Still Protected! Medicare's Six Protected Drug Classes Policy Survives Trump's Attack

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

In the waning days of the Trump Administration, Medicare Part D once again faced a serious threat. The Centers for Medicare & Medicaid Services (CMS) had authorized a potentially harmful demonstration project, which would have limited patient access to medications covered by the six protected classes (6PC) policy. The 6PC demonstration project would have proved disastrous for patients living with chronic health conditions, such as HIV/AIDS. Fortunately, President Joseph R. Biden Jr. pumped the brakes on the proposed changes.

Photo Source: The Associate Press

In Medicare Part D, 6PC protects vulnerable seniors and low-income beneficiaries with serious and complex health conditions, while also allowing Part D insurance plans to use the tools they need to control costs. Medicines for some of the sickest patients in Part D are covered within the six protected classes, including those for cancer, epilepsy, HIV/AIDS and mental illness.  Many of these conditions require patients to attempt a variety of therapies before they and their doctor settle on the most appropriate treatment, so there is no one-size fits all medicine for these conditions.[1]

Healthcare decisions for complex health conditions should be left to patients, and their doctors. For people living with HIV/AIDS, numerous factors come into play when determining the appropriate highly active anti-retroviral therapy (HAART). And now with the advent of injectable HIV therapy, such decisions take-on an entirely new dimension.  

Earlier this year, HealthHIV's Executive Director Brian Hujdich spelled out the importance of the Medicare Part D's 6PC for the HIV-positive community: "Those medications are protected for good cause. About 25 percent of people living with HIV in the United States depend on Medicare for their antiretrovirals, care, and preventative services. These patients often require very tailored treatment regimens."[2]

The insurance industry welcomed the proposed changes, but otherwise the 6PC demonstration project was universally condemned by the pharmaceutical industry, patient advocacy groups, and numerous powerful trade associations. Said Guy Anthony: “I’m deeply concerned as someone living with HIV and Bi-polar disorder. Insurers would be allowed to institute new prior authorization or step therapy requirements – or ‘fail first’ – as community advocates commonly call it. Let’s be clear, no patient should fail before being afforded life-saving treatment.”

The latest 6PC demonstration project wasn't the first time that the Trump Administration had attempted to weaken Medicare Part D. In the end, however, patients won the day! There is an inherent value in advocacy partnerships...AGAIN!

Photo Source: Partnership for Part D Access

The effort to fight the proposed changes to Medicare’s six protected classes policy was spearheaded by the Partnership for Part D Access, which is a broad coalition of healthcare stakeholders working to ensure that Medicare continues to provide beneficiaries with access to vital medications. The ADAP Advocacy Association actively fought against the proposed changes.

“Medicare beneficiaries with the most complex, chronic conditions are breathing a sigh of relief,” said Chuck Ingoglia, President and CEO of the National Council for Behavioral Health, who serves as Executive Director of the Partnership for Part D Access. “The Biden administration’s decision demonstrates the need to maintain the six protected classes policy as an essential patient safeguard in Medicare Part D.”[3]

According to the Partnership for Part D Access,[4] it was stakeholder mobilization against the 6PC demonstration project that led to it being halted by the Biden Administration. Advocacy efforts included:

• 67 bipartisan Members of Congress signed a letter to HHS and CMS urging them to withdraw the proposal;
• several thousand patients from across the country wrote letters to the CMS comment portal;
• over 130 individual patient groups joined a letter to HHS Secretary-designate Xavier Becerra;
• nine leading pharmacy stakeholder groups penned a letter to the Acting CMMI Director Amy Bassano;
• the Center for Medicare Advocacy and Medicare Rights Center sent a letter to Acting HHS Secretary Norris Cochrane; and
• a group of 30 leading HIV groups sent a letter to HHS Secretary-designate Becerra.

Although the Biden Administration is widely viewed more favorably by the patient advocacy community, now is not the time for the HIV community to let down its guard. Much more work needs to be done to reverse other harmful policies enacted by the Trump Administration, such as drug importation and co-pay accumulator programs.

