Let's get our Australian Therapeutic Goods Administration (TGA) to approve 'Egrifta' (tesamorelin)! 

There are many HIV+ long-term (and other general) patients experiencing HIV  and HIV antiretroviral-associated lipodystrophy with dangerous abnormal fat distribution around the heart, liver, and surrounding endodontic areas.  This can cause cardiovascular disease, insulin resistance, neurocognitive impairment and mortality  Early antiretrovirals up through 2015 were found to cause this damage and were discontinued.

Unfortunately again, some newer antiretrovirals have recently been found to do the same - adding up to a dangerous 25% weight gain in some persons.

It's important to note some newer HIV antiretroviral medications that are also being prescribed to HIV negative persons (general public) for various reasons, that they too are subject to the same above adverse health effects.

The Australian TGA is 10 years behind the US Food & Drug Administration (FDA)'s 2010 approval of Egrifta (tesamorelin) after clinical trial success at Harvard University in Boston.  https://www.latimes.com/archives/la-xpm-2010-nov-10-la-heb-lipdystrophy-drug-20101110-story.html

Unfortunately, Egrifta has been missed by our TGA, and is only accessible through arduous paperwork required under the TGA 'Special Access Scheme.'  It is almost impossible for patients undertaking HIV antiretroviral treatment to find doctors familiar with Egrifta.  Furthermore, using the Scheme requires much time and cost of healthcare professionals to prepare 'Special Access Scheme' documentation.

Getting Egrifta (tesamorelin) approved by our TGA would cut costly healthcare professional paperwork time, and facilitate faster prescriptions to patients to combat dangerous HIV antiretroviral-associated lipodystrophy, non-alcoholic fatty liver disease (NAFLD) and other associated multi-morbidities - to live healthier lives.

Historically, HIV antiretroviral drugs have been given 'emergency approval' to fast-track antiretrovirals and related drugs to patients to compact HIV and multiple associated morbidities.  Egrifta has proven successful in US HIV long-term patients and even the general public during the past 10 years.  Egrifta needs to be fast-tracked for listing on the Australian TGA..

About Egrifta:  It is a synthetic version of an injectable human growth hormone–release directed to the pituitary gland in the brain to produce growth hormone, which both builds muscle and breaks down fat. It was approved in 2010 by the US FDA.  https://www.egriftasv.com/  or https://www.youtube.com/watch?v=iTUFH5OFhcY (start at minute 7.20 - first part about Canada healthcare system)

The research team behind this clinical study and subsequent 2010 US FDA approval was led by Colleen M. Hadigan, MD, a senior research physician in the laboratory of immunoregulation at the National Institute of Allergy and Infectious Disease (NIAID), and Harvard Professor Steven K. Grinspoon, MD, chief of the metabolism unit at Massachusetts General Hospital in Boston.

US NIAID director Anthony S. Fauci, MD, said, “Many people living with HIV have overcome significant obstacles to live longer, healthier lives, though many still experience liver disease. It is encouraging that Egrifta, a drug already approved (in the US) to treat other complications of HIV, may (also) be effective in addressing non-alcoholic fatty liver disease.”