Theratechnologies: Tesamorelin study results on NAFLD published in Lancet HIV
Theratechnologies is pleased to announce that results from a recent trial conducted at the Massachusetts General Hospital and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health on the effects of tesamorelin on Non-alcoholic Fatty Liver Disease in HIV were published today in the Lancet HIV. NAFLD is a substantial cause of liver-related morbidity in people living with HIV and is a precursor of Non-alcoholic steatohepatitis. The randomized, double-blind, multicenter trial assessed the effect of tesamorelin on liver fat and histology in people living with HIV with NAFLD. At baseline, liver biopsies revealed that 43% of patients had liver fibrosis and 33% had NASH. A total of 61 patients received 2mg of tesamorelin daily or an identical placebo for a period of 12 months. The primary endpoint of the study was a change in hepatic fat fraction. After 12 months of treatment, liver fat in patients on tesamorelin had decreased by 32% while it had increased by 5% in placebo patients, from baseline, amounting to a 37% relative reduction in liver fat. Furthermore, 35% of patients in the tesamorelin group returned to liver fat values below 5% in comparison to only 4% of patients on placebo. The study concluded that only 10.5% of patients in the tesamorelin group experienced progression of liver fibrosis compared to 37.5% in patients receiving a placebo. Exploratory analyses showed that the higher the baseline NASH score was, the more change was seen among the tesamorelin-treated individuals, whereas a similar relationship was not observed in the placebo group.