Making U=U Foundational in Our Efforts to End the HIV Epidemic

By: Murray Penner, U.S, Executive Director, Prevention Access Campaign/U=U

Undetectable = Untransmittable, or U=U, was created in July 2016, BY people living with HIV (along with leading researchers and other advocates), FOR people with HIV. The U=U campaign is approaching the fifth anniversary of its launch. As such, it is the perfect time to expand the U=U message with an advocacy focus on how U=U contributes to ending the HIV epidemic. 

Photo Source: Prevention Access Campaign

The medications people with HIV take to stay healthy also make it impossible for them to pass on HIV. That’s because when people are on effective HIV treatment, their HIV is suppressed in the body to such low levels that it’s undetectable by most lab tests. And when one’s viral load is undetectable, HIV also is not transmitted through sex. 

The U=U message is revolutionary and has a positive impact on people’s lives and on ending the epidemic:  

• U=U improves the well-being of people with HIV, transforming their social, sexual, and reproductive lives.
• U=U reduces the anxiety associated with HIV testing and adds an incentive for people with HIV to start and stay on treatment and in care. 
• U=U dismantles stigma on individual and community levels. 
• U=U provides a strong public health rationale for universal access to treatment, care, and support services. We refer to this as the U=U public health strategy.   

The U=U public health strategy is important to use in advocacy efforts. It works like this: When people with HIV have the treatment, care, and support services they need to stay undetectable, they remain healthy, and they cannot transmit HIV through sex. In other words, care and treatment is good for the personal health of people with HIV and good for the public health of the community. 

Photo Source: The Lancet

In a recent article in The Lancet, prominent U.S. leaders called for action to end the HIV epidemic. Among other strategies, it prioritizes the inclusion of U=U in efforts to end the HIV epidemic. 

One strategy in The Lancet article states that “Advocates should be equipped to use the so-called public health argument from U=U in advocacy to increase access and remove barriers to quality health care; ensuring people with HIV have the treatment and services they need to achieve and maintain an undetectable viral load. This not only saves lives, but also is an effective way to prevent new transmissions.” In keeping with this recommendation, PAC has created this U=U resource for use in advocacy efforts.As we continue our focus on ending the epidemic, advocacy is critical to make U=U a foundational strategy of our efforts. U=U is essential for the well-being and health of people with HIV. And it’s also critical for ending the epidemic, because U=U also prevents transmission. 

Dr. Anthony Fauci, Director of NIAID at the NIH and chief medical advisor to President Joe Biden, says it best, stating that “U=U is the foundation of being able to end the HIV epidemic.”

Photo Source: NBC

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Immunocompromised: Get Your Covid-19 Vaccine

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

On March 2, 2021, President Joseph R. Biden announced the United States would have enough Covid-19 vaccines available for every American by the end of May,[1] thus accelerating by two full months what was already an ambitious plan. The new timeline came, in large part, thanks to the U.S. Food & Drug Administration (FDA) approving yet another vaccine, and recent developments between the Biden Administration and key drug manufacturers. For the HIV-positive community, it represented a glimmer of hope after recent studies suggested Covid-19 outcomes are worse for people living with HIV.

According to research conducted by James M. Tesoriero, PhD, Carol-Ann E. Swain, PhD, and Jennifer L. Pierce, BS (et al.) and published earlier this year in JAMA Network Open, "Persons living with an HIV diagnosis experienced poorer COVID-related outcomes (principally, higher rates of severe disease requiring hospitalization) relative to those without an HIV diagnosis." The study evaluated the association between HIV diagnosis and Covid-19 diagnosis, hospitalization, and in-hospital death in New York State, which was once seen as the epicenter in the United States.[2]

The study found New Yorkers living with diagnosed HIV received a diagnosis of Covid-19 at a rate of 27.7 per 1000, compared to only 19.4 per 1000 among persons living without diagnosed HIV. Covid-19 hospitalization rates were also elevated for persons living with diagnosed HIV compared to their counterparts living without diagnosed HIV (8.29 per 1000 vs 3.15 per 1000, respectively). The same elevated risk was true for persons living with diagnosed HIV and a Covid-19 diagnosis and died in the hospital.[3]

