Intersection between Substance Use Disorder & HIV

By: Ranier Simons, ADAP Blog Guest Contributor

Drug use and drug abuse intersect many aspects of the health journey of substance users and those with substance use disorders. This includes HIV. The complex intersection of HIV and drug use affects HIV acquisition, treatment, and spread. To create solutions with the goal of better health outcomes for those dealing with HIV and substance abuse issues, it is necessary to research and understand how drug use affects the HIV trajectory. It is equally important to understand the barriers in place that hinder effective outreach and care.

Photo Source: Recovery Research Institute

Past and present research indicates a higher level of drug use and drug abuse in the population of those living with HIV than to those who are not infected.[1] The drugs include alcohol, crack cocaine, methamphetamines, prescription opioids, and heroin.[2] There is a distinction between drug use and drug abuse. Drug use is more episodic, whereas drug abuse or substance use disorder is consistent and chronic. Regardless of the level of use or addiction, drug use results in suboptimal HIV outcomes.

Substance abuse affects the entire continuum of the HIV care cycle, starting with acquiring infection. Drug use and abuse have been shown to increase the odds of engaging in risky behaviors that lead to infection.[2,3,4] Research shows that being under the influence lowers inhibitions, can result in a higher prevalence of multiple sex partners, and poor judgment resulting in unprotected sex.[2,4] Moreover, injectable drug usage can be a direct path to infection when needle sharing is involved.

A good deal of research has been focused on HIV in MSM (men who have sex with men), given that the rate of HIV infection is higher in this group than in the general population. It is observed that the usage of amyl nitrites, methamphetamine, and club drugs is higher in this group as well.[4] Thus, it is imperative to target this group to curb the transmission of HIV within. Intervention would also benefit the general population since there are MSM who have sex with women. 

Recreational or episodic drug use can lead to substance disorders or drug abuse. HIV-positive people dealing with substance disorders have additional challenges. One substance abuse group research has focused on is injection drug abusers. Injectable drug users tend to inject opiates, like heroin, alone or in combination with other drugs, even stimulants such as cocaine.[4] Not only are injectable drug users at a higher risk of contracting and spreading HIV, but they are also more likely to contract other infections.

Photo Source: CDC

Regardless of the drug, drug use and abuse exacerbate poor HIV outcomes because it causes additional damage to the body. The drugs are taxing on organs such as the liver, heart, and kidneys. Illicit drug use has also been shown to suppress the immune system.[6] Having a decreased immune response is detrimental to drug users living with HIV. This can lead to a faster progression to adverse HIV outcomes, especially for HIV-positive addicts not on antiretroviral therapy.

Treatment adherence is another intersection of HIV and drug abuse. Research shows that substance abusers on ART have lower treatment adherence. A study from 2007 showed that drug use resulted in a fourfold greater risk of medication adherence failure.[5] Drug use affects cognitive functioning and psychosocial conditioning. Drug addiction makes it difficult to focus on the importance of consistent and timely taking of medication, especially when multiple pills and times are involved. Poor medication adherence can result in subpar treatment response or complete drug resistance.

To improve the outcomes of HIV-positive people with substance abuse issues, it is paramount to remove the stigma of drug use. It should be treated just as any other chronic medical condition. Encouraging a cultural change to remove stigma would result in treating substance abusers with dignity, which could result in self-motivated behavior modification. Stigma against drug abusers sometimes results in medical professionals not dealing with the addiction with compassion and prohibiting infected individuals from seeking consistent care. Stigma also creates policy that hinders people from getting the help they need.

Photo Source: Wellthy

Anecdotal and evidence-based research shows that it is best to reach drug-addicted HIV-positive individuals where they are in their journey. They should be treated without the expectation of stopping drug use. Ongoing drug use is not a contraindication for antiretroviral therapy.[3] Educating drug users to understand they can still be on ART while still being on drugs could increase adherence. Reducing stigma could also affect policy change. For example, many politicians are against needle exchange programs. However, needle exchange programs are places that drug-addicted people living with HIV are more likely to visit regularly. They are places where additional services can be provided, including treatment. Handing out clean needles, cookers, and pipes would lower the risk of transmission while also creating a space to meet other needs.

