The injectable hormone tesamorelin was found to reduce liver fat and prevent liver fibrosis or scarring in people living with HIV, according to researchers and the National Institutes of Health and the National Institute of Allergy and Infectious Disease (NIAD).

Published in The Lancet, the study included approximately 61 participants, 31 of whom were randomized to receive daily 2-mg injections of tesamorelin and 30 who were randomized to receive identical-looking injections containing a placebo.

Among the participants enrolled in the study, 43% had at least mild fibrosis and 33% met the diagnostic criteria for a more severe subset of non-alcoholic fatty liver disease (NAFLD) called nonalcoholic steatohepatitis. Researchers provided nutritional counseling to all participants as well as training in self-administering the daily injections.

Researchers then compared measures of liver health in both groups at baseline and 12 months. After 1 year, participants receiving tesamorelin had better liver health than those receiving placebo, according to the study. This was defined by a reduction in hepatic fat fraction (HFF), or the ratio of fat to other tissue in the liver, in which a healthy range is less than 5%.

Thirty-five percent of study participants receiving tesamorelin achieved a normal HFF, whereas only 4% of those on placebo reached that range with nutritional advice alone. Overall, tesamorelin was well-tolerated and reduced participants’ HFF by an absolute difference of 4.1%. This corresponds to a 37% relative reduction from the beginning of the study.

Additionally, levels of several blood markers associated with inflammation and liver damage, including the enzyme alanine aminotransferase, decreased more among those taking tesamorelin compared with those on a placebo, particularly among individuals with increased levels at the beginning of the study.

Given these positive results, investigators suggest expanding the indication for tesamorelin to include people living with HIV who have been diagnosed with NAFLD. They also recommend additional research to determine whether tesamorelin could contribute to long-term protection against serious liver disease in people without HIV.

Reference
  1. Drug Reverses Signs of Liver Disease in People Living with HIV [press release]. National Institute of Allergy and Infectious Disease website. Published October 11, 2019. https://www.niaid.nih.gov/news-events/drug-reverses-signs-liver-disease-people-living-hiv. Accessed October 14, 2019.