The U.S. Department of Health & Human Services (HHS) updated its Interim Guidance for COVID-19 and Persons with HIV, which reviews special considerations regarding Covid-19 for people with HIV and their health care providers in the United States. In response to the latest research the revised guidelines encourage PLWH to follow all applicable recommendations of the U.S. Centers for Disease Control and Prevention (CDC), as well as to receive Covid-19 vaccines, regardless of CD4 or viral load.[4]

For people living with HIV, like many others living with chronic health conditions, gaining access to the Covid-19 vaccine is an entirely different challenge. According to an analysis by the Kaiser Family Foundation (KFF), states set different Covid-19 vaccination priorities for people with high-risk conditions. Among them, twelve states list HIV as a qualifying condition for early access, while seven states  do so without specifying which health conditions are included under immunocompromised state.[5]

KFF summarized: "Overall, we found that there is wide variation across the country, including in the conditions listed by states, whether these are limited or allow for additional conditions to be considered, and how clearly the information is presented. Some states stick to the CDC’s list exactly, but most do not. It is also quite difficult to locate information.  Given the challenges and confusion with vaccine roll-out thus far, this variation and lack of clarity could have significant bearing on the ability of those with high-risk medical conditions, some of whom may be among the most vulnerable, to access the vaccine in early phases."

KFF continually monitors and updates populations eligible for the Covid-19 vaccine by state, which is available online on their state policy dashboard (as of March 15, 2021). These state policies are important because, in some cases, they adversely impact many non-elderly people with disabilities at high risk from Covid-19. Data suggests that people with disabilities who use long-term services and supports (LTSS) but live outside of nursing homes are at higher risk, yet often lack vaccine priority.[6]

TheBody's Tim Murphy provided an excellent summary on these vaccine developments as they relate to the HIV community, "Here’s the Latest on COVID-19 Vaccine Priority for People Living With HIV in the U.S." Murphy's analysis also shares some facts to keep in mind about HIV and the Coronavirus, which are worth reading.[7]

Pop culture has even weighed-in as "Queer Eye" star Jonathan Van Ness, who is HIV-positive, urged the HIV-positive community to look up COVID-19 vaccine eligibility. It was a welcomed message to counter the dogmatic idea among certain circles that getting early access to the vaccine implied vulnerability or weakness. "If you’re HIV+ please check your states guidelines to see if you’re eligible and get vaccinated against covid-19," Van Ness pleaded.[8]

The announcement on the accelerated vaccine timeline by the Biden Administration could very well make it a mute-point. Vaccines will become available sooner to more Americans because the Pfizer-BioNTech vaccine and Moderna vaccine are now accompanied by the Johnson & Johnson vaccine. On the heels of the Johnson & Johnson vaccine approval by the FDA came news about the historic partnership between the company and its rival, Merck, to support manufacturing of the former’s single-shot Covid-19 vaccine.[9] 

Anthony Fauci, MD
(Photo Source: GettyImages)

Dr. Anthony Fauci, who is the nation’s top infectious disease expert, urged Americans not to be picky about which Covid-19 vaccine they receive. Fauci's plea came in response to misinformation about the effectiveness of the Johnson & Johnson vaccine. He noted that any direct comparison isn't feasible because the three approved Covid-19 vaccines' clinical trials were conducted during different times, under different circumstances in the United States.[10]

Fauci's message as been echoed by other public health experts, too. The Kaiser Family Foundation explained, "don’t worry about the numbers." An analysis by KFF's Arthur Allen and Liz Szabo stresses some key points, among them: (1) all three vaccines protect against hospitalization and death; (2) efficacy levels could be a case of apples and oranges; (3) speed is of the essence; (4) some vaccines have different advantages.[11] 

Advocates living with HIV also appear to agree! Murray Penner, Prevention Access Campaign's North America Executive Director, urged his fellow residents of the DMV (also known as the District of Columbia) to get vaccinated, and take advantage of the expanded access for people with underlying health conditions (i.e., HIV). Penner, who participated in Moderna's clinical trials, used Twitter to spread the gospel of getting people vaccinated against Covid-19. The District of Columbia opened its vaccine eligibility on March 1, 2021.

