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Clin Ther. 2004 Nov;26(11):1890-4.
Retrospective evaluation of interferon-beta treatment in subacute sclerosing panencephalitis.
Anlar B, Aydin OF, Guven A, Sonmez FM, Kose G, Herguner O.
Hacettepe University, Department of Pediatric Neurology, Ankara, Turkey.

BACKGROUND: Few effective treatment methods are available for subacute sclerosing panencephalitis (SSPE),an infection associated with the measles virus. Interferons have shown some benefit in previous studies and clinical practice. OBJECTIVE: The purpose of this study was to compare the efficacy of 2 different regimens of interferon-beta(IFN-beta) in the treatment of SSPE in pediatric patients. METHODS: We retrospectively compared the results obtained with 2 regimens of IFN-beta1a: 60 microg administered intramuscularly once weekly (IFN-beta 1/wk), or 22 microg administered subcutaneously 3 times per week (IFN-beta 3/wk). All patients also received oral inosiplex 50 to 100 mg/kg daily, a treatment known to have partial efficacy in SSPE. Patients who continued treatment for at least 3 months and had at least 1 year of follow-up data were evaluated. Clinical parameters included the Neurological Disability Index (NDI), a measurement of mental, motor, and sensory functions; disease stage; and mental status. Data obtained at 6 and 12 months were compared with those at the time of diagnosis, and the percent change from baseline was calculated. A satisfactory clinical response was defined as reduction or stabilization of the NDI or stage improvement at 6 or 12 months. RESULTS: Patients treated with IFN-beta 3/wk had increased survival time (P < 0.02) and higher clinical response rates compared with those treated with IFN-beta 1/wk (P < 0.05). When stage 2 and stage 3 patients were evaluated separately, survival was significantly longer (P = 0.007) and the rate of progression slower in both stage groups with IFN-beta 3/wk. CONCLUSION: The results obtained for this patient sample suggest that IFN-beta administered subcutaneously times per week combined with inosiplex may be an effective treatment option in SSPE. This treatment regimen warrants further study.
Combined treatment with subcutaneous interferon-alpha, oral isoprinosine, and lamivudine for subacute sclerosing panencephalitis.
J Child Neurol. 2003 Feb; 18(2):104-8.
Aydin OF, Senbil N, Kuyucu N, Gurer YK.
Department of Pediatric Neurology, Dr. Sami Ulus Children's Hospital, Ankara, Turkey.
We compared patients with subacute sclerosing panencephalitis who received treatment according to our protocol for at least 6 months (19 patients) with the patients who could not receive any treatment (13 patients). The treatment protocol consisted of oral isoprinosine (100 mg/kg/day), subcutaneous interferon alpha-2a (10 mU/m2/three times a week), and oral lamivudine (10 mg/kg/day). There were no statistical differences between the two groups according to Neurological Deficit Index, clinical stage, and average age on admission and also on the final evaluation after treatment. The mortality rates of both groups were similar: 3 (15.7%) for the treatment group and 6 (46%) for controls. The remission rates for the treatment and control groups were 7 of 19 (36.8%) and 0 of 13 (0%), respectively, and the difference was statistically significant (P = .036). The mean survival period of the treatment group was significantly longer than that of the control group (P = .01). In conclusion, this combination treatment protocol resulted in higher remission rates and longer survival periods when compared with controls, as well as a remission rate that was better than the spontaneous remission rate of 5%. For this reason, and as well as because interferon-alpha therapy has an easier route of application and a higher family compliance, we have considered this an alternative protocol for patients with subacute sclerosing panencephalitis.
JAMA. 2000;284:1931-1938
The June 21 issue of the New England Journal of Medicine reports a randomized, placebo-controlled trial of inosine pranobex (isoprinosine), an experimental immunomodulating agent. The study involved 866 persons infected with HIV, the AIDS virus, in Sweden and Denmark. The report suggests that patients in the isoprinosine arm of the trial were significantly less likely to progress to AIDS than those patients in the placebo arm of the trial. According to this report, during the 24-week trial, 17 patients in the placebo arm progressed to AIDS as opposed to 2 patients in the isoprinosine arm. Although the raw data from this study have not been submitted for review to FDA by the drug's sponsor, Newport Pharmaceuticals Inc. of Laguna Beach, Calif., the FDA's division of antiviral drug products has reviewed the report. The division prepared a response to the study report which also appears in the same issue of the journal. The division's response expresses a number of concerns about this study and other studies conducted on isoprinosine, and states its belief that more clinical investigation of this drug is needed before its value to patients can be well enough evaluated to decide whether, and on whom, it should be used. -MORE- Page 2, isoprinosine, T90-26 Isoprinosine has been under development as a treatment for HIV-infection for approximately 5 years. Previous studies of isoprinosine's effectiveness in delaying or preventing the onset of AIDS in HIV-infected patients conducted in the U.S. and other countries have not demonstrated that the drug had any significant effect in slowing disease progression in treated patients. For example, the company reported in November of 1988 that a multicenter trial of the drug involving 696 HIV-infected patients in the U.S. and the U.K. showed no significant benefit in those treated with isoprinosine as opposed to those given placebo. The sponsor is currently reanalyzing data from this study in order to evaluate why it produced a different result than the Scandinavian trial. There are also some issues concerning the design and analysis of this latest Scandinavian study of isoprinosine. For example, the classification system for determining endpoints was changed during the course of the study was one of a number of changes in the study's implementation and analysis that may have affected the study results, and may require additional, balanced assessment. An editorial in the journal written by members of FDA's division of anti-viral drug products also notes that the 24 weeks of the trial is a relatively short study period. FDA believes that additional clinical testing should be conducted. These could incorporate the use of pneumocystis prophylaxis and retroviral treatments that have recently been developed as standard therapies for HIV-individuals, in order to determine how isoprinosine therapy, if proven effective, could be maximized in today's current therapeutic scene.
Ugeskr Laeger 1994 May 30;156(22):3314-8
Controlled, clinical trial of isoprinosine administration to HIV-infected patients. Results of a Danish/Swedish multicenter study. The Scandinavian Isoprinosine Study Group
Thorsen S, Pedersen C, Sandstrom E, Petersen CS, Norkrans G, Gerstoft J, Karlsson A, Christensen KC, Hakansson C, Pehrson PO, et al.
Infektionsmedicinsk afdeling, Hvidovre Hospital, Kobenhavn

The safety and efficacy of isoprinosine in HIV-infected individuals were assessed in a multicentre, randomized, double-blind, 24-week study phase, followed by an optional 24-week open treatment phase. The results of the double-blind phase have been reported separately. Of 866 HIV-seropositive individuals randomized, 832 were eligible for efficacy analysis. On completion of the double-blind phase, 596 patients started open treatment. All patients were evaluated with regard to progression to AIDS. Within 48 weeks, 10/412 patients (2.4%) assigned isoprinosine and 27/420 (6.4%) assigned placebo progressed to AIDS (p = 0.005; odds ratio: 2.8, 95% CI: 1.3-6.2). Intention-to-treat analysis showed identical results. No severe adverse reactions or toxicities were observed. We conclude that HIV-infected individuals without AIDS may be safely and effectively treated with isoprinosine.
Clin Immunol Immunopathol 1988 Jun;47(3):363-7
Pharmacologic immunoenhancement in the elderly: in vitro effects of isoprinosine
Delafuente JC, Panush RS
Department of Pharmacy Practice, College of Pharmacy, University of Florida, Gainesville

The loss of immune competence that occurs with aging may be responsible for increased morbidity and mortality in elderly individuals. Pharmacologic modulation of the immune response might reverse the immunologic aberrations associated with aging. We, therefore, investigated the effects of isoprinosine, an immunoenhancing drug, on selected in vitro immune responses in elderly subjects. Subjects studied were 65 years of age or older, and all had chronic diseases. We chose this population since they were at greatest risk for morbid events. Isoprinosine significantly enhanced mitogen-stimulated mononuclear cell proliferation, did not affect unstimulated cell growth, and needed to be present for the entire culture period for maximum effect. Isoprinosine is a potent in vitro immunoenhancing agent in aged humans.
Int J Immunopharmacol. 1986;8(4):437-41
Isoprinosine effects on interleukin-1 production in acquired immune deficiency syndrome (AIDS)
Tsang KY, Donnelly RP, Galbraith GM, Fudenberg HH