Navigating the intersection of HIV and drug use starts by acknowledging they do not exist in separate vacuums. Drug treatment programs should include HIV testing, and HIV treatment should involve screening for substance abuse.

[1] Shiau, S., Arpadi, S. M., Yin, M. T., & Martins, S. S. (2017). Patterns of drug use and HIV infection among adults in a nationally representative sample. Addictive behaviors, 68, 39–44. https://doi.org/10.1016/j.addbeh.2017.01.015

[2] CDC. (2021, April). HIV and substance abuse. Retrieved from https://www.cdc.gov/hiv/basics/hiv-transmission/substance-use.html

[3] HIV.GOV. (2021, June 3) Considerations for antiretroviral use in special patient populations. Retrieved from https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/substance-use-disorders-and-hiv

[4] Strathdee, S., Patterson, T. (2006) Behavioral interventions for HIV-Positive and HCV-Positive drug users. AIDS and Behavior, 10(2), 115-130

[5] Hinkin, C. et al. (2007) Drug use and medication adherence among HIV-1 infected individuals. AIDS and Behavior, 11(2), 185-194

[6] Nnorom-Dike, O., Ekwebelem, O., Ofielu, E., Attah, M., Ekwe, D. (2020, December 9). Long term immunologic consequences of illicit drug abuse. Retrieved from https://www.heraldopenaccess.us/openaccess/long-term-immunologic-consequences-of-illicit-drug-abuse

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.  

Intersection between Intimate Partner Violence & HIV

By: Ranier Simons, ADAP Blog Guest Contributor

As with any chronic disease, quality of life and effective disease management requires consideration of the whole person, not just the disease. Regarding HIV, many different social determinants of health affect treatment, outcomes, and disease acquisition. The social, cultural, and physical environment of people living with HIV can be a crucial positive or negative factor. A recent study investigates the intersection of domestic violence and HIV. The Lancet published a retrospective study in December 2022 exploring the relationship between intimate partner violence (IPV) and women’s acquisition of HIV and experiences in the HIV treatment and care cascade (Stillman, 2023).

Photo Source: Fighter Law

Globally, more than one in four women experience IPV in their lifetime (McGill University, 2023). IPV is a subset of domestic violence and is not limited to physical abuse. Its forms include sexual, psychological, and even economic abuse. IPV is defined as violence that happens between people in an ongoing or former intimate or romantic relationship (Cerulli, 2022). Men experience it as well. Nearly one in ten men has experienced it in their lifetime. The Lancet study focuses on women in Sub-Saharan Africa, the regions of Africa south of the Sahara. This includes West Africa, East Africa, Central Africa, and Southern Africa (Wikipedia, 2022).

The study is a retrospective pooled analysis of cross-sectional surveys encompassing 280,259 women across 30 countries administered between January 1, 2000, and December 31, 2020. Ages ranged from 15-64 years old, and all the women were currently or formerly married or cohabitating. Sub-Saharan Africa was chosen because, in global comparison, the region has a very high prevalence of IPV and HIV (Cerulli, 2022). For the purposes of the study, IPV was limited to physical and sexual abuse. The study estimated the effects of past-year physical, sexual IPV, or a combination of both. Four outcomes were the focus of the study: recent HIV infection, HIV testing in the past year, antiretroviral regimen adherence, and viral load suppression (Kuchukhidze, 2022).

Photo Source: Loma Linda University 

Overall, 21.2% of the women self-reported having experienced physical or sexual IPV in the past year, and 29.1% had experienced it at some point in their lifetime. Self-reporting of HIV testing was very similar between the groups of women who did and did not experience past-year physical or sexual IPV, and more than a quarter of both groups had been tested in the past year. 

