translation agency

Gay Men's Health Crisis
Experimental and Alternative Therapies for Liver Disease
David Gold
July 1, 1994
GMHC Treatment Issues 1994 Jul 1; 8(5): 5

The following therapies have been studied or proposed by proponents as treatments for liver disease. They are unapproved in the U.S. and may entail risks of unexpected toxicities or drug interactions.

Ribavirin - a nucleoside analog (like AZT, ddI and ddC). Ribavirin has shown little efficacy against HIV but may be useful as a treatment for chronic hepatitis C. It is active against HCV in the test tube, and a trial at the NIH has shown interesting results in individuals with chronic hepatitis C.[1] Of the sixteen given drug (600 mg twice daily for twelve months), four "responded" (normal levels of ALT, a liver enzyme), and seven had a "partial response." After therapy was stopped, ALT levels rose in most patients, indicating renewed liver damage. Small studies in Italy and Taiwan suggest that the combination of ribavirin and alpha interferon may be more effective than alpha interferon alone in treating HCV.[2] Ribavirin is an over- the-counter drug in Mexico and available through the PWA Health Group in New York (212/255-0520). The manufacturer has filed an application requesting FDA approval of the drug for hepatitis C. (Test-tube studies indicate that ribavirin may cancel out the anti- HIV effect of AZT and enhance the effect of ddI - although no human data support this observation.) Lamivudine (3TC) - a nucleoside analog developed by Glaxo Pharmaceuticals that is active against both HIV and hepatitis B in the test tube. Human phase II trials of lamivudine in chronic hepatitis B are nearing conclusion, and a phase III trial is set to begin this fall. An expanded access program is presently under way for HIV-infected adults and children with CD4 counts of less than 300. Eligible individuals must have failed or be intolerant to approved anti-HIV therapies. They also must be unable to qualify for ongoing clinical trials. Physicians may call Glaxo at 800/248-9757 for information.

Alpha Thymosin - a synthesized thymic peptide that showed promise in phase I trials for chronic hepatitis B as well as HIV. A recent phase III trial indicated that it may be no better than placebo for hepatitis B, though. [See Treatment Issues, May 1994; vol. 8, no. 4.] Tests are underway using thymosin combined with alpha interferon for both hepatitis B and C.

Thymic Humoral Factor (THF) - another thymic hormone. It too has been investigated as a treatment for HIV. A small British study reported that the combination of THF and alpha interferon is beneficial in patients with chronic hepatitis B who have failed alpha interferon alone.[3] N-Acetyl Cysteine (NAC) - a derivative of cysteine, which is essential for the production of the antioxidant glutathione in the body. NAC is being studied as a treatment for HIV and is used to treat acetaminophen (Tylenol) poisoning, which damages the liver. A small study in Spain reports that NAC may enhance the effectiveness of alpha interferon in people with chronic hepatitis C.[4] The Spanish investigators think that HCV, like HIV, causes a depletion in glutathione levels. Fourteen patients with chronic hepatitis C who had failed alpha interferon were given NAC (orally, 600 mg, three times a day). Six patients had a normalization of liver tests and eight had a "marked reduction in HCV virus levels." NAC had no effect without alpha interferon in these patients.

Beta Interferon - a second type of the interferon that has shown promise in small studies for treatment of chronic and acute hepatitis C. In one Japanese study, eleven of twelve patients with acute HCV infection experienced significant benefits from beta interferon.[5] Another Japanese study reported that beta interferon (nine million units twice weekly for four weeks) produced a "remarkable decrease in HCV DNA at the end of treatment."[6] But a recent Italian study, found that natural beta interferon was significantly inferior to alpha interferon in the treatment of chronic hepatitis C.[7] Beta Interferon (brand name: Betaseron, produced by Triton Biosciences of Alameda, California) is an approved treatment for multiple sclerosis. It can cause side effects similar to alpha interferon.

Astragalus - an herb used in China (Astragalus memranaceious), reportedly for the purpose of boosting the immune system and preventing chemotherapy-related bone marrow suppression and nausea. There are some reports that astragalus protects the liver against toxicities from drugs, a claim supported by some cursory controlled studies. [See Treatment Issues, January 1994; vol. 7, no. 11-12.] Glycyrrhizin - a substance isolated from the root of the licorice plant (Glycyrrhiza radix) and widely used in Japan against infectious diseases. Some people argue that it has benefits in the treatment of chronic hepatitis B although, once again, no well designed, controlled studies have been done. [See Treatment Issues January 1994; vol. 7, no. 11-12.] Milk Thistle - specifically, the seeds of "milk thistle," or silybum marianum. Proponents of milk thistle consider the seeds useful for such problems as cirrhosis, jaundice, hepatitis, diarrhea, and drug, alcohol, and chemical toxicity. There is some interesting research, but little solid human data. [See Treatment Issues January 1994; vol. 7, no. 11-12.] Thioctic Acid - a synthetic version of a natural compound found in the liver and other tissues and also known as "lipoic acid" or "alpha lipoic acid." A few authors recommend use of thioctic acid in conjunction with anti-parasitic drugs and other liver-damaging medications, but there are almost no clinical data documenting its liver-protecting qualities. [See Notes from the Underground, October 1993, and "Thioctic Acid: A Liver Protective Nutrient," an unpublished paper by Vic Hernandez.] 1 Di Bisceglie AM, et al. 44th Annual Meeting of the American Society for the Study of Liver Disease. Chicago, November 4-7, 1993, abstract 145.

2 Brillanti C, et al. 28th Meeting of the European Association for the Study of the Liver. Paris, September 1-4, 1993, abstract T-69.

3 Farhat BA, et al. 28th Meeting of the European Association for the Study of the Liver. Paris, September 1-4, 1993, abstract T-138.

4 Beloqui J, et al. 28th Meeting of the European Association for the Study of the Liver. Paris, September 1-4, 1993, abstract P2-133.

5 Omata M, et al. Lancet. 1991; 338(8772):914-5.

6 Kanai K, et al. Lancet. 1990; 336(8709):245.

7 Boccia S, et al. 28th Meeting of the European Association for the Study of the Liver. Paris, September 1-4, 1993, abstract T-51.

Copyright (c) 1994 - GMHC Treatment Issues. Noncommercial reproduction encouraged. Distributed by AEGIS, your online gateway to a world of people, knowledge, and resources. Direct Dial: v.34+: 714.248.2836; v.120/ISDN: 714.248.0433 Internet: www: