New testosterone treatment product easier to manage
Topical gel is applied once a day
Studies have shown that HIV patients who also have low testosterone will benefit from some sort of testosterone treatment, which will decrease their depression, improve their sex drive, and increase lean body mass. But administering yet another treatment to men who already are taking many medications is problematic at best.
UNIMED Pharmaceuticals of Buffalo Grove, IL, recently received U.S. Food and Drug Administration approval for a possible solution to that problem. The company is marketing a testosterone gel called AndroGel, which is the first testosterone treatment approved for use in a gel form.
"Testosterone administration is a difficult problem technically," says Adrian Dobs, MD, MHS, associate professor of medicine at Johns Hopkins School of Medicine in Baltimore. Dobs is one of the investigators for the testosterone gel product.
Testosterone given in injections every two weeks has two drawbacks, she explains. "It hurts a little bit, and the levels get very high after the injections and then get low every two weeks," she says. "People call it a roller-coaster effect."
Testosterone also can be delivered by a skin patch. The patches sometimes cause skin irritation, or they might not result in sufficiently high testosterone levels, Dobs adds. Testosterone pills often don’t deliver enough testosterone because they are broken down by the liver so quickly.
The new testosterone gel consistently raises the hormone to high levels and is well-tolerated, Dobs says.
"We’ve been working with the gel for two years in drug development, and we’ve had good experiences with it," she notes. "There’s no irritation, and the serum levels are quite good."
For example, the normal range of testosterone is 300-800 ng/dL. AndroGel was found to raise levels to 700 ng/dL and keep the levels in this range.
The gel is available in daily application packets that a man rubs on his shoulders, upper arms, and/or abdomen each morning. The product dries within a few minutes. As the skin absorbs the testosterone, it is gradually released into the blood, where it restores normal testosterone levels within one to four hours.
Studies have looked at the gel’s use with men who had hypogonadism due to conditions like Klinefelter’s syndrome or because of their age. While the product has not been tested on men who have HIV, it would appear to be a solution to low testosterone for them as well, Dobs says.
"We’ve done studies looking at the end effects of testosterone, and it turns out this has been very efficacious in increasing lean body mass and improving sexual function, and these things are all very relevant to an HIV population," she explains.
Studies showed that the product is very safe, Dobs says. "We did have one man who dropped out of the study because he said it was a little messy."
Clinicians prescribing the gel will need to monitor patients’ hematocrit levels every three months for at least a year, Dobs advises.
Other precautions are that the testosterone could be transferred from one person to another through vigorous skin-to-skin contact at the application site. So patients should be cautioned to wash hands immediately with soap and water and cover the application sites with clothing after the gel has dried.
Also, the product is not recommended for men with prostate cancer, breast cancer, or heart, kidney, or liver disease. Also, geriatric patients may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.
The price of the gel had not been determined by the time AIDS Alert went to press.
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