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] Johnson, Juliet (2019, January 31). New Research Shows Changes to the Six Protected Classes Would Harm Most Vulnerable Patients and Are Unnecessary. ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2019/01/new-research-shows-changes-to-six.html.

[2] Hujdich, Brian (2021, February 26). President Biden must rescind a last-minute Trump rule that could leave people with HIV on the hook for thousands in prescription costs. HIV Plus Magazine. Retrieved online at https://www.hivplusmag.com/opinion/2021/2/26/trumps-parting-shot-hiv-patients.

[3] The Partnership for Part D Access (2021, March 16). Patient Advocates Applaud Biden Administration for Maintaining Medicare's Six Protected Classes Policy. Retrieved online at http://www.partdpartnership.org/newsroom/patient-advocates-applaud-biden-administration-for-maintaining-medicares-six-protected-classes-policy.

[4] The Partnership for Part D Access (2021, March 16). Patient Advocates Applaud Biden Administration for Maintaining Medicare's Six Protected Classes Policy. Retrieved online at http://www.partdpartnership.org/newsroom/patient-advocates-applaud-biden-administration-for-maintaining-medicares-six-protected-classes-policy.

New CDC Surveillance Reveals Risks Among Transgender Women, Including HIV

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

On April 15, 2021, the U.S. Centers for Disease Control released a new special report on HIV infection, risk, and tertiary issues impacting transgender women. The report included a literature review and community survey among 1,608 self-identified transgender women in 7 US cities (Atlanta, Los Angeles, New Orleans, New York City, Philadelphia, San Francisco, and Seattle), which was conducted between late 2019 and early 2020.

The findings of the report could be considered startling to those unfamiliar with HIV data among transgender populations. However, advocates for transgender equality have been shouting about this issue for years. Despite the CDC issuing guidelines for collecting data on transgender people in 2015, many state and local health departments were slow to implement this guidance; from debate on language to a grueling process in the massive undertaking to update official HIV screening forms. Further down the “food chain”, contract providers did not necessarily have the funding to reprogram electronic health records to reflect collecting this information or did not prioritize doing so. As a technical issue, this is the least of concerns in reaching out to transgender people. Cultural competency is lacking, programs directed toward transgender people may be managed by cis gender people, creating a disconnect between the experience of a target audience and program design. The Denver Principles demand “nothing about us, without us” and, even in HIV, this part gets forgotten about when establishing or operating transgender programs.

Photo Source: CDC

Back to the CDC’s findings.

The special report found an HIV prevalence of 42% among participants with a valid HIV screening within the last 12 months (note: 3% of participants did not have a valid HIV screening within the last 12 months, all findings are self-reported). Of those tested, along race and ethnic identity, the highest rates of HIV prevalence were among Black (62%), Hispanic/Latina (35%), and American Indian/Alaska Native (65%) transgender women. The cities with the highest prevalence were Atlanta (58%), New York (52%), and Philadelphia (51%). Of prevention activities, participants were generally well-educated regarding pre-exposure prophylaxis (PrEP) at better than 90% overall, however, uptake was lagging at around 30%. Participants cited medical mistrust due to incidents of transphobia in medical settings, lack of information regarding interactions with gender-affirming hormone therapies, and lack of trans oriented PrEP marketing materials. 63% of self-reported HIV-positive participants reported receiving HIV related care within 1 month of diagnosis and 89% having received care within the year prior to interview. 

The most stunning findings of the study include 63% of participants reporting living at or below the federal poverty level and 17% being uninsured. As a result, unsurprisingly, 42% of participants had experienced homelessness in the last 12 months. The statistic that should receive the greatest attention but - also unsurprising as 2020 was the worst year on record for anti-transgender violence in the US – 54% of participants reported having experienced verbal abuse or harassment as a result of their gender identity. Additionally, 15% of participants reported having experienced verbal threats or physical attack resulting in rape.* 

*Editor's Note: the report refers to “forced sex” – this author will not coddle this experience. “Sex” without consent, either by force, threat, or coercion, is rape.

