Tesamorelin F8 (NASH HIV)

The prevalence of liver disease has increased significantly in recent years. Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are the leading cause of liver disease.¹ These diseases are common in HIV patients and the prevalence is 35% to 40%² The progression of the pathology is characterized by the development of fibrosis that is present in about 20% of people living with HIV and NASH. Several factors are associated with NASH including lipodystrophy.³

The treatment of this pathology is essential since patients with HIV seem to be more at risk than the general population. The effect of tesamorelin has recently been evaluated in patients with HIV and NAFLD following one-year treatment. This study demonstrated that the use of 2.0 mg daily causes a significant decrease in hepatic fat (37%) compared to the control group. In addition, 35% of patients treated with tesamorelin demonstrated hepatic fat normalization, compared to only 4% in the control group. This study also suggests potential benefits on the prevention of fibrosis.

Considering this evidence, Theratechnologies has announced its willingness to continue a randomized clinical trial for the evaluation of tesamorelin in patients with HIV and NASH. This study will begin in the coming months and results are expected approximately 24 months later.

Tesamorelin is the only potential treatment for NASH in people living with HIV to be at such an advanced stage of development.

¹ LaBrecque et al., Nonsalcoholic fatty liver disease and nonalcoholic steatohepatitis, World Gastroenterology Organization Global Guidelines, June 2012

² Maurice et al., AIDS 2017; 31: 1621-1632

³ Chalasani et al., 2007, 55 (6); 2005-23