Could New Research Pave Way for Official Guidelines for the Treatment of Lipohypertrophy

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

There purports to be an "obesity epidemic" in the United States,[1] though strong evidence suggests that people can be healthy at every size.[2] Data shows from 1960-2002, in the United States the average male weighed 25 pounds more and average female weighed 24 pounds more. Putting the debate over obesity aside, undesirable weight gain for many people living with HIV/AIDS is often grudgingly accepted as normal. This paradigm could soon be changing because new research could pave the way for better guidelines for treating HIV-related weight gain — namely, Lipohypertrophy.

Photo Source: myclickfine.com

Research published in the Clinical Infectious Diseases by a panel of international authors (U.S., Canada, Europe) from 12 universities represents a consensus opinion on the diagnosis, clinical consequences and treatment of excess fat in adults with treated HIV infection. The groundbreaking study offers some hope to people living with HIV-infection concerned about facial wasting, belly fat, lipomas, or the dreaded "buffalo hump" on the back of the neck.

The publication, "Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection," concludes, "Both generalized obesity and lipohypertrophy are prevalent among HIV-infected persons on ART. Aggressive diagnosis and management are key to the prevention and treatment of end-organ disease in this population, and critical to the present and future health of HIV-infected persons."

Among the research findings, management of HIV-related weight gain includes lifestyle changes in diet and exercise, though there was "insufficient data to support any specific dietary or exercise strategy in patients with HIV and abdominal obesity."[3] Changes in anti-retroviral therapy is also suggested, since some of the new medications have less side-effects.[4] Medical interventions are also identified as viable options — including Growth Hormone (GH) Axis Therapy and Metformin.[5] Finally, surgical interventions are also included in the options identified by the authors.[6]

The research findings are already gaining attention in respected HIV news publications, too.

The ADAP Advocacy Association sees promise in the report findings for patients suffering from a condition for which treating physicians are paying little attention, and in many cases where payors — including many State ADAPs — are excluding coverage for treatment options approved by the U.S. Food & Drug Administration. In late 2016, we urged the Health Resources and Services Administration ("HRSA") to update to the Guide for HIV/AIDS Clinical Care. The national sign-on letter wasn't an endorsement of a specific product or treatment, but rather an attempt to afford patients suffering from HIV-associated lipodystrophy syndrome the opportunity to access the available treatment options (all of which were identified in the aforementioned research).

HRSA now has a template for updating its treatment guidelines. It is up to the federal agency to respond to the needs to the patients!



Read our related blogs on this topic:

• Despite Treatment Improvements, Patients Remain Concerned about Lipo (published January 27, 2017)
• Why HIV Medical Treatment Guidelines Matter (published on October 28, 2016)
• Mandating Treatment for HIV-Related Lipodystrophy: The Massachusetts experience and a call for national action (published on August 25, 2016)
• HIV-Related Belly Fat: More Than Just an Appearance Issue (published on June 23, 2016)

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[1] Rauh, Sherry (2010); Is Fat the New Normal? A rise in average body weight may be changing how we see ourselves. WebMD. Retrieved from http://www.webmd.com/diet/obesity/features/is-fat-the-new-normal#1.
[2] Bacon, Linda (2010, May 4); Health At Every Size: The Surprising Truth About Your Weight; BenBella Books. Retrieved from https://lindabacon.org/health-at-every-size-book/.
[3] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[4] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[5] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[6] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.

Linkages to Care - Plugging the Treatment Gap: Navigating Patient Assistance Programs

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

In the United States, everyone hates how insurance companies "stick" it to consumers. There is pretty much universal agreement that the cost of prescription drugs are too high. There is also near consensus that the marketplace plans under the Affordable Care Act ("ACA") have caused a lot of headaches for patients with chronic conditions — including HIV/AIDS — especially with respect to the high tier drug plans. It is no wonder that so many cracks exist within the current healthcare framework. Fortunately, there also exist patient assistance programs ("PAPs") designed to plug the treatment gaps for these patients. PAPs serve as key linkages to care...and treatment!

According to PatientAssistance.com, "Commonly referred to as PAPs, Patient Assistance Programs are services offered by pharmaceutical companies for those who cannot afford their medication. Patient assistance programs are available to low-income individuals or families who are under-insured or uninsured and are provided to those who meet the eligibility guidelines. Assistance may range from reduced cost of drugs to free medicine. Each drug that a company offers will have its own unique program and may even have a different eligibility requirement than the other drugs they offer. As there is no unified standard of designation for these programs, you may also see them referred to as medication assistance programs, indigent drug programs, and charitable drug programs."[1]

Photo Source: MedicineCoupons.net

PAPs are vitally important to patients living with chronic conditions. They not only improve access to care and treatment, but they also save consumers money and reduce lost productivity. They also benefit the drug manufacturers because PAPs keep patients (would-be consumers) in treatment. The data shared by the Partnership for Prescription Assistance ("PPA") — which connects qualifying patients with the assistance program that’s right for them — is mind-blowing.