Advocates, myself included, argue the Trump administration’s anti-transgender agenda released a social contagion of permission to enact violence against transgender people, Black transgender women in particular. Despite the precedent set by the Supreme Court’s Bostock decision in 2020, several states have decided to make 2021 a record-breaking year in introducing anti-transgender legislation. Again, experienced advocates expect this pattern to result in more violence against us. 

This is of particular note, given the CDC’s report cited medical mistrust due to experiences of transphobia in medical settings. 

Small, yet meaningful steps that can be taken in the immediate: both private and public funders must change the metrics in which they consider funding transgender programming and acceptable “competency”. Funded entities must conduct transgender cultural competency at onboarding of all staff and at least once annually and demand their staff satisfy a post-training assessment as part of their employment. Funders must require these metrics in order for an entity to receive funding. Entities should not be “developing” new transgender programs but courting existing trans led by-for organizations to manage trans oriented HIV programing. 

The Denver Principles were meant for all of us, every one of us, every piece of us. And beyond our status we have failed to implement these cornerstone values into our HIV prevention efforts and care programs. 

For providers seeking resources on trans oriented HIV prevention materials, the CDC provides model materials at no cost to providers via the CDC’s Let’s Stop HIV Together campaign. You can order these and other materials here.

Additionally, "TRANSGENDER HEALTH: Improving Access to Care Among Transgender Men & Women Living with HIV/AIDS under the AIDS Drug Assistance Program" are educational resources published by the ADAP Advocacy Association. They include an infographic, and a policy white paper.

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.

It Is Time to Advocate for the Patient

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

       Jeffrey R. Lewis, President & CEO, Legacy Health Endowment 

       (The views expressed are his own)

Republicans and Democrats used to boast about protecting people from having to use hospital emergency rooms unnecessarily.  Both parties rallied around the flagpole, trying to demonstrate who cared more. In the end, empty promises.

Before leaving office, the Trump administration decided to throw a large bone to the health insurance industry and their partners in this caper, pharmacy benefit managers (PBMs). The solid gold bone allows health insurers and PBMs to exclude medications that a patient receives through pharmaceutical manufacturer patient assistance programs (PAPs) from counting against their deductible and maximum out-of-pocket amount, otherwise known as copay accumulator programs.

Photo Source: Daily Caring

Many pharmaceutical companies offer PAPs and Copay cards, covering all or part of medication expenses to enable patients to be able to afford medications. These programs are used by millions of Americans who suffer from one or more chronic disease conditions. Cancer patients, for example, need PAPs because the cost of their overall care is so expensive, and the medications they take often do not have a generic equivalent. 

Historically, the value of a PAP or copay card was counted toward an individual's health insurance policy deductible. Most people are familiar with paying a deductible as part of their medical and prescription drug coverage. Once the deductible is met, a larger portion of their medical expenses is paid for by the insurer. With the advent and expansion of high deductible health plans (HDHPs), individuals may face deductibles of at least $1400/year and up to $6900/year for total annual out-of-pocket expenses.

Guy Anthony of Brooklyn, N.Y., lives with HIV and bipolar disorder and relies heavily on the manufacturer's copay assistance program to afford his Genvoya® medication to treat his HIV. He describes his situation in simple terms: "I'm not rich, and most people living with co-morbidities aren't either. My grandmother takes close to 10 different medications, and this new policy is making it hard for her to live."

Why? Because as insurance companies and PBMs expand the use of copay accumulators and watch their profits and stock price increase, Guy's assistance is reduced and he and patients like him end up increasing their out-of-pocket expenses to meet their deductibles. And his grandmother's health is threatened by the Trump Rule. 

The pharmaceutical company programs were created to help people like Guy and his grandmother.  Restrictions like the Trump Rule result in reduced medication adherence, poorer health outcomes, and ultimately, higher healthcare costs. When cost-containment such as Copay Accumulator Programs negatively impact prescription compliance, it is the patient who suffers.

A recent West Health-Gallup survey underscored the importance of what happens under the Trump Rule: In the last year, tens of millions of Americans said they were forced to cut back on necessities like food (12%) and utilities (9%) to pay for basic healthcare. Nearly 30% found paying for general healthcare a significant financial burden, behind housing (51%), taxes (48%), and food (41%). Costs for prescription drugs are a substantial financial burden for more than one in five adults (22%). More than half (52%) of all Americans also said they are either "worried" or "very worried" that a health event will wipe out their savings.

