AIDS Drug Assistance Program: September 2023

Thursday, September 28, 2023

Tell HIV Stigma: Stay in Your Lane

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

****Important Support Resources Included****

Recently, I posted some commentary on my personal Twitter handle (@Purple_Strategy) noting an observed uptick in HIV stigma in the gay dating world. Gay dating apps are notorious for it. Likely, it isn't limited to the dating space, evidenced by a recent report issued by GLAAD, as well as subsequent commentary in private conversations and social shares highlighting examples of HIV stigma. It is very rare for me to interject my personal life's situations into ADAP Advocacy's daily advocacy and public policy activities, but it is vitally important to combat such stigma whenever possible. Frankly, HIV stigma has no place in my life and thus it needs to stay in its lane.

Tweet: "Lately, I can say from my experience in the gay dating world there is also an uptick in guys uncomfortable dating poz guys. 3:5 last few guys I was talking to all abruptly ended our chatting / dating once I disclosed."

I'm a Taurus; we're pretty confident. I'm Italian; we're tough as nails. You hit me; I hit you ten times harder. But not everyone is like me. These recent dating rejections surrounding my status (undetectable, since 2004) weren't the first experiences with HIV stigma, and I know they won't be the last of them. But I can honestly say that I've taken them with a grain of salt. And now, U=U (undetectable equals untrabnsmittable) and fine work being done by Prevention Access Campaign and U=U plus has changed the national conversation.

BUT! Not everyone is a stubborn bull like me. I've had countless conversations with friends and colleagues, whereby their personal "run-ins" with HIV stigma really hurt them. It hurt their feelings, self-confidence, pride, and dare I even say, their self-worth. It has always bothered me on a very deep level seeing them struggle to cope with the ugliness that is HIV stigma.

Fighting HIV stigma won't come easily. According to GLAAD's 2023 State of HIV Stigma Report, only half of the respondents indicated they're "knowledgable" about HIV. Whereas GenX is considered most "knowledgable" about HIV, still one in four don't fall into that designation. What is most troubling is the trend line is going in the wrong direction on the general publics' comfortability interacting with people living with HIV—especially among certain professionals such as barbers or hair stylists, and teachers. Interacting with co-workers living with HIV is now problematic for 1:3 respondents.

Photo Source: GLAAD, 2023

It is 2023, and we're still dealing with 1993 attitudes (pre-HAART). I truly believe that there is plenty of fight left in all of us. I also believe that we are in this fight together, so I felt compelled to share some helpful resources available to my fellow POZ folks who might be coping with HIV stigma:

(email info@adapadvocacy.org if you wish to recommend a resource be added above)

Life is hard enough without having to confront stigma, simply over sero status. HIV stigma says more about the people dishing it out, and less about defining who you are. We have the tools to keep HIV stigma in its lane. There are over a million of us POZ folks in the United States, so remember that you're not alone and there are resources available!

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.

Thursday, September 21, 2023

340B Hypocrisy: The Inconvenient Truth Behind Why We Need to Reform This Vital Safety Net Program

By: Brandon M. Macsata, CEO, ADAP Advocacy
Jen Laws, President & CEO, Community Access National Network

The 340B Drug Pricing Program (“340B”) is probably one of the most transformative public health programs providing lifesaving supports and services to people living with HIV in the United States, second only to the Ryan White HIV/AIDS Program (“RWHAP”). As such, rigorous debate about the future of the program is not only healthy, but it is also paramount to its success. As patients (and patient advocates), it is our responsibility to demand accountability, transparency, and stability. There is universal agreement about the vital role 340B plays in improving access to healthcare. But for many – including ADAP Advocacy and the Community Access National Network – we contend that the program could be doing more…and better! The focus of the program should be on the patients, and not the Covered Entities, medical or service providers, or any other business enterprises making lots of money off it. That is the inconvenient truth behind why we need to reform this vital safety net program.

