When someone is first infected with the microbe HBV - hepatitis B virus - it causes inflammation of the liver. Some people can recover from HBV infection, but in people who are not able to recover the virus causes ongoing liver damage, slowly destroying the liver. In some cases, HBV infection eventually leads to liver cancer. Although drugs such as interferon-alpha and 3TC (Epivir, lamivudine) can help some people recover, the majority of people treated with these drugs do not experience a sustained recovery (their recovery is only temporary). Researchers are testing combinations of other drugs to assess their long-term effectiveness.
Meanwhile researchers in Bologna, Italy, have been studying the impact of vitamin E on HBV infection for several years. The researchers chose this nutrient because it may protect the liver from damage associated with HBV infection and it may also enhance the immune system's ability to fight the virus. Preliminary results from experiments on people with HBV by these researchers suggested that 600 mg/day of vitamin E was safe and useful in some people with HBV. We now present their results from a larger study.
Researchers recruited 32 subjects (8 female, 24 male) who had HBV detected in samples of their liver and blood. As well, all subjects had higher-than-normal levels of the liver enzyme ALT (alanine aminotransferase) for at least six months, suggesting ongoing liver damage. No subject tested positive for HIV or for hepatitis C virus. Before entering this study, 23 subjects had received treatment with interferon-alpha for HBV but it did not work. Doctors randomly assigned 15 subjects to receive 300 mg of vitamin E twice daily for three months. The remaining 17 subjects received no treatment and served as a control or comparison group. At the end of three months, subjects were monitored for 12 more months.
By the end of the study (month 15), 47% of subjects in the vitamin E group and 0% in the control group had recovered from HBV infection. This difference in recovery between the two groups was statistically significant, that is, not likely due to chance alone.
Four subjects stopped taking vitamin E by the second month of the study because their liver enzyme levels rose to more than 10 times the upper limit of normal. The research team reported no side effects due to vitamin E.
The research team found that in the vitamin E group there appeared to be a "delayed response" to treatment. They noted that levels of HBV continued to decline over time, especially after the third month, when subjects stopped taking vitamin E. The researchers stated that this type of response does not usually occur with the use of anti-HBV drugs such as 3TC. But it has been reported in clinical trials of the immune booster thymosin-alpha1 (Zadaxin) for HBV.
Further studies need to be done by other researchers to confirm these findings in a larger number of subjects. As well, although no subject in this study had HIV, we hope that other research teams will test the impact of vitamin E - with and without anti-HBV drugs - in people who are co-infected with HIV and HBV.
REFERENCES
1. Andreone P, Gramonzi A and Bernardi M. Vitamin E for chronic hepatitis B. Annals of Internal Medicine 1998;128(2):156-157.
2. Andreone P, Fiorino S, Cursaro C, et al. Vitamin E as treatment for chronic hepatitis B: results of a randomized controlled pilot trial. Antiviral Research 2001;49:75-81.
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Copyright © 2001 - TreatmentUpdate. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Editor, The Canadian AIDS Treatment Information Exchange, 555 Richmond St. West, Suite 505, Box 1104, Toronto, ON, M5V 3B1 • Phone: 416-203-7122 • Toll Free: 1-800-263-1638 • Fax: 416-203-8284 http://www.catie.ca.
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