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CURRENT NEWS - January 31, 2005

News Articles of Interest, related to the usage of Oyster Extract Health Supplements.

The Immune System is your natural ability to protect your body from disease. Zinc activates the correct function of your immune cells. Studies show that people who suffer from Zinc deficiency nearly always have a decreased immune system and are subject to infections and illness.

Each month, OY-EX.com will provide an interesting article of topical discussion regarding medical issues related to liver disease. OY-EX is an important part of a regime to maintain good health, including the best vitamins and minerals found in nature to provide a healthy liver and immune system.

Research

Very high-dose ribavirin improved response rate of chronic hepatitis genotype 1, but with high toxicity, in pilot study.

By Jillian L Lokere, MS

January 31, 2005

In a small, open-label study, very high-dose ribavirin in combination with peginterferon alfa-2a for 48 weeks gave a response rate of 90% in patients with chronic hepatitis C genotype 1, but the toxicity profile was very high.

Standard treatment with 48 weeks of peginterferon plus weight-based ribavirin for chronic HCV genotype 1 infection provides a sustained virologic response (SVR) rate of about 40%. Recent studies have suggested that the SVR rate may be improved in this population when the higher doses of ribavirin are used. In the current study, Lindahl and colleagues used a pharmacokinetic formula to tailor the plasma concentration of ribavirin in each patient in order to evaluate the safety and efficacy of very high ribavirin doses.

Eligible patients had a viral load of greater than 800,000 IU/mL, elevated serum alanine aminotransferase (ALT) levels, a positive anti-HCV antibody test, detectable serum HCV RNA, and a liver biopsy consistent with chronic HCV but without cirrhosis. Those with other forms of liver disease, infection with hepatitis A or B viruses or HIV, hepatocellular carcinoma, anemia, psychiatric disease, significant cardiac disease, renal disease, seizure disorders, or severe retinopathy were excluded from the study.

Ten patients received peginterferon alfa-2a 180 ?g weekly in combination with daily ribavirin for 48 weeks. Initially, the ribavirin dose was individually calculated from a pharmacokinetic formula based on renal function. The goal was to achieve a steady-state plasma ribavirin concentration of 15 ?moles/L. When necessary, the dose of ribavirin was increased to reach this target.

Patients were monitored every 2 to 4 weeks during treatment and for 24 weeks of follow-up. Plasma ribavirin concentrations were measured every 2 to 4 weeks during the first 24 weeks and every 8 weeks thereafter. Treatment was discontinued in patients who had a viral load of greater than 600 IU/mL at 24 weeks of treatment.

At the start, the average daily ribavirin dose was 1520 mg. When plasma ribavirin concentrations were measured at week 4, the mean was found to be 8.6 ?moles/L. The daily ribavirin dose was then escalated up to an average of 2540 mg, giving a mean plasma concentration of 14.7 ?moles/L. The highest individual dose given in this study was 4000 mg daily.

This regimen gave very impressive response rates. After 24 weeks of therapy, 8 patients had a viral load less than 50 IU/mL. Only 1 patient discontinued treatment because of a viral load greater than 600 IU/mL. By the treatment endpoint, all 9 patients who remained on-treatment after 24 weeks had a viral load of less than 50 IU/mL. This included 1 patient who discontinued treatment at 39 weeks because of side-effects.

Toxicity was very high. Patients' hemoglobin levels decreased during treatment, so all patients received erythropoietin 9000 to 30,000 IU/week plus an oral iron supplement. Hemoglobin levels decreased to below 8.0 g/dL in 2 patients, requiring 2 blood transfusions each and a reduction in ribavirin dose for 1 week. The hemoglobin levels in an additional 5 patients decreased to between 8.0 and 10.0 g/dL, and the ribavirin dose was slightly reduced for 2 of them. The investigators noted that fatigue, nausea, and dermatologic problems were more frequent and more severe than what is usually seen with standard combination treatment, and working capacity was reduced in all patients.

The investigators concluded that very high-dose ribavirin treatment is feasible, without major treatment interruptions, but it causes frequent and serious side effects. They note that potentially life-threatening anemia would put patients with coronary heart disease or cirrhosis at great risk.

In an accompanying editorial, Lutchman and Ghany point out that, despite the highly toxic nature of the regimen, Lindahl and colleagues' study "raises the question as to whether ribavirin should continue to be administered based on body weight or dosed to achieve a target serum concentration." They suggest that "patients who are nonresponders to weight-based therapy may be receiving subtherapeutic doses of ribavirin."

Reference

Lindahl K, Stahle L, Bruchfeld A, Schvarcz R. High-dose ribavirin in combination with standard dose peginterferon for treatment of patients with chronic hepatitis C. Hepatology. 2005;41:275-279.

Lutchman G, Ghany M. Pushing the treatment envelope for chronic hepatitis C: is more necessarily better? Hepatology. 2005;41:234-236.

http://clinicaloptions.com/hep/news/news_imed_348.asp

CURRENT NEWS-February 4, 2005