Photo Source: CANN

Section 340B of the Public Health Service Act (PHSA) is a Drug Pricing Program established by the Veterans Health Care Act of 1992. That year, Congress struck a deal with pharmaceutical manufacturers to expand access to care and medication for more patients; if pharmaceutical manufacturers wanted to be included in Medicaid’s coverage, then they’d have to offer their products to outpatient entities serving low-income patients at a discount. The idea was brilliantly simple. Drug manufacturers could have a guaranteed income from participation in the Medicaid program and Covered Entities could have guaranteed access to discounted medications. Congress set-up a payment system by way of rebates and discounts affording certain healthcare providers a way to fund much needed care to patients who could not otherwise afford it.

“…to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”

H.R. Rep. No. 102-384(II), at 12 (1992)

THAT is the legislative intent behind 340B. THAT is where some of us want to return 340B’s focus. THAT is why reform is coming!

Ironically, critics of the 340B reform movement – often motivated by self-preservation and protecting their ever-expanding budget and geographic footprint – are quick to attack the idea of the need for reforms. Sadly, they’re also quick to turn their criticism into personal attacks, including questioning the intentions, morals, and character of the people supporting reform. They charge, using Inspector Clouseau “gotcha” style rhetoric, that we’re in the “pockets” of the drug manufacturers because we accept their money to help with our patient advocacy and education (yet there is no “gotcha”, since this information is quite publicly available on our websites, annual tax returns, Guidestar, as well as frequent public commentary).

Isn’t it funny how the “gotcha” mentality cannot accept the obvious, that maybe our interests align with the drug manufacturers because it is in the best interest of the patients. Drug manufacturers make products patients want and need. Ensuring funding flows in a way that expands patient access to medications does indeed benefit both patients and the drug manufacturers. It should be noted, this criticism tends to also neglect mentioning the interests of the entities challenging reform: anti-competitive consolidation among hospitals and pharmacies (leaving whole areas without services), increasing profits, paying for salaries unrelated to healthcare, and increasing administrative salaries are all excellent examples of why we’re left asking “Who is actually benefiting from this program?”

The truth of the matter is, aside from a growing list of patients, patient advocacy organizations, and drug manufacturers, there is a growing chorus calling for reform. Academia wants it (NEJM, Penn LDI, USC Schaeffer), economists want it (Nikpay, Gracia), national trade associations want it (NACHC, NTU), policy think tanks want it (CMPI, NAN), and even multiple news media outlets are suggesting it (Forbes, NYT, WSJ). Local activists are also increasingly fed-up with what they’re witnessing (Dinkins, Feldman, Winstead).

Dr. Diane Nugent, Founder & Medical Director of the Center for Inherited Blood Disorders, recently noted an opinion piece in the Times of San Diego, “A September 2022 analysis by the Community Oncology Alliance revealed that some hospitals participating in 340B price leading oncology medications nearly five times more than the price they paid. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions.”

But speaking of deep pockets, isn’t it also an inconvenient truth that the very folks fighting reform, and fighting improving the program so patients can benefit more directly from it, are the same folks financed by big hospital systems, and mega service providers abusing 340B intent?

A question often asked by advocates learning about 340B: “So, exactly how much money are we talking about here?”

Photo Source: Business 2 Community

Well, we don’t really know…sort of. For Federal Grantees covered under 340B, their grant contracts require accounting of 340B rebates as part of their programmatic revenues. Those revenues are required to be re-invested in the program, which generated the income. This level of transparency is pretty much a “gold standard” that other Covered Entities (less maybe hemophiliac centers) in the 340B space are required to meet. That’s part of why we, and other advocates, are calling on minimum reporting requirements for hospitals, contract pharmacies, and pharmacy benefit managers (insurers covering medications) to begin providing some data. Clearing up the murkiness, if you will. What we do know is drug manufacturers reported more than $100 BILLION in 340B-related sales last year.

