Long-Acting Injectable Agents Continue to Reshape the HIV Care Continuum

By: Ranier Simons, ADAP Blog Guest Contributor

Long-acting injectable (LAI) agents remain at the forefront of medical innovation, especially regarding HIV treatment and prevention. LAIs are significant because they increase access options for people living with HIV/AIDS (PLWHA) for treatment, opening pathways for sustained viral suppression. LAIs are a solution for PLWHA who experience challenges adhering to daily oral antiretrovirals. Taking pills daily is unduly mentally burdensome as a reminder of living with HIV/AIDS; some patients cannot take daily pills due to stigma and living in an unsafe environment, and many deal with housing instability or travel frequently (New Vision, 2025). Updated study results and other recent developments solidify the efficacy and promise of LAIs as the future of treatment and prevention.

Photo Source: EATG

Cabenuva (cabotegravir plus rilpivirine), approved in January 2021, is the first and only complete long-acting injectable and two-drug regimen available for HIV treatment. Initially, it was approved for monthly injection, then expanded to bi-monthly dosing (Haelle, 2025). However, Cabenuva was developed for PLWHA who have already achieved viral suppression before starting use. Ongoing research has been investigating the efficacy of Cabenuva for PLWHA with detectable viral loads, known as viremia. 

A recent study led by Ricky Hsu, MD, of NYU Langone Medical Center in New York City, indicates Cabenuva would also be effective for widespread use for PLWHA with viremia (Haelle, 2025). The study group consisted of patients selected from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) cohort. OPERA includes over 150,000 PLWHA. Among the eligible subjects who were U.S. residents, eighty-eight percent achieved viral suppression. PLWHA with viremia on oral medication need options to facilitate reaching viral suppression, and the study shows the promise of future widespread indications for LAIs to achieve that goal (Haelle, 2025). 

Moreover, the final results of the CARES study on LAI antiretroviral therapy in Africa, released in March of this year at the Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, further support the efficacy of LAIs. The results were so promising that the World Health Organization (WHO) updated its guidelines to inform that virally suppressed PLWHA on oral medications may switch to Cabenuva because it is equivalent (New Vision, 2025). As future studies confirm the widespread use for PLWHA with viremia, the goal would be for the WHO to add this to its guidelines.

Photo Source: European Pharmaceutical Review

While very effective, Cabenuva must be administered in a medical office setting, as it is given through intramuscular injection. The requirement of travel to a clinic setting is a potential barrier for PLWHA, particularly those with transportation challenges, especially if they do not live near a conveniently located facility. A study led by Eric Meissner, M.D., Ph.D., at the Medical University of South Carolina (MUSC) examined the possibility of LAI injections in a home setting (MUSC, 2025). The project gave thirty-three participants the option to receive injections in a clinic setting or at home. Eighteen chose the home setting.

In the home setting, eighteen PLWHA were visited by licensed practical nurses (LPNs) who gave the injections. Meissner’s group arranged for pharmacies to mail LAIs to patients, along with instructions to store the medication in their refrigerators until LPN arrival. Patients were highly satisfied, indicating that home administration is a plausible way to enhance patient adherence. Home injections would be more challenging on a widespread level, given the logistics necessary to coordinate pharmacy with staffing LPNs to visit homes (MUSC, 2025). Moreover, insurance does not reimburse for the staff coordination of pharmacy and nurse visits. Making home LAI administration commonplace would require innovation of funding infrastructure as well as staffing solutions.

Photo Source: Tu Salud

Cabenuva is a beneficial first step in the widespread use of LAIs for HIV treatment; however, it is not universally appropriate. Some PLWHA cannot use Cabenuva because they have resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs). The rilpivirine component of Cabenuva is an NRRTI (Haelle, 2025). One possible solution is the use of lenacapavir (Sunlenca) in addition to Cabenuva. Sunlenca is a semi-annual LAI used for people on oral antiretroviral treatment who have multiple-drug resistance issues. However, the future of long-acting agents should also include other options, such as those that are oral. One option under study is a weekly dosage of an oral combination of islatravir, a nucleoside reverse transcriptase translocation inhibitor, and lenacapavir (Haelle, 2024).