The Biden Administration can be an advocate for the patient. All it takes is an Executive Order issued by President Biden to eliminate the Trump Rule. And every day that Congress and the Biden Administration delay, they become Trump High Healthcare Cost co-conspirators.

This opinion piece was also published in the April 12th edition of the Cision PR Newswire.

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.

Cabenuva is a Shot 💉 of Hope for People Living with HIV/AIDS

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

On January 21, 2021, a shot of hope was provided by the U.S. Food & Drug Administration (FDA) in the forty-year fight against HIV/AIDS with the agency's approval of the first extended-release, injectable drug regimen. Administered once a month, Cabenuva (cabotegravir and rilpivirine, injectable formulation) further progressed the HIV treatment evolution – which once included people living with HIV/AIDS (PLWHA) taking up to a dozen pills...down to three pills...then two pills...and eventually leading to the single-tablet regimen. Ask anyone living with AIDS Survivor Syndrome (A.S.S.), it is a development of particular importance because there was a time when the words 'hope' and 'HIV' weren't necessarily used in the same sentence.

The foundations for the advances in HIV treatment regimens, such as Cabenuva, are linked to the transformative work behind the creation of the AIDS Drug Assistance Program (ADAP) and its eventual federal funding thanks to the National ADAP Working Group (NAWG). Created in the 1990s, when advocates were mistrustful of the pharmaceutical industry and critical of the government’s slow response to the epidemic. Likewise, the industry was skeptical of some of the advocacy community’s brass-knuckles tactics, however necessary they were at the time. But ADAP's existence helped to change that paradigm.[1] 

More recently, Operation Warp Speed and the search for vaccines against Covid-19 have demonstrated what pharmaceutical innovation can achieve. It also caused many PLWHAs to reflect, What the Global Covid-19 Vaccine Means to HIV? Nonetheless, Cabenuva offers us some hope on the treatment front!

The FDA announcement included a statement by John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, which read: “Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen. Having this treatment available for some patients provides an alternative for managing this chronic condition.”

Photo Source: Associated Press

Cabenuva was developed in partnership by ViiV Healthcare and Janssen Pharmaceutical Companies, and it offers a way to maintain viral suppression with only 12 treatments a year. As a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults, Cabenuva replaces a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.[2] 

Lynn Baxter, Head of North America, ViiV Healthcare, said in the ViiV Healthcare statement: "Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year. At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission."[3]

As Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson, says in Janssen's announcement, "While much more remains to be done to make HIV history, today's milestone reminds us how far medical innovation has come since the first reported cases of the virus almost 40 years ago."[4]

The Body's David Malebranche, M.D., M.P.H. penned, Cabenuva for HIV Treatment: Everything You Need to Know, which is an excellent resource for patients interested in learning more about the new injectable therapy. Dr. Malebranche tackles general information about the new drug, how to take it, potential side effects and drug interactions, as well as the costs.[5] A must read! 

For Warren Alexander O'Meara-Dates, diagnosed with HIV in November 2009, it was an easy decision to switch once he learned that his health insurance carrier would cover the new treatment. O'Meara-Dates summarized, "On April 6th, I had my first injection and now, I no longer have to manage taking oral medication everyday with my busy lifestyle. I'm humble and grateful that I've progressed to a point where this was an option and encourage anyone who meet the criteria to strongly consider it."

In the early years of the HIV epidemic, treatment advances were often hampered by some significant challenges faced by people taking the medicines. Aside from the stigma – which was very real for people forced with lugging around countless pill bottless – there were other issues. Some medicines required food, while others needed to be taken on an empty stomach. Morning versus night management. Navigating the potential drug interactions was a difficult task. And the side effects were numerous, and often severe.

Photo Source: HLTSAD.org

Some long-term survivors have already hailed the single-tablet regimen, and now they expressed similar enthusiasm for Cabenuva for HIV treatment. Joey Wynn, a former board member of the ADAP Advocacy Association who has been living with HIV for 34 years, contends not since the advent of the protease inhibitor class have we seen such a watershed moment in the history and evolution of HIV therapy. 

