Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial

Publication date: Available online 11 October 2019Source: The Lancet HIVAuthor(s): Takara L Stanley, Lindsay T Fourman, Meghan N Feldpausch, Julia Purdy, Isabel Zheng, Chelsea S Pan, Julia Aepfelbacher, Colleen Buckless, Andrew Tsao, Anela Kellogg, Karen Branch, Hang Lee, Chia-Ying Liu, Kathleen E Corey, Raymond T Chung, Martin Torriani, David E Kleiner, Colleen M Hadigan, Steven K GrinspoonSummaryBackgroundNon-alcoholic fatty liver disease (NAFLD) is a substantial cause of comorbidity in people with HIV and there are no proven pharmacological treatments for the disease in this population. We assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD.MethodsThis randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA. People with HIV infection and a hepatic fat fraction (HFF) of 5% or more by proton magnetic resonance spectroscopy were eligible. Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily. The randomisation list was prepared by the study statistician using a permuted block algorithm within each stratum with randomly varying block sizes. The primary endpoint was change in HFF between baseline and 12 months. The primary safety endpoint was glucose. Analysis was by intention to ...
Source: The Lancet HIV - Category: Infectious Diseases Source Type: research