2025: A Look Back on Our Advocacy

By: Brandon M. Macsata, CEO, ADAP Advocacy

ADAP Advocacy inches toward the conclusion of an active year in advocacy, one defined by chaos, perseverance, and targeted success. At the outset of 2025, we issued a call to serve for grassroots patient advocates. The MAGA movement's return to power set the stage for upheaval. Still, very few advocates could have predicted the scope of the damage being done to the nation's public health system, ranging from vaccine skeptics driving misinformation into the mainstream to dangerous price control schemes, or draconian cuts to both prevention and treatment services for people living with HIV/AIDS. ADAP Advocacy was among the first national advocacy organizations to warn that cuts were coming to popular programs, like the Ryan White HIV/AIDS Program, despite the widely accepted belief these programs were "safe" from ideological attacks.

Our contribution to fighting the Trump Administration's dangerous policies was to re-engage our grassroots network, which had last been deployed during the ADAP Crisis in 2008-2012. It's older now, with even more ailments, but still vibrant and committed enough to deliver effective patient advocacy. At no time was it more necessary than when the bombshell hit that HIV prevention funding was being gutted at the Centers for Disease Control & Prevention. When these critical HIV prevention programs faced elimination, ADAP Advocacy, like so many other organizations, stepped up and warned lawmakers about the negative repercussions. These cuts were only exacerbated by the One Big Beautiful Bill Act (OBBBA) and its steep cuts to Medicaid, which our grassroots efforts also opposed. Whereas far too many funding cuts have occurred this year, they have also sparked a renewed call for patient advocates to be more vocal about the policy decisions that could affect them.

There is no greater example of the need for patient advocates to engage than the 340B Drug Pricing Program. In 2025, ADAP Advocacy launched its 'Too Big To Fail?' national advocacy campaign, comprised of blogs, television commercials, fact sheets, policy papers, and op-eds. Our commercial calling out hospitals for aggressive debt collection garnered over half a million views on YouTube, alone. Our op-ed in POZ Magazine, "Why the 340B Rebate Model Puts Patients Before Profits", added the patient perspective to this important policy debate.

Photo Source: POZ Magazine

As long-overdue reforms to the program appear within reach, primarily designed to improve access to care and treatment through better accountability and transparency, special interest groups are turning up the heat. These paternalistic ableist voices are a growing threat to silence patient advocates. Provider groups with executives making hundreds of thousands of dollars in compensation packages, and in some cases, exceeding $1 million, telling patients who cannot afford their copayments what is "best" for them is something even the best Hollywood screenwriter couldn't dream up. Starting this year, we're calling a spade a spade when it comes to this behavior.

One key area of success was on long-acting injectables. Despite more state AIDS Drug Assistance Programs (ADAP) following in the footsteps of their state Medicaid programs and covering Cabenuva on their drug formularies, there remain some holdouts. Until 2025, Texas's HIV Medication Program (THMP) had refused to offer Cabenuva...that is, until Texas advocates mobilized and relentlessly pushed for change. ADAP Advocacy, to the extent it was asked to help, chimed in on several occasions. But it was the local voice that brought about real change for people living with HIV/AIDS in their state. We've long embraced the need for national organizations to lead on federal policy, leaving state and local policy debates to the folks who call them home. National groups "meddling" in state policy affairs are rarely successful.

Photo Source: Prism Health North Texas

Our collaborative work was highlighted with the Partnership for Safe Medicines, combating counterfeit drugs, with PlusInc, about the patient perspective on prior authorization, with the Global Coalition on Aging, safeguarding innovation and access for older adults, or spearheading 37 organizations seeking an HIV carveout from the harmful impacts of the Inflation Reduction Act. We hosted key stakeholders for Health Fireside Chats in Minneapolis, Minnesota, and Atlanta, Georgia. Our three patient advisory committees engaged throughout the year to ensure that the voice of persons living with HIV/AIDS shall always be at the table and the center of the discussion.

As ADAP Advocacy enters 2026, patient-centered advocacy resources and tools will become even more critical, and our organization is eagerly preparing to deliver some new ideas. A look back at our advocacy has to focus on the future, mainly by improving access and addressing affordability. 

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.

State Payors Make Advancements in Coverage of HIV Long-Acting Injectable Treatments

By: Marcus J. Hopkins, ADAP 340B Consultant

As of June 2025, 47 state AIDS Drug Assistance Programs (ADAPs) and all state Medicaid programs offer coverage for Cabenuva (cabotegravir; rilpivirine), a long-acting injectable (LAI) for the treatment of HIV/AIDS. This represents a significant change from 2023, when ADAP Advocacy found that just 40 state ADAP and 39 state Medicaid programs offered coverage for Cabenuva.

According to the National Alliance of State and Territorial AIDS Directors (NASTAD), only four state ADAP programs—Louisiana, Missouri, South Dakota, and Texas—do not currently offer coverage for Cabenuva. However, last month the Texas Legislature approved $338 billion two-year spending plan with funds to support Long-Acting Injectables (LAIs) for the Texas AIDS Drug Assistance Program (Figure 1).

Figure 1 – Long-Acting Injectable Coverage Map – Cabenuva – ADAP Coverage by State, June 2025

In addition to 47 state ADAPs offering coverage for Cabenuva, all state Medicaid programs currently provide coverage through either their fee-for-service Medicaid program or one of their Managed Care Organizations (MCOs; Figure 2). Medicaid coverage of Cabenuva, along with coverage provided by commercial insurance plans, is more difficult to quantify, as many plans may include coverage as a medical benefit rather than a pharmacy benefit. Finding information about drugs covered as medical benefits often requires searching through dozens, if not hundreds, of plan documents.

This was the case when researching Medicaid Preferred Drug Lists (PDLs). When ADAP Advocacy was unable to find direct confirmation of coverage for Cabenuva, it relied upon Long-Acting Agent Resource Center’s Cabenuva Coverage Map, a project of the American Academy of HIV Medicine (https://hivlaa.org/map/), to provide coverage information. Coverage information for the following 11 states was gleaned using this resource: Colorado, Georgia, Indiana, Iowa, Kansas, Kentucky, Montana, Nebraska, South Carolina, South Dakota, and Wisconsin.

