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a comment re: re: Magic Johnson.....

May 3, 2004

I may be totally off base here, but it seems to me the writer is asking for clinical studies on compounds that healthy HIV+ people can use. He is correct in stating there is no standardized treatment regimen for this population. It is a very frustrating position to be told not to stress out and nothing can be done except healthy lifestyle choices and wait to become impaired (CD4 decline). Whatever happened to the NIH sponsored studies in alternative therapies. It would be appropriate to study the effects of +/- HAART crossed with the various compounds you mentioned or supplements as well as treatment naive +/- any preventive/palliative pretreatment. There are numerous compounds which have excellent safety records simply by historical use such as curcumin and as you mentioned licorice, NAC etc... Many of these compounds, mostly from various traditional medicines herbal histories, have been shown to have anti HIV activity or to be protective to CD4 cell populations in culture (ie. Shikonin) and serve as lead compounds for pharmaceutical development. Why isn't this information recycled into clinical practice? Zi Cao which contains high levels of shikonins is cheap, $2 for a month supply. If these compounds are effective in assisting HAART treatment, in prolonging STI, extending non progression, or improving predisposition to treatment shouldn't we know or at least investigate this potential? No need for phase I, II clinical trials, just efficacy studies similar to those used for already approved drugs prescribed for other conditions (ie. rituximab for chrone's after approval for RA). I would be wary of diffusing focus or scattering energies which might produce a cure and I am without a doubt grateful and astonished at the rapid rate of progress in developing new compounds, but the previous writer brings up valid and important points of consideration. I am grateful to and your staff for all the insights you provide. I only want to raise the question without simply accepting pharmaceutical profiteering as the patent answer or excuse. Thank you.

Response from Dr. Pierone

Your points are well taken. The proper course of action for people with early or slowly progressing HIV infection is not known. In the absence of data, but mindful that the risk of short-term complications is quite low, we recommend watchful waiting. For many people, the idea of doing nothing in the face of an active viral infection is very distressing (it would be for me too).

Previously, we have discussed the SMART study aimed at comparing early continuous treatment versus later treatment (CD4 count driven) that includes an STI approach. The BASTA study is looking at early treatment with STI one goal is to not let allow the CD4 cells to drop to low levels. Since the newer HIV medications are safer and less prone to development of resistance, I think the pendulum will swing back to earlier treatment in the coming years.

With regard to alternative therapies, there are two view points.

One is to take the traditional healer approach Aunt Millie was given a cream made from a mixture of herbs by her herbalist and her skin rash went away, it worked for two of her friends as well. This strategy towards healthcare is intuitive, practical, and often works quite well. Over the years, many patients have come in to see me with a shoebox full of supplements and tell me how great they feel since starting their regimen. Aside from the cost , which may rival the cost of prescription antiretrovirals (herbal company profiteering), it is tough to take about 20 pills or powders a day as a supplemental program and maintain this long-term.

The other approach towards alternative therapy is evidence based. Let's take Aunt Millie's herbal cream, concoct a similar appearing cream without the active ingredients (the placebo cream) and do a study on 50 subjects with a skin rash of psoriasis. Half are randomly selected to get the active cream, the other half get the placebo cream. The doctor is not allowed to know which treatment is given for the subject as well; he/she is blinded to the treatment arms. So the placebo cream had better be indistinguishable from the real thing since, the doctor may be biased for or against Aunt Millie (it depends whether Aunt Millie is really his or her Aunt).

So we do the experiment: Of the subjects getting the placebo cream, 5 get dramatically better, 5 get a little better, and for the rest nothing happens. Of the subjects that get the active cream, 10 get dramatically better, 10 a little better, and nothing happens in the last 5. Now we have some evidence that Aunt Millie was right all along, 20 responders (80%) vs 10 (40%) in placebo cream group.

If we take an evidence-based approach for alternative treatment of early or slowly progressing HIV infection, we are confronted with several obstacles. The first has to do with the nature of the treatment. Is this treatment an antiretroviral medication or is it an immune stimulant?

If it is felt to have antiviral properties this is relatively easy to test. A 15 patient pilot study of monotherapy with the alternative agent for 2 weeks with frequent monitoring of viral load will tell if this agent is active and will also provide early information about toxicity as well.

Alternative treatments that support immune function are more difficult to test and verify benefit. If a substance can raise CD4 cells in the blood that would be a good start, but would not be sufficient to show benefit. What if the agent increased CD4 cells in the blood by stimulating their release from tissue stores? The numbers look better, but does an increase in CD4 count (which may be temporary) translate into improved quality of life or length of life? This is very difficult to prove and the road to approval for immune based therapy is long and rocky because of the challenges in proving that treatment is ultimately beneficial. My point is that an efficacy study of immune based approach would, of necessity, have to target persons with compromised immune function, enroll thousands of patients, and last for many years (see SILCAAT for example).

Immune therapy advocates should not despair though. An STI-based testing strategy would be another (less definitive) approach for testing of immune based therapy. This would involve a small group of patients on HAART that undergo a series of treatment interruptions. Typically, it takes several weeks for virus to rebound after treatment is discontinued and a control group of matched patients would give us this number. The immune therapy patients would receive the alternative immune-based agent and then have treatment discontinued, if it takes them longer to experience viral rebound the presumption is that their immune system has been bolstered by the agent and that it has translated into specific benefit to the immune system by allowing better control of HIV replication. This is the general approach being used for early testing of therapeutic vaccines and could be also utilized for testing other immune therapies as well.

Thanks for reading and for your post!

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