Source: Thailand Medical News Oct 26, 2019 5 years, 1 month, 4 weeks, 6 hours, 9 minutes ago
Medical researchers from the US National Institutes of Health and the Massachusetts General Hospital (MGH) in Boston report that the injectable hormone
tesamorelin (
Egrifta) reduces liver fat and prevents
liver fibrosis (scarring) in people living with
HIV.
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Dr Anthony S. Fauci,NIAID Director (NIAID is one of the entities under the NIH) commented in a phone interview with
Thailand Medical News “Many people living with
HIV have overcome significant obstacles to live longer, healthier lives, though many still experience
liver disease.It is encouraging that tesamorelin, a drug already approved to treat other complications of
HIV, may be effective in addressing
non-alcoholic fatty liver disease.”
The findings were published in October in the
The Lancet HIV journal.
NAFLD or
Non-alcoholic fatty liver disease frequently occurs alongside
HIV, affecting as many as 28% of people living with
HIV in the developed world. No effective treatments currently exist to treat the condition, which is a risk factor for progressive
liver disease and liver cancer.
Medical researchers led by Colleen M. Hadigan, M.D., senior research physician in NIAID’s Laboratory of Immunoregulation, and Steven K. Grinspoon, M.D., Chief of the Metabolism Unit at MGH, tested whether
tesamorelin could decrease liver fat in men and women living with both HIV and NAFLD.
Of the participants enrolled, 43% had at least mild fibrosis, and 33% met the diagnostic criteria for a more severe subset of
NAFLD called
nonalcoholic steatohepatitis (NASH). Thirty-one participants were randomized to receive daily 2-mg injections of
tesamorelin, and 30 were randomized to receive identical-looking injections containing a placebo. Researchers then compared measures of liver health in both groups at baseline and 12 months.
After 12 months, participants receiving
tesamorelin had better liver health than those receiving placebo, as defined by reduction in hepatic fat fraction (HFF) ie the r
atio of fat to other tissue in the liver. The healthy range for HFF is less than 5%. Thirty-five percent of study participants receiving
tesamorelin achieved a normal HFF, while 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% (corresponding to a 37% relative reduction from the beginning of the study). While nine participants receiving placebo experienced onset or worsening of fibrosis, only two participants in the
tesamorelin group experienced the same. Additionally, levels of several blood markers associated with inflammation and liver damage including the enzyme alanine aminotransferase (ALT),decreased more among those taking
tesamorelin compared to those on a placebo, particularly among those with increased levels at the beginning of the study.
Considering 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 if tesamorelin could contribute to long-term protection against serious liver disease in people without
HIV.
Dr Colleen M. Hadigan further commented to
Thailand Medical News via phone, “Our hope is that this intervention may help
people living with HIV, as well as benefit
HIV-negative people with liver abnormalities.Further research may inform us of the potential long-term benefits of this approach and develop formulations that can benefit everyone with liver disease, regardless of
HIV status.”
Tesamorelin (
Egrifta) was approved in 2010 by the US FDA to reduce excess abdominal fat in
HIV patients with lipodystrophy,a complication characterized by an abnormal distribution of body fat initially associated with older classes of
HIV medications. The most commonly reported side effects in previous clinical trials evaluating
Egrifta included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in trial participants treated with
Egrifta than with placebo.
As
tesamorelin proved effective in treating abnormal fat build-up in the abdomens of people in the context of
HIV and related medication use, the researchers hypothesized that the drug might also reduce fat that accrues in the liver and causes damage in a similar population.
While
liver disease is often associated with heavy alcohol use,
NAFLD occurs when excess fat builds up in the liver without alcohol as a contributing factor. This condition may progress to liver damage, cirrhosis or cancer that could be life-threatening and necessitate liver transplantation.
Previous studies have found that vitamin E supplements, weight loss and other lifestyle changes can improve outcomes among
HIV-negative people with
NASH. However, treatment options for
NASH and
NAFLD are often not tested in people with
HIV and none are available for this group. Obesity and type 2 diabetes raise the risk of developing
NAFLD regardless of
HIV status, and people with
HIV are at increased risk of
NAFLD because some
HIV medications and
HIV itself are associated with gaining abdominal fat and may contribute to liver fat build-up.
Individuals living with
HIV are advised to have routine liver screenings and if signs of
NAFLD or liver fibrosis are developing to consult their doctors about starting
Tesamorelin (
Egrifta) therapy.
Reference: “Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial” by Takara L Stanley, MD; Lindsay T Fourman, MD; Meghan N Feldpausch, ANP; Julia Purdy, CRNP; Isabel Zheng, BS; Chelsea S Pan, BA; Julia Aepfelbacher, BS; Colleen Buckless, MS; Andrew Tsao, BS; Anela Kellogg, MSN; Karen Branch, RN; Hang Lee, PhD; Chia-Ying Liu, MD; Kathleen E Corey, MD; Raymond T Chung, MD; Martin Torriani, MD; Prof David E Kleiner, MD; Colleen M Hadigan, MD and Prof Steven K Grinspoon, MD, 11 October 2019, The Lancet HIV. DOI: 10.1016/S2352-3018(19)30338-8 
