purine derivative licensed in 1971 that exhibits both immune modulating and antiviral properties. Isoprinosine modulates T cell and NK function (Diaz-Mitoma et al., 2003). Isoprinosine did not exhibit side effects in safety studies or post-marketing experience (Diaz-Mitoma et al, 2003). Isoprinosine has been used by physicians in Europe for CFS patients with evidence of active HHV-6 infection, although no in vitro efficacy studies have been done specifically for HHV-6 infections. Isoprinosine is not currently available in the United States. Immunoglobulin Study results using intravenous immunoglobulin (IVIG) for treatment of CFS have been mixed. Several clinical studies have been done in patients with CFS utilizing IVIG compared to placebo. One double-blind, placebo controlled study of 30 CFS patients (Peterson et al. 1990) did not demonstrate symptom amelioration or improvement in functional status. A similar study of 99 CFS patients from Australia (Vollmet-Conna, 1997) also showed lack of statistically significant benefit of IVIG compared to albumen. However, another randomized, double-blinded study (Lloyd et al., 1990) comparing monthly high-dose IVIG (2 g/kg) versus placebo showed improvement as defined by decrease in symptoms, increased functional status and improved immunologic measures. A study of relapsing/remitting MS patients (Fazekas et al., 1997) compared IVIG at smaller doses (0.15-0.2 mg/kg) to placebo. In this 150 patient study benefits were noted in the IVIG group as measured by the Kurtzke expanded disability status score. Over 90% of immunoglobulin batches tested by Dr. Sudhir Gupta of at University of California, Irvine contained IgG antibody to both HHV-6 and EBV at levels sufficient to inhibit the cell free virus. While the reasons for the discrepancies among these studies remains unclear, it is thought that if humoral immunity is more important than cell mediated immunity to control an HHV-6 infection then IVIG would be a valuable treatment. IVIG is also expensive and is associated with a variety of adverse effects. Interferon: HHV-6 infection induces production of certain cytokines from infected macrophages which play a role in controlling and containing the viral infection (Inoue et al, 1993). One of these cytokines, Interferon, has broad antiviral properties and has been shown to have in vitro activity against HHV-6 infections. However there is little information regarding treatment of HHV-6 with any of the three types of interferon. Treatment with alpha interferon has contributed to improved quality of life scores in CFS patients (See & Tilles, 1996). Interferon beta has been used to treat MS patients for over 20 years as it has shown effectiveness in decreasing the progression of the disease and reducing disability (Fillipini, 2003), particularly with relapsing/remitting MS. One group demonstrated in vitro that interferon beta at concentrations of 0.5 ug/ml reduced the replication of HHV-6 in a line of T cells. Additionally, they examined the sera of MS patients treated with interferon beta compared to control MS patients and found that the treatment group had reduced levels of HHV-6 DNA and lower levels of IgM antibody reactivity. The group also noted that the sera obtained after treatment showed decreased levels of HHV-6 DNA as compared to the pretreatment sera. Another study (Alvarez-Lafuente, 2004) evaluated 105 patients with relapsing/remitting who were treated with interferon beta, and compared them to similar patients who were not treated and found that the viral load was twice as high by quantitative PCR in the untreated patients versus the treated cases. These effects were only seen during relapse; no differences were seen when patients were in remission. Additionally, all cases of HHV-6 were variant A. Thus, interferon beta may exert some of the same antiviral properties exhibited in HHV-6 treatment as for MS. Interferon therapy is associated with several adverse effects including fever, fatigue, myalgia, nausea, and headache, among others (Fillipini, 2003) Transfer factor: Transfer factor (TF) is a molecule that can transfer cell-mediated immunity from an immune donor to a non-immune recipient. TF seems to have the properties of a cytokine that can induce an immune response in the recipient. While TF is antigen specific, it is not species specific and can thus be transferred from one species to another without an allergic reaction in the recipient. There are several potential sources of TF; one of the most common is and accessible is bovine colostrums (Jones, 2003).
Few studies have been published regarding the efficacy of TF. One study described 28 patients given TF from bovine colostrum with specific activity for HHV-6 compared to 10 patients who were given TF devoid of activity for HHV-6. The group given the HHV-6-specific TF showed significant improvement in symptom s as well as improved NK immune function compared to the placebo group (Fudenberg and Pizza, 1989; Brewer and Wilson, 2003). Another report (Ablashi et al, 1996) was published on the treatment of two CFS patients with active HHV-6 infections treated with HHV-6 specific TF. One patient improved rapidly and resumed normal activities and the other patient did not improve. These studies, among others, have reported no adverse effects from the use of TF. However, if the patient is lactose intolerant he or she should not use the TF from colostrums but find another source of HHV-6 specific TF, such as human cell line. While the data for TF in the treatment of HHV-6 infection is limited, it may be an attractive option that warrants further investigation as it has proven to be an effective therapy in some cases and has a clean safety record. See Experimental & Alternative Treatments DISCLAIMER: The HHV-6 Foundation is not in the business of the practice of medicine and does not intend to give medical advice regarding diagnosis or treatment of any medical condition. Please consult your physician regarding the diagnosis or treatment of any personal medical condition.
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