New Study Demonstrates Value of Tesamorelin for Non-Alcoholic Fatty Liver Disease

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association since its inception has advocated for more open drug formularies under the AIDS Drug Assistance Program ("ADAP") because they promote greater access to care and treatment for people living with HIV/AIDS. By omitting therapies that are approved by the U.S. Food & Drug Administration ("FDA") for the treatment of HIV-infection and related co-morbidities, some State ADAPs are being counter-productive to the needs of the people they're intended to serve. One example is the unfair limitation often put on the drug tesamorelin for the treatment of lipodystrophy. A new study published online in The Lancet shows promise for non-alcoholic fatty liver disease, and as such it might finally change some opinions about adding it to drug formularies.

Photo Source: Drugs.com

Current restrictions on the use of tesamorelin do a disservice to the needs of people living with HIV/AIDS, and diagnosed with HIV-related abnormal accumulation of visceral adipose tissue (VAT) by concluding that the potential discontinued use of tesamorelin and its “expense” is limited its use. Yet, research has shown that between 20% and 30% of HIV-positive patients are experiencing excess VAT. For years, there's been a common misconception that this belly fat is just a physical cosmetic issue that is a side effect of earlier HIV treatments - something that must be accepted as a reality of now living longer with HIV-infection. Recent research dispels that myth so that even with newer anti-retro viral regimens this condition continues to exist.

Some states, such as Massachusetts, have long recognized the value of tesamorelin - not only within its ADAP drug formulary, but by also mandating treatment for HIV-related lipodystrophy for private insurance. The Massachusetts model was largely based on the FDA's findings: “The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy. The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”[1]

The new study - "Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial" - yielded positive results, such as demonstrating tesamorelin can reduce liver fat and prevent scarring of the liver.[2]

According to the study, "Non-alcoholic fatty liver disease (NAFLD) is a substantial cause of comorbidity in people with HIV and there are no proven pharmacological treatments for the disease in this population. We assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD."[3]

The study's findings concluded:

"61 patients were enrolled between Aug 20, 2015, and Jan 16, 2019, of whom 30 received tesamorelin and 30 received placebo. Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of −4·1% (95% CI −7·6 to −0·7, p=0·018), corresponding to a −37% (95% CI −67 to −7, p=0·016) relative reduction from baseline. After 12 months, 35% of individuals receiving tesamorelin and 4% receiving placebo had a HFF of less than 5% (p=0·0069). Changes in fasting glucose and glycated haemoglobin were not different between groups at 12 months. Individuals in the tesamorelin group experienced more localized injection site complaints than those in the placebo group, though none were judged to be serious."[4]

These findings bode well for people living with HIV/AIDS, especially as it relates to co-morbidities such as cardiovascular and type 2 diabetes risks. Now it is time for more State ADAPs to take notice.



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[1] U.S. Food & Drug Administration (2010, November 10). FDA approves Egrifta to treat Lipodystrophy in HIV patients. U.S. Department of Health & Human Services. Retrieved online at https://aidsinfo.nih.gov/news/889/fda-approves-egrifta-to-treat-lipodystrophy-in-hiv-patients---november-10--2010.
[2] Brokaw, Sommer (2019, October 15). NIH: Drug reverses liver fat, slows fibrosis in HIV-positive people. UPI. Retrieved online at https://www.upi.com/Health_News/2019/10/15/NIH-Drug-reverses-liver-fat-slows-fibrosis-in-HIV-positive-people/8621571156412/?sl=3.
[3] Stanley, MD, Takara L*, Lindsay T Fourman, MD*,. Meghan N Feldpausch, ANP, Julia Purdy, CRNP, Isabel Zheng, BS, Chelsea S Pan, BA, et al. (2019, October 11). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet. Retrieved online at https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/fulltext.
[4] Stanley, MD, Takara L*, Lindsay T Fourman, MD*,. Meghan N Feldpausch, ANP, Julia Purdy, CRNP, Isabel Zheng, BS, Chelsea S Pan, BA, et al. (2019, October 11). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet. Retrieved online at https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/fulltext.

Why HIV Medical Treatment Guidelines Matter

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

As with all chronic diseases and conditions the approved medical treatment guidelines serve as an important marker, not only for patients and the medical professionals who treat them, but also the payors. This is certainly no different with HIV/AIDS. That is why the ADAP Advocacy Association is calling on the Health Resources and Services Administration ("HRSA") at the U.S. Department of Health & Human Services to update its treatment guidelines for HIV-associated lipodystrophy. HRSA's current guidelines need to correct a statement regarding growth hormone-releasing factor, because it does not accurately reflect the available treatment to patients suffering from lipodystrophy disease.

According to WebMD, "Lipodystrophy is a problem with the way the body produces, uses, and stores fat. It is also called fat redistribution. Since the widespread use of antiretroviral therapy began, the numbers of HIV-positive people with lipodystrophy has increased. Today, lipodystrophy occurs in 30% to 50% of people who are infected with HIV (human immunodeficiency virus)."[1]

The ADAP Advocacy Association has increasingly supported educational initiatives aimed at tackling HIV-related co-mordibities, as well as HIV-related stigma. Combatting lipodystrophy falls under both categories. Researchers have concluded lipodystrophy is associated with increased rates of hypertension, diabetes, and lipids for patients experiencing lipodystrophy. Furthermore, long term psychological affects are present among patients, especially among those patients age 65 and older.[2]

Lipodystrophy is more than a cosmetic issue, especially for the HIV-positive patients living with the disease. For example, people living with HIV often believe the doughy fat around their midsection can be addressed by a healthy diet and exercise alone. But diet and exercise may not be enough to combat the challenges associated with visceral adipose tissue ("VAT"). The "Don’t Take VAT" website – www.DontTakeVAT.com – includes fact sheets about VAT and healthy living with HIV, as well as a video that provides a deeper look at VAT and tips about what to ask your doctor.