That’s concerning especially because “charity care” is declining and medical debt is a growing issue for more and more patients and their families. The Affordable Care Act mandated “charity care”, or “financial assistance”, to be offered by non-profit hospitals seeking to qualify as 340B entities but did not place any definitions behind the mandate, including any “floor” of how much charity care a hospital has to offer.

Now, in all rhetoric opposing any type of transparency in 340B, hospitals tend to conflate their “uncompensated care” and “unreimbursed care” or “off-sets” for public health programs – these don’t necessarily reflect any “charity” being provided to patients. These things should be separated when considering what benefit hospitals provide a community. And under that lens, things get kind of ugly with far too many of the 340B hospitals reporting providing less than 1% of their operating costs as charity. When reviewing how much hospitals write off in bad debt, or going after patients who can’t afford care, often far exceeding those charity care levels, we’re left asking if the “non-profit” designation is really a declaration of concentrating “profits” by way of salaries to top executives rather than formal shareholders?

That bad debt shows up for patients as medical debt. And we need to be very specific here: according to the Urban Institute, some 72% of patients with medical debt owe some or all of that debt to hospitals. Meaning, what we call medical debt is really hospital debt. The situation is unarguably bad. This year alone the Los Angeles County Office of Public Health issued a report outlining for policymakers the role and responsibility hospitals have in driving medical debt and how increasing charity care might stem this problem.

Photo Source: Business Insider

As patients, and frankly as patient advocates who represent thousands like us, medical debt isn’t an issue that can be swept under the carpet. Entire communities avoid necessary care to protect their financial interests. We’ve personally watched our friends open GoFundMe accounts to cover medical expenses. We’ve helped our loved one’s cover food and light bills to not miss a medical bill. We also well recognize how negative credit reporting from medical debt can hurt people from getting rental housing or a car loan, or even simple necessities. And when thinking about how much we don’t know about what’s behind that $100 billion price tag, the fact that patients face these concerns on the regular is pretty obscene.

We do know there are plenty of good actors in the 340B space. Particularly, Federal Grantee Covered Entities, like Ryan White Clinics and AIDS Drug Assistance Programs (ADAPs). And we know they’re generally great actors because of that transparency in reporting and the oversight offered by their grant contracts. Ultimately, we’re not necessarily asking for a whole lot more than that for literally everyone else who stands to make a buck in the chain between drug manufacturers and patients. Indeed, that trust on Federal Grantees, particularly Ryan White Clinics and ADAPs, is part of why drug manufacturers restricting 340B sales held a carve out for these Federal Grantees. (To be fair and without much public fanfare, years ago, we – as in ADAP Advocacy and CANN – helped to negotiate these carve-outs as part of our advocacy. Our relationship with drug manufacturers isn’t a one-way street as detractors might try and sell you on.

$100 billion is a lot of money! Is it too much to ask, “Why aren’t patients benefiting more directly from this ever-growing healthcare program?” Facts show that 340B revenues are soaring year after year, yet against the grim backdrop of consistently declining charity care in the impoverished communities needing the most help. To make matters worse, rising medical debt is crushing families. Patients deserve better. People living with HIV who depend on the RWHAP and 340B deserve better! And THAT is why we need reform.

Read our policy reform suggestions here.

Thursday, September 14, 2023

New Study Dissects Efficacy of Lenacapavir

By: Ranier Simons, ADAP Blog Guest Contributor

Lenacapavir, a novel HIV treatment medication, again appears in the medical news cycle. A recent article in Medical Express, ‘FDA approves treatment for multi-drug resistant HIV,’ was published on September 1st.[1] The article title would lead the reader to think the drug was just approved. However, the U.S Food and Drug Administration (FDA) initially approved lenacapavir in December of 2022.[2] Gilead Sciences released the medication under the name Sunlenca. Please view the previous ADAP Advocacy discussion of Sunlenca and its background here. So, what happened?