"Having a continuous therapeutic level of medication over a very long period (weeks or months, not days) guarantees a better chance at remaining undetectable," Wynn said. "This impacts us as people with HIV, as well as helping our community viral load remain as low as possible as well. This will greatly reduce the rate of spread, helping us to end the epidemic in our lifetimes!"

With Cabenuva's introduction into the HIV therapy options, Wynn has so much hope for the future, for the HIV community, and for himself. 

But personal circumstances do play a role in how the news has been received by the community. According to Tez Anderson, founder of Let's Kick ASS—AIDS Survivor Syndrome, injectables are great if they help people stay in HIV care and treatment, but they are largely irrelevant for long-term survivors on salvage therapy. 

"Personally, I’m good with taking pills because they simply are routine and I never miss any doses," argued Anderson. "Despite injectable medications on the market to treat multi-drug resistant HIV-infection, such as Trogarzo, I’ve shied away from taking it. Frankly, I treat my pills like my friends and they do not take up as much time as having to go get shots." 

Anderson acknowledges injectables do provide a valuable tool in the HIV treatment toolbox, whether Cabenuva for those people virally suppressed or Trogarzo for those people multi-drug resistant.

According to Theratechnologies, "Up to 25,000 Americans with HIV are currently multidrug resistant, of which 12,000 are in urgent need of a new treatment option because their current treatment regimen is failing them and their viral load has risen to detectable levels, jeopardizing their health and making HIV transmittable."[6]

In the end, it boils down to treatment adherence. Sticking firmly to an HIV medication regiment is probably the single most important thing PLWHAs can do to help themselves remain healthy with an undetectable viral load. 

"Generally speaking about all health-related conditions, non-adherence results in additional healthcare costs, more hospital admissions, and approximately 125,000 deaths annually," said Glen Pietrandoni, Vice-President of Industry Relations for Avita Pharmacy. "Cost is often identified as the biggest barrier to better medication adherence, but other barriers certainly exist. Replacing daily oral HIV medication with twelve treatments over the course of the year cannot be overlooked as a way to improve adherence." 

The face of the HIV epidemic has changed over the last four decades, and with it so has treatment. One dozen pills taken daily has steadily been replaced with the groundbreaking injectable treatment, done monthly. New treatment options, such as Cabenuva, are offering hope. A new day has dawned in the fight to end the HIV epidemic, truly.

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] Jeffrey R. Lewis (2020, February 6). The Lion of Modern-Day HIV/AIDS Advocacy. The ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2020/02/the-lion-of-modern-day-hivaids-advocacy.html.

[2] U.S. Food & Drug Administration (2021, January 21). FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV. United States Department of Health & Human Services. Retrieved online at https://www.fda.gov/news-events/press-announcements/fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv.

[3] ViiV Healthcare (2021, January 21). ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment. Retrieved online at https://viivhealthcare.com/en-us/us-news/us-articles/2021/viiv-healthcare-announces-fda-approval-of-cabenuva--cabotegravir/. 

[4] Janssen United States (2021, January 21). Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV. Johnson & Johnson. Retrieved online at https://www.jnj.com/:~:text=Janssen%20Announces%20U.S.%20FDA%20Approval%20of%20CABENUVA%20(rilpivirine,new%20once-monthly%20injectable%20option%20for%20maintaining%20viral%20suppression.

[5] David Malebranche, M.D., M.P.H. (2021, February 22). Cabenuva for HIV Treatment: Everything You Need to Know. The Body. Retrieved online at https://www.thebody.com/health/hiv-cabenuva?ic=700100.

[6] Theratechnologies (2018, March 6). Theratechnologies Announces FDA Approval of Breakthrough Therapy, Trogarzo™ (ibalizumab-uiyk) Injection, the First HIV-1 Inhibitor and Long-Acting Monoclonal Antibody for Multidrug Resistant HIV-1. Cision News Wire. Retrieved online at https://www.prnewswire.com/news-releases/theratechnologies-announces-fda-approval-of-breakthrough-therapy-trogarzo-ibalizumab-uiyk-injection-the-first-hiv-1-inhibitor-and-long-acting-monoclonal-antibody-for-multidrug-resistant-hiv-1-300609280.html.

