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Re: "Question About Magic Johnson"
Mar 24, 2004

Dear Dr. Pierone, I was very pleased to read your response regarding how some people have transitioned from mono-therapy and/or dual-therapy to HAART without major problems (paraphrased).

> Many people that did receive single or dual nucleoside therapy > were successfully transitioned to triple therapy when protease > inhibitors became available.

Given that relatively non-toxic drugs like Hydroxy Chloroquine (HCQ) have demonstrated similar viral load reductions as AZT(Sperber), and given that compounds similar to HCQ are now in clinical trials under the title of "integrase inhibitors"(Mathe), and given that we don't know how to repair our approximately 100 lymph nodes once HIV destroys them(Schacker), wouldn't it be wise to revisit the concept of early treatment to preserve the adaptive immune system with the least toxic regimens?

It's my understanding that the window for early treatment has been widened from 6 to 18 months (Lacabaratz-Porret).

What's wrong with lowering viral load to (say) below 50 copies/mml with only dual-NRTI in patients - Aquitaine cohort 1996-98(Morlat)?

Isn't it a well known fact that the adaptive immune system can adapt to HIV's mutations - at least in the first six months?

Isn't it a well known fact that the adaptive immune system can clear 6 or 7 log of HIV from peripheral blood in many recently infected patients(Fauci)?

Doesn't it follow that preserving the immune system with the least amount of anti-HIV drugs is equal in value to a seven or eight drug HAART regimen?

I've read that "...a clinical trial conducted in Zimbabwe in 2001 showed that aspirin monotherapy (1.2gr.) increased CD4 count an average of 83, and that was at the nine month point. At the 12 month point, CD4 counts were still approximately 35 above baseline (compared with AZT at 35 below baseline). Overall, moderate-dose aspirin monotherapy increased CD4 counts more than twice as much as high-dose AZT therapy, and maintained CD4 counts above baseline for about three times as long as AZT could."

The highest number of abstracts on a single subject at the 1994 Yokohoma International AIDS Conference was on an extract of the licorice root (Glycyrrhiza glabra). Many Asian studies demonstrated that it had a similar viral load suppression capability to AZT.

Similar data is available for an extract of coconut oil (monolaurin).

We are now hearing about an extract of Green Tea having some ability to suppress HIV.

We know from studies at UCSF that the vitamin N-Acetyl-Cysteine is protective and supportive in HIV disease.

Several studies of Selenium show that it can suppress several types of viruses, including HIV.

Something near ten billion dollars of profit for the patent holder(s), drug wholesalers and drug retailers of AZT has been realized.

While the budget for the world's largest HIV/AIDS clinical trials group (AACTG) is only 100M annually - or one hundred times less than the profits made on AZT over its ongoing patent period.

AZT had Orphan Drug status. The FDA approval process was FREE(Maeder). The AACTG paid for most (if not all) of AZT's U.S. clinical trials.

Given the enormous profits being made on our oldest anti-HIV drug (AZT), I can't help but wonder if 14,000 people are needlessly dying each year because just as effective, less toxic, and far cheaper drugs are being ignored until they can be transformed into patented drugs, with the help of a few superfluous molecular changes, and priced beyond the reach of most HIV+ people.

I suspect that the recent incident with Abbott Labs increasing the price of Norvir/ritonavir just to price the competition out-of-the-race with their new protease inhibitor is typical of our shadow government (pharmaceutical industry).

Peptide-T sold for 90.00 for a six month supply eight years ago. Now it sells for 2,000.00/month (as much as T-20/Fuseon), and at least one Peptide-T copy-cat drug is now in clinical trials.

I've heard time and time again, from top HIV doctors in the U.S., that IF AND WHEN we have less toxic drugs that it will make sense to begin treatment as soon as patients learn that they are HIV+, rather than allowing HIV to destroy their immune systems. Given the above, I have no reason to believe them.

Why are there no large studies of multiples of these less-costly, less-toxic substances, with equivalent viral load suppression capabilities, in healthy HIV+ patients with high CD4+ T cell counts?

Kind regards,

Tom

Response from Dr. Pierone

Your post is very interesting, but covers so many different topics that I will address just some of your points.

With regard to dual nucleoside therapy, generally less than 10% of people will suppress virus under 50 copies and that is a generous estimate. For people with higher viral loads 2 nukes are not potent enough (and 3 nukes often not sufficient as well).

The notion of early therapy for HIV infection hit early, hit hard, has fallen into disrepute because of medication-related toxicity. It is definitely time to revisit this strategy, since newer HIV medications are less toxic than old-style protease inhibitors. Perhaps the paradigm for future HIV treatment will be to initiate therapy with CD4 count greater than 500 cells with the intention to interrupt therapy after a while. Then restart when CD4 cells approach 500 and keep the counts in the normal range through a CD4 count driven approach. This is experimental of course, but the SMART study is using similar tactics in the United States (with lower CD4 parameters) and BASTA is doing the same in Europe.

The immune response to HIV is able control viral replication extremely well in some infected persons. Eventually, the virus appears to develop mutations that enable it to escape immune control and this certainly portends ill for vaccine development. So for the near future, antiretroviral medications are the only game in town. As such, it might be best to use them in earlier innings (but this remains to be demonstrated). I have never seen a poll of HIV clinicians on this topic, but I suspect that if they had HIV infection, most experienced clinicians would personally begin antiretroviral therapy earlier than the guidelines call for.

Pharmaceutical profits are essential and well deserved for companies that successfully embark upon and complete an intensive drug development project. If there were not the potential for make a lot of money we would not have a pipeline of new medications. This capitalistic imperative does not excuse Abbott for their unethical action in which they raised the price of Norvir an unprecedented 400 percent. This move was anti-competitive and will hamper future development of protease inhibitors that depend on Norvir for pharmacokinetic boosting.

I don't believe that there is credible data on in vivo (i.e. human being viral load reductions) antiviral activity for inexpensive, commonly available, natural source, anti-HIV compounds. Granted, there is no financial incentive to test potential compounds that are not patentable. And the price tag for development and meeting FDA rules for approval mean that even inexpensive agents become expensive when all is said and done.



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