[Editor's Note: Read our related blog, "HIV-Related Belly Fat: More Than Just an Appearance Issue"]

But more needs to be done, frankly!

In 2010, the U.S. Food & Drug Administration ("FDA") approved Tesamorelin (trade name Egrifta) as treatment for lipodystrophy. Whereas some private health insurance plans cover this treatment option, public payors mostly don't cover it. Only three State AIDS Drug Assistance Programs ("ADAP") include Tesamorelin on its approved drug formulary, including Minnesota (though it requires a prior authorization), New Jersey, and Washington State. Not a single Medicaid program includes Tesamorelin on its Preferred Drug List ("PDL"). By restricting access to an FDA-approved treatment represents a disservice to the patients suffering from HIV-associated lipodystrophy.

Ironically, some states cite "cost" as the prohibitive factor for the reason lipodystrophy treatment isn't added to their approved drug formulary or PDL. Yet, other costly (and still needed) supports and services are covered -- such as counseling, physical therapy, and in some cases, surgery.

Photo Source: GLAD

That is why HRSA should update its "Guide for HIV/AIDS Clinical Care." It would provide better guidance for ADAPs nationwide seeking the necessary budgetary justification for adding Tesamorelin to its approved drug formulary. It is the only treatment available to these patients, and they are crying out for help! To read the draft letter to HRSA requesting an update to the medical treatment guidelines, CLICK HERE.

This effort shouldn't be interpreted as an endorsement of the particular product, Tesamorelin. The simple fact is Tesamorelin is the only product on the market approved by the FDA used in the treatment of HIV-associated lipodystrophy. Talk to patients who are living with HIV-associated lipodystrophy, and listen to their stories about the physical discomfort associated with the disease, or the stigma that they encounter on a daily basis living with the physical disformity caused by the disease.

Massachusetts is already leading the way to improve access to care and treatment for people living with HIV-associated lipodystrophy. The Treat Lipodystrophy Coalition fought tirelessly for the law to require insurance coverage for treatment of a debilitating and disfiguring side effect of HIV medications. Patients living with HIV-associated lipodystrophy are now demanding the same be done with public payors, such as ADAP and Medicaid.

Summarized Carl Sciortino, executive director for the AIDS Action Committee, and former representative in the Massachusetts Legislature who introduced the aforementioned legislation: "Some of our long-term survivors carrying the physical scars of earlier life-saving treatments have been denied the dignity and medical treatment they are entitled to for far too long. Lipodystrophy affects our veterans, and as a country we have effectively turned our backs on their need to treat their epidemic-inflicted wounds. I'm proud of our step forward in providing insurance coverage in Massachusetts, and I'm grateful for any interest it sparks in providing care to people living with HIV across the country."

To endorse this effort by adding your organization to the ADAP Advocacy Association's national sign-on letter, CLICK HERE. The deadline for signing on to the letter is COB on Monday, November 7, 2016.

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[1] WebMD, "Lipodystrophy and HIV," 2016; available online at http://www.webmd.com/hiv-aids/guide/lipodystrophy_and_hiv.
[2] Mascolini, Mark, "HIV Drug Therapy, Glasgow Oct 23-26 2016," NATAP, 2016; available online at http://www.natap.org/2016/GLASGOW/GLASGOW_18.htm. 

HIV-Related Belly Fat: More Than Just an Appearance Issue

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Excess belly fat, known in medical circles as VAT (visceral adipose tissue), is a type of hard fat that can affect people living with HIV-infection. Research has shown that between 20% and 30% of HIV-positive patients are experiencing excess VAT. For years, there’s been a common misconception that this belly fat is just a physical cosmetic issue that is a side effect of earlier HIV treatments – something that must be accepted as a reality of now living longer with HIV-infection. Recent research dispels that myth so that even with newer anti-retro viral regimens this condition continues to exist.

Photo Source: Don't Take VAT

"Don’t Take VAT" is an educational initiative supported by the ADAP Advocacy Association, that is shedding light on excess belly fat and the medical complications it can potentially create in order to help people living with HIV-infection learn about the condition, how to identify it, and what questions to ask their doctor. Since VAT is a type of hard fat that can surround a person’s organs and make it difficult for people to do things like bend over to tie their shoes or breath normally, the ramifications of this type of belly fat go far beyond the emotional strain caused by the stigma of carrying VAT. Excess abdominal VAT is also associated with a variety of health concerns, including diabetes and cardiovascular disease, which is why it’s important for patients to talk to their doctor about it.

Far too often, people with HIV believe the doughy fat around one’s midsection can be addressed by a healthy diet and exercise alone. But VAT doesn’t work that way. It can be challenging to reduce VAT with exercise and healthy living alone. The "Don’t Take VAT" website – www.DontTakeVAT.com – includes fact sheets about VAT and healthy living with HIV, as well as a video that provides a deeper look at VAT and tips about what to ask your doctor.

A doctor can determine if a person has excess abdominal VAT by assessing the individual’s medical history and HIV therapy regimen and by measuring around a patient’s waist and hips and calculating waist-to-hip ratio. But this often requires a patient’s willingness to make such a request, as often even doctors mistake VAT for regular belly fat and don’t always conduct this type of assessment during routine medical appointments.

While having excess HIV-related belly fat can cause physical, medical and emotional difficulties, nobody should feel ashamed or embarrassed about it. It is important that you take ownership of your own health and take the first step toward talking to your doctor and examining your treatment option.