Is Testosterone (T) treatment safe and effective in men with HIV infection? A meta-analysis

Background Prevalence of hypogonadism is high (30%) in men with HIV. In these patients T treatment (TT) is currently used mainly to counteract wasting syndrome and/or HIV-related lipodystrophy, irrespective of patients’ serum T. However, its effect and safety in HIV-infected men is still not completely known. Aim To investigate both beneficial and adverse effects related to TT in HIV-infected men using a meta-analytic approach. Methods An extensive MEDLINE search was performed using ‘PubMed’ with the following key-words: ‘HIV’ and: ’hypogonadism’, ‘TT’, ‘T’, ’androgens’ or ‘sex steroids’ from 1946 to April 2015. Meta-analysis included 19 placebo-controlled- clinical trials evaluating TT in HIV patients and was conducted according to PRISMA statement using RevMan. Results All 19 trials evaluated the effect of TT on body weight on a total of 952 subjects (TT group: 557; placebo group: 395). Patients’ gonadal status was often not reported and most of patients were presumably eugonadal. All data are shown as standardized mean and Confidence Interval (CI). TT significantly improved total lean body mass (1.44 [0.82–2.07], P!0.001), total body weight (0.99 [0.25–1.72], PZ0.008) and fat free mass (1.48 [0.85–2.12], P!0.001). This improvement is characterized by higher heterogeneity (I 2Z84%, 88%, and 60%, respectively). Conversely, no beneficial effects were seen on total fat mass (K0.17 [K1.58–1.25], PZ0.820). TT was associated with an increased incidence of minor adverse events (ORZ1.50[1.11–2.01], PZ0.008) and increased mean serum PSA (0.10 ng/mL, [0.03–0.17], PZ0.007). No change in hemoglobin (0.39 g/dL, [K0.29–1.07], PZ0.260) was seen. Conclusions Our study suggests that TT in HIV-infected men is effective in improving body composition (increase in lean body mass), although the incidence of general adverse events is higher than in the placebo group. However, studies show a highest variability and the real benefits of TT in HIV-infected men remains still to be established.