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Tesamorelin ‘very promising’ for reversing liver disease in people with HIV
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The injectable hormone tesamorelin reduces liver fat and prevents liver fibrosis in patients living with HIV, suggesting it may provide significant clinical benefits in this population, according to study results published in The Lancet HIV.
“We’re putting an emphasis, appropriately, on comorbidities of HIV infection,” National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, told Infectious Disease News, who classified the findings as “an important advance.”
“We have phenomenally successfully direct-acting antiretrovirals for HIV that have saved the lives of people and allowed them to go on and live essentially normal lifespans, if you get them early enough and it also prevents them from infecting others,” Fauci said. “But what we’re left with are comorbidities. One is in the liver and in the liver, with people who have HIV, is an incidence of nonalcoholic fatty liver disease and sometimes that progresses and can lead to liver function abnormalities and liver decompensation.”
According to Steven K. Grinspoon, MD, professor of medicine at Harvard Medical School and chief of the metabolism unit at Massachusetts General Hospital, nonalcoholic fatty liver disease (NAFLD) occurs in up to 35% to 40% of patients living with HIV, and there are no effective treatments available to them.
“Moreover, most of the studies in NAFLD do not include HIV patients, so this is a real urgency to study such patients,” Grinspoon told Infectious Disease News.
In their study, Grinspoon and colleagues assessed whether tesamorelin could decrease liver fat in men and women living with HIV and NAFLD. Tesamorelin is a “hypothalamic analogue of growth hormone-releasing hormone [that] works to increase the natural pulsatility of the body’s own growth hormone, which is reduced in HIV,” Grinspoon explained.
According to the study, 43% of participants enrolled had at least mild fibrosis and 33% met diagnostic criteria for more severe subset of NAFLD called nonalcoholic steatohepatitis. Overall, 31 participants were randomly assigned to receive 2 mg injections of tesamorelin and 30 were randomly assigned to receive placebo injections. Researchers provided nutritional counseling and training for self-administering to both groups and compared liver heath at baseline and 12 months.
Results showed that after 1 year, participants receiving tesamorelin experienced better liver health than the placebo group. According to the study, 35% of patients in the tesamorelin group achieved normal hepatic fat fraction compared with 4% in the in the placebo group. Grinspoon and colleagued reported that tesamorelin was well tolerated, reduced patients’ hepatic fat fraction and reduced odds of onset or worsening fibrosis. Additionally, blood markers associated with inflammation and liver damage decreased among participants in the tesamorelin group.
“Tesamorelin represents a new potential treatment strategy for the large percentage of HIV patients with NAFLD, that may be useful not only to reduce liver fat but to critically prevent progression of fibrosis,” Grinspoon said.
In an accompanying comment, also published in The Lancet HIV, Jennifer Audsley, PhD, and colleagues from The Peter Doherty Institute for Infection and Immunity at the University of Melbourne and Royal Melbourne Hospital, call for further studies examining side effects of stopping tesamorelin treatment, long-term effects and data and accessibility in low- and middle-income countries where NAFLD prevalence is “substantial and rising.”
“Increased investment will be needed to increase the awareness of the condition to allow for early diagnosis and a focus on prevention,” Audsley wrote. “Tesamorelin provides a new therapeutic approach that is important to managing people living with HIV and NAFLD and warrants further investigation.”
Grinspoon said further studies are needed to confirm results, but this study is “a very promising advance.” – by Caitlyn Stulpin
References:
Audsley J, et al. Lancet HIV. 2019;doi:10.1016/S2352-3018(19)30331-5.
Stanley TL, et al. Lancet HIV. 2019;doi:10.1016/S2352-3018(19)30338-8.
Disclosures: Audsley and Fauci report no relevant financial disclosures. Grinspoon reports serving on a scientific advisory board and being a consultant for Theratechnologies, receiving research support from Theratechnologies, and being a named inventor on a patent application on the effects of tesamorelin in the treatment of hepatic disease. Please see the study for all other authors’ relevant financial disclosures.
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