Swiss biotechnology group Serono’s recombinant human growth hormone (r-hGH) has shown further promise in a recent Phase III trial assessing its potential as a treatment of HIV-associated adipose redistribution syndrome, a condition involving abnormal accumulation of visceral fat.
HARS is a subset of HIV-associated lipodystrophy syndrome, which encompasses a group of physical and metabolic changes that HIV drug therapy, in particular protease inhibitors, can induce in patients.
Results from the double-blind, placebo-controlled study, unveiled during a late-breaker session at the XVI International AIDS Conference in Toronto, Canada, showed that 326 patients receiving r-hGH 4mg daily for 12 weeks showed a substantial reduction in visceral adipose tissue, trunk fat and non-high-density lipoprotein cholesterol, as well as experiencing health-related quality of life outcomes, the group said.
“The findings from the HARS study provide promising news for the HIV community and for people living with HARS...for which there is currently no approved drug treatment,” commented 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,” he added.
Serono's r-hGH products are already approved in the USA for the treatment of pediatric growth hormone deficiency, adult growth hormone deficiency, HIV wasting or cachexia and for the treatment of short bowel syndrome, and the group filed a supplemental New Drug Application with US regulators for HARS in the second quarter of this year.