Photo Source: sunlencahcp.com

The impetus for the recent article is newly reported data regarding lenacapavir’s ongoing clinical trials. The August 2023 issue of The Lancet included the story, 'HIV presents an article where researchers discuss week 52 results of the phase 2/3 trial',[3] which discusses the study's results. But just as important is examining the study’s design.

The ongoing clinical trial of lenacapavir is also known as the Capella study, ClinicalTrials.gov number NCT04150068. There are 72 subjects divided into two cohorts. Previous data had been reported for evaluations performed at 26 weeks. In Cohort 1, 36 subjects were randomly assigned oral lenacapavir or placebo on days 1,2, and 8 in addition to simultaneously continuing their failing antiretroviral therapy for 14 days. On day 15, those in the lenacapavir group began subcutaneous lenacapavir once every six months (26 weeks) in addition to an optimized background therapy. On day 15, the placebo group began oral lenacapavir plus an optimized background therapy for one week, then switched to subcutaneous lenacapavir once every six months.[3]

The primary efficacy endpoint was the percentage of patients that had a decrease in the HIV-1 viral load of at least 0.5log10 copies/ml by day 15. In the lenacapavir group, that endpoint was seen in 88% of the patients while in only 17% of the placebo group.[4] In Cohort 2, 36 subjects were given an optimized background regimen on day 1 along with oral lenacapavir on days 1,2, and 8, switching to subcutaneous lenacapavir once every six months (26 weeks) starting on day 15.

A secondary efficacy endpoint involved viral load. The endpoint was a viral load of less than 50 copies per/ml or a viral load of less than 200 copies per/ml. In cohort 1, at 26 weeks, a viral load of 50 copies per/ml was seen in 81% (29 of 36), and a viral load of less than 200 copies was seen in 89% (32 of 36).[4] In cohort 2, less than 50 copies per/ml was observed in 83% (30 of 36); and less than 200 copies in 86% (31 of 36).[4] The recent report in Lancet: HIV reports data at the 52-week point. At week 52, 83% (30 of 36) subjects in cohort 1 had HIV-1 RNA of less than 50 copies per mL, and 86% (31 of 36 ) had HIV-1 RNA of less than 200 copies per mL.[3] For cohort 2 at 52 weeks, 72% (26 of 36) had less than 50 copies per/ml, and 78% (28 of 36) had less than 200 copies per/ml.

Photo Source: European AIDS Treatment Group

The overall theme is that the results at 52 weeks support the efficacy of lenacapavir injections every six months for those with multi-drug resistance to retrovirals. Consistent viral suppression was met, and therapeutic drug levels were maintained in the blood between injections. Most importantly, since lenacapavir is to be used with other medications, the injections do not increase pill burden or complicate daily regimens.

Although the results are promising, there are reasons to research much further before expanding lenacapavir for other uses, such as prevention. The cohort size was very small, at 72 participants. That is partly due to the requirements of the subjects. The participants had to have documented resistance to at least two drugs from at least three of the four major antiretroviral classes in addition to having advanced HIV disease. Additionally, while the data showed no significant safety issues, people living with HIV are known to have hypersensitivity issues with drug reactions. The CAPELLA clinical trial, along with CALIBRATE, a different lenacapavir clinical trial, together only have a total of 229 subjects.[5]

Much larger cohorts need to be examined in order to have comprehensive cross-sectional data to explore gender, age, and ethnicity differences. The complex variances of combination antiviral regimens of multi-drug resistant patients are also a significant concern. Once further lenacapavir research is conducted, the path of its utilization will be more apparent. It could even possibly become paired with another complete long-acting drug, creating an easy-to-use twice-yearly injection for all patients, whether multi-drug resistant or not.[5]

[1] Rivera, Viviana. (2023, September 1). FDA approves treatment for multi-drug resistant HIV. Retrieved from https://medicalxpress.com/news/2023-09-fda-treatment-multi-drug-resistant-hiv.html

[2] FDA Press Release (2022, December 22). FDA Approves New HIV Drug for Adults with Limited Treatment Options. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-drug-adults-limited-treatment-options