Fake Symtuza® Serves as Wake-Up Call Over Counterfeit HIV Medications

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

For over a decade counterfeit drugs have been a concern of the ADAP Advocacy Association, especially with all of the hoopla over drug importation. Despite the unsubstantiated claims about lowering drug costs for Americans, drug importation would come at too high a cost for people living with chronic health conditions, including HIV. Such an ill-advised public policy change would weaken the safety of the nation's drug supply chain, and prescription anti-retroviral (ARVs) medications aren't immune from counterfeit threats. The recent news about fake Symtuza® – prescribed medicine for the treatment of HIV-1 infection – identified in the United States is a case in point about looming risks.

Photo Source: MPR

In December 2020, Janssen Pharmaceutical Companies of Johnson & Johnson issued a drug warning alert about the counterfeit HIV drug. As you can read here, Janssen was made aware that counterfeit Symtuza® had been distributed to three pharmacies in the United States. 

Janssen's alert, in part, read:

"We are working closely with the U.S. Food and Drug Administration (FDA) to prevent further distribution and to support the agency’s investigation into the reported instances. The pharmacies involved procured the counterfeit product from distributors that have not been authorized by Janssen.  We are confident that SYMTUZA® obtained through authorized distributors is authentic and safe for use, in accordance with the Prescribing Information."[1]

Whereas there were no reported adverse events related to the use of the counterfeit product, it nonetheless sounded the alarm over fake HIV medications potentially reaching medicine cabinets in American households. Fortunately, Janssen's strong ties to the patient advocacy community helped to raise awareness quickly to counter the threat (Editor's Note: The ADAP Advocacy Association at the time pushed numerous Tweets about the alert).

The most recent threat wasn't the first incident whereby fake HIV medication had found its way into the nation's drug supply chain. In 2001, counterfeit Serostim® – prescribed injectable medicine used for the treatment of HIV-related wasting – was found in U.S. pharmacies nationwide. According to news reports at the time, Serono, Inc. countered the threat by mailing drug alert letters to distributors, pharmacies, physicians and patients, as well as sending hundreds of alerts to AIDS service organizations.[2]

Photo Source: Willis QS Consulting

The Partnership for Safe Medicines (PSM), which is the preeminent policy expert on counterfeit drugs, has raised awareness about fake insulin, fake cancer medications, and fake hepatitis medicines. In the past, PSM has also tackled fake HIV medications.

Rick Roberts, an HIV-positive advocate on the PSM board of directors, has spent the past two decades warning of the threat of counterfeits. Roberts argues, "For all-in-one treatments, the possibility that a counterfeit could leave a patient without any treatment at all is a heartbreaking life-threatening situation. Having counterfeit Symtuza show up in a licensed U.S. pharmacy, as the counterfeit Serostim I received in 2000 did, is proof that our supply chain can't allow any foreign wholesalers or pharmacies that can't easily be regulated as some proposals to do foreign drug importation suggest.

According to Roberts, at least the counterfeiters that targeted him could be brought into court. Many foreign counterfeit criminals never see the inside of the U.S. courtroom.

Counterfeit medication isn't something that only happens in "other" countries, evidenced by warnings on the FDA website. Although the U.S. drug supply chain remains among the safest and most secure systems internationally, it still remains susceptible to nefarious activities. Fake HIV medications, such as Symtuza or Serostim, should serve as a reminder to patients and policy-makers alike that more needs to be done to protect our access to medications.

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] Marcus A. Wilson (2020, December 24). IMPORTANT DRUG WARNING: Information About Counterfeit HIV Drug. Janssen Pharmaceutical Companies of Johnson & Johnson.
[2] Naomi Aoki (2001, February 5). Maker of AIDS Drug Battles Counterfeiters / Serostim's growth hormone may give it black-market value. Boston Globe. Retrieved online at https://www.sfgate.com/business/article/Maker-of-AIDS-Drug-Battles-Counterfeiters-2955169.php.

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.