Regarding the women in the study who are living with HIV, there were differences in antiretroviral adherence. The ones who reported past-year physical or sexual IPV had lower uptake of ART (64.2%) than those who did not report any past-year IPV (71.3%) (Kuchukhidze, 2022).Those who had experienced physical or sexual IPV had missed 2-3 times as many pills in the past month as those who had not experienced past-year IPV. Additionally, women on antiretroviral therapy who had experienced past-year physical or sexual IPV were 5% less likely to be virally suppressed than those who had not. Regarding infection, women who had experienced physical or sexual IPV in the past year were 3.22 times as likely to acquire a recent HIV infection as those who had not experienced it in the past year (Kuchukhidze, 2022).

The mechanisms by which IPV can affect HIV acquisition are layered. One major pathway is infection through sexual violence, and another is the culture of the men who are abusers. Many may have multiple concurrent sexual partners coupled with a lack of condom use which would increase HIV transmission if they live with HIV. Knowledge of HIV status is an essential initial factor in reducing the adverse effects of IPV on HIV. Another barrier caused by IPV is antiretroviral adherence. Some women may fear being tested, dreading the possible reactions from their abusers if the test is positive. Treatment adherence is negatively impacted due to women not disclosing their status out of fear of abuse from their partners, making it hard to get them into consistent care.

Photo Source: Harvard Health Publishing

The study highlights the need for more research into the effects of IPV on HIV and systemic change to help the women involved. The researchers suggest that healthcare providers need to be trained on how to have patients safely disclose their instances of living with IPV. Additionally, there need to be innovative ways to safely deliver consistent antiretroviral and HIV care to those living with HIV in IPV situations. Creating patient-focused safe service delivery platforms, such as safe medication pick-up points, are policies to be considered (Kuchukhidze, 2022).

The Lancet study is further confirmation that there are many levels of barriers to overcome in the fight against HIV. Networks that span locally to globally are necessary to manipulate the mesh of life factors that complicate the transmission and treatment of HIV.

[1] Stillman, A. (2023, January 9). The link between HIV and domestic violence. Retrieved from https://news.yahoo.com/between-hiv-domestic-violence-213422389.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr

[2] McGill University. (2023, January 6). Women experiencing intimate partner violence three times more likely to contract HIV

[3] University of Rochester, Cerulli, C. (2022, March 23). What is intimate partner violence? It’s not just physical abuse. Retrieved from https://www.rochester.edu/newscenter/what-is-intimate-partner-violence-domestic-violence-516342/

[4] Sub-Saharan Africa. (2023, January 9). In Wikipedia. https://en.wikipedia.org/wiki/Sub-Saharan_Africa

[5] Kuchukhidze, S. et al. (2022, December 01). The effects of intimate partner violence on women's risk of HIV acquisition and engagement in the HIV treatment and care cascade: a pooled analysis of nationally representative surveys in sub-Saharan Africa. Lancet.Retrieved from https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00305-8/fulltext DOI:https://doi.org/10.1016/S2352-3018(22)00305-8

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.  

FDA Approves Promising New Injectable

By: Ranier Simons, ADAP Blog Guest Contributor

A new year is upon us, full of potential for progress in the fight against HIV/AIDS. The battle includes creating policy, improving the social determinants of healthcare inequality, and advancing medical science. A recent announcement by the U.S. Food & Drug Administration (FDA) presents itself as promising medical science news. On December 22, 2022, a new injectable antiretroviral called Sunlenca (lenacapavir) was approved by the FDA (FDA, 2022). The drug's manufacturer, Gilead Sciences, states Sunlenca will help people living with HIV/AIDS (PLWHA) who have limited options for successful antiretroviral treatment due to drug resistance, intolerance, safety considerations, or other issues (FDA, 2022). 

Photo Source: The Associated Press

Sunlenca is not a stand-alone treatment option like some current one-pill drug cocktails or other recent combination injectables. It is meant to be used in combination with other drugs. Sunlenca is part of a new class of medicines called capsid inhibitors. The capsid is a protein shell that protects the virus’ genetic material and enzymes needed for replication (HIV.gov). For a virus to infect a cell, it has to pass its genetic information that codes its replication into another cell. The capsid protects that information from being destroyed by enzymes as it passes from the virus into the target cell, as well as helps it to attach and penetrate the target cell’s membrane (FSU, 2015). Capsid inhibitors block the capsid's creation, thus inhibiting the vehicle necessary for infection.

