Low-dose Naltrexone and Lipodystrophy

Editor's Preface

This month we are including an article on low-dose naltrexone for lipodystrophy. There are no studies to prove or disprove the effectiveness of this drug for lipodystrophy. We are including this report because we know that some members of the affected community are using this, but at the same time know little about the efficacy of its use. Additionally, little is known about potential side effects or adverse drug interactions with HIV medications since no formal studies have been done of this drug for use in combination with HIV medications. A major unanswered question is whether or not low-dose naltrexone adversely affects drug level of HIV meds, although Dr. Bihari's report would seem to suggest no evidence of any adverse affects.

Unproven therapies for HIV-related illness and side effects have been around for years. Some have been harmless remedies while others have been more toxic and deadly. A couple of examples of such therapies are:

  1. Amitriptyline -- an FDA approved antidepressant that has been used to treat drug-related peripheral neuropathy in people with HIV. Subsequent studies found strong evidence that the drug actually did not work to reduce peripheral neuoropathy, although many patients self-reported improvement.

  2. Dextran Sulfate -- a non-FDA approved drug used widely in the late 1980s and early 1990s as an HIV antiviral. The drug is approved in Japan to lower blood cholesterol and as a blood thinner. Some early reports suggested the drug had anti-HIV affect in test tubes, but it was later found not to provide significant anti-HIV affect in people. The drug did have some side effects including diarrhea.

STEP strongly recommends you work closely with your provider and use extreme caution when considering use of medications such as naltrexone. The information which follows is anecdotal, and may not turn out to be true. Use of such a product may also turn out to be harmful in the event it lowers the drug levels of HIV antivirals in the blood to sub-optimal levels. STEP does not endorse the use of this product, and is supplying this as information only to its readers.

Anecdotal Report on Low-Dose Naltrexone

Dr. Bernard Bihari, a New York physician who treats a large number of people with HIV, has reported that using low-dose naltrexone may prevent or reverse lipodystrophy. In a paper released August 1999, Dr. Bihari makes an observational report on the incidence of lipodystrophy in 136 HIV-infected patients in his practice treated with protease inhibitors, other antivirals, and low-dose naltrexone. Dr. Bihari states in this paper that low-dose naltrexone appears to provide "significant protection against development of lipodystrophy."

For the purpose of the observational report, Dr. Bihari defined lipodystrophy as:

  1. Peripheral fat wasting with loss of subcutaneous fat in the face, arms, legs, and buttocks.

  2. Central truncal adiposity due to abdominal visceral fat accumulation. (Commonly called "crix belly.")

  3. Breast hypertrophy. (Breast enlargement.)

  4. Presence of dorsal fat pad or "buffalo hump."

  5. Ectodermal dysplasia. (Abnormal growth of tissues.)

  6. Elevated levels of cholesterol and triglycerides.

  7. Insulin resistance with, in some cases, associated diabetes mellitus.

Dr. Bihari reports that he became aware of a lack of lipodystrophy cases after reading several reports on the symptoms in the summer of 1998. His first case of a patient with lipodystrophy was in February 1999, when a patient who had moved away from New York the previous year made a follow-up appointment and reported a gradual loss of subcutaneous fat in the face, arms, and legs. At the time, this patient was on Crixivan, Viramune, AZT, and 3TC. The patient had previously been on low-dose naltrexone with no symptoms of lipodystrophy, but had discontinued the naltrexone after leaving New York. The patient self-reported noticing fat loss 7 or 8 months after stopping low-dose naltrexone.

The same patient resumed taking low-dose naltrexone in March 1999. In July 1999 the patient's cholesterol level had fallen below 300 and blood sugar had returned to normal. The patient self-reported a gradual reappearance of subcutaneous fat and a one-third reduction in abdominal girth. Dr. Bihari speculates that the reduction in lipodystrophy side effect is a result of a protective effect of naltrexone, and that the low-dose administration of the drug may be effective in preventing or reversing the side effect of lipodystrophy. The report cites several other patients who experienced similar results while taking low-dose naltrexone.

What is Naltrexone?

Naltrexone is an FDA-approved drug used by recovering heroin or opiate addicts to help keep them off drugs. Naltrexone works by blocking the opiate receptors on cells, preventing the opiate drug from having any effect if taken. Low-dose naltrexone has been used experimentally in HIV treatment as an immune system enhancer since the mid-1980s. The dosing level prescribed by Dr. Bihari is three mg every night at bedtime. Naltrexone must be "compounded" into a liquid formulation to get the dosage down to three mg. Most insurers will not cover the cost of this and a one-month supply runs about $35.00. There are no known side effects from low-dose naltrexone.

It should be noted that the information provided here is anecdotal, and that an observational report is not the best way to evaluate the efficacy of a specific medication for a specific symptom. The only way to truly measure the effectiveness of low-dose naltrexone in preventing or reversing lipodystrophy would be through a controlled study. However, it is unlikely this will happen since naltrexone is already an FDA-approved drug and there is insufficient financial incentive for any drug company to undertake such a study.

To receive a copy of Dr. Bihari's full report, e-mail us your full name and mailing address and ask for the report on "Low-Dose Naltrexone". E-mail requests to: step@lifelongaidsalliance.org.

STEP does not endorse the use of this product and is supplying this report as information only.