Figure 2 – Long-Acting Injectable Coverage Map – Cabenuva – Medicaid Coverage by State, June 2025

ADAP Advocacy, under the direction of its 13-member ADAP Long-Acting Injectables Patient Advisory Committee, first began tracking ADAP and Medicaid coverage of Cabenuva, along with other LAIs to prevent or treat HIV in 2023 (Hopkins, 2023), when it was discovered that several state Medicaid programs were offering coverage of Cabenuva—first approved for monthly treatment in 2021, with a secondary approval for bi-monthly injections in 2022 (ViiV Healthcare, 2022)—in name only, with many states placing virtually insurmountable prior authorization (PA) requirements between patients and their life-saving medications. The formulary research into drug coverage and PA requirements led ADAP Advocacy to conduct original quantitative and qualitative patient-side research on sentiments and attitudes toward long-acting agents.

Key findings from ADAP Advocacy's research include:

• The majority of respondents to the Treatment Survey (52.3%) indicated that they would prefer receiving LAI medication to treat their HIV over a daily pill-based regimen; In the Prevention Survey, the majority of respondents (71.4%) indicated they would prefer an LAI over a daily pill-based regimen to prevent HIV.
• The vast majority of respondents to the Treatment Survey (87.8%) indicated being aware of Cabenuva as an LAI to treat HIV. Of those respondents who learned about the existence of LAI medications through this survey, half (50%) reported being open to discussing them with a medical provider; Just over half of respondents to the Prevention Survey (58.4%) indicated being aware of Apretude for use as LAI PrEP. More than four out of every ten respondents (42.2%) who learned about the existence of Apretude through this survey reported being open to discussing it with a medical provider;
• A majority of respondents to the Treatment Survey (87.7%) indicated having no issues finding information about LAI medications. Of those respondents who did have trouble finding information (12.3%), most respondents had trouble finding information about insurance coverage (78.6%), prior authorization requirements (78.6%), and the cost they would have to pay to access LAIs (71.4%);
• Insurance coverage barriers impacted respondents’ ability to pursue LAIs, with more than 1 in 4 survey respondents (27%) reporting this barrier in the Treatment and Prevention surveys. In the case of PrEP, a majority of those experiencing this (66%) indicated that the barriers to access were so cumbersome that they decided Apretude was not right for them.

In addition to coverage for Cabenuva, ADAP Advocacy also found that:

• 2 state ADAP programs (MA & MN) and 40 state Medicaid programs offer coverage for Apretude as Pre-Exposure Prophylaxis (PrEP);
• 43 state ADAP and 42 state Medicaid programs provide coverage for Sunlenca as HIV salvage therapy; and,
• 50 state ADAP and 32 state Medicaid programs provide coverage for Trogarzo as HIV salvage therapy.

Coverage for LAI drugs is of ever-increasing importance for People Living with HIV/AIDS (PLWHA) as long-acting agents may help to increase medication adherence and reduce the risk of creating multi-drug-resistant strains of the HIV virus. ADAP Advocacy will continue to monitor coverage of LAIs and provide updates when significant changes are made.

[1] Hopkins, M. J. (2023, July 20). The state of long-acting injectable Medicaid coverage. Nags Head, NC: ADAP Advocacy. https://adapadvocacyassociation.blogspot.com/2023/07/the-state-of-long-acting-injectable.html

[2] ViiV Healthcare. (2022, January). ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting HIV treatment. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/january/viiv-healthcare-announces-fda-approval-of-cabenuva-for-use-every-two-months/

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.    

Infusion Clinics Could Expand Utilization of Long-Acting Injectables, but Barriers Hinder Access

By: Ranier Simons, ADAP Blog Guest Contributor

The advent of long-acting injectables (LAI) for HIV prevention and treatment is a noteworthy breakthrough in medical science. Despite the growing number of options and continuing clinical studies showcasing their efficacy, they are under-utilized. While there are various drug-level and patient-level barriers to LAI uptake, one of the most significant barriers is access at the system level (Cooper et al., 2022). Many people who would greatly benefit from LAIs for prevention and people living with HIV/AIDS (PLWHA) in need of better options for treatment can’t access them. Logistics and coverage issues stand as obstacles to life-saving treatment and public health prevention.

Photo Source: HIV.gov

Discrepancies in insurance coverage constitute a significant barrier. In the U.S., 40 percent of PLWHA are insured by Medicaid, and 27 percent get medication from state AIDS Drug Assistance Programs (ADAP) (Zalla et al., 2025). A recent study examined prescription drug formulary coverage of long-acting cabotegravir/rilpivirine (CAB/RPV-LA) for HIV treatment for those who achieved viral suppression and lenacapivir (LEN) for adults with multi-drug-resistant strains. CAB/RPV-LA was not covered without prior authorization (PA) by 26 state Medicaid programs and had no coverage by 15 state ADAPs. LEN was not covered without prior authorization by 32 Medicaid programs and had no coverage by 18 ADAPs (Zalla et al., 2025). Eighteen state Medicaid plans had unencumbered uniform coverage of CAB/RPV-LA with no PA, and 11 had unencumbered uniform coverage of LEN with no PA (Zalla et al., 2025). A distinction is made between coverage with and without PA because prior authorizations for LAIs are particularly cumbersome. Additionally, many health insurers require reapproval processes for continued treatment.

Another recent study surveyed providers inquiring about identified barriers to LAI utilization for treatment and prevention regarding long-acting cabotegravir/rilpivirine (CAB/RPV-LA) for treatment and long-acting cabotegravir (CAB-LA) for HIV prevention (Marcus et al., 2025). These providers highlighted PA approval and appeals, re-verification of eligibility for continuous coverage, and coverage of LAIs as a medical benefit instead of a pharmacy benefit (Marcus et al., 2025).

Both studies highlight the central barrier of insurance bureaucracy as a hindrance to LAI access. Cumbersome PAs delay the initiation of treatment. Requiring re-verification of eligibility for treatment not only causes treatment delays but also adds to the administrative burden of providers (Marcus et al., 2025; Zalla et al., 2025). Providers cannot afford to be saddled with the extra administrative burden of soliciting and managing PAs or the financial expenditure of hiring staff for that purpose. Additionally, when LAIs are covered under insurance as a medical benefit instead of a pharmacy benefit, that can require a provider to purchase medications on the front end and bill the insurance on the back end in a “buy and bill” situation (Marcus et al., 2025). Not only is a financial investment for the medications required, but special storage and refrigeration is required. This may be logistically challenging and cost-prohibitive to a provider.

