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Background:  TH9507, a growth hormone–releasing factor (GRF) analog, has been shown to significantly decrease truncal and visceral fat without reductions in extremity and subcutaneous fat in a 12-week, multi-center, double-blind, placebo-controlled study conducted in HIV-infected patients with evidence of abdominal fat accumulation considered to be part of the HIV lipodystrophy syndrome. Here, we report the results on quality of life.

Methods:  A health-related quality of life questionnaire (PLC, Quality of Life Profile for the Chronically Ill) was completed by 61 patients randomized to receive either placebo or TH9507 at 1 or 2 mg subcutaneously daily. The PLC questionnaire included a general, non-specific part assessing 6 dimensions of global health, as well as a disease specific part capturing the impact of enlarged abdominal girth, abdominal bloating, tenseness and pain, as well as diarrhea, visible facial changes, visible changes in physical appearance, and the feeling of being recognized as an HIV-positive person.

Results:  Study population included 54 men and 7 women. Baseline mean age was 46 ± 7 (SD), body mass index 28 ± 3 (SD) kg/m², waist circumference 102 ± 8 (SD) cm and waist-to-hip ratio 1.0 ± 0.1 (SD). No significant difference between groups was noted for subscales of the main portion of the PLC. Slight changes were observed within the treated groups in the positive mood and social well-being scores, but were not considered as clinically significant. Clinically significant improvements were noted for the enlarged abdominal girth (placebo:  –0.13; 1 mg:  –0.93, p = 0.06 vs baseline; 2 mg:  –1.19, p < 0.05 vs baseline, NS vs placebo) and bloating scores (placebo:  +0.56; 1 mg:  –0.50, NS vs placebo; 2 mg:  –0.69, p < 0.05 vs placebo). Improvement in abdominal pain was observed at 1 mg only (p < 0.05 vs baseline, NS vs placebo) along with a trend for an improvement in abdominal tenseness (P = 0.07 vs baseline, NS vs placebo). No significant changes were observed in the other disease-specific items.

Conclusions:  These data suggest that administration of TH9507, a GRF analog, in HIV patients with abdominal fat accumulation improved quality of life with regard to enlarged abdominal girth and related factors, consistent with the decrease in truncal and visceral fat observed in this population, and warrant further investigation in larger and longer term trials.

Keywords: Lipodystrophy syndrome; GRF analog; Quality of life