Jen Laws, Board Member of the ADAP Advocacy Association, and HIV/transgender health advocate, addressed the misguided concerns over Johnson & Johnson's vaccine efficacy. Laws said that he kept an eye on data from the FDA's Emergency Use Authorizations (EUAs), and further narrowed his focus to three benchmarks: inhibiting symptom development, morbidity, and transmissibility. Of the current US-approved vaccine products, Johnson & Johnson was the only to include data concerning transmissibility and efficacy against variants *in the application* as opposed to having plans to evaluate in post-market trials. For him, providing data more in alignment with traditional authorization applications absolutely helped ease any of his concerns about the speed of development. 

"While I'm excited about the use of mRNA vaccines and adding another tool in our tool-belt, viral vector method (J&J's product) has a longer track record of success as a technology, with minor genetic manipulation of existing vaccines - a 'piggy back' method that I trust my body to respond to better," Laws argued. "Furthermore, Johnson & Johnson also very intentionally included special populations, with 1,218 PLWH in trial phases used for the EUA which is exceptionally meaningful in terms of including us. We're still waiting on data to come back regarding our care metrics specific to HIV status, but it was this mindfulness of a long-term ally in industry that helps build necessary trust."

Building trust in the vaccines is at the center of the efforts by the advocacy community, government agencies, and the medical community. Vaccination hesitancy is now one of the biggest challenges, but progress is being made according to recent polling. Kaiser Family Foundation indicated, "The share that wants to 'wait and see' how the vaccine is working for others before getting vaccinated themselves decreased from 31% in January to 22% in February, while a persistent one in five say they will get the vaccine “only if required for work, school, or other activities” (7%) or will “definitely not” get vaccinated (15%)."[12]

However, specific to the HIV community, Dr. Princy N. Kumar, Professor of Medicine & Microbiology at the Georgetown University School of Medicine, and Chief of the Division of Infectious Diseases and Tropical Medicine, has a message for the remaining vaccine skeptics: "All currently approved Covid-19 vaccines are safe to administer in people living with HIV. For this reason, it's important that people living with HIV get whatever Covid-19 vaccine they are able to get, as soon as they can."

Dr. Kumar points to a study just presented at the Conference of Retroviruses and Opportunistic Infections (CROI) 2021 (Abstract 103), data looking at people living with HIV and solid organ transplant Patients, compared to HIV negative participants showed that in PLWH, once they are infected with Covid-19, had much higher rates of both hospitalizations and the need to be placed on a ventilator. This increased risk of hospitalization for PLWH is especially significant if they have underlying cardiopulmonary disease or renal disease.[13]

As the world marks the one year anniversary of the Covid-19 pandemic tightening its grasp across the globe, it is important to reflect on what can be done to return the world back to 'normal' here in the United States. With the Biden Administration's leadership, it is evident that the country is turning the corner from the debacle leftover from the previous one. Vaccines are an important element of the journey, along with proven public health strategies (i.e., wearing masks, remaining social distant, washing hands). For the HIV-positive community, it is even more important for us to do our collective part to protect ourselves, as well as the people around us. Get your Covid-19 vaccine!

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

[1] Brenton Blanchet (2021, March 2). Biden Promises 'Enough Vaccines' for Every American by End of May. Yahoo!News. Retrieved online at https://news.yahoo.com/biden-promises-enough-vaccines-every-230146965.html. 

[2] James M. Tesoriero, PhD,  Carol-Ann E. Swain, PhD, Jennifer L. Pierce, BS, et al (2021, February 3). COVID-19 Outcomes Among Persons Living With or Without Diagnosed HIV Infection in New York State. JAMA Network Open. Retrieved online at https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2775827. 

[3] James M. Tesoriero, PhD,  Carol-Ann E. Swain, PhD, Jennifer L. Pierce, BS, et al (2021, February 3). COVID-19 Outcomes Among Persons Living With or Without Diagnosed HIV Infection in New York State. JAMA Network Open. Retrieved online at https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2775827. 

