CALL TO ACTION: HIV Medication Carve-Out Exemption from the Medicare Drug Price Negotiation Program

By: Marcus J. Hopkins, ADAP 340B Consultant

ADAP Advocacy has submitted public comments to the Centers for Medicare and Medicaid Services (CMS) regarding the proposed guidance for the Medicare Drug Price Negotiation Program (“Negotiation Program”) established under the Inflation Reduction Act (2022):

While ADAP Advocacy’s objections to the Negotiation Program’s proposed implementation are several, our primary request is for the creation of a carve-out exemption for all medications used for the treatment of HIV/AIDS in the U.S. that would prevent these treatments from being eligible for any future Medicare price negotiations.

Photo Source: CMS

ADAP Advocacy has requested this carve-out exemption due to the serious nature of the threat facing People Living with HIV/AIDS (PLWHA), should HIV medications be selected as part of the Negotiation Program. While the HIV treatment landscape has improved significantly over the last 25 years, today only a handful of manufacturers continue to work in the HIV space, including Gilead Sciences, ViiV Healthcare, and Merck. Over the past decade, three manufacturers—Bristol Myers Squibb, AbbVie, and Johnson & Johnson—have withdrawn from the HIV space for various reasons, not least of which is the difficulty of competing in a landscape where many of the most significant innovations, including well tolerated single-pill regimens, long-acting injectable agents, and highly effective oral and injectable prophylaxis, have already occurred.

As part of this effort, ADAP Advocacy has also spearheaded a national sign-on letter seeking support from national, state, and local advocacy organizations. The letter and the signature form are available online at: https://www.adapadvocacy.org/letter-cms-hiv-carveout.php. 

The Negotiation Program essentially requires manufacturers to accept the final price after four negotiation meetings set by CMS, reject the offer, and pay a 95% excise tax on all of the medications sold to Medicare payors, or remove their products from the Medicare formularies altogether (Hammond, 2024). Because no business can feasibly accept a 95% excise tax and remain viable, manufacturers are left with the unenviable decision to either accept significant profit losses in the Medicare market or withdraw their drugs.

Photo Source: Inside Sources

The prospect of losing access to HIV medications paid for through Medicare poses a significant risk to PLWHA. Medicare is the 2nd-largest payor of HIV treatment and care in the United States, accounting for 39% of federal spending in 2020, and serving 28% of PLWHA (Dawson, et al., 2023). Additionally, 77% of PLWHA who are enrolled in Medicare first qualified for the program not because of age but because of a disability diagnosis.

Patients who lose access to HIV medications may fall out of treatment entirely, placing them at risk of dying from opportunistic infections or having their HIV mutate to develop resistance to the medications used to achieve viral suppression—when the number of actively replicating HIV cells drops below 200 copies per milliliter of blood. In addition to these primary risks, patients whose HIV is not virally suppressed, or undetectable, can pass along the virus to others. In contrast, those whose viral load is undetectable are unable to do so.

In addition to the carve-out for HIV medications, ADAP Advocacy made the following recommendations:

1. CMS should implement a standardized Market Fair Price calculation methodology that replaces the methodology outlined in section 60.3 that is clear, transparent, and made available to manufacturers at the time the Market Fair Price is determined and when the initial offer is made to manufacturers;
2. CMS should revise its definition of “selected drug” as set forth in section 30.1 to ensure limit the inclusion of multiple formulations and strengths of medications to ensure that price determinations and negotiations are made in good faith;
3. CMS should undertake an immediate patient engagement campaign prior to the implementation of the proposed guidance for the Negotiation Program to ensure that Medicare beneficiaries have a clear understanding of how the Program will directly impact them and to allow patients to provide meaningful feedback and opinions to help guide the program to better patient-centered outcomes; and
4. CMS should exclude any cost-effectiveness calculations that utilize biased and discriminatory metrics, including Quality-Adjusted Life Years and similar measures of medical intervention efficacy.

A precedent already exists for protecting vulnerable populations from the unintended consequences of changes to the healthcare ecosystem, as evidenced by Medicare’s six protected classes (6PC). In Medicare Part D, 6PC protects vulnerable seniors and low-income beneficiaries with severe and complex health conditions, while also allowing Part D insurance plans to utilize the necessary tools 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 (Johnson, 2019).

Photo Source: VAROS

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."

These recommendations represent the bare minimum of changes that should be made to the Negotiation Program. ADAP Advocacy asks advocacy organizations to add their names to the circulating sign-on letter, as it continues to work with legislative and administrative officials to ensure that patient voices are heard and their access to life-saving treatments is sustained.