Eliminating HIV has required and will continue to require multiple tools of treatment. Current utilization of LAIs will lead to the development of new injectables and non-injectable long-acting agents. The variety of available therapies needs to keep up with the increasing variance in the characteristics of PLWHA in need of treatment. Continued research and funding innovation will be necessary to ensure the rapid growth of LAIs, and other non-injectable long-acting agents continues.

[1] Haelle, T. (2024, March 11). Once-Weekly ART Showed Similar Efficacy for HIV as Daily ART. Retrieved from https://www.medpagetoday.com/meetingcoverage/croi/109111

[2] Haelle, T. (2025, August 4). The Future of ART Regimens for HIV Is in Long-Acting Agents. Retrieved from https://www.msn.com/en-us/health/other/the-future-of-art-regimens-for-hiv-is-in-long-acting-agents/ar-AA1JTX8S?ocid=socialshare

[3] New Vision. (2025, August 6). Long-acting injectable HIV treatment as effective as daily oral pill — study. Retrieved from https://www.msn.com/en-xl/news/other/long-acting-injectable-hiv-treatment-as-effective-as-daily-oral-pill-study/ar-AA1K4slS?ocid=socialshare

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.    

Facing HIV Health Disparities in Latino Communities

By: Ranier Simons, ADAP Blog Guest Contributor

While overall HIV rates in the United States have been in decline, HIV is still a present and impactful issue. This is especially true for communities that experience a higher impact of HIV-related health disparities. One of these groups is the Latino community. The Latino community is second to the Black community about bearing the HIV burden. Several challenges converge in maintaining HIV’s disproportionate impact on the Latino community, including racism, stigma, language barriers, and access. In recently reported data for 2022 by the Centers for Disease Control & Prevention (CDC) the Latino community was about 18 percent of the U.S. population, but represented 33 percent of new HIV diagnoses.[1]

Photo Source: Baton Rouge AIDS Society

According to PlusInc, which addresses health disparities in the United States, HIV disproportionately impacts Black and Hispanic/Latino Americans (according to 2019 data). PlusInc’s HIV health disparities statement notes:

"While Black and Hispanic/Latino make up just 13.4% and 18.5% of the U.S. population, respectively, Black Americans account for 40.3% and Hispanic/Latino Americans account for 24.7% of the total population of Persons Living with HIV/AIDS (PLWHA). Additionally, this disparity extends to the incidence, with 42% of new HIV diagnoses occurring in Black Americans and 27.8% in Hispanic/Latino Americans. According to the Centers for Disease Control and Prevention (CDC), 26% of new HIV diagnoses were among Black gay and bisexual Men who have Sex with Men (MSM), 23% were among Hispanic/Latino gay and bisexual MSM, and 45% among gay and bisexual MSM under the age of 35."

Access is a significant issue contributing to HIV challenges among Latinos. Latinos are the most underinsured/uninsured ethnic group in the United States.[2] Approximately 19 percent did not have health insurance in 2023, in contrast to 5.8 percent of White Americans and 8.6 percent of Black Americans.[3] Lack of health insurance means reduced access to HIV treatment and prevention, reduced or lack of primary healthcare services, or comorbidity management. Only 84 percent of the Latino community is aware of their HIV status, compared to 87 percent of the general population.[4] Of Latinos living with HIV who know their status, in 2021, only 72 percent received some kind of HIV care, 54 percent consistently remained in care, and only 64 percent were virally suppressed.[5]

Many Latinos are underinsured or uninsured due to financial barriers, language barriers, occupation, and even immigration status. In 2022, One-third of Latinos without health insurance were undocumented, and 37.7 percent were dependent upon Medicaid.[6] Some Latinos struggle to understand the healthcare system, and others do not seek out healthcare due to fear of deportation because of their immigration status. In states where they may be eligible for Medicaid, some Latinos in the process of acquiring citizenship are hesitant to apply out of fear of being deemed a public charge. However, only one-tenth of one percent of deportations result from public charge determinations.[6] Moreover, although ACA Medicaid expansion enables more adults to be covered, ten states have not expanded Medicaid, including Texas, Florida, and Georgia, which have large numbers of uninsured Latino residents.[6]

Photo Source: Axios

Two specific HIV care access challenges affecting the Latino community are PrEP and long-acting injectables. In 2021, Latinos represented 17 percent of PrEP users and 27 percent of new HIV diagnoses.[7] While PrEP could drastically improve outcomes, access barriers are high. Additionally, many Latinos living with HIV could greatly benefit from long-acting injectable treatments, such as Cabenuva, which would ameliorate adherence issues. However, it is expensive, and thus, paying for it out of pocket is impossible. Moreover, getting it covered in public assistance programs is also a challenge.

