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John
G. Babish, Ph.D.
Dr.
Babish, is a molecular biologist who served as a tenured Associate Professor
of Pharmacology and Toxicology at Cornell University for 17 years.
He has authored or co-authored over one hundred peer-reviewed scientific
articles, eight position papers, and two book chapters. The inventor of
14 U.S. and world patents, Dr. Babish is the Chairperson of BIOnexus®Ltd.
located in Ithaca, New York, the makers of NutriVirÔ.
This report is the result of a literature review on N-acetylcysteine (NAC)
, which was one of the several complementary therapies that Dr. Babish
researched as a member of the National HIV Nutrition Guidelines Working
Group.
The molecule N-acetylcysteine
(Figure 1 on page two)
is interesting from both the research and regulatory
points of view. A recent Medline search using NAC as the sole keyword yielded
4,766 hits. Research into the biological activities of NAC ranges from
prevention of catabolism associated with anaerobic exercise (37) and improvement
of blood flow in micro-vasculature in cigarette smokers (40) to immune
reconstitution in HIV (11). NAC appears to have applications in a variety
of physiological and pathological processes.
From a regulatory perspective,
NAC is interesting because it is classified as dietary supplement and a
drug in the U.S., while in the rest of the world it is regulated as a drug.
Because it is a dietary supplement in the U.S., branded products are abundant
and are readily available in drug, supermarket or specialty vitamin stores.
Acetylcysteine is available by prescription in the U.S. for use as an inhalant
for its mucolytic action in cystic fibrosis or as an IV infusion for the
treatment of Tylenol® (acetaminophen) overdose.
The objectives of this
article are to (1) provide the reader with a background in the functioning
of NAC; (2) describe results of well-designed clinical studies and; (3)
integrate the results of studies using NAC for applications in HIV/AIDS.
From the Medline search described above and several other search sites,
approximately 445 references were identified with NAC and HIV. Aside from
laboratory studies, a majority of those articles were reviews, abstracts
of presentations, comments and opinions, or involved the use of NAC with
other viral diseases such as hepatitis A, B and C. Seven peer-reviewed
articles described in-vivo and ex-vivo studies of NAC in healthy subjects.
There were 15 peer-reviewed articles describing clinical trials in HIV
patients and eight, peer-reviewed articles on the pharmacokinetics of NAC.
Fifty-eight references are cited within this literature review. (1-58)
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