Photo Source: Pharmacy Practice News

When vulnerable patients rely on Medicaid or ADAPs to obtain LAIs, poor formulary coverage means a lack of access. Even if there is coverage, patients fall in and out of eligibility for Medicaid and ADAPs regularly due to income restrictions. When there is non-alignment of coverage between Medicaid and ADAP in a state, patients risk lengthy treatment interruptions. This is dangerous because LAIs remain in the body for long periods of time at low levels. As such, treatment interruptions can result in developing drug resistance (Zalla et al., 2025).

One solution to assist providers in avoiding some of the challenges of administering LAIs is referral to infusion clinics. Increasing the utilization of infusion clinics to administer LAIs would be an innovation of care delivery and implementation science from a process improvement perspective. As founder and CEO of Agile Infusion Services LLC, Yossi Faber states, “Freestanding ambulatory infusion clinics play a crucial role in expanding access to long-acting injectables for HIV prevention and treatment. However, without addressing systemic barriers such as restrictive insurance policies, provider education gaps, and operational constraints, these therapies won’t reach those who need them the most. Ensuring sustainable policies and adequate provider support is key to equitable access.”

Infusion centers that are not inside hospitals or other medical practices solely focus on infusion and injection therapies. Freestanding centers are in communities; thus, they are often more convenient for patients in terms of physical access. Additionally, the centers’ staff are highly trained with respect to injections and infusions. The advanced training increases patient safety and is a standard operational characteristic of their care model. They have lower overhead and can negotiate with payers at a lower price (Cheney, 2022).

Photo Source: Rx Toolkit

Primary care doctor offices and other medical clinics do not typically have the built-in workflow, refrigeration, and storage capacity, nor administrative capacity to effectively handle the utilization of LAIs. Infusion centers are experienced with the administrative navigation of prior approvals, medication handling, medication dispensing, and the logistics of obtaining drugs from specialty pharmacies. Moreover, primary care doctors are not well-versed on preventative LAIs. PLWHA utilize providers experienced with LAIs for their care. Those desiring LAIs for PrEP are typically unfamiliar with the HIV treatment landscape and have an unclear path to access. Faber explains, “This lack of awareness on the part of providers can result in significant underutilization of these therapies, as providers are often hesitant to recommend treatments with unfamiliar medications or modalities, particularly if they are unaware of where such therapies can be obtained.” Referring patients to infusion centers to administer LAIs for treatment and prevention is part of a comprehensive solution.

There is a dire need to improve access to long-acting injectable medications. Patients need to access many other beneficial therapies, such as Trogarzo, an LAI for treatment-resistant HIV, and Abilify Maintena for antipsychosis. Solutions to access issues require a multi-faceted approach. Policy intervention is necessary for insurers to streamline the PA process and remove the need for LAI reapproval. Congress should pass PrEP legislation to bolster assistance to people who are uninsured or underinsured. States should fund PrEP assistance programs. Congress should also increase funding for the Ryan White HIV/AIDS Program to help with the evolving demand for LAIs for treatment and prevention to make sure those vulnerable populations who can benefit the most are empowered with access. Medical science is evolving quickly. Thus, policy and funding innovation must also evolve to ensure equitable access to effective treatment for all.

[1] Cheney, C. (2022, August 3).Standalone Infusion Center CEO: 'The Patient Experience Is Superior.' Retrieved fromhttps://www.healthleadersmedia.com/clinical-care/standalone-infusion-center-ceo-patient-experience-superior#:~:text=Standalone%20infusion%20centers%20can%20offer,with%20lower%20overhead%20and%20expenses.

[2] Cooper, S. E., Rosenblatt, J., & Gulick, R. M. (2022). Barriers to Uptake of Long-Acting Antiretroviral Products for Treatment and Prevention of Human Immunodeficiency Virus (HIV) in High-Income Countries. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 75(Suppl 4), S541–S548. https://doi.org/10.1093/cid/ciac716

[3] Lauren C Zalla, Tim Horn, Sita Lujintanon, Catherine R Lesko, State-Level Variation in Access to Long-Acting Injectable Antiretroviral Therapy for HIV in the United States, Health Affairs Scholar, 2025;, qxaf016, https://doi.org/10.1093/haschl/qxaf016

[4] Marcus, J. L., Weddle, A., Kelley, C. F., Agwu, A., Montalvo, S., Sherman, E., Vijayan, T., Gutierrez, J., Hickey, M. D., Dilworth, S. E., Krakower, D., Davis, T. L., Collins, L. F., McNulty, M. C., Colasanti, J. A., & Christopoulos, K. A. (2025). Policy recommendations to support Equitable access to Long-Acting Injectables for Human Immunodeficiency virus prevention and Treatment: A policy paper of the Infectious Diseases Society of America and the HIV Medicine Association. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae648

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. 

A Call to Serve: Patient Advocates Must Step-Up During T2

By: Brandon M. Macsata, CEO, ADAP Advocacy

In December 2024, ADAP Advocacy hosted its final Health Fireside Chat of the year as part of a broader Health Policy Retreat held in collaboration with the Community Access National Network. Despite hopes that the country's better angels would be reflected at the ballot box, both organizations had been preparing for what once seemed impossible: Trump Two (T2). POSITIVELY AWARE captured the sentiments shared by members of several national and state-level HIV advocacy and policy organizations from across the country prior to the Election. But now the rubber meets the road...

ADAP Advocacy CEO Brandon M. Macsata on The Morning Meeting, 12/09/24

At the Health Fireside Chat, political commentator Mark Halperin, editor-in-chief of 2WAY Interactive and host of The Morning Meeting podcast, pointedly dished out some straight talk about how patient advocates need to view the election as a call to serve. During the 2024 presidential election, Halperin scooped that President Joe Biden was dropping out of the presidential race days before the news broke, as well as three weeks prior to the election sounding the alarm that the Harris-Walz campaign was in big trouble in the swing states' suburbs. Agreeing to disagree in a few areas, most attendees in the room understood the merits of the advice being given by a political insider.

In fact, Halperin's message echoed the words of the late Bill Arnold (former President & CEO of the Community Access National Network and former founder and board co-chair of the ADAP Advocacy Association): leave your personal politics at the door! Halperin challenged the patient advocates and other stakeholders in the room to fight for a seat at the preverbal table. Ironically, it sounds awfully similar to The Denver Principles and the "Nothing About Us Without Us" principle!