One novel aspect of Sunlenca is that the injection occurs every six months. There is a “loading phase” of the treatment, consisting of tablet regimen by mouth and injections (Hassanein, 2022). Afterward, its maintenance phase requires injections just every six months. According to the U.S Centers for Disease Control & Prevention (CDC), about 44% of those in HIV treatment have not achieved viral suppression (CDC, 2022). This treatment would be especially beneficial for older patients who are treatment resistant due to being diagnosed much earlier in the HIV/AIDS epidemic when treatment regimens were complicated and challenging to adhere to (Hassanein, 2022).

Photo Source: The Associated Press

Additionally, those with barriers to care such as transportation issues, homelessness, or home stigma, would greatly benefit from a twice-yearly injection option (Hassanein, 2022). Another critical aspect of the treatment is that it is a subcutaneous injection in contrast to other injectable therapies that are intramuscular. The difference in administration could mean a better quality of life for those using injectables and possibly make it available for home use instead of requiring a clinic visit.

The expense of Sunlenca is a potential treatment barrier for many who may need it. It costs $42,250 to start the therapy and $39,000 annually for the maintenance shots. As discussed in the December 1, 2022, ADAP Blog, injectable treatments such as Cabenuva have already highlighted the dire need for policy and insurance formulary change that needs to occur to make injectable therapies equally accessible to all (Simons, 2022). It is likely these costs will decline as additional injectables are introduced to the market, as was witnessed with therapies for Hepatitis C (HCV).  

The novelty of capsid inhibitors like Sunlenca, in addition to its cost, adds to the challenge of getting it to those that genuinely need it. Sunlenca being approved by the FDA represents an important step in the fight to end the HIV/AIDS epidemic in the United States. Patient advocates will likely contribute to the national dialogue on Sunlenca, in hopes of seeing its promise grow unencumbered.

[1] 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

[2] HIV.Gov. HIV/AIDS Glossary: Capsid Inhibitors. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-drug-adults-limited-treatment-options

[3] Florida State University. (2015). Virus Structure. Retrieved from https://micro.magnet.fsu.edu/cells/virus.html

[4] Hassanein, N. (2022, December 30). A new HIV treatment shot is given only twice a year. It could be a 'game changer.' Retrieved from https://www.freep.com/story/news/health/2022/12/30/hiv-injection-treatment-lenacapavir-approved-fda/10959568002/

[5] CDC. (2022). HIV Prevention in the United States: Mobilizing to End the Epidemic. Retrieved from https://www.cdc.gov/hiv/pdf/policies/cdc-hiv-prevention-bluebook.pdf

[6] Simons, R. (2022, December 1). Advocacy Needed to Reduce Barriers to Accessing Long-Acting Agent Therapies. Retrieved from https://adapadvocacyassociation.blogspot.com/2022/12/advocacy-needed-to-reduce-barriers-to.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.  

HIV/AIDS Patient Advocacy: 2023 Insights

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

The New Year is here! Our patient advocacy work is likely to be influenced by numerous mitigating factors that fall completely outside of our control, most of which will make meaningful public health policy changes unlikely. A narrowly divided, partisan federal government, an indictment of a former president (pick a crime), an increase in anti-science rhetoric fueled by right-wing media and Internet-fueled conspiracies, and the ongoing economic uncertainty will all muddy the legislative agenda. But that is no reason to remain idle.

Photo Source: FreePik.com

The Covid-19 pandemic isn't over, especially here in the United States. According to the Kaiser Family Foundation, as of December 22, 2022, over 400 people in this country are still perishing daily to this virus. Aside from the human toll of the cumulative effect of the infections, hospitalizations, and deaths, Covid-19 has upended public health in so many ways. Its impact on our own HIV community cannot be overstated, as we outlined last year. Covid-19 also further exposed the significant gaps that remain in our HIV care delivery system. It has also defined the shape of the broader public health advocacy over the last three years.