There are states, such as Texas, that do not carry Cabenuva on their drug formulary under the AIDS Drug Assistance Program (ADAP). Steven Vargas, Texas HIV advocate and long-term survivor, argues, “What I really want is for our Texas ADAP to be brought to its full potential in easing the burden of HIV on Texans.” 

Vargas offers some novel ideas to help Latinos in need, as well as all Texans access Cabenuva. One way would be for Texas to expand Medicaid since Cabenuva is covered by Medicaid. Another option would be to utilize state ADAP funds to purchase insurance for those in need. Unfortunately, presently, in Texas, that is not possible due to exaggerated concerns about costs and solvency. A policy proposal Vargas suggested involves the federal agency, Health Resources & Services Administration (HRSA). He suggests that the agency “...create a policy clarification mandating non-Medicaid expansion states to use ADAP funds to purchase health insurance for HIV-positive individuals. This would ensure more equitable access to healthcare and align with efforts to end the HIV epidemic in these intransigent states. Without such measures, the current inequities will persist, and achieving the goal of ending the HIV epidemic will remain out of reach.”

Stigma is another barrier from a policy, healthcare, and cultural perspective. Vargas points out, “Stigma is an overarching and deeply entrenched challenge significantly hindering Hispanic/Latino engagement in HIV services. Local efforts to increase community awareness and knowledge about HIV prevention and treatment are not prioritized and buried beneath the weight of stigmatizing edicts from our Governor and Texas Legislature.” A 2022 study shows that 11 percent of Latinos living with HIV reported encountering discrimination in a healthcare setting at least three times in a 12-month period.[5]

Photo Source: The Hill

Cultural stigmas and norms are also high barriers to improved HIV outcomes as well. Latino men who have sex with men accounted for the highest number of new HIV diagnoses in 2022. There is a sizeable Catholic influence in Latino culture. Thus, discussing sex and sexual health is not a widely socially acceptable norm, especially if one is gay. There is also the existence of marianismo and machismo. Marianismo is the idea that women should be subservient to men even in sexual encounters, including not wearing a condom if that is what the man desires. Machismo is the ideal that men should be masculine, dominant, and virile.[8] Social pressures and stigma cause many to be fearful of seeking out care and live secretly with their status if, they are positive. This could result in increased transmission by allowing social norms to influence decision-making when it comes to sexual health and partner selection.

Reducing the impact of HIV in the Latino community will require interventions from both policy and community perspectives. The Latino community is not monolithic. Thus, there is a need for stigma intervention that explicitly targets different groups, such as youth groups, church groups, and parent groups. One such national campaign is Celebro Mi Salud (I Celebrate My Health).[9] It is designed to normalize HIV and encourage people living with HIV to seek out care and stay in care. Policy interventions would include means to strengthen collaboration between communities and local governments. There needs to be more culturally competent and bi-lingual healthcare providers as well as those involved with helping Latinos in need navigate the challenges of poverty, food insecurity, homelessness, and immigration.

There is no single simple solution. Addressing the impact of HIV requires making people whole. A holistic approach means helping Latinos in need navigate the challenges of poverty, food insecurity, homelessness, and immigration, as well as healthcare. Providing stability with the basic needs of life facilitates making personal health a priority instead of an afterthought.