To that end, ADAP Advocacy is returning some of its targeted advocacy efforts back to the very roots of the organization's founding some seventeen years ago...GRASSROOTS, that is. Back in 2010 during the height of the ADAP Crisis that landed over 1,300 people living with HIV/AIDS in thirteen states on waiting lists under the State AIDS Drug Assistance Program (ADAP), including a couple reported deaths, ADAP Advocacy helped to galvanize state grassroots networks to raise awareness and demand action by lawmakers. It is time to re-activate these state grassroots networks to push back against those dark forces seeking to gut the social safety-net, spread misinformation about science and vaccine efficacy, and perpetuate hate and stigma against marginalized communities...many of whom are disproportionately impacted by HIV.

ADAP Advocacy CEO Brandon M. Macsata at Florida town hall in 2010

Patient advocates are encouraged to contact ADAP Advocacy at info@adapadvocacy and indicate which state they're residing in, and how they might help with advocacy efforts. Aside from targeting federal lawmakers with constituent visits to better educate them, there will be plenty of opportunity for patient advocates to influence their state legislatures on many HIV-related issues.

Additionally, ADAP Advocacy leverages patient advocates and other public health stakeholders to serve on numerous patient advisory committees. This is a call to serve!

• ADAP State Drug Formulary Patient Advisory Committee

RE: Drug Formularies

Committee Chair: Rev. Alexander Garbera (Connecticut)

ADAP Advocacy works to improve access to timely, appropriate care and treatment for people living with HIV/AIDS being served by the State AIDS Drug Assistance Programs (ADAPs) under the Ryan White HIV/AIDS Program, including promoting robust drug formularies to best serve the needs of clients. Whenever feasible, ADAP Advocacy strongly supports "open" drug formularies. Approximately 20 seats need to be filled for this committee.

Learn more about the ADAP State Drug Formulary Patient Advisory Committee.

• ADAP Long-Acting Injectables Patient Advisory Committee

RE: Long-Acting Injectables

Committee Chair: Joey Wynn (Florida)

ADAP Advocacy strives to identify best practices on how to improve patient access to long-acting injectable therapies for the treatment of (and prevention of) HIV/AIDS. As general guidelines, they would be designed to help State AIDS Drug Assistance Programs (ADAPs), and other relevant payers, remove the barriers to accessing injectable HIV-related therapies, as well as other non-ARV, health-related injectable therapies. Three seats need to be filled for this committee.

Learn more about the ADAP Long-Acting Injectables Patient Advisory Committee.

• Ryan White Grantee 340B Patient Advisory Committee

RE: 340B Drug Pricing Program

Committee Chair: Guy Anthony

ADAP Advocacy ensures the voice of people living with HIV/AIDS shall always be at the table and the center of the discussion, including on how supports and services are financed under the Ryan White HIV/AIDS Program. To that end, reforming the 340B Drug Pricing Program is of paramount concern by returning the program to its original legislative intent: putting the patient first. Two seats need to be filled for this committee.

Learn more about the Ryan White Grantee 340B Patient Advisory Committee.

ADAP Advocacy has long prided itself on using its Values Statements to define its advocacy work. Among these values, that the voice of persons living with HIV/AIDS shall always be at the table and the center of the discussion. Patient advocates must step-up during T2, so join the fight!

Photo Source: shutterstock.com

Drug Shortages Growing, but Spares HIV-related Injectable Therapies

By: Ranier Simons, ADAP Blog Guest Contributor

Periodic shortages of all kinds of products are common. The height of the coronavirus pandemic even created a widespread shortage of toilet paper, Lysol, and baby formula. At times, drug shortages are also not uncommon. Nevertheless, drug shortages have been a trending topic in the media. The heightened discourse is atypical for so many drugs to be experiencing shortages simultaneously. Not only are there many drugs in shortage, but they have been in scarcity for a long time. Moreover, some of the drugs in shortage treat life-threatening conditions. Now shortages appear to be impacting injectable therapies.

Photo Source: Forbes

Drug shortages have increased over time, with the end of 2023 being the highest in the past ten years. At the end of 2025, according to the U.S. Food & Drug Administration (FDA), 125 drugs were in shortage status. Some of the drugs were new to the shortage list. However, many have been in shortage status for years. Furthermore, the duration of shortage status has also been increasing. In 2023, the average shortage was about three years compared to a duration of two years in 2020.[1] Unfortunately, at 2023 year-end, about a quarter of the drugs on the list had been in shortage for approximately five years, and treatments such as epinephrine injections had been in shortage for over ten years.[1,2]

Drug shortages affect all aspects of healthcare. No one therapeutic class is disproportionately harmed. Clinicians are frustrated because shortages of life-saving medications endanger many living with life-threatening conditions. Complete outages of supply mean that some patients must suffer through dangerous delays in care. In other cases, doctors must switch regimens completely due to shortages, forcing them to use medications they do not feel are the best options for patients. This results in using less efficacious medications with poorer desired outcomes and undesirable side effects. Additionally, when shortages result in switching from a regimen in progress, there is a danger of the body becoming unresponsive to the original regimen when the shortage is resolved.

A myriad of issues create drug shortages. Some of those issues are economic, supply and demand, and even manufacturing quality problems. Shortages are more common with lower-priced drugs such as generics.[3] A prescription for most of the injectables and solid oral medications in shortage costs less than five dollars to produce.[1,2] This translates into meager manufacturer profit margins, especially with wholesalers and purchasing groups driving down pricing. Thus, manufacturers are not incentivized to produce those medications in sustained large quantities. The FDA cannot force a company to make a particular medication, even if it is needed.

Photo Source: FDA

Supply and demand issues also drive shortages. In some cases, demand outpaces supply when drugs are used for expanded use cases. This is the case for drugs like Ozempic and Wegovy, which are GLP-1 drugs whose primary indications are to treat diabetes. The discovery of its effectiveness in weight loss has resulted in a vastly increased demand. The demand driven by the population of those dependent upon GLP-1 drugs to manage diabetic conditions in combination with those using them for weight loss has driven outages as well as increased pricing. Some of the demand for other drugs is driven by increases in prescriptions due to telemedicine. During the pandemic, restrictions were lifted on the prescribing of certain classes of medicines via telemedicine, such as Adderall, which is used for ADHD.[4] This resulted in increased demand for the drug which contributed to shortages that are still seen presently. This is especially pertinent since some obtain Adderall and other medications online for purposes of substance abuse.

