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Fat Reduction With Improved Liver Enzymes In Hiv Patients With Tesamorelin
Tesamorelin has proven to reduce visceral adipose tissues (VAT) in HIV patients. The studies investigated whether the reductions in visceral adipose tissue was associated with the changes of aspartate aminotransferase or alanine aminotransferase. Using data from two Phase III trials of tesamorelin among eight hundred and six HIV patients with abdominal obesity, the study was conducted.
The studies showed most patients treated with tesamorelin are responders achieving eight percent reduction in visceral adipose tissue. The current analysis examined the impact on VAT reduction among patients taking part in the trials. Within the group, changes were compared in ALT and AST in VAT responders versus those that did not respond after twenty-six weeks of treatment.
The VAT was positively associated in the HIV patients assigned tesamorelin at baseline. Those responding positively experienced a higher reduction in ALT and AST. This improvement continued over fifty-two weeks, even in those that switched to a placebo. Significant VAT reduction with tesamorelin was associated with improved liver enzymes among those with HIV ...
... that had abdominal obesity and elevated baseline transaminase.
Twenty percent of people with HIV experience abnormal liver tests, when compared to ten percent of the general US population. Reports of HIV infected patients, nonalcoholic fatty liver disease was the most common condition and is associated with elevated liver enzymes. This is followed by excessive alcohol use and chronic hepatitis B and hepatitis C.
Studies have determined that abdominal obesity is a high-risk factor for increases hepatic transaminase in patients with HIV. Along with unaffected individuals. A study found that for every visceral adipose tissue that was doubled, the ALT was elevated by up to ten percent in HIV patients.
Tesamorelin, a synthetic growth hormone releasing hormone analogue, has been approved for treatment of abdominal adiposity in patients with HIV with two phase III clinical trials that include HIV patients taking place. Tesamorelin reduced VAT by fifteen percent over a twenty-six-week period without altering the subcutaneous adipose tissue or body mass index.
Each study went through an FDA approving process with sixty nine percent of subjects receiving tesamorelin for VAT reduction and thirty percent receiving a placebo. Based on this data, FDA approved tesamorelin for the treatment of VAT in HIV patients in 2010.
Liver dysfunction is very common in HIV infected patients, especially those with increased abdominal adiposity. The study searched for characteristics that clinically impact tesamorelin mediated VAT reduction among the Phase III clinical trial participants. Using the FDA definition, the information was compared focusing on the changes in liver enzymes among those responded to tesamorelin and experienced VAT reduction.
All eligible participants were HIV men and women aged eighteen to sixty-five years of age that had abdominal fat accumulation. In men this was a 95cm waist circumference and 94cm in women. Those excluded from the study had a history of diabetes and required medication.
This study's strength was the large number of HIV infected participants. The limitation on the analysis was that from the two large trials, no detailed measurement of alcohol use was available.
Overall, the study showed that selective, clinically significant VAT reduction of less than eight percent was associated with an improvement of AST and ALT in those treated with tesamorelin. The decrease occurred irrespective of the viral status and outlasted the reduction in VAT among tesamorelin responders who were later reassigned to the placebo.
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