[1] CDC. (2024, May). Estimated HIV incidence and prevalence in the United States, 2018–2022. HIV Surveillance Supplemental Report 2024;29(No. 1). Retrieved from https://www.cdc.gov/hiv-data/nhss/estimated-hiv-incidence-and-prevalence.html

[2] Guilamo-Ramos, V., Thimm-Kaiser, M., Benzekri, A., Chacón, G., López, O. R., Scaccabarrozzi, L., & Rios, E. (2020). The Invisible U.S. Hispanic/Latino HIV Crisis: Addressing Gaps in the National Response. American journal of public health, 110(1), 27–31. https://doi.org/10.2105/AJPH.2019.305309

[3] Vankar, P. (2024, July 10). Percentage of people in the U.S. without health insurance by ethnicity 2010-2023. Retrieved from https://www.statista.com/statistics/200970/percentage-of-americans-without-health-insurance-by-race-ethnicity/#:~:text=Percentage%20of%20people%20in%20the,insurance%20by%20ethnicity%202010%2D2023&text=In%202023%2C%20approximately%20nineteen%20percent,national%20average%20was%209.1%20percent.

[4] Helmer, J. (2024, June 2). HIV/AIDS in Hispanic and Latino Populations. Retrieved from https://www.webmd.com/hiv-aids/hiv-aids-hispanic-latino-populations

[5] The Body. (2024, April 30). How HIV Impacts Latinos in the U.S. Retrieved from https://www.thebody.com/health/hiv-aids-latinx

[6] Smith, C. (2024, April 22). Hispanics make up nearly half the nation's uninsured. Retrieved from https://www.governing.com/health/hispanics-make-up-nearly-half-the-nations-uninsured

[7] AIDSVU. (2022, July 29). AIDSVu Releases New Data Showing Significant Inequities in PrEP Use Among Black and Hispanic Americans. Retrieved from https://aidsvu.org/news-updates/prep-use-race-ethnicity-launch-22/

[8] Nuñez, A., González, P., Talavera, G. A., Sanchez-Johnsen, L., Roesch, S. C., Davis, S. M., Arguelles, W., Womack, V. Y., Ostrovsky, N. W., Ojeda, L., Penedo, F. J., & Gallo, L. C. (2016). Machismo, Marianismo, and Negative Cognitive-Emotional Factors: Findings From the Hispanic Community Health Study/Study of Latinos Sociocultural Ancillary Study. Journal of Latina/o psychology, 4(4), 202–217. https://doi.org/10.1037/lat0000050

[9] HIV.GOV. 2022. Celebrao Mi Salud. Retrieved from https://www.hiv.gov/es/respuesta-federal/campanas/celebro-mi-salud

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Evidence Suggest Long-Acting Injectables Game Changer for Adherence

By: Ranier Simons, ADAP Blog Guest Contributor

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

Photo Source: Pharmalive

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

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

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

Photo Source: NIAID

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

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

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

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

Photo Source: HIV.gov

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

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

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

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

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

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

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

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

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

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

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

The State of Long-Acting Injectable Medicaid Coverage

By: Marcus J. Hopkins, ADAP Blog Guest Contributor, and Founder & Executive Director of the Appalachian Learning Initiative (APPLI)

A review of state Medicaid programs has revealed that coverage of recently approved Long-Acting Injectable (LAI) drugs used for the treatment of HIV is mixed, with several key states making access to these drugs difficult for patients. Currently, such products include Cabenuva (cabotegravir; rilpivirine| ViiV Healthcare), Sunlenca (lenacapavir | Gilead Sciences), and Trogarzo (ibalizumab | Theratechnologies).

Cabenuva received full approval from the U.S. Food and Drug Administration (FDA) in 2021 and is used to treat patients who have already proven to be adherent to daily pill regimens and have achieved undetectable viral suppression, meaning that they have fewer than 50 copies of the HIV virus per milliliter of blood. Cabenuva is a series of two injections (200mg cabotegravir; 200mg rilpivirine) administered to patients by a healthcare provider once every month or every other month.

Sunlenca is a salvage therapy—a treatment option utilized in patients who have multi-drug-resistant strains of HIV or who have experienced drug toxicity—that is administered twice a year and used in combination with other antiretroviral drugs.

Trogarzo is also a salvage therapy — a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. The drug is approved, in combination with other antiretrovirals, for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen.

The FDA approval of LAIs presents Persons Living with HIV/AIDS (PLWHA) with one of the most exciting opportunities to ever occur in the HIV treatment landscape: the chance to remain undetectable without having to remember to stop every day to take your HIV medications. Cabenuva is specifically designed for patients who have a proven track record of medication adherence, and the prospect of having to treat your HIV only once every month or every other month is both appealing and revolutionary—a sea change in a treatment landscape that has all too often been beset by horrific, painful, disfiguring, and/or sickening side effects and short medication half-lives that placed patients at risk of developing multi-drug-resistant strains of HIV after missing even a single dose.