Manufacturing problems and supply chain issues strongly contribute to drug shortages as well. The U.S. is dependent upon sources outside of the country for many of the drugs in shortage status. Less than one-quarter of the oral generics used in the U.S., and about 40 percent of sterile injectable generics are manufactured domestically. Approximately 17% of injectables used in the U.S. are manufactured in China.[5] Most importantly, many of the raw ingredients for pharmaceuticals are sourced outside of the U.S., with materials for 90-95 percent of U.S. generic injectable drugs coming from China and India.[5,6] Manufacturing certain older generic drugs, especially sterile injectables, is difficult due to the sterile manufacturing conditions required; thus, the number of capable facilities is low.

About 53 percent of the newest drug shortages are generic injectable medicines.[7] Sterile injectables include normal saline, antibiotics, flu vaccines, chemotherapy drugs, morphine, and insulin. Shortages in chemotherapy drugs have caused doctors and hospitals to resort to drug rationing. In those instances, hard decisions must be made regarding the treatment of life-threatening cancers. Doctors must choose which patients receive certain medications based on decisions based on curative intent and probability versus overall survival.

Photo Source: ADAP Advocacy

Drug shortages were also of heightened concern for those living with HIV during the coronavirus pandemic. In March 2020, ADAP Advocacy received assurances directly from each drug manufacturer that the coronavirus pandemic wasn’t negatively impacting the availability of anti-retroviral medications. The pharmaceutical industry was applauded for its efforts to protect the anti-retroviral drug supply chain.[8] At that time all of the drug manufacturers – AbbVie, Janssen Pharmaceuticals, Gilead Sciences, Merck. Theratechnologies, and ViiV Healthcare – did not foresee disruption to their supply chain.

Considering injectable therapies are increasingly showing up on the FDA’s drug shortage list, ADAP Advocacy once again inquired with its industry partners about potential concerns over shortages of injectable HIV-related medications, such as the injectables Cabenuva for the treatment of HIV, and Sunlenca for the prevention of HIV. 

Reaching out to the industry resulted in very positive feedback. A representative from ViiV Healthcare stated that “there are no current shortages nor anticipation of any prolonged shortages of any injectable within the ViiV portfolio.”

A Gilead spokesperson likewise stated, “Gilead’s commercial supply chain is robust, and we have a strong inventory position. We continually monitor the forecast and actively manage supply; thus, we do not anticipate any supply concerns related to Sunlenca®, Gilead’s twice-yearly injectable HIV treatment option for people living with the virus who are heavily treatment-experienced with multi-drug resistant HIV. We are committed to person-centric HIV treatment research and development, ensuring our advances in biomedical innovation reach the wide range of individuals and communities who are most in need.” 

Drug shortage is a serious concern that will require a multi-pronged approach to solve. The White House, FDA, and others must find solutions to the manufacturing, regulatory, and supply chain challenges. The government is already looking into investing in some of the raw materials needed for drug creation, which is a good start.

[1] Lokuwithana, D. (2024, June 15). U.S. drug shortages worsen to reach a decade high: report. Retrieved from https://seekingalpha.com/news/4116477-us-drug-shortages-reach-decade-high

[2] Silverman, E. (2024, June 4). U.S. drug shortages have reached a decade high and are lasting longer, too. Retrieved from https://www.statnews.com/pharmalot/2024/06/04/shortages-medicines-drugs-hospitals-manufacturing-cancer-adhd-gpo/

[3] IQVIA. (2023, November 15). Drug shortages in the U.S. 2023. Retrieved from https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/drug-shortages-in-the-us-2023

[4] Gilbert, D., Amenabar, T. (2023, March 14). An Adderall shortage has not let up. Here is why. Retrieved from https://www.washingtonpost.com/business/2023/03/14/adderall-shortage-telehealth-prescriptions/

[5] Owens, C. (2024, January 5). Low prices are contributing to America's drug shortage problem. Retrieved from https://www.axios.com/2024/01/05/america-generic-drug-shortage-reasons

[6] United States Senate Committee on Homeland Security and Governmental Affairs. (2023, March). Short Supply: The Health and National Security Risks of Drug Shortages. Retrieved from https://www.hsgac.senate.gov/wp-content/uploads/2023-06-06-HSGAC-Majority-Draft-Drug-Shortages-Report.-FINAL-CORRECTED.pdf

[7] U.S. Pharmocopeia. (2024, June). USP Annual Drug Shortages Report. Retrieved from https://go.usp.org/l/323321/2024-05-31/92zsjg/323321/1717187146zgOpt4vW/GEA_GC_056R_MSM_Report_2024_05_FINAL.pdf?_gl=1*e6c4sj*_gcl_au*Mjc1NzUzOTg5LjE3MTc1MTMzOTM.*_ga*OTI0OTQ1ODI4LjE3MTc1MTMzOTM.*_ga_DTGQ04CR27*MTcxNzUxMzM5My4xLjEuMTcxNzUxMzc1Ny4wLjAuMA

[8] ADAP Advocacy. (2020, March 26). Press Release: ADAP Advocacy Association Applauds Pharmaceutical Industry Efforts on Protecting the Drug Supply Chain during the Coronavirus Pandemic. Retrieved from https://www.adapadvocacy.org/pdf-docs/2020_ADAP_Press_COVID_19_Supply_Chain_03-26-20.pdf

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.  

Evidence Suggests Long-Acting Injectables Game Changer for Adherence

By: Ranier Simons, ADAP Blog Guest Contributor

Adherence to medication is one of the most important tenets of antiretroviral therapy (ART) for people living with HIV (PLWH). Adherence is taking the appropriate medications in the proper dosages on the correct schedule. Reaching an undetectable viral load requires strict adherence, with which many PLWH have difficulty for various reasons. The recent innovation of long-acting injectables (LAI) is an attempt to strengthen adherence for PLWH who have difficulty with pill regimens. In January 2021, the U.S. Food & Drug Administration (FDA) approved Cabenuva, the first injectable drug combination for HIV.[2,5] GSK recently released results from clinical trial data indicating Cabenuva works better than daily pills for patients with adherence challenges.[1,4,5,6]

Photo Source: Pharmalive

Cabenuva is a two-injection regimen of cabotegravir and rilpivirine administered either once a month or once every two months.[7] This month, GSK released data from the LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily Life) study comparing the efficacy of Cabenuva in contrast with daily pill regimens regarding adherence.[1] The screened participants were verified as having challenges with ART adherence. They were initially given a three-drug oral ART regimen, receiving comprehensive and incentivized adherence support.[1] Once they were virally suppressed, they were randomly selected to receive Cabenuva injections every four weeks or continue with daily pill therapy.[1] The strong evidence of superior efficacy of Cabenuva over daily pill therapy led the Data Safety Monitoring Board (DSMB) for Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) to recommend removal of the randomization and offer all participants the option to take Cabenuva.[1]

This new development is an optimistic win in the fight against HIV. Joey Wynn, activist and chair of the ADAP Long-Acting Injectables Patient Advisory Committee, states, “Although definitely not for everyone, this is the next phase of evolution in HIV therapy. Injections allow us to get on with our lives and not be weighed down with the daily burden of taking pills.” 