Celebrating its 12-year anniversary, PPA recently reported that its website is visited by over 75,000 consumers per month and makes available information on more than 475 patient assistance programs. It also offers a database of nearly 10,000 free or low-cost health care clinics across the country. Over 10 million consumers have been helped since the program's inception.[2]

Aside from the resources made available to consumers directly from the drug manufacturers, there also exists other patient-centric organizations designed to assist patients with prescriptions, discount drug cards, and other patient resources. Just to name a few, they include the Patient Access Network Foundation ("PAN"), Patient Advocate Foundation ("PAF"), and NeedyMeds. Each of these organizations serve as vital linkages to care for social workers, case managers, and allied health professionals assisting patients. These organizations also each partner with the ADAP Advocacy Association.

In an effort to raise awareness about patient assistance program and how they serve people living with HIV/AIDS and/or viral hepatitis, we will host an educational training webinar on May 31, 2017. The webinar, "Plugging the Treatment Gap: Navigating Patient Assistance Program," will showcase important information about these patient-centric PAPs. It will provide webinar attendees with a greater understanding about patient assistance programs, tools for how to navigate patient assistance programs to best assist patient needs, strategies for better seamless delivery of health-related care and treatment, and useful resources and tools to plug the treatment gap.

Registration is open to all stakeholders. Registration is complimentary for PASWHA members, and it is also complimentary for patients living with HIV/AIDS. Use this scholarship link if you are a patient living with HIV/AIDS applying for a webinar scholarship.

Additional information about the webinar is available online at https://www.123signup.com/event?id=nhjqn.


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[1] PatientAssistance.com (2014); The Catalyst; What are Patient Assistance Programs?; PatientAssistance.com, Inc. Retrieved from https://www.patientassistance.com/faq.html.
[2] Mooney, Hannah (2017, April 5); 12 years of the Partnership of Prescription Assistance; Pharmaceutical Research and Manufacturers of America®. Retrieved from http://catalyst.phrma.org/12-years-of-the-partnership-of-prescription-assistance.

Is it Time for a Reset to the Ryan White CARE Act?

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

It has been almost 27 years since the mother of a young boy dying of AIDS received a phone call from the late Senator Edward Kennedy (D-MA), asking if it would be okay to attach the boy's name on federal legislation.1 That young boy's name was Ryan White, and it has become synonymous with the Ryan White Comprehensive AIDS Resources Emergency Act (Ryan White CARE Act). Since 1990, it has saved countless lives of people living with HIV/AIDS in the United States. The law is due to be re-authorized by Congress, and some are asking if the time is right for a "re-set" so that the supports and services authorized under the law better reflect the state of the epidemic.

HIV surveillance data reveals some interesting trends about the epidemiology of the disease over time. Diagnosis of HIV infection demonstrates that some things have remained constant, such as men who sex with men (MSM) and intravenous drug use (IDU) represent two of the high-risk transmissions groups. But today, HIV infection disproportionately impacts communities of color, as well as people living in rural areas of the country. Heterosexual woman and adolescents are also greatly at risk for HIV infection.

The following charts published by the Centers for Disease Control & Prevention (CDC) help to explain the trends in HIV diagnoses in the United States between 2010 - 2014:2

Photo Source: CDC

Photo Source: CDC

Photo Source: CDC

According to the CDC, "The South now experiences the greatest burden of HIV infection, illness, and deaths of any U.S. region, and lags far behind in providing quality HIV prevention and care to its citizens." It begs the question, shouldn't the federal government adopt a "money follows the person" paradigm to reflect the changing epidemiology?

Some of the important questions surrounding Ryan White reauthorization include the following:

• should funding stream formulas count cumulative AIDS cases or only living HIV-positive people?
• should wrap-around services be expanded for clients who have Medicare Part D, Medicaid or Veterans Affairs healthcare?
• should coverage include inpatient hospital care?
• should coverage include Hepatitis C (HCV) drug therapies?
• should commercial health insurance premium assistance programs be liberalized?

"At a time when we have the most effective and simple HIV treatments and a very volatile healthcare insurance landscape, WE NEED the Ryan White safety net program for continuity - less we forget without care and treatment HIV is a deadly and transmissible disease," summarized David Poole, Director of Legislative Affairs at AIDS Healthcare Foundation."

Next week this issue will be discussed at the ADAP Advocacy Association's AIDS Drug Assistance Program Regional Summit in Raleigh, North Carolina. "Ryan White & Service Delivery Systems in the Age of Budget Austerity" is one of the topics on the agenda with leading policy stakeholders concerned about the future of the program, and potential impact on patients living with HIV/AIDS and other underserved populations.

For complete information about the Ryan White CARES Act please visit http://hab.hrsa.gov/abouthab/legislation.html.


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[1] Groppe, Maureen (2014, July 30); Future of Ryan White program not clear; JConline. Retrieved from http://www.jconline.com/story/news/2014/07/30/future-ryan-white-program-clear/13376961/.
[2] National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (2017, March 24); HIV Surveillance—Epidemiology of HIV Infection (through 2015); Centers for Disease Control & Prevention, U.S. Department of Health & Human Services. Retrieved from https://www.cdc.gov/hiv/pdf/library/slidesets/cdc-hiv-surveillance-genepi.pdf.
[3] Centers for Disease Control & Prevention (2016); HIV in the Southern United States; TheBody.com. Retrieved from: http://www.thebody.com/content/76879/hiv-in-the-southern-united-states.html.