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AIDS Treatment with Naltrexone?
Oct 26, 2002

I started seeing a doctor in New York City for HIV infection a few years ago. My t-cells were around 700. He told me that I didn't need anti-virals at the time. He did prescribe a low dose of Naltrexone which he said stops HIV infection from progressing to AIDS. I followed his advice and took the Naltrexone each night. When I went for repeat labs in November of 2001 I found out I had progressed to AIDS with a t-cell count of 178(9) and a viral load of 224000. As you can imagine I was very upset. My question to you is: is it legal for doctors to promote this drug as an AIDS treatment when it is not approved by the FDA for such purposes? I am now on anti-virals and I am recovering. I just don't want this to happen to anyone else.

Response from Dr. Young

Thanks for your question.

You raise a couple of issues. The first, is the use of non-FDA approved uses of medications. This in fact happens frequently in the HIV field. When the FDA approves a medication, there are "package insert" indications and doses of the drug. Often, the medical science moves faster than the regulatory process, leading to common place use of a medication that is different that the "FDA approved" one. Examples of this are all of the ritonavir-boosted protease inhibitors (save for ritonavir/lopinavir)and once-daily use of nevirapine. In these circumstances, there might be a reasonable scientific or clinical basis for the use of the medication. In other circumstances, a drug might be used for a disease that was not part of the regulatory approval process.

One could interpret the use of naltrexone for HIV in the later situation. I am not, however, aware of relevant data that suggests the use of this drug to prevent AIDS progession. As such, I find that the promotion of the medication in this context as unsupported. There are many who promote the use of drugs and supplements as ways to augment the immune system without verified scientific evidence. Unfortunately, your situation bears witness to another example of this.

Thanks for pointing this out. I hope that your health continues to improve. -BY



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