There are many reasons daily pill therapy adherence is a challenge for some. Psychologically, taking daily pills is a reminder of disease that is too much for some to handle. There are people with developmental challenges who can't keep up a daily regimen. Stigma and privacy are adherence challenges for PLWH in living situations that are not safe or supportive, where the discovery of medication bottles is not ideal or dangerous.[2,3]

Photo Source: NIAID

As Riley Johnson, project manager for ADAP Advocacy's Long-Acting Injectables Project, points out, “LAIs can mean consistent medication instead of having meds lost or stolen and having to navigate bureaucratic hoops to pursue replacement.”

While very promising, Cabenuva does have hurdles to its implementation. Presently, there are three main criteria to be eligible for Cabenuva. It is only approved for PLWH who are virally suppressed, have documented absence of resistance to either cabotegravir or rilpivirine, and have no prior antiretroviral treatment failures.[2] Viral suppression requires adherence to oral medication, which is the challenge LAIs were created to remedy. In 2019, the Centers for Disease Control & Prevention (CDC) estimated that only 56.8% of PLWH were virally suppressed or undetectable.[2] This means that less than half of PLWH in the U.S. would qualify for Cabenuva. 

Just as with pill regimens, cost is also a hurdle for widespread adoption. The wholesale acquisition cost of the initial/loading dose is $5,940, and monthly/maintenance injections are $3,960.[5] Insurance companies must approve Cabenuva before patients can begin therapy. This is an access issue for those who do not have medical insurance. It is also an access issue for those with insurance because some insurance companies do not have an official classification of Cabenuva as a pharmaceutical or healthcare benefit. Thus, even though ViiV Healthcare has a payment assistance program for those who have commercial insurance, the lack of clarity of benefit status means ambiguity in which costs will be billed to patients and which to insurance companies.[2]

Studies have shown that multiple social determinants of health affect many patients' ability to maintain adherence regarding pill regimens. The same challenges apply to Cabenuva. Cabenuva must be administered in a healthcare setting by a health professional. Even though the visits would only be monthly or bi-monthly, that still poses a challenge for PLWH who lack reliable and affordable transportation. While pill forms of the medications are available for emergency doses if a patient misses an injection, on-time injections of Cabenuva are imperative to ensure resistance to either of the components does not occur.[2] Shipping doses of emergency medication is not viable for people with unstable housing or living situations where receiving medication is not optimal.

Photo Source: HIV.gov

Widespread adoption of Cabenuva also requires providers to adopt changes. Currently, with HIV healthcare, patients on established therapy only see their infectious disease doctors once or twice a year, and the responsibility of pill treatment adherence is on the patient. With Cabenuva injections, the facility's operational flow is disrupted since the injections require more frequent visits. Additionally, responsibility is added to the medical practices by ensuring patients do not miss their injection appointments and following up with them when they do. Moreover, practitioners must be trained in the z-track injection technique required for the intramuscular injection and have proper refrigeration equipment to store the Cabenuva between 2°C and 8°C.[8]

The recent data from the Cabenuva trial is a promising step in the right direction, though not without its challenges. Joey Wynn adds, “Understandably, there are issues of access for those on private insurance, clinic flow issues, and limited distribution shortages, meaning advocates need to demand improved pipeline delivery from the manufacturer so people can get what they need/want/require with less difficulties.” Riley Johnson adds, “no degree of adherence is possible if the medication is not available or accessible.” To ensure the success of the LAI landscape, policy and holistic community support will be required to keep up with the advances of science.

[1] GSK. (2024, February 21). Press release: LATITUDE phase III interim trial data indicates ViiV Healthcare’s long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine) has superior efficacy compared to daily therapy in individuals living with HIV who have adherence challenges. Retrieved from https://www.gsk.com/en-gb/media/press-releases/latitude-phase-iii-interim-trial-data-indicates-cabenuva-has-superior-efficacy-compared-to-daily-therapy/

[2] Pinto, R. M., Hall, E., & Tomlin, R. (2023). Injectable Long-Acting Cabotegravir-Rilpivirine Therapy for People Living With HIV/AIDS: Addressing Implementation Barriers From the Start. The Journal of the Association of Nurses in AIDS Care: JANAC, 34(2), 216–220. https://doi.org/10.1097/JNC.0000000000000386

[3] Simoni, J. M., Tapia, K., Lee, S. J., Graham, S. M., Beima-Sofie, K., Mohamed, Z. H., Christodoulou, J., Ho, R., & Collier, A. C. (2020). A Conjoint Analysis of the Acceptability of Targeted Long-Acting Injectable Antiretroviral Therapy Among Persons Living with HIV in the U.S. AIDS and Behavior, 24(4), 1226–1236. https://doi.org/10.1007/s10461-019-02701-7

[4] Hart, R. (2024, February 21). First long-acting injectable HIV treatment works better than daily pills for some patients, GSK says. Retrieved from https://www.msn.com/en-us/health/other/first-long-acting-injectable-hiv-treatment-works-better-than-daily-pills-for-some-patients-gsk-says/ar-BB1iDCzR?ocid=socialshare

[5] Bernstein, L. (2021, January 22). FDA approves breakthrough injectable HIV medication. Retrieved from FDA approves breakthrough injectable HIV medication

[6] Liu, A. (2024, February 21).GSK’s long-acting HIV med Cabenuva beats daily therapy in patients who've faced adherence hurdles. Retrieved from https://www.fiercepharma.com/pharma/cabenuva-trial-modified-gsks-long-acting-hiv-med-beat-daily-therapy-patients-adherence

[7] VIIV Healthcare. (2024, January). Cabenuva. Retrieved from https://www.cabenuva.com/  

[8] De Vito, A., Botta, A., Berruti, M., Castelli, V., Lai, V., Cassol, C., Lanari, A., Stella, G., Shallvari, A., Bezenchek, A., & Di Biagio, A. (2022). Could Long-Acting Cabotegravir-Rilpivirine Be the Future for All People Living with HIV? Response Based on Genotype Resistance Test from a Multicenter Italian Cohort. Journal of personalized medicine, 12(2), 188. https://doi.org/10.3390/jpm12020188

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. 