[3] Ogbuagu, O., Segal-Maurer, S., Ratanasuwan, W., Avihingsanon, A., Brinson, C., Workowski, K. A., Antinori, A., Yazdanpanah, Y., Trottier, B., Wang, H., Margot, N., Dvory-Sobol, H., Rhee, M. S., Baeten, J. M., Molina, J., DeJesus, E., Richmond, G., Berhe, M., Ruane, P., . . . Rassool, M. (2023). Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial. The Lancet HIV, 10(8), e497–e505. https://doi.org/10.1016/s2352-3018(23)00113-3

[4] Segal-Maurer, S., DeJesus, E., Stellbrink, H., Castagna, A., Richmond, G., Sinclair, G., Siripassorn, K., Ruane, P., Berhe, M., Wang, H., Margot, N., Dvory-Sobol, H., Hyland, R. H., Brainard, D. M., Rhee, M. S., Baeten, J. M., & Molina, J. (2022). Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. The New England Journal of Medicine, 386(19), 1793–1803. https://doi.org/10.1056/nejmoa2115542

[5] SHarris, M. (2023). Lenacapavir: an attractive option, but proceed with caution. The Lancet HIV, 10(8), e486–e487. https://doi.org/10.1016/s2352-3018(23)00170-4

Thursday, September 7, 2023

Cardiovascular Disease and Living with HIV...and the Benefit of Statins

By: Ranier Simons, ADAP Blog Guest Contributor

The evolution of HIV treatment has turned HIV into a manageable chronic disease. As such, people living with HIV/AIDS (PLWHA) live longer lives with an expectation of lifespans comparable to those without HIV.[1] PLWHA are now more likely to die from ailments other than HIV. One of those ailments is cardiovascular disease. PLWHA have twice the risk of atherosclerotic cardiovascular disease than the general populace.[2,3] Specifically, the higher risks include heart attack, stroke, heart failure, and pulmonary hypertension.[4] Unfortunately, the reasons for the increased risks are not readily understood.

X-ray image of the body with cardiovascular system highlighted in red

Photo Source: AIDSmap

Traditional risk factors for heart disease, such as high blood pressure and smoking, are the same for PLWHA and the general population. However, ongoing research indicates cardiovascular disease risk factors unique to PLWHA, such as the effects of antiretroviral therapy and biological mechanisms of HIV itself, such as chronic inflammation.[4] Lack of a thorough understanding of the increased risk for cardiovascular disease among PLWHA means there is no established way to battle the issue to improve outcomes. Clinical trials are being conducted to investigate means to treat the problem. One such trial conducted is the REPRIEVE trial.

REPRIEVE stands for ‘Randomized Trial to Prevent Vascular Events in HIV.’ The purpose of the phase 3 trial was to investigate the efficacy of statins in reducing the risk of cardiovascular disease in PLWHA. The idea is to use statins as a primary prevention tool for major adverse cardiovascular events (MACE) in HIV. Statin use was chosen as an intervention because research shows statins lower LDL cholesterol, a significant factor in cardiovascular disease. Additionally, statins positively affect vascular inflammation and immune system activation in PLWHA.[3]

The multinational phase 3 randomized REPRIEVE trial, which included the United States, contained 7769 subjects. Assigned to two groups through computer randomization, the subjects received either oral pitavastatin calcium (at a dose of 4 mg per day) or a placebo. Pitavastatin was chosen because it does not interact with antiretroviral medications. The subjects' inclusion criteria included being 40 to 75 years old, living with HIV, on stable antiretroviral therapy, having no previously known cardiovascular disease, and having no history of statin use in the previous 90 days of entering the study. Another important criterion is that all “had a low-to-moderate risk of atherosclerotic cardiovascular disease, as determined by the score on the American Heart Association and American College of Cardiology 2013 Pooled Cohort Equation risk calculator.”[3]