[4] HIV.gov (2021, February 26). Guidance for COVID-19 and People with HIV. U.S Department of Health & Human Services. Retrieved online at https://clinicalinfo.hiv.gov/en/guidelines/covid-19-and-persons-hiv-interim-guidance/interim-guidance-covid-19-and-persons-hiv.

[5] Jennifer Kates, Lindsey Dawson, and Jennifer Tolbert (2021, February 16). The Next Phase of Vaccine Distribution: High-Risk Medical Conditions. Kaiser Family Foundation. Retrieved online at https://www.kff.org/policy-watch/the-next-phase-of-vaccine-distribution-high-risk-medical-conditions/.

[6] MaryBeth Musumeci and Priya Chidambaram (2021, March 1). COVID-19 Vaccine Access for People with Disabilities. Kaiser Family Foundation. Retrieved online at https://www.kff.org/medicaid/issue-brief/covid-19-vaccine-access-for-people-with-disabilities/.  

[7] Tim Murphy (2021, March 2). Here’s the Latest on COVID-19 Vaccine Priority for People Living With HIV in the U.S. The Body. Retrieved online at https://www.thebody.com/article/hiv-covid-19-coronavirus-vaccine-priority?ic=700100.  

[8] Megan Stone (2021, February 24). Jonathan Van Ness urges HIV-positive community to look up COVID-19 vaccine eligibility. Good Morning American. Retrieved online at https://www.goodmorningamerica.com/culture/story/jonathan-van-ness-urges-hiv-positive-community-covid-76085002.

[9] Zacks Equity Research (2021, March 3). Merck (MRK) to Help J&J Make COVID-19 Vaccine to Boost Supply. Yahoo!Finance. Retrieved online at https://finance.yahoo.com/news/merck-mrk-help-j-j-122012149.html.

[10] Sarah Grealish (2021, February 28). Dr Fauci begs Americans NOT to be choosy about Covid vaccines after Johnson & Johnson one shot vax approved. The U.S. Sun. Retrieved online at https://www.the-sun.com/news/2424964/fauci-begs-americans-not-to-be-choosy-about-vaccines/.

[11] Arthur Allen and Liz Szabo (2021, February 28). When Your Chance for a Covid Shot Comes, Don’t Worry About the Numbers. Kaiser Family Foundation. Retrieved online at https://khn.org/news/article/when-your-chance-for-a-covid-shot-comes-dont-worry-about-the-numbers/.

[12] Liz Hamel, Grace Sparks, and Mollyann Brodie (2021, February 26). KFF COVID-19 Vaccine Monitor: February 2021. Kaiser Family Foundation. Retrieved online at https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-february-2021/.

[13] Princy N. Kumar, MD, FIDSA, MACP. Interview conducted by Brandon M. Macsata on Friday, March 12, 2021.

PAF’s Co-Pay Relief Expands Assistance to Cover Insurance Premiums (including HIV/AIDS Fund)

By: Beth Moore, Executive Vice-President of Corporate Communications, Patient Advocate Foundation

Beginning on March 1, 2021, Patient Advocate Foundation’s (PAF) Co-Pay Relief (CPR) program will be expanding its assistance to cover health insurance premiums through their COVID-19, Cystic Fibrosis, and HIV/AIDS & Prevention funds. CPR can directly reimbursement patients for insurance premiums or can pay their insurance premiums directly to their insurance provider. 

Current, new and renewal patients will be able to use their grant award to pay for expenses related to individual medical insurance premiums and to co-payments, co-insurance and deductibles required by the patient’s insurer for medications prescribed to treat and manage their illness. Spouse or family, nor dental or vision plan premiums can be covered by the fund. 

To learn more, or to apply for assistance, either visit https://copays.org/portal/#/login, with access available for patients, providers, and pharmacies, or call our dedicated CPR team toll-free at 866-512-3861. You will know immediately upon completion of the application if you are eligible for assistance, and upon approval you are able to begin using your award right away.          

The Co-Pay Relief Program may help with all therapeutic and supportive medications, including generic or bioequivalent products prescribed to treat and/or manage the patient’s disease or condition. The program helps patients on a first-come, first-serve basis and processes applicants in the order in which their completed applications are received. 