Fireside Chat Retreat in Philadelphia, PA Tackles Pressing Public Health Issues

By: Brandon M. Macsata, CEO, ADAP Advocacy

ADAP Advocacy hosted its "Health Fireside Chat" retreat in Philadelphia, Pennsylvania among key stakeholder groups to discuss pertinent public health issues facing patients in the United States. The Health Fireside Chat convened Thursday, September 21st through Saturday, September 23rd. The growing threat to public health from the spread of medical misinformation and disinformation, reforming the 340B Drug Pricing Program to better serve patients rather than providers, and the effective implementation of longer-acting HIV treatment and prevention programs were evaluated and discussed by the 20 diverse stakeholders.

The Fireside Chat's “ice breaker” activity included some fun and games at Dave & Buster's with their pool tables, video games, carnival challenges, and virtual reality. Attendees enjoyed some bonding and laughter before collectively rolling up their sleeves and taking a deep dive into the policy discussions.

Photo Source: Getty Images

The Health Fireside Chat included moderated white-board style discussion sessions on the following issues:

• Public Health Alert: Medical Misinformation Can be Dangerous to Your Health — moderated by Rick Guasco, Acting Editor-in-Chief and Creative Director at Positively Aware
• 340B Drug Discount Program: The Issues Spurring Discussion, Stakeholder Stances, and Possible Resolutions? — moderated by Tim Horn, Director, Medication Access at NASTAD
• Long Acting Injectables: Effective Implementation of Longer-Acting HIV Treatment and PrEP Requires Delivery System Innovation — moderated by Jeffrey Crowley, Distinguished Scholar/Program Director, Infectious Disease Initiatives at the O'Neill Institute/Georgetown Law

The discussion sessions were designed to capture key observations, suggestions, and thoughts about how best to address the challenges being discussed at the Health Fireside Chat. The following represents the attendees:

• Ninya Bostic, National Policy and Advocacy Director, IDV, Johnson & Johnson
• Jeffrey S. Crowley, Distinguished Scholar & Program Director at the Infectious Disease Initiatives, O'Neill Institute for National and Global Health Law, Georgetown Law
• Theresa Daugherty, Patient Advocate
• David Gana, Patient Advocate
• Alexander Garbera, Co-Chair, New Haven Mayor’s Task Force on AIDS, City of New Haven, CT
• Dusty Garner, Patient Advocate
• Rick Guasco, Acting Editor-in-Chief and Creative Director at Positively Aware
• Tim Horn, Director, Medication Access at NASTAD
• Riley Johnson, Founder, RAD Remedy
• Thomas Johnson, Executive Director, Alliance to Save America’s 340B Program
• Jen Laws, President & CEO, Community Access National Network
• Darnell Lewis, Program Coordinator, RAO Community Health
• Brandon M. Macsata, CEO, ADAP Advocacy
• J. Maurice McCants-Pearsall, Government Relations Director (Southeast), ViiV Healthcare
• Aisha McKenzie, Patient Advocate
• Warren O’Meara-Dates, Founder & CEO, The 6:52 Project Foundation
• Brian Smith, Alliance Development and Strategic Advocacy
• Matt Toresco, CEO & CPO, Archo Advocacy LLC & Elavay
• Stacey L. Worthy, Director, Healthcare Policy & Strategy, Johnson & Johnson
• Joey Wynn, Chairman, Florida HIV/AIDS Advocacy Network

The Covid-19 pandemic is still ongoing. Covid-19 cases and hospitalizations are both on the rise again, according to data by the Centers for Disease Control & Prevention (CDC) With that in mind, ADAP Advocacy implemented strong Covid-19 safety protocols for the Health Fireside Chat, which included proof of vaccination/booster, robust self-administered testing (prior to travel, upon arrival, and after returning home), complimentary rapid self-test kits and hand sanitizer for each of the attendees, as well as guidelines for masks on commercial travel to the event, and optional masks during the sessions (which some attendees exercised without feeling shunned).

ADAP Advocacy is pleased to share the following brief recap of the Health Fireside Chat.

Medical Misinformation:

The first policy session, “Public Health Alert: Medical Misinformation Can be Dangerous to Your Health”, lead by the Positively Aware Magazine’s Rick Guasco, challenged guests to evaluate their own role in potentially sharing medical misinformation without even knowing it. Guasco highlighted that everyone can do something about misinformation, starting with being cognizant of how people can potentially spread it. A little information is a dangerous thing. Medical misinformation is information that is false, inaccurate, or misleading. A little misinformation can become the building block of lies and ignorance. As such, medical disinformation is misinformation with a purpose. According to the Kaiser Family Foundation's recent poll, most Americans encounter health misinformation, and most aren’t sure whether it’s true or false local TV.

Drawing on KFF's Misinformation Pilot Poll, KFF released three follow-up reports examining exposure to, and belief in, health misinformation among Black adults, Hispanic adults, and rural communities.

Guasco shared what he viewed as the best three ways to combat medical misinformation and disinformation. They included 1) promoting the truth by proactively talking about health literacy, 2) pre-bunking fake medical news by putting counter-arguments out in anticipation, and 3) de-bunking fake medical news, but it is more difficult because it is harder to change minds once the misinformation and disinformation is spread. Significant conversation centered around lingering medical mistrust in the Black community after the Tuskegee Airmen experiments. Rev. Alexander Garbera offered an excellent quote to summarize how to combat the dangers associated with medical misinformation and disinformation: "Combat fear with empathy."

Photo Source: Florida International University

The following materials were shared with retreat attendees:

• Ex-JAMA Chief: Cut the Hype, Spin in Published Studies — Howard Bauchner, MD, says researchers want to report accurately, but "they too have their biases" via MedPage Today
• Doctors who put lives at risk with covid misinformation rarely punished via The Washington Post
• Abortion health information via National Library of Science
• Science Communication in the Age of Misinformation via CROI 2023

ADAP Advocacy would like to publicly acknowledge and thank Rick Guasco for facilitating this important discussion.