When studies are done, researchers define a primary outcome. The primary outcome is the most essential occurrence to be examined as a result of applying the intervention in question. For the REPRIEVE, the primary outcome was the occurrence of a MACE. The MACE for this study was not just one issue but considered a composite of the existence of many issues: cardiovascular death; myocardial infarction; hospitalization for unstable angina; stroke; transient ischemic attack (TIA); peripheral arterial ischemia; revascularization of a coronary, carotid, or peripheral artery; or death from an undetermined cause, as measured in a time-to-event analysis.[3]

Photo Source: New England Journal of Medicine

In the pitavastatin group, the incidence of MACE was 4.81 per 1000 person-years and 7.32 per 1000-person-years in the placebo group. That equates to a 35% lower MACE incidence in the pitavistatin group.[5] Non-cardiovascular outcomes included muscle and diabetes issues. Myalgia and myopathy occurred in 2.3% of the pitavastatin group and 1.4% of the placebo group. Regarding diabetes, there was a 1.13 incidence rate (5.3%) in the pitavastatin group and a 0.84 incidence rate (4.0%) in the placebo group.[3] This was not surprising since previous research shows that statin use is associated with increased diabetes mellitus as it can increase blood sugar by preventing the body’s proper utilization of insulin.

Additionally, results showed that adverse event rates increased with increasing subgroup risk categories for atherosclerotic cardiovascular disease. However, the number needed to treat (NTT) decreased with rising risk category.[3] This means there is a possible greater benefit of statin use among those who started the study with more baseline cardiovascular risk. NTT is a statistical description indicating how many people need to be treated before a positive outcome is seen. Theoretically, the perfect NTT is 1, meaning that every person treated has a positive outcome. Since the NTT decreased with increasing risk category, more positive outcomes occurred among those with higher levels of diagnosis.

Trials like the REPRIEVE study open the door to investigating the use of other possible statins. Moreover, additional research is imperative since there is currently no established therapeutic or diagnostic paradigm for addressing the increased risk of cardiovascular disease in PLWHA. Without identifying the specific mechanisms contributing to atherosclerotic cardiovascular disease pathology among PLWHA, it is impossible to find or create medical interventions against it.

[1] Hayes, R. (2023, July). Life expectancy for people living with HIV. Retrieved from https://www.aidsmap.com/about-hiv/life-expectancy-people-living-hiv#:~:text=Many%20people%20living%20with%20HIV,adhere%20to%20their%20HIV%20treatment

[2] Boccara, F., Cohen, A. (2016) HIV and heart disease: What cardiologists should know. Revista Espanola De Cardiologia, 69(12), 1126-1130. DOI: 10.1016/j.rec.2016.05.032

[3] Grinspoon, S. K., Fitch, K. V., Zanni, M. V., Fichtenbaum, C. J., Umbleja, T., Aberg, J. A., … Douglas, P. S. (2023). Pitavastatin to Prevent Cardiovascular Disease in HIV Infection. New England Journal of Medicine, 389(8), 687–699. doi:10.1056/NEJMoa2304146

[4] Feinstein, M. J. (09 2022). HIV, Subclinical Cardiovascular Disease, and Clinical Progression: Insights From Immunologic Heterogeneity. JAMA, 328(10), 931–932. doi:10.1001/jama.2022.15226

[5] Susman, E. (2023, July 24). Statin reduced risk of heart disease in people with HIV. Retrieved from https://www.medpagetoday.com/meetingcoverage/ias/105613

[6] Lerner, A. M., Eisinger, R. W., & Fauci, A. S. (2020). Comorbidities in Persons With HIV: The Lingering Challenge. JAMA, 323(1), 19–20. https://doi.org/10.1001/jama.2019.19775

[7] Mulcahy, L. (2023, July 27). Menopause may start earlier for aging women with HIV. Retrieved from https://www.webmd.com/hiv-aids/news/20230627/menopause-may-start-earlier-aging-women-hiv

AIDS Drug Assistance Program