Topical transdermal testosterone gel offers significant clinical benefits in hypogonadal HIV-positive patients

Testosterone deficiency is common in HIV-positive men. Several studies have shown that testosterone replacement can alleviate symptoms associated with hypogonadism, including loss of libido, fatigue and depression.

Testosterone injections are not easy, however, especially since they may be given by weekly or biweekly deep intramuscular injections of testosterone esters, which are painful, cause wide, non-physiologic variations in serum testosterone levels and may lead to morbidities such as deep abscesses.

Fortunately, a daily topical transdermal testosterone formulation (AndroGel®) is available which provides sustained levels of serum testosterone; however, there are few trials comparing AndroGel to IM testosterone.

In a study by Cohan and associates, the tolerability of a topical testosterone formulation and its effect on quality-of-life were evaluated in 30 hypogonadal HIV-positive male patients on stable regimens of 200-300 mg intramuscular testosterone cypionate (IMT). These patients were recruited from a large HIV treatment centre in Los Angeles.

All subjects were evaluated for eight weeks on IMT and then switched to a daily transdermal application of 5.0-10.0 gm AndroGel. The follow-up period was eight weeks and study outcome variables included serum free (FT) and total testosterone concentrations, body composition analysis (BIA), and quality of life and patient perception surveys. Compliance and adverse events were evaluated at each study visit.

The pharmacologic data collected indicates that the daily application of AndroGel provides a more stable steady state serum testosterone concentration than does IMT, with a mean difference trough to peak FT with AndroGel of 2.2 pg/ml and with IMT of 15.6 pg/ml. In addition, both the mean peak FT of AndroGel (22.7 pg/ml) and of IMT (42.2 pg/ml) were within the normal range for males 20-49 years of age of 13.0-40.0 pg/ml.

The BIA remained stable in both groups. No adverse events were reported at a preliminary interim analysis of 12 patients and results suggested that AndroGel is well tolerated. Quality of life surveys for patients treated with AndroGel showed a trend toward greater physical and emotional well-being and cognitive function.

The authors conclude that topical transdermal testosterone gel used for testosterone replacement therapy in hypogonadal HIV positive patients offers significant clinical benefits and improved patient acceptance versus IM testosterone ester injections.

This study confirms the findings of many clinicians who use AndroGel in their practices but longer-term data regarding comparability of outcomes and improved patient satisfaction are still needed.

GR Cohan et al. A Prospective Study of the Safety and Efficacy of a Topical Transdermal Testosterone Gel versus Intramuscular Injections of Testosterone for the Treatment of Testosterone Deficiency in Male HIV-Infected Patients. Abstract 1912. 42nd ICAAC, September 27 – 30, 2002, San Diego, CA.