340B Drug Discount Program:

As a backdrop to the discussion over the 340B Drug Discount Program, an opinion piece dropped calling out the hypocrisy behind the forces fighting reform. NASTAD's Tim Horn kicked-off the discussion with an overview of the program, including an analysis on how 340B intersects with the Ryan White HIV/AIDS Program, including State AIDS Drug Assistance Programs (ADAP). In that, some challenges were addressed – such as explosive program growth, lack of transparency, and calls for more oversight. There was particular focus on ADAPs and their specific programmatic use of the 340B dollars exclusively for patient care, and that in many ways it represents the "gold standard" among Covered Entities participating in the program. The discussion also centered around some of the pros and cons associated with ongoing reform proposals; they included contract pharmacy restrictions, discriminatory reimbursement laws, and possible federal legislation (e.g., ASAP 340B). The conversation touched the rising medical debt crisis in the United State (of which, most medical debt is actually hospital-associated debt), declining charity care among hospitals, as well as the adverse impact on patients via provider consolidation. Ongoing scrutiny over the lack of transparency in the program continues to grow, evidenced by the Request for Information (RFI) issued by a group of bipartisan senators, including Senator John Thune (R-SD), Senator Debbie Stabenow (D-MI), Senator Shelley Moore Capito (R-WV), Senator Tammy Baldwin (D-WI), Senator Jerry Moran (R-KS), and Senator Benjamin Cardin (D-MD). Read the joint statement by ADAP Advocacy and CANN, here.

Photo Source: Positively Aware

The following materials were shared with retreat attendees:

• ADAP Crisis Task Force Fact Sheet via NASTAD
• Principles for Ensuring the 340B Program Benefits Patients and True Safety-Net Providers via ASAP 340B
• Creating Long-Overdue Clarity Around Patient Definition in the 340B Program via ASAP 340B
• Estimated Changes in Manufacturer and Health Care Organization Revenue Following List Price Reductions for Hepatitis C Treatments via JAMA Network
• 340B-Where Do We Go From Here? via JAMA Network 
• Pharmaceutical Manufacturer 340B Price Restriction Policies and Exemptions Summary. Ryan White Clinics for 340B Access via RWC340B
• HIV Prevention and the 340B Drug Pricing Program via The New England Journal of Medicine
• The 340B Drug Discount Program Exceeds #100B in 2022 via IQVIA
• 340B and Ending the Epidemics via National Coalition of STD Directors
• 340B: A Critical Program for Health Centers via National Association of Community Health Centers
• A Syndemic Approach to STD 340B Correctional Facility Partnerships for Health Department Prevention Programs via NASTAD
• Best Practices for Shared ADAP and Other 340B Covered Entity Clients via NASTAD
• Association of 340B Contract Pharmacy Growth with County-Level Characteristics via American Journal of Managed Care
• How a Hospital Chain Used a Poor Neighborhood to Turn Huge Profits via The New York Times

ADAP Advocacy would like to publicly acknowledge and thank Tim Horn for facilitating this important discussion.

Editor's Note: The ADAP Advocacy Association has offered opinions on 340B over the last several years, including Industry’s Changes to 340B Drug Discount Program (April 2022), 340B – Reply Hazy, Try Again (January 2020), The Federal 340B Program: A Call to Order (March 2019), and 340B Program: Don't Throw the Baby Out with the Bathwater (March 2017)

Long-Acting Injectables:

The O'Neill Institute for National and Global Health Law recently published a brief, Effective Implementation of Longer-Acting HIV Treatment and PrEP Requires Delivery System Innovation. The O'Neill Institute summarized long-acting injectables:

"Scientific advancements resulting from our long-term national commitment to HIV research have begun producing new products both for HIV treatment and prevention that do not require daily dosing. The first standalone longer-acting (LA) FDA-approved products are delivered by intramuscular injection every 1-2 months, but future products may require far less frequent injections or could come in other forms such as small implants under the skin or oral medications. These products represent exciting advances because they give users more options to stay engaged in the HIV treatment or prevention continuum. While many patients and providers speak of how transformative these products can be, access to these products is limited and a myriad of barriers prevent individuals from accessing them. Deliberate policy actions are needed to ensure that these innovations do not bypass the individuals and communities that stand to benefit the most from them."

Read the brief and its related materials. 

Jeffrey S. Crowley led this important discussion. While early in the implementation of these products, several barriers have arisen that must be overcome.  Among these are:

1. Adapting our current clinics and health care programs to allow for greater scale;
2. Overcoming insurance and financing barriers to access;
3. Addressing regulatory and financing barriers to new delivery models, such as greater use of pharmacies, mobile clinics, or self-administration; and,
4. Ensuring that innovations in HIV services delivery reduces rather than increases equity.

Some perspective was also shared on the work done by the O'Neill Institute in this area. Dusty Garner offered his perspective on some of the challenges he has encountered accessing his LAI treatment. Additionally, several members of the ADAP Advocacy's ADAP Injectables Advisory Committee, including Jen Laws, Riley Johnson, and Warren O-Dates, offered their perspectives on LAIs and the challenges being faced by patients.

Photo Source: European AIDS Treatment Group

The following materials were shared with retreat attendees: 

• Big Ideas Brief: Effective Implementation of Longer-Acting HIV Treatment and PrEP Requires Delivery System Innovation via O'Neill Institute
• Quick Take: Equitable Access to New HIV Treatment and Prevention Options is Needed Across Payers via O'Neill Institute
• Quick Take: New Options for HIV Treatment and Prevention are Here via O'Neill Institute
• Cabenuva (cabotegravir & rilpivirine extended-release injections) Considerations for AIDS Drug Assistance Programs via NASTAD
• Pipeline Report 2023 via Treatment Action Group
• Long-Acting Injectable Cabotegravir for PrEP: Understanding Results of HPTN 083 & 084 and key areas for advocacy via AVAC
• Long-Acting Injectables Antiretrovirals for Treatment and Prevention via AVAC

ADAP Advocacy would like to publicly acknowledge and thank Jeffrey S. Crowley for facilitating this important discussion.

Additional Fireside Chats are planned for 2023 in New Orleans, Louisiana.

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.