PAF Disclaimer: Enrollment in and financial assistance from any disease-specific fund is provided on a first come, first serve basis to the extent funding is and remains available. PAF will not consider the identity of any physician, provider, supplier of items or services, donor, drug therapy, services or supplies being utilized or the referral source when assessing whether an applicant is qualified for financial assistance from a PAF CPR disease-specific fund. Under no circumstances will PAF recommend or refer an applicant or enrollee to any fund donor, provider, supplier, or product. 

WATCH VIDEO

Welcome to Co-Pay Relief!

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Painting Roses in the Desert: Despite Medicaid Expansion, Gaps Remain in Arizona

By: Jen Laws, Board Member, ADAP Advocacy Association, and HIV/transgender health advocate 

It shouldn’t be a surprise to anyone that many AIDS Drug Assistance Program advocates are in favor of Medicaid expansion. Indeed, as noted in last week's blog, those same advocates view Medicaid expansion as an opportunity to strengthen health care access for the most vulnerable people living with HIV, meet needs unaddressed by a state’s ADAP coverage, and help ADAPs remain financially stable. For ambitious advocates (I’m talking about myself), when sufficient support exists to support those at or below the expanded Medicaid eligibility threshold of 138% of the federal poverty level, state ADAPs could consider expanding income eligibility above 400% of the federal poverty level. Indeed, Louisiana is one such state.

However, like all health care policy, the details matter.

In Arizona, the state’s Medicaid formulary is restrictive and slow to adapt to the needs of qualified people living with HIV, shifting financial pressure to the state’s ADAP and requiring the most impoverished clients to manage interacting programs in order to achieve coverage of certain medications. As the payer of last resort, when ADAP clients have other coverage (ie. Medicaid), conflicting payment processes are most often felt at the point of medication delivery or when a client gets told, inadvertently, their medication is not paid for. The process of correcting this mistake can take a matter of days or weeks, depending on a pharmacy’s experience with co-occurring payers. 

In that time, patients can fall out of care, drastically reducing their likelihood of achieving an undetectable viral load.

Artwork provided by The Feminist Farmwife

For ADAP formulary advisory committees, for states that have them, the process of adding and adjusting formularies is sometimes relatively expedient. Relatively, in part, because those medical experts and community experts understand the need and nature for ensuring access to an expansive list of antiretroviral medications and modern advancements. Arizona’s Medicaid formulary lacks several single tablet regimens and, in the opinion of Glen Spencer, executive director of Aunt Rita’s Foundation, favor outdated “cocktails” (or multi-tablet regimens), complicating daily care for people living with HIV and accessing Medicaid, often subjecting clients to greater experiences of toxicity, and ultimately interjects an unnecessary interruption in both patient choice and provider care.

In aiming to impress the need of Arizona’s Medicaid formulary to expand in both supporting the sustainability of the state’s ADAP and meeting national initiatives Mr. Spencer stated, “It is critically important that Arizona’s Medicaid program include all single-tablet regimens on its formulary to offer patients the right medication for them, and to provide medical providers with the flexibility they need to prescribe the right medication for each patient.”

To this end, Aunt Rita’s advocacy efforts are also expanding with proposed legislation addressing the failure of Arizona’s Health Care Cost Containment System (AHCCCS) to take up the issue. According to Mr. Spencer, the bill is not likely to make it out of committee this year and lacks any great deal of interest for legislators battling over other budgetary and policy concerns and does not currently have a companion bill in the state Senate. On the other hand, the bill is sponsored in the Arizona House by a bipartisan coalition of 9 legislators.

“In order to end the HIV epidemic, both the patient and provider community will need all therapies available to them to support persons living with HIV, save lives, and get patients to an undetectable viral load.” Mr. Spencer added, “This policy not only promotes patients’ ability to lead a robust life, but also prevents new infections given the science behind U=U.”

Arizona’s situation offers a critical reminder that even with the value of Medicaid expansion, in order to achieve the greatest reach of ADAPs and tackle the absolutely critical inclusion of treatment and retention in prevention efforts, the details matter and advocates will need to adapt old fights to new environments.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.