The in vitro effects of isoprinosine (ISO) on the production of IL-1 in AIDS patients and normal controls were investigated in this study. IL-1 production from adherent cells was measured by an indirect method using EL-4 cells. Five of eleven AIDS patients had depressed IL-1 production. Various concentrations of ISO were used to treat the adherent cells in vitro and the optimal concentration for stimulating IL-1 production was determined to be 100 micrograms/ml/10(6) cells. IL-1 production was augmented to normal or to near normal levels in four of five AIDS patients. Our results indicate that depressed immunity seen in some AIDS patients may be partly due to the depressed in IL-1 production and also that ISO can act as an immune potentiation in enhancing the production of this lymphokine in vitro.
Int J Immunopharmacol 1983;5(6):481-90
An in vitro study on the effects of isoprinosine on immune responses in cancer patients
Tsang KY, Fudenberg HH, Pan JF, Gnagy MJ, Bristow CB

The in vitro effects of Isoprinosine on the immune responses of cancer patients were investigated. Forty seven patients with primary tumors (26 lung carcinoma, 14 breast adenocarcinoma, 7 melanoma) were studied. Concanavalin A (ConA)-induced lymphocyte proliferation, natural killer cell (NK) activity, and monocyte chemotaxis were measured. In 40 of the 47 patients (85%), ConA-induced lymphocyte proliferation was depressed; NK activity was depressed in 32 (68%), and monocyte chemotaxis was found to be depressed in 36 (77%). In the presence of Isoprinosine, all three parameters were restored to normal or near normal levels in those that were depressed.
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Drug information

Isoprinosine have both immunomodulating and antiviral properties. It helps to treat acute and chronic viral infections. Isoprinosine acts on the immune system to restore impaired cell-mediated response to baseline in addition to enhancing humoral response. It has also a direct antiviral activity. Isoprinosine can reduce the intensity of symptoms and shorten the duration of the viral infection. In addition, the occurrence of complications is reduced and the frequency and severity of recurrences is minimised. Isoprinosine is an immunoenhancing agent in aged humans.

1. How Does Isoprinosine Work? Isoprinosine is a synthetic purine derivative with immunomodulatory and antiviral properties, which result from an apparent in vivo enhancement of host immune responses due to the drug.

The action of Isoprinosine can be summarized as follows:

Normalizes the cell-mediated immunity by stimulating the differentiation of T-lymphocytes into T-cytotoxic cells and T-helper cells and increasing lymphokine production
Increases production of IL-1 (interleukin-1) and IL-2 (interleukin-2) and IFN-? (gamma interferon)
Increases NK cell (natural killer cell) function
Increases the humoral immune response by stimulating the differentiation of B- lymphocytes into plasma cells and by enhancing antibody production
Increases the number of IgG and complement surface markers
Potentiates neutrophil, monocyte and macrophage chemotaxis and phagocytosis
Inhibits viral growth by suppressing viral RNA synthesis while potentiating depressed lympocytic
RNA synthesis and translational ability

2. Other Benefits of Isoprinosine Treatment: Studies have documented the ability of Isoprinosine to slow the progression of AIDS in HIV-infected persons by increasing the total number and activity of T-cells, T-helper cells and NK (natural killer) cells. The largest study, which was published in The New England Journal of Medicine on June 21, 1990 found that HIV infected people with CD4 cells count over 500 experienced significant benefits from Isoprinosine therapy. T-lymphocyte defects are common in cancer and AIDS patients according to a study in Medical Oncological Tumor Pharmacotherapy in 1989, which found that Isoprinosine and levamisole (another immune-boosting drug) mimic the actions of the thymic hormones to promote T-cell development. Combinations of Isoprinosine, low-dose Interleukin 1 and 2, and other immune-modulating hormones such as Melatonin are suggested as possibly effective cancer therapies.

3. Prescribing Information: The prescribing physician will ultimately decide about the details of therapy (dosing, duration, etc.). According to dosing information obtained from published references; patients with cancer can take 2000 mg to 3000 mg of Isoprinosine daily for two months(2-3g/day; 4-6 tabs of 500 mg inosine pranobex). Then they may stop taking Isoprinosine for two months, and then resume taking it at the same dose for another two months.

Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.

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