[1] Dawson, L., Kates, J., Roberts, T., Cubanski, J., Neuman, T., & Damico, A. (2023, May 27). Medicare and People with HIV. KFF: HIV/AIDS. https://www.kff.org/hivaids/issue-brief/medicare-and-people-with-hiv/

[2] Hammon, J. (2024, August 19). Price controls – bad policy, big problems. Washington, DC: Paragon Health Institute. https://paragoninstitute.org/paragon-prognosis/price-controls-bad-policy-big-problems/

[3] Inflation Reduction Act of 2022, Pub. L. No. 117-169, 136 Stat. 1818 (2022). https://www.congress.gov/117/plaws/publ169/PLAW-117publ169.pdf

[4] 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 

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.     

OPINION: The 340B Program Isn't Broken—It Was Built to Exclude Us

By: Ryan Alvey, Founder & Executive Director of the Positive Change Movement, and ADAP Advocacy 340B Patient Advisory Committee Member

I grew up gay in rural Kentucky—bullied, shamed, and told I had to pray the “sissy” away. At 17, I joined the military, thinking it would make me a man. It didn’t. What followed were years of trying to survive—through addiction, toxic relationships, and the adult film industry. Systems designed to help people struggling with life often fall short for someone like me.

In 2020, I was diagnosed with HIV. I thought it would break me. But instead, it sparked something in me—a drive to help others, to create something better, to make sure no one else felt the isolation I did. I pursued certifications. I trained. I showed up ready to lead. I believed that my lived experience was not a barrier, but an asset.

When I tried to step into leadership, the door was slammed shut. Local HIV service organizations in Kentucky weren’t interested in patients speaking up for themselves, especially not those of us living openly with HIV, eager to speak.

Fast-forward to 2025, when the ADAP Advocacy Association took a chance on me and offered me a seat on their 340B Patient Advisory Committee. I spent months digging into the 340B Drug Pricing Program, created over 30 years ago to help poor patients access lifesaving care. What I found instead was a program rife with exploitation, where profits are protected, and patients like me are left out.

So, I launched Fiscal Watchdog, a project to track the money and shed light on what these nonprofit giants would rather keep hidden. What I’ve discovered so far is infuriating. Multi-million-dollar hospital CEOs, while clinics serving marginalized people close their doors. 340B discounts meant for patients are instead generating surplus revenue, and very little is reinvested in community care. Tax-exempt organizations spend more on real estate and branding than on direct services, claiming to “empower” us. And across the board, People Living with HIV are excluded from boards, executive roles, and decision-making tables.

These organizations claim to serve us, but their filings and financial statements suggest otherwise.

Photo Source: 340B Map

This isn’t just about one organization. This is about an entire system that pretends to serve while quietly excluding. Hospitals and mega-service providers are helping patients, yes, but not to the extent that they could be helping us, because money is being spent on executive pay increases, questionable capital improvements, and sometimes, even funding ballot initiatives. How do any of these things help patients like me? I’ve seen it firsthand: people with lived experience—those in recovery, those living with HIV, those who've survived the streets—are pushed to the margins, tokenized when convenient, and discarded when they speak up.

These systems weren’t designed to empower us. They were built to contain us. However, participating in the 340B Patient Advisory Committee has allowed me to speak up and demand change. Pharmaceutical manufacturers aren’t perfect, but their calls for greater accountability and transparency seem reasonable to me, and that’s why it is time to remove any barrier that prohibits patients from seeing what is really going on.

Across Kentucky and beyond, gatekeeping in HIV services is rampant. Organizations claim to value equity, but their leadership is overwhelmingly white, cisgender, and disconnected from the communities they serve. Funding is allocated in ways that prioritize status quo institutions, rather than grassroots solutions. And when people like me speak up, we’re labeled "difficult" or "unprofessional," simply for demanding what’s right.

I’m sharing my story because I'm not the only one. Countless others—brilliant, resilient people—are kept out of leadership positions, denied jobs, or dismissed by systems meant to support us. Patients like me deserve to be at the table on issues like the 340B Program.

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.    

Fireside Chat Retreat in Minneapolis, MN Tackles Inflation Reduction Act's Adverse Impact on Patient Care

By: Brandon M. Macsata, CEO, ADAP Advocacy & Ranier Simons, ADAP Blog Guest Contributor

ADAP Advocacy hosted its Health Fireside Chat retreat in Minneapolis, Minnesota, among key stakeholder groups to discuss the adverse impact on patient care being caused by the Inflation Reduction Act (IRA). The Health Fireside Chat was held from Thursday, June 12th, to Saturday, June 14th. An analysis of the IRA's drug price controls—including its pill penalty provisions, challenges community pharmacies are facing, more restrictive drug formularies increasing, non-medical switching, and patients absorbing greater costs due to shifts from co-pays to co-insurance—were all evaluated and discussed by the 24 diverse stakeholders.

Photo Source: Getty Images

The IRA discussion was 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:

• Meg Beaven, Senior Director, Rational 360
• Ninya Bostic,  National Policy & Advocacy Director, Johnson & Johnson
• Grant Cale, Senior Director, Alliance Development Lead, U.S. Policy and Government Affairs, Bristol Myers Squibb
• Tori Cooper, Director of Community Engagement, Human Rights Campaign
• Jeffery S. Crowley, Director of the Center for HIV and Infectious Disease Policy at the O’Neill Institute
• Olivier Viel, Associate Director, Policy and Government Affairs, Merck
• Jazlyn Gallego, Policy and Advocacy Manager, Cancer Support Community
• Max Grechko, Associate Director, Strategic Alliances and Issue Advocacy, Novartis
• Rick Guasco, Editor-in-Chief, Positively Aware
• Connie Jorstad, Director of Government Relations, ViiV Healthcare
• Patrick Ingram, Implementation Project Manager, Midwest AETC
• Kristy Kibler, CEO, Lupus Colorado
• Amanda Kornegay, Owner, Kornegay Consulting, LLC
• Jen Laws, President & CEO, Community Access National Network
• Darnell Lewis, Paramedic Crew Chief & Patient Advocate
• Brandon M. Mascata, CEO, ADAP Advocacy
• Heidi Mesik, Senior Director, PhRMA
• Michiel Peters, Head of Advocacy Initiatives, Global Coalition on Aging
• Kalvin Pugh, Director of State Policy, 340B, Community Access National Network
• Ranier Simons, Consultant, ADAP Advocacy
• Jason Sterne, Director, Policy Advocacy and Alliances, Gilead
• Scott Suckow, Senior Consultant, Perry Communications Group
• Matt Toresco, CEO, Archo Advocacy
• Monique Whitney, Executive Director, Pharmacists United for Truth and Transparency

To level set and provide background for discussions, attendees are sent suggested readings in advance. The following are just a few from the thorough list provided for this session:

• The Inflation Reduction Act (IRA): Impact on Medication Pricing, Spending, Affordability, and Access – Analysis by Pioneer Institute
• Independent Pharmacies Reluctant to Stock Drugs in Medicare Negotiation Program, New Survey Shows – Survey by the National Community Pharmacy Association
• Executive Summary: Impact of the IRA on Patient Access & Discovery of Small Molecule Drugs – Report by the Global Coalition on Aging
• CMS Draft Guidance Creates Regulatory Vacuum in 340B Drug Pricing – Blog by Travis Manint, Community Access National Network
• How the IRA's Part B Coinsurance Inflation Adjustments Can Raise Seniors' Drug Costs – Analysis by Dr. Adam Fein, Drug Channels Institute

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

The overarching theme of the discussions was how varying aspects of issues, directly or indirectly related to the IRA, can affect patients and their access to medical care. Drug pricing was a significant thread throughout the gathering. Participants expressed a consensus that the pricing of pharmaceuticals is a complex system involving many players, with patients often being stuck in the middle or positioned at the bottom. High prescription drug expenditures are partially the result of multiple bad actors making profits at the expense of the masses who need drugs for their care. The discussion largely mirrored the conclusions reached by Kenneth E. Thorpe in his June 2024 piece in Health Affairs, "Penny Wise And Pound Foolish: IRA Impact On Chronic Disease Costs In Medicare."

In-depth dialogue occurred surrounding the IRA's effects on independent, community pharmacies. These pharmacies, in particular, routinely operate within thin margins or sometimes at a loss. Due to issues such as under-reimbursement, many pharmacies are already closing. The IRA’s Maximum Fair Price (MFP) key provision for Medicare drug price negotiation has the potential to harm pharmacies further. The MFP could negatively impact pharmacies by lowering reimbursement rates, further causing financial strain. Discourse revealed that many independent pharmacies are quietly already stating they will not be stocking many of the medications subject to the MFP because they cannot afford to. Independent pharmacies are the lifeblood of communities where larger pharmacies are not present. Closing due to financial strain would rob citizens of auxiliary services and preventative care services, in addition to drug access.

Photo Source: National Community Pharmacy Association

The conflict involving pharmacy benefit managers (PBMs) and their pharmacies was also discussed. There has been an uptick in state legislation aimed at preventing PBMs from owning and operating pharmacies in the states where they do business. Vertical integration is a problem as it allows pharmacy steering and predatory independent pharmacy contracting. When PBMs own and operate pharmacies, they manipulate pricing to their advantage, steering patients to their networks at higher costs. They also offer independent pharmacies less favorable contracts, lower reimbursements, and higher fees, among other disadvantages. Attendees gleaned from the discourse that vertical integration is considered self-dealing, which is a form of fraud. It is not ethical for a health plan to own a pharmacy, just as it is not ethical for a PBM to own one.

Moreover, under the IRA, if pharmacies choose not to participate in the MFP under the Medicare Drug Price Negotiation program, they are, in essence, excluded from participating in Medicare Part D for the drugs in question. Independent pharmacies are not in favor of the new IRA mechanism because their cash flow would be split between reimbursement from CMS and refunds from drug manufacturers to make up the difference. Pharmacies would have to suffer delays in cash flow waiting to be made whole, with the possibility of not being made whole at all. The conversation specifically acknowledged that CMS is acting as a payer without any understanding of care delivery for multiple disease states.

During the period spent discussing strategy and solutions, the underlying focus was on messaging. The concern was how to effectively convey the right message to the public and into the marketplace. Some attendees suggested that the pharmaceutical industry should be more proactive in generating opposition to the current administration. It was acknowledged that “big pharma” has taken steps, especially through extending relationships with advocacy groups. However, there remains a notion that the pharmaceutical industry needs to embrace the concept that “dead people do not buy medications.” This means that they should embrace concerted efforts to protect patients and patient access, not just from a position of altruism but as a sensible business strategy. The reality is, as Dr. Adam J. Fein of the Drug Channels Institute has pointed out, "a growing number of Part B drugs now have inflation-adjusted coinsurance rates that are rising, not falling...[and] in many cases, the rate dips temporarily before snapping back to the standard 20%." It begs the question: Are patients paying more?

Photo Source: Drug Channels Institute

Discussions of messaging also zeroed in on patient perception. The issues surrounding the IRA and its various aspects are complex, even for those well-versed in the issue. Attendees emphasized the importance of engaging patients by creating messaging that is simple yet resonates with their humanity in ways they understand. The price is being conflated with out-of-pocket costs, and messaging needs to highlight how the IRA can increase out-of-pocket costs for patients.

The Cancer Support Community (CSC) has developed patient-centered principles to help guide its advocacy work, which is available online. These patient-centered principles are also included in CSC's sign-on letter on the EPIC Act, to which ADAP Advocacy also signed.

With so many of the IRA's targeted drug price controls falling on chronic health conditions and rare diseases, such as cancer and HIV, they have the potential to fuel already exacerbated health disparities among medically underserved communities. The sole focus on "price" largely ignores the money saved by treating these conditions with life-altering and life-saving therapeutics. Sadly, proponents of these anti-patient drug price controls—including several groups financed by Arnold Ventures' special interests efforts pushing harmful state drug affordability boards, or PDABs—leverage potentially harmful metrics. Among them is the dehumanizing quality-adjusted life years (QALYs). 

Suggestions included campaign-style messaging that utilizes both traditional and non-traditional media to educate patients by making the message more personal. Presenting the public with stories that explain how specific policies directly affect aspects of their daily lives is a way to empower patients and transform the patient community into a voting bloc. Populist patient-centered messaging and actions promote community building to engage policymakers as well as empower citizens. 

Going forward, discussions also emphasized the importance of finding ways to navigate within the confines of the challenging current administration, as its operations are adversarial, unpredictable, and unprecedented. The consensus indicated that an effective way to do this is to make “new friends.” This means engaging with untapped entities, such as labor unions, insurance commissions, Ryan White service providers, and disability groups. Many entities that potentially could be drastically affected by the IRA and other issues are unaware of their risk of adverse outcomes. Forging new avenues of communication with groups like these is a way to create infrastructure that can effect change.

Woven throughout the day's policy analysis was recognition that patient advocacy groups need to push back harder against the fallacy that their advocacy efforts aren't genuine simply because they accept financial support from drug manufacturers. Ongoing attempts to discredit patient advocacy by faux news outlets, such as the 340B Report, ignore the realities that patients and drug manufacturers often have shared interests, and that the financial support provided by industry acknowledges those values. It is also disingenuous to have patients living with chronic health conditions and rare diseases be faulted by paternalistic critics who aren't patients themselves.

ADAP Advocacy would like to publicly acknowledge and thank Jen Laws, Heidi Mesik, Michiel Peters, Jazlyn Gallego, and Matt Toresco for co-facilitating this critically important discussion.

Additional Fireside Chats are planned for 2025 in Atlanta (September).

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.

New Study Yields Insights to Women Living with HIV/AIDS, and Viral Suppression

By: Ranier Simons, ADAP Blog Guest Contributor

The goal of HIV antiretroviral therapy (ART) is viral suppression. Viral suppression is reducing the level of HIV in the blood to an undetectable status. Viral suppression is achieved through strict adherence to antiretroviral therapy (ART) regimens in their various forms. Insufficient adherence can result in increased viral loads or even virological drug resistance. As advances in ART continue, it is essential to determine the level of adherence considered sufficient for viral suppression. In a perfect world, all people living with HIV/AIDS would have 100 percent adherence to treatment regimens, meaning that they never missed a dose. That is not realistic. Thus, consensus in medical science views 95% as a high level of adherence. Even 95% adherence is not achievable for many people living with HIV/AIDS (PLWHA). Because data show that viral suppression can be achieved with adherence of less than 95% using newer medications, scientists are investigating the levels of adherence required for this outcome. A recent Canadian study examined viral suppression and treatment adherence among women, taking into account the unique characteristics of many women’s lived experiences (Mokaddam et al., 2025).

Photo Source: HIVinfo | NIH

Presently, ART is lifelong. Thus, effective treatment requires consistent and ongoing adherence. Women living with HIV/AIDS (WLWHA) have unique social, biological, and other categories of lived experience that result in unique challenges to ART adherence (Ogden et al., 2004). Canadian researchers performed a longitudinal study of WLWHA because 2020 data showed women lagged behind men concerning the Joint United Nations Programme on HIV/AIDS target for HIV care. The target is 95-95-95, meaning 95% of all PLWHA should be aware of their status, 95% of those diagnosed should be on effective therapy, and 95% of those on ART should have viral suppression (Mokaddam et al., 2025). PLWHA Data from 2020 shows men at target levels of 90%–87%–96% and women at 88%–85%–90% (Mokaddam et al., 2025). 

The Canadian study utilized data from the Canadian HIV Women's Sexual and Reproductive Health Cohort Study (CHIWOS), a community-based, prospective cohort study. The CHIWOS study was conducted in three waves from 2013 to 2018. The recent Canadian study executed a longitudinal analysis of self-reported survey data, including socioeconomic data, health history including HIV and ART, substance abuse, and even history of violence and abuse (Mokaddam et al., 2025). The researchers specifically included subjects only if they reported utilizing a regimen consisting of an antiretroviral backbone with a third agent. The ‘backbone’ consists of two nucleoside reverse transcriptase inhibitors (NRTIs). The backbone is then combined with a third medication chosen from several classes, including non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), or integrase strand transfer inhibitors (INSTIs) (HIV.Gov, n.d.). The researchers made this distinction as a standard for inclusion to rule out other forms of ART that may be prescribed due to previous drug resistance or other drug interactions and conditions to lower the possibility of confounding factors affecting adherence.

Photo Source: HIV.gov

The cross-sectional analysis of the third wave of participants revealed that overall, 95.5% reported viral suppression, and 76.2% of participants had an ART adherence level of ≥ 95% (Mokaddam et al., 2025). Of those reporting ≥95% adherence, 97% of those achieved viral suppression. Other levels of reported adherence were associated with different viral suppression percentages. Respondents who reported 85-89% adherence had a viral suppression of 78.6%, those with 75-79% adherence had a viral suppression of 75%, and those with less than 65% reported a viral suppression of 76.5% (Mokaddam et al., 2025). Those reporting 90-94% adherence to ART had a viral suppression level of 97.2%, similar to that of those with ≥95% adherence. There were no differences in the odds of participants reporting viral suppression across the various medications used as a third agent to the ART backbone. Approximately 27.2% were on a first-generation INSTI, 34.0% on a second-generation INSTI, 22.9% on a NNRTI, and 15.9% were on a PI (Mokaddam et al., 2025). 

This Canadian study suggests that the odds of achieving viral suppression with adherence rates of 90% or less are significantly lower than those with adherence rates of 95% or higher. Several studies have indicated that viral suppression can be achieved with adherence levels of 75% to 80%. Interestingly, the study observed an increase in the utilization of INSTIs as a third agent, specifically dolutegravir, over the course of the waves between 2013 and 2018 (Mokaddam et al., 2025). The use of dolutegravir increased the odds of virologic suppression (VS) across varying levels of adherence.

WLWHA have unique issues to deal with that affect their ability to maintain treatment adherence. Medication access, living situations, women-specific health conditions, and many other factors influence the ability to engage in care. It is imperative to continue exploring the impact of their lived experience on their ability to maintain adherence, coupled with the development of ART that is more forgiving in terms of the levels of adherence required to maintain viral suppression. This data is vital for women as well as PLWHA as a whole.

[1] Mokaddam, M., Kronfli, N., Sheehan, N. L., Reyes, A. G., Dubuc, D., Loutfy, M., Kaida, A., & De Pokomandy, A. (2025). Antiretroviral therapy use, self‐reported adherence, and viral suppression among women living with HIV in Canada. HIV Medicine. https://doi.org/10.1111/hiv.70034. Retrieved from https://onlinelibrary.wiley.com/doi/10.1111/hiv.70034

[2] NIH Office of AIDS Research (HIV.Gov). (n.d.). HIV/AIDS Glossary: Backbone. Retrieved from https://clinicalinfo.hiv.gov/en/glossary/backbone

[3] Ogden, L., Ogden, J., Mthembu, P., & Williamson, N. (2004). Impact of HIV on women internationally. Emerging infectious diseases, 10(11), 2032–2033. https://doi.org/10.3201/eid1011.040624_01. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC3329028/

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.   

ViiV's Positive Perspectives Research Provides Insights to Patient-Provider Relationships

By: Ranier Simons, ADAP Blog Guest Contributor

The doctor-patient relationship is the cornerstone of healthcare. Patients cannot fully benefit from the many advances in medical science without a solid relationship with their provider, where they feel listened to and cared for. The relationship has been defined as “a consensual relationship in which the patient knowingly seeks the physician’s assistance and in which the physician knowingly accepts the person as a patient” (Chipedza et al., 2015). Mutual trust and vulnerability are required, especially regarding people who are living with HIV/AIDS (PLWHA). ViiV Healthcare recently released data from the third wave of its Positive Perspectives Research study (PP3), which examines the lived experiences of PLWHA globally. This wave of inquiry is heavily focused on improving health outcomes by digging into the interactions between PLWHA and their healthcare providers.

Photo Source: GoodTherapy

The current wave, PP3, will eventually include 3,000 participants. The newly released data is a result of the first 698 participants representing 16 countries, including the United States, United Kingdom, and Canada (Lutton, 2025). Eventually, it will cover 29 countries. Wave One surveyed 1,111 PLWHA and 250 of their partners, covering nine countries. Wave 2 involved 2,389 PLWHA covering 25 countries (ViiV, Press Release 2025). All the waves investigate various themes surrounding the lived experiences of PLWHA. PP3 aims to further define and raise the voices of PLWHA to improve healthcare outcomes by informing healthcare providers and other stakeholders of the realities of how PLWHA navigate their care and day-to-day lives.

Early PP3 data suggest an overarching theme of communication issues between PLWHA and their healthcare providers. The early findings indicate that there are strong levels of trust in PLWHA’s patient-provider relationships. Approximately 80% of those currently surveyed reported trusting their healthcare provider. (Lutton, 2025). However, while the trust is solid, there are reported weaknesses in areas such as patients' practical understanding of information and their inclusion in care decisions.

Photo Source: Doctor Patient Relationship

Although a high level of trust has been reported, 47.5% of PLWHA surveyed feel that their healthcare providers do not effectively listen to them, and 39.7% reported that they were not included in the choice of their antiretroviral regimen (ART) (ViiV, 2025). Successful HIV health outcomes are holistic, involving more than just a focus on viral suppression. Patients need to be able to fully express their values, preferences, and individual life circumstances to their healthcare providers. Empathy is associated with patient satisfaction and treatment adherence (James, 2023). When healthcare professionals truly listen, they can better understand how their patients interact with life, which is often vastly different from their own lives and familiar ways of thinking.

Part of ART selection is based on patients’ specific virological needs. However, there are nuances of selection that are influenced by patient preference when patients are fully informed of all their options. The preliminary study results indicated that 53% of patients were worried about long-term effects of ART (ViiV Press Release, 2025). ART comes in many different combinations of drugs with the potential for short-term and long-term side effects. Approximately 53% of respondents had ART-related weight gain as a side effect concern. It is essential for healthcare professionals to engage in transparent discussions about the aspects of different drug combinations, empowering patients to make informed decisions rather than leaving them to accept the physical manifestations of regimens that are unilaterally imposed upon them. Patients’ ability to be consistent with their regimen is also a consideration in education about all modalities, such as long-acting injectables. Approximately 43.2% of the current respondent group stated a disdain for daily medication because it was a daily reminder of their HIV status (ViiV Press Release, 2025). When patients feel fully included in their care, they are more likely to adhere to their medication schedule.

Photo Source: Patient Voices

A notable early revelation of the study is that the concept of undetectable equals untransmittable, or “U=U”, is not fully embraced or understood. Medical science has proven that PLWHA cannot transmit the HIV virus when they have reached and maintained an undetectable viral load. However, only 58% of respondents truly believed it. Approximately 93.7% knew U=U, but low uptake of it as a belief system means that many PLWHA are not empowered to fully live their lives without the guilt and stigma of embracing their relationships and sexual expression. Moreover, only 31.1% of patients were able to explain the concept of U=U to other people (ViiV Press Release, 2025). It is essential for healthcare providers to thoroughly educate PLWHA on the science behind U=U, enabling them to advocate for themselves and combat stigma within their social networks.

Wave three of the Patient Perspectives study is only partially complete. The goal of 3,000 participants will yield a more comprehensive picture of the patient-doctor relationship, providing healthcare professionals with an informed understanding of its strengths and weaknesses. Understanding what is being done well in comparison to areas needing improvement will enable providers to make effective changes to the status quo. Health literacy is influenced by socioeconomic status, age, racial and ethnic factors, and educational levels (Dawson-Rose et al., 2016). Once fully completed, PP3 will inform healthcare providers on how to facilitate improvements in patients’ health literacy, as well as bolster care professionals’ ability to step outside their own spheres of understanding into an empathetic place of true patient communication.

[1] Chipidza, F. E., Wallwork, R. S., & Stern, T. A. (2015). Impact of the Doctor-Patient Relationship. The primary care companion for CNS disorders, 17(5), 10.4088/PCC.15f01840. https://doi.org/10.4088/PCC.15f01840

[2] Dawson-Rose, C., Cuca, Y. P., Webel, A. R., Solís Báez, S. S., Holzemer, W. L., Rivero-Méndez, M., Eller, L. S., Reid, P., Johnson, M. O., Kemppainen, J., Reyes, D., Nokes, K., Nicholas, P. K., Matshediso, E., Mogobe, K. D., Sabone, M. B., Ntsayagae, E. I., Shaibu, S., Corless, I. B., … Lindgren, T. (2016). Building Trust and relationships between patients and providers: An essential complement to health literacy in HIV care. Journal of the Association of Nurses in AIDS Care, 27(5), 574–584. https://doi.org/10.1016/j.jana.2016.03.001

[3] James, T. (2023, January 12). Building Empathy into the Stucture of Health Care. Retrieved from https://postgraduateeducation.hms.harvard.edu/trends-medicine/building-empathy-structure-health-care#:~:text=Studies%20demonstrate%20how%20empathy%20improves,they%20feel%20heard%20and%20understood.

[4] ViiV Healthcare. (May 2025). Positive Perspectives Research. Retrieved from https://viivhealthcare.com/hiv-community-engagement/positive-perspectives-research/#:~:text=Wave%203%20survey

[5] ViiV Press Release. (2025, May 27). ViiV Healthcare Positive Perspectives 3 Study Finds Widespread Communication Barriers: Half of People Living with HIV Feel Unheard by Healthcare Providers Despite High Trust. Retrieved from https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/may/positive-perspectives-survey/

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.   

Closing the Book on Maryland's HIV Criminalization Law

By: Ranier Simons, ADAP Blog Guest Contributor

Science and equity slowly continue to push policy forward. On May 21, 2025, Maryland became the fifth state to decriminalize HIV. In February 2025, Maryland Senate Bill 356 and House Bill 39 passed in their respective chambers. On May 21, Governor Wes Moore signed the legislation into law with the official name, ‘The Carlton R. Smith Act’. Carlton R. Smith was an activist, long-term HIV survivor, and advocate championing Baltimore LGBTA and HIV services (Bishop, 2024; Medina, 2024). He passed away in May 2024, and as an active proponent of this legislation, it was fitting to name it after him. The effective date of the legislation is October 1, 2025. 