Lest we forget there are still nefarious forces at play trying to undermine our drug supply chain with counterfeit medicines, evidenced by numerous high-profile cases involving fake HIV medicines. With our partners, we will continue to advise patients on how to spot fake HIV medicines. It is imperative that patient advocates resist ongoing attempts to reshape the national dialogue on drug pricing with faux policies, such as drug importation. The reality is drug importation won't lower the cost of prescription drugs for patients, but it could very well weaken the world's safest drug supply system. Look no further than the drug importation plans in Florida and Colorado. 

Our focus will also remain on improving access to care and treatment, expanding it as much as possible while fending off threats to the Ryan White HIV/AIDS Program (RWHAP). We fully anticipate another attempt by mega service providers and special interests to push for raiding RWHAP funding for PrEP-related rebates under the 340B Drug Pricing Program. Robbing Peter to pay Paul is never the solution, because the result is restricting access. We stand firm with people living with HIV/AIDS.

Long-acting agents for HIV therapy (LAAs) represents probably the single greatest opportunity to expand access, reduce community viral load, and further the U=U Gospel ("undetectable equals untransmittable"). The recent news by the U.S. Food & Drug Administration (FDA) to approve a new HIV drug for adults with limited treatment options is big news! It builds on the momentum already established with new LAAs, such as Cabenuva and Trogarzo. 

As the chaos continues to unfold in our nation's capitol, it is imperative for patient advocates to be armed with the resources and tools to influence public policy on HIV/AIDS. Our organization is eager to engage our community to meet any challenge head-on.

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.

Guest Blog Contributor - A Year of Enlightenment

By: Ranier Simons, ADAP Blog Guest Contributor

This is my last blog post of 2022. It is hard to believe that a year has already passed. It does not feel like I have been a guest blog contributor for an entire year. When I was blessed with the opportunity to contribute, I was unsure of what to expect. As every writer knows, the end product is always the result of creating something from nothing. In the case of this blog, the ‘something’ is not some fanciful creative writing artistic endeavor. The ‘something’ is meant to educate, reveal, inspire action, promote, support, highlight, battle misinformation and in some cases disinformation. Writing for this blog is acceptance of the responsibility to make sure every blog is properly researched, has a purposeful message, and most importantly respects and does not waste the time of those who take the time to read it. 

Photo Source: JerryJenkins.com

I have a master’s degree in healthcare innovation, many years of science and medical education and research experience, firsthand experience as a healthcare worker, life experience as a caregiver, and I am currently a clinical operations healthcare data analyst. However, those things are not why I felt equipped to write for this blog. I felt confident to effectively contribute because I knew I was willing to dig into the jargon-filled weeds of medical journals and other scientific periodicals, scour digital sites of evidence-based discourse, and seek insight from experts in order to distill information into a format easily accessible to all. Communication goes both ways. Real communication happens when information is delivered and the recipients truly comprehend and digest what is given. Medical discourse regarding HIV/AIDS and other related healthcare issues is vast. This makes distillation very important.

My path has crossed with many people living with HIV/AIDS, some of whom have passed due to HIV/AIDS. I have been very close to a good number of them and tangentially exposed to others. Even though I have a high level of exposure to the HIV/AIDS landscape, I was not fully aware of all of the layers before this year of contributing to his blog. I learned about a few HIV/AIDS concepts and related disease etiologies of which I was not previously aware. Researching some of the posts resulted in my discovery of resources I didn’t know about. Most importantly, writing for this blog revealed to me the vastness of the global network of people working towards the eradication of HIV/AIDS on many different levels.

