The HIV-associated adipose redistribution syndrome (HARS) study, a phase III, double-blind, placebo-controlled trial, was designed to evaluate recombinant human growth hormone (r-hGH) as a potential therapy for reducing abnormal accumulations of visceral fat.
In the HARS study patients, r-hGH 4mg daily for 12 weeks significantly reduced visceral adipose tissue (VAT), trunk fat, non-HDL cholesterol, and improved pre-specified health-related quality of life outcomes. Maintenance therapy for 24 weeks with a lower dose of r-hGH helped sustain the clinical benefits.
“The findings from the HARS study provide promising news for the HIV community and for people living with HARS, a metabolic condition for which there is currently no approved drug treatment,” said Dr Paul Lammers, chief medical officer for Serono. “Visceral fat accumulation and lipid changes are concerns for HIV patients who are living longer due to advances in antiretroviral therapy. We are pleased that the study met all pre-specified primary and major secondary efficacy endpoints and we look forward to working with the FDA during the review process.”
Serono submitted a supplemental new drug application (sNDA) covering this indication to the FDA during the second quarter of 2006.