LAIs still face several barriers they must overcome before they become the first-line standard of care, including (but not limited to) provider and patient awareness and acceptance of the regimens, payor Prior Authorization limits, and the requirement that the drugs be administered by clinicians rather than by patients, themselves. The latter barrier makes prescribing LAIs in rural and remote areas a difficult proposition, as patients in those regions often face their own barriers to accessing care and treatment, including geographic, transportation, and financial barriers.

The new review of state Medicaid programs in the United States found that 38 states provide coverage for Cabenuva, of which 20 states list it as a Preferred Drug, 7 as a Non-Preferred Drug, and 13 have Prior Authorization requirements restricting access to the drug. 13 states Medicaid Programs—AR, CO, DE, GA, IN, IA, KS, KY, MT, NE, SC, TN, WI—offer either no coverage or list the drug as non-formulary (Figure 1).

Figure 1 – State Medicaid Preferred Drug List Coverage of Cabenuva, July 2023

State Medicaid program coverage of Sunlenca is less robust, which is to be expected given that the drug only received FDA approval in January 2023. 30 states currently offer coverage for Sunlenca, of which 23 states list the drug as a Preferred Drug, 7 as a Non-Preferred Drug. 21 states offer either no coverage or list the drug as Non-Formulary (Figure 2).

Figure 2 – State Medicaid Preferred Drug List Coverage of Sunlenca, July 2023

State Medicaid program coverage of Trogarzo is even less robust. 30 states currently offer coverage for Trogarzo, of which 22 states list the drug as a Preferred Drug and 8 as a Non-Preferred Drug. 21 states offer either no coverage or list the drug as Non-Formulary (Figure 3).

Figure 3 – State Medicaid Preferred Drug List Coverage of Trogarzo, July 2023

Several states have restrictions against prescribing Cabenuva as a treatment regimen, including Delaware, which requires failure with two Preferred Agents before Prior Authorization requests will be approved, and Wisconsin, in which both Cabenuva and Sunlenca are considered “Non-Formulary” (Table 1).

This review of Medicaid PDL coverage was initiated after receiving a report from Positive Health Clinic in Morgantown, WV, that West Virginia’s state Medicaid program was denying virtually all prescriptions for Cabenuva. A Patient Care Navigator reported that West Virginia’s Medicaid program has essentially classified the drug as a salvage therapy through its Prior Authorization requirements.

To date, Positive Health Clinic has had all new prescriptions denied by the state’s Medical Director, even after multiple appeals and conversations with state Medicaid officials. Those appeals included copies of the FDA approval and treatment indication, highlighting that the state has misclassified the drug.

The one exception has been an approval as a result of medication continuation. A patient who moved to West Virginia from Pennsylvania and was already prescribed the regimen. In order to get their prescription approved, Positive Health Clinic had to submit multiple forms of proof that the patient was fit to continue therapy, including:

1. An active prescription for the drug
2. Evidence that the patient was 100% compliant with receiving each dose
3. Proof that the patient would continue to remain compliant.

We reviewed West Virginia’s state Medicaid PDL and Cabenuva Prior Authorization form in order to confirm this report and found the following guidance:

Cabenuva requires review by the Medical Director and is available only on appeal. Medical reasoning beyond convenience or enhanced compliance over preferred agents must be provided.

This approval guidance exists in direct opposition to the FDA’s approval and treatment indication guidance:

CABENUVA, a 2-drug co-packaged product of cabotegravir, a human immunodeficiency virus type-1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

While Prior Authorization requirements for new (and often expensive) therapeutic drugs are not uncommon, the West Virginia Medicaid program’s blanket preemptive denial of a highly effective and proven HIV therapy appears to be an attempt to staunch what they believe will be an influx of prescriptions for an expensive drug. This approach is likely a response to increased efforts on the part of HIV and Harm Reduction advocates to utilize Cabenuva as the go-to therapy in West Virginia’s hard-to-reach, hard-to-treat patient populations.