Photo Source: African Constituency

The most important thing I’ve gleaned as a guest blog contributor is how far we have left to go in the fight against HIV/AIDS. Because medical science has advanced to the point of treating it like a chronic disease, on the surface it seems as if the general public doesn’t view it with the same sense of urgency or danger as in the past. However, there is so much more work to be done, so many more people to reach, so many more policies to write and change, so much more research to be done, many more breakthroughs to discover, and multitudes of lives to save.

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. 

Why a Secure Drug Supply Chain Matters

By: Brandon M. Macsata, CEO, ADAP Advocacy Association
       Shabbir Imber Safdar, Executive Director, Partnership for Safe Medicines

Since the start of the AIDS crisis, people living HIV (PLWHA) have looked forward to a day when medicines could allow them to live a life in which their HIV is undetectable and untransmittable (otherwise known as, “UequalsU). Today, PLWHA with access to treatment and adherent to their antiretroviral therapy are expected to live well into their 80’s. There is so much promise in the fight to end the epidemic. 

PLWHA can be confident of the security of those medications from fraudsters because they are protected by the Drug Supply Chain Security Act (DSCSA). This medication protection system, originally created in 2013, completes its rollout next year in 2023. It assigns a number to each package of medicine at time of manufacture, and that number is tracked at every change of ownership from factory to distributor to pharmacist. “Track and trace” is the name associated with this drug supply safety system.

Photo Source: Pharmaceutical Technology

Though criminals never stop trying to defraud patients and pharmacists, we know the DSCSA works because it has been tested. A pharmacist in Texas who checked the serial numbers on “too-cheap-to-be-true” HIV medicine discovered fraud and returned that medicine to the seller without dispensing it to patients. Furthermore, because these kinds of serial numbers allow very fine-grained tracking of medicine in the supply chain, no broad recalls were necessary which might have taken perfectly good medicine off the market and endangered patient access.

DSCSA has protected PLWHA and all patients in the United States, but as with any system, it needs support. There are two key places where the federal government needs to help:

• Charge people who forge DSCSA paperwork with DSCSA fraud

Criminals, such as the recent spate of HIV counterfeit criminals, have yet to be charged with criminal offenses for DSCSA fraud. In fact, to-date there is no record of anyone ever having been charged with DSCSA fraud. To protect patients there must be a deterrent to forging DSCSA paperwork, and to do that, the DOJ must ensure that this crime draws a criminal charge.

There are currently 140 defendants in the existing civil litigation brought by Gilead Sciences and Johnson and Johnson Healthcare Systems against the criminals trafficking in counterfeit and diverted HIV and Hepatitis C (HCV) medications. Not even one has drawn a criminal charge of forging DSCSA paperwork. 

The Biden Administration’s Department of Justice needs to make prosecution of criminals who violate the DSCSA a priority with resources and training.

• Do not undermine the DSCSA for political expediency

For decades it has been in vogue to suggest buying medicine from other countries to make it cheaper. However, countries suggested, like Canada, don’t have a system like DSCSA and we cannot provide this same level of safety assurance to patients and pharmacists. Regulations that intentionally break the DSCSA, like the regulations that govern bulk importation of drugs from Canada that break the DSCSA will endanger HIV, HCV, and many other categories of American patients.

The Administration’s Department of Health & Human Services needs to revoke the rules governing bulk importation until Canada has an interoperable DSCSA system to protect medicine imported.

Ensure broad understanding of DSCSA features for physicians

As the DSCSA finishes its rollout, one part of the dispenser community unlikely to get the message is physicians who administer long-acting HIV injectables. These injectables, which can control HIV with just two shots every month or two months, are an enormous innovation.

However recent history includes a few failures of physicians to understand the dangers of criminals in the supply chain, including:

• Physicians purchasing black market oncology from unlicensed sellers (including Canadian criminals) and administering in their offices it to cancer patients;
• Physicians in thirteen states who purchased black market none-sterile IUDs and implanted them in patients, resulting in horrific medical adverse events; and
• Physicians who purchase black market Botox, and administered them to patients, endangering them.