Photo Source: CHLP

The act repeals the previous law, which consisted of two concise sections: 

• (a) An individual who has the human immunodeficiency virus may not knowingly transfer or attempt to transfer the human immunodeficiency virus to another individual. 
• (b) A person who violates the provisions of this section is guilty of a misdemeanor and, on conviction, is subject to a fine not exceeding $2,500 or imprisonment not exceeding 3 years or both.

HIV criminalization means criminalizing living with HIV by criminalizing behavior that is not commonly criminalized when a person is HIV-negative. It also means adding enhanced punitive actions for a crime to those living with HIV convicted of a crime, more than the punishment if HIV was not involved (CHLP, 2025 May). The Maryland legislation was inherently problematic because it did not specify the means of transmission, did not require actual, verified transmission of the virus, and did not require any proof of intent. It merely needed someone to ‘knowingly’ expose another person to HIV (Cisneros et al., 2024). Additionally, it carved out HIV from general health statutes surrounding the spreading of other communicable diseases, adding a misdemeanor, monetary fine, and a maximum three-year imprisonment term (Cisneros et al., 2024).

The repealed Maryland statute was discriminatory regarding HIV status and race. From 2020-2022, enforcement of HIV criminalization laws was heavily concentrated in predominantly Black counties: 32% of the state's cases were in Baltimore City, 19% in Montgomery County, and 18% in Prince George’s County (Cisneros et al., 2024). Additionally, Black Marylanders were only 30% of the state's population and 71% of PLWHA, but they accounted for 82% of all HIV-related cases (Cisneros et al., 2024).

The Maryland statute ignored scientific evidence, which shows that a person with an undetectable viral load cannot transmit the virus. It also did not give any weight to a person living with HIV who disclosed their status or received consent from the other party (Cisneros et al., 2024). Thus, the latitude of defining actions as ‘knowledgeable exposure’ was predatorily wide.

Photo Source: The 19th

According to the Center for HIV Law and Policy (CHLP), in the United States, 32 states currently have HIV-specific criminalization laws, and 28 have HIV-related criminal penalty enhancements (CHLP, 2025 February). Additionally, some states have general statute criminal laws that allow HIV to be prosecuted in terms of assault with a deadly weapon or reckless endangerment. These laws are fundamentally not evidence-based because HIV cannot be transmitted through spitting, biting, fighting, or throwing bodily fluids. Outdated laws contribute to the stigma and reinforce opinions that contradict current medical science. 

In March of this year, North Dakota also got rid of its HIV criminalization laws. Before repeal, N.D. Cent. Code § 12.1-20-17 stated that PLWHA could be prosecuted for having sex if they did not disclose their status, even if the activity was low risk or posed no risk at all, such as with oral sex. The penalties for conviction were up to 20 years in prison and a Class A felony conviction. Additionally, people who shared syringes or needles without proper sterilization could have been prosecuted even without intent to transmit or any verified actual infection, as well as qualify for the same maximum 20-year imprisonment penalty and felony classification.

HIV criminalization laws do not benefit or improve public health or safety. In fact, HIV criminalization laws make people fearful of getting tested, seeking care, or even disclosing when undetectable and in treatment. It is imperative to continue to educate legislators as well as the public. It is unacceptable to allow these laws to keep PLWHA tangled in the justice system unduly, demoralize their existence, and continue to marginalize and disenfranchise racial and sexual minoritized groups.

[1] Bishop, K. (2024, June 6). Remembering Carlton Smith. Retrieved from https://chasebrexton.org/blog/remembering-carlton-smith

[2] Center For HIV Law and Policy (CHLP). (2025, February). Mapping HIV Criminalization Laws in the U.S., CHLP (2025). Retrieved from https://www.hivlawandpolicy.org/maps#:~:text=In%20the%20United%20States%2C%2032,knowledge%20of%20their%20HIV%20status.

[3] Center For HIV Law and Policy (CHLP). (2025, May 20). Maryland Repeals HIV Criminalization Law. Retrieved from https://hivlawandpolicy.org/news/maryland-repeals-hiv-criminalization-law

[4] Cisneros, N., Tentindo, W., Sears, B., Macklin, M., Bendana, D. (2024, January). Enforcement of HIV Criminalization in Maryland. Retrieved from https://williamsinstitute.law.ucla.edu/wp-content/uploads/HIV-Criminalization-MD-Jan-2024.pdf

[5] Medina, J. (2024, June 24). The Life and Work of Carlton Smith. Retrieved from https://www.freestate-justice.org/the-life-and-work-of-carlton-smith

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.