Since 2018, West Virginia has endured two concurrent, unrelated (according to molecular surveillance), and unabated HIV outbreaks in Cabell and Kanawha Counties. These outbreaks, for which the state has received very limited funds from federal agencies to combat, have occurred primarily in populations of Persons Who Inject Drugs (PWIDs)—populations that are notoriously difficult to reach, treat, and retain in care.

Prior to 2018, West Virginia saw an annual average of just 67 new HIV diagnoses. Beginning in 2018, the state began seeing significant increases in new diagnoses, more than half of which were directly related to Injection Drug Use. This outbreak of new diagnoses among PWIDs was further exacerbated by the state’s increasing hostility toward comprehensive harm reduction measures, specifically Syringe Services Programs (SSPs). Even in 2020, when COVID-19-related shutdowns led to a 2/3 reduction in the number of HIV tests administered in the state of West Virginia, the state identified 135 new HIV infections, of which 108 (80%) were directly related to IDU.

Since 2020, the state has struggled significantly with increasing provider buy-in for proactive HIV testing, leaving the bulk of HIV testing to be done in hospital emergency rooms during overdose events (using an opt-out delivery method that requires informed denial of testing) and by a mere handful of non-profit agencies and the state’s overworked, but extremely dedicated, Director of HIV Care and Prevention. This Director is one of the very few in the United States who regularly goes into communities to conduct testing events. His efforts are, however, hampered by inadequate levels of state and federal funding and increased scrutiny from a state legislature that continues to grow more hostile to HIV testing and prevention efforts.

According to the most recent report, West Virginia identified 140 new cases of HIV in 2022, of which 98 (70%) were directly attributed to IDU. 2023 is likely to be an equally devastating year, with 25 of the 48 cases identified to date (52.1%) being directly related to IDU.

The thinking behind utilizing LAIs as the first-line treatment option in PWIDs is that it has the potential to increase treatment adherence in a population that often faces numerous barriers to care and treatment, including a potential lack of stable housing, a lack of safe places to store daily HIV regimens, a potential inability to remain consistent with treatment regimens.

Prior Authorization requirements for drugs that treat infectious diseases already create arguably unnecessary barriers to treatment for patients. West Virginia’s blanket refusal to cover an FDA-approved and highly effective HIV treatment regimen for patients who are already adherent and virally suppressed serves as an unacceptable and unconscionable barrier to care in a state that is in desperate need of more convenient treatment options.

While Cabenuva, Sunlenca, and Trogarzo are still relatively new drugs, state Medicaid programs should be jumping at the opportunity to decrease treatment abandonment rates and increase easy treatment options for qualifying patients. We hope that more programs will abandon unnecessary restrictions upon this vital tool in the HIV treatment toolkit.

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.

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. 

FDA Extends Cabenuva Approval to Every Two Months

By: Ranier Simons, ADAP Blog Guest Contributor

The primary weapons in the fight against HIV are anti-retroviral drugs, commonly referred to as ARVs. ARVs work by lowering the levels of HIV, known as viral load, in the body to stop HIV’s damage to the immune system. Viral load is measured by the number of copies of HIV RNA in a milliliter of blood.[1] The goal of ARV’s is to decrease the viral load to the point that standard tests cannot detect it. This level of viral suppression is commonly known as ‘undetectable’, and with it comes the important  'undetectable equals untransmissible' (#UequalsU) treatment goal.[2] Moreover, viral suppression means a significant reduction in the damage HIV can do to the body. This fight recently gained a new weapon, with two-month dosing of the injectable HIV therapy, Cabenuva.

Effective treatment means maintaining the levels of the medications in the body. This requires adherence to daily dosing. Not keeping the drugs at appropriate levels in the blood can increase viral load, damage immune cells such as CD4’s, and even drug resistance.[3] Drug resistance means that mutations of HIV could develop that are not responsive to a person's treatment regimen rendering that regimen ineffective and making it harder to find other medications that will work. 