Unlike pills taken by PLWHA, which can be examined by the pharmacist and patient, injectables administered by physicians don’t necessarily have this protection. Additional steps are needed to ensure patients can participate in medication verification safety. All too often, patients never see touch the injectable, and likely never see the packaging it came in. Physicians, who are not typically trained to check pharmaceutical wholesaler licenses or verify DSCSA safety features, have repeatedly been the targets for criminals. PLWHA need to be empowered to involve themselves more in this process.

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As the DSCSA rollout proceeds, we urge the Biden Administration to resource the U.S. Food & Drug Administration (FDA) so they can prioritize education of physicians about the new security features of the DSCSA and the risks to their patients and their practice if they ignore them.

People living with HIV in the United States have witnessed significant progress in managing their condition. The advent of new medicines has greatly improved their quality of life greatly, and equally the safety of their drug supply has been enhanced by the Drug Supply Chain Security Act. It’s critical that we do everything possible to support it.

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.  

Advocacy Needed to Reduce Barriers to Accessing Long-Acting Agent Therapies

By: Ranier Simons, ADAP Blog Guest Contributor

Medical science continues to advance at a rate that outpaces healthcare policy and subsequently healthcare practices. This is especially true regarding novel lifesaving therapies and modalities for chronic diseases such as HIV/AIDS. Treatment for people living with HIV/AIDS (PLWHA) is expensive, long-term, and requires consistency in its administration to be effective. Moreover, antiretroviral medications and other related compounds are rapidly evolving. There have already been challenges to ensure equal access, for all, for established and widely used therapies. The situation is even more dire for some of the newest treatments available. That is why the ADAP Advocacy Association created its ADAP Injectables Advisory Committee. 

Photo Source: PRC

The advisory committee was a collaboration of patients, as well as representatives from pharmaceutical manufacturers, advocacy groups, healthcare providers, and pharmacy groups. In August 2022, the advisory committee released its report: HIV LONG-ACTING AGENTS: Policy Considerations for Injectable Therapies under the Ryan White HIV/AIDS Program & State AIDS Drug Assistance Programs. It was in response to the need to reduce the operational burdens and other barriers of ensuring that PLWHA dependent upon the State AIDS Drug Assistance Program (ADAP) for their care receive equal access to newly developed injectable treatments in the same manner as people who are fully insured. The report also addressed barriers experienced under private insurance.

Long-acting agents include more than just antiretroviral therapies, such as Cabenuva, which is used to treat HIV. They also include treatments such as Apretude, an injectable used as PrEP, Egrifta used to reduce visceral abdominal fat as a result of lipodystrophy, Serostim for wasting, and Trogarzo which is intravenous therapy for those with multi-drug resistant HIV infections. 

These therapies are proven to be effective. However, not only are they expensive, but they are logistically challenging for supply and administration even for those who are fully insured. The challenge is even greater for those who utilize ADAP. The report described policy considerations to improve equity of care regarding injectables. Those considerations included discussions of how to reduce provider bias in offering injectable therapy as an option, ways to expand the network of facilities where injections and intravenous therapies can be administered for ADAP recipients, and ways to utilize community level resources for peer education and advocacy. 

Photo Source: Regional Center for Infectious Disease Research

A very important section of the report involved insurance. ADAP’s have formularies just in the same manner as insurance plans. Moreover, ADAP can use private insurance for patients for medication and can now assist with paying insurance premiums for low-income patients. The report discussed ways to navigate ADAP versus Medicaid insurance coverage for injectables. There was also policy discussion of how to maintain drug formularies to ensure consistent coverage.

HIV long acting agents are powerful tools in the fight against HIV and those utilizing ADAP deserve the same equity of care and access as those who are fully insured with more robust financial means. Whether it be geographical logistical challenges, treatment education deficiencies, supply chain issues, or even provider bias; ADAP recipients have many injection therapy barriers to overcome. The work of the ADAP Injectables Advisory Committee was to define necessary policy changes as well as guide discussions on how organizations can provide more ADAP recipient patient-centered care. Click here to read the report's cover letter, executive summary, and full report.

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.