Photo Source: Very Well Health

Early in the fight against HIV, drug regimens consisted of multiple pills several times a day. Toxicity issues, as well as issues keeping dosage schedules, were significant barriers to treatment. Modern-day once-daily one pill regimens were developed to combat both of those issues. However, some patients still experience difficulties with adherence. The most reported adherence challenges are forgetfulness, stigma, health perception, and digestive side effects.[4]

Some patients report having issues remembering to take their medication daily, especially those who have been on long-term therapy. Stigma is a concern by those who do not want family members to know they are living with HIV or to see them take medications. They do not want coworkers to know they are on medication and are psychologically harmed by the daily reminder of their health status. Health perception is an issue for long-term ARV patients because they feel healthy; thus, they become inconsistent with their dosing. Some patients also are inconsistent with their regimens due to perceived and experienced side-effects they experience from the drugs.

The evolution of ARV drug development has led to recent innovations to battle adherence issues. In January 2021, the U.S. Food & Drug Administration (FDA) approved a once-a-month injectable HIV treatment called Cabenuva. It is an extended-release injectable of cabotegravir and rilpivirine. The drug is a collaboration between Janssen Pharmaceuticals of Johnson & Johnson and ViiV Healthcare. Cabenuva is two separate injections into the buttock muscles, with the extended-release rilpivirine having been developed by Janssen and the extended-release cabotegravir from ViiV Healthcare.[5]

Photo Source: The New York Times

Cabenuva is meant for those who are virologically suppressed on a stable regimen and who have no history of treatment failure or known resistance to cabotegravir or rilpivirine. Proper administration requires one month of daily administration of rilpivirine and cabotegravir in pill form to assess tolerance before beginning the monthly injections of Cabenuva. 

Continued research into daily Cabenuva proved that it is effective. Its efficacy has proven to be so positive that on February 1, 2022, the FDA approved it for two-month injectable treatment. Therefore, some patients can be treated with only six sets of injections annually instead of twelve. The extended label approval of Cabenuva from one to two months is based on the ATLAS-2M phase IIIb trial results. An ongoing clinical trial shows that in terms of virologic suppression, every two-month dosing is not inferior to monthly dosing. ATLAS-2M is being conducted in Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden, and the United States.[6]

The most common adverse reactions were fever, injection site reactions, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The type and frequency of experienced adverse reactions were similar in those receiving the injection monthly or every two months. Additionally, the rates of serious adverse events or withdrawal due to adverse events were similar between the two groups.

This new FDA approval has the potential to be life-changing for those where Cabenuva treatment is appropriate. For further information on ATLAS-2M, please see https://clinicaltrials.gov/ct2/show/NCT03299049.

[1] Peabody, R. (2017, May). Viral load. Retrieved from https://www.aidsmap.com/about-hiv/viral-load#:~:text=The%20results%20of%20a%20viral,100%2C000%20would%20be%20considered%20high
[2] NIH. (2020, June 12). 10 Things to know about HIV suppression. Retrieved from https://www.niaid.nih.gov/diseases-conditions/10-things-know-about-hiv-suppression#:~:text=Daily%20antiretroviral%20therapy%20can%20reduce,to%20keep%20the%20virus%20suppressed
[3] Peabody, R. (2019, July). Adherence to HIV treatment. Retrieved from https://www.aidsmap.com/about-hiv/adherence-hiv-treatment
[4] Genberg, B. L., Lee, Y., Rogers, W. H., & Wilson, I. B. (2015). Four types of barriers to adherence of antiretroviral therapy are associated with decreased adherence over time. AIDS and behavior, 19(1), 85–92. https://doi.org/10.1007/s10461-014-0775-2
[5] Janssen Pharmaceuticals. (2022, February 1). U.S. FDA approves CABENUVA (rilpivirine and cabotegravir) for use every two months, expanding the label of the first and only long-acting HIV treatment. Retrieved from https://www.janssen.com/us/sites/www_janssen_com_usa/files/us_fda_approves_cabenuva_rilpivirine_and_cabotegravir_for_use_every_two_months_expanding_the_label_of_the_first_and_only_long_acting_hiv_treatment.pdf
[6] ViiV Healthcare. (2022, February 1). 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. Retrieved from https://viivhealthcare.com/en-us/media-center/news/press-releases/2022/january/viiv-healthcare-announces-us-fda-approval-of-cabenuva/

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

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

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

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

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

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

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

Photo Source: Associated Press

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

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

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

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

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

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

Photo Source: HLTSAD.org

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

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

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

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

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

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

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

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

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

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

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

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

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

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

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

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

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