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.   

Injectable PrEP a Game Changer for HIV Prevention, But is it Accessible?

By: Ranier Simons, ADAP Blog Guest Contributor

Benjamin Franklin is credited with the phrase ‘an ounce of prevention is worth a pound of cure.’ In other words, it is better to prevent something than to deal with the consequences or attempt to fix the damage after the fact. This sentiment can be applied to many aspects of the human condition, including public health, in general, and specifically HIV/AIDS. That is why developments in Pre-Exposure Prophylaxis (PrEP) are so valuable. Recently, researchers reported a new milestone in clinical trials involving the long-acting injectable antiretroviral lenacapavir as an option for PrEP. It could be a game-changer for HIV prevention, if potential patients can access it.

Photo Source: European AIDS Treatment Group

The FDA approved Gilead Science’s lenacapavir, under the brand name Sunlenca, in December 2022 as an HIV treatment for adults with limited treatment options because of things such as multi-drug resistance.[1] Sunlenca is administered as a twice-yearly injection that is given in conjunction with combinations of other HIV antiretrovirals. Gilead has continued developing additional utilizations of lenacapavir, with clinical trials exploring its efficacy as a pre-exposure prophylaxis option. This month, Gilead released interim results from one of those studies that are so promising it will begin to start seeking global regulatory approval towards the end of the year.[2]

The recent successful clinical trial results came from the Phase III PURPOSE 2 study. This study involved 2,180 subjects who were cisgender men, transgender men, transgender women, and gender non-binary individuals who have sex with partners assigned male at birth.[2] The study compared twice-yearly injections of lenacapavir to taking a once-daily Truvada pill. There were only two cases of HIV infection among the 2,180 subjects, meaning 99.9% of those in the lenacapavir arm did not acquire HIV. The comparative arm consisted of 1,087 people who take a daily Truvada pill. That group contained nine subjects who contracted HIV.[3] The study proved that twice-yearly lenacapavir performed better than the current standard form of PrEP in daily Truvada. Compared to Truvada, researchers reported that lenacapavir reduced the likelihood of contracting HIV by 96% as compared to no intervention.[3]

Photo Source: Amfar

These findings support lenacapavir’s effectiveness, as proven by Gilead’s Phase III PURPOSE 1 Study. The PURPOSE 1 clinical trial involved over 5,300 cisgender adolescent girls and young women ages 16-26 in South Africa and Uganda.[4] This trial also compared twice-yearly injected lenacapavir to daily oral Truvada (emitricitabine/ tenofovir disoproxil fumarate) or daily oral Descovy (emitricitabine/tenofovir alafenamide). The efficacy of lenacapavir was 100%, with none of those receiving lenacapavir contracting HIV. Conversely, 16 of the 1,068 women who took Truvada and 39 of the 2,136 women who received Descovy contracted HIV.[4]

Long-acting injectables for PrEP create a prevention option offering more ease of use than daily pills, thus increasing uptake and consistency.[5] Studies have shown that some people have adherence challenges regarding taking daily medication. For some, keeping up with a daily regimen is too psychologically or logistically taxing. For others, like some of the women in countries in Africa, having their medication discovered could pose personal safety issues. Moreover, various access challenges, including transportation, have an affect on successfully utilizing daily treatments for PrEP. A twice-yearly injection helps maintain privacy, reducing stigma, and requires less of a burden on the frequency of physical access to clinics. Moreover, it is easier to get patient buy-in on a twice-yearly injection compared to adherence to a daily treatment to prevent a disease they do not have.

Lenacapavir as PrEP would also be an injectable PrEP alternative to Apretude (cabotegravir). Presently, cabotegravir is an FDA-approved long-acting injectable for PrEP that is administered bi-monthly. However, in the two years since its approval in the U.S., there have only been about 11,000 prescriptions given compared to the roughly 382,000 annual users of oral PrEP.[6] That is only about 1.4% of PrEP users. Additionally, lenacapavir is administered subcutaneously in the abdominal area, unlike cabotegravir, which is a deep intra-muscular injection. A subcutaneous injection may be more appealing to some than a deep intra-muscular injection. Furthermore, a subcutaneous injection could mean easier access for administration since it requires less expertise than a deep intra-muscular injection.

Photo Source: Daily Caring

The innovation of long-acting injectable PrEP is lost if those who are most in need cannot access it. Thus, financial innovation needs to occur as well. Long-acting injectable PrEP will most likely cost significantly more than the current generic version of Truvada as daily PrEP in pill form, which can be obtained for about $20 a month.[3] Insurers will need to be convinced of the benefits of covering twice-yearly injectable lenacapavir. Most importantly, Medicaid, which provides care for over 40% of adults under the age of 65 living with HIV, will need to effectively cover long-acting injectable PrEP.[7] Data shows that PrEP uptake is lower among those on Medicaid compared to people with private insurance, with privately insured people initiating PrEP at a seven times higher rate.[7]

The O’Neill Institute for National and Global Health Law released a publication suggesting how Medicaid can ensure coverage for long-acting injectables. The two overarching ideas are that the federal government facilitates support for long-acting integration and states modify practices to effect widespread long-acting injectable access.[8] On the federal level, the institute suggests that the Centers for Medicare and Medicaid Services (CMS) issue guidance on Medicaid’s role in supporting PrEP uptake and update their 2016 Informational Bulletin on HIV Prevention and Care Delivery to include all currently available HIV therapies and services. Additionally, they point out there is no senior administrator in CMS with HIV expertise focused on coordinating HIV policy with Medicare and Medicaid regarding the National HIV/AIDS Strategy. Thus, they should appoint an official to handle that task.[8] On a state level, they suggest that states should examine their Medicaid managed care contract standards to ensure all covered HIV medications are available across all health plans.[8]

Ongoing inquiries provide data showing that patients have favorable inclinations toward long-acting injectables, especially once they become fully aware of what is available. One source of this data is a project executed by ADAP Advocacy entitled ‘HIV LONG-ACTING INJECTABLES: Patient Access Considerations for Injectable HIV Therapies & Injectable HIV Pre-Exposure Prophylaxis’. The project consisted of a quantitative survey, a qualitative focus group, and an analysis of data among those who were HIV-positive in terms of long-acting injectables for treatment and those who were HIV-negative regarding long-acting injectables for prevention.

The sample population focused on long-acting injectables for prevention included participants from 35 states, the District of Columbia and Puerto Rico.[9] Of these respondents, the majority reported that they would prefer provider or self-administered long-acting injectable PrEP as opposed to daily oral pills.[9] There was a mixture of awareness of the specific medication, Apretude. However, upon being made aware of it, those who were already aware and those newly aware were mostly open to learning more about using it or would strongly consider switching from a pill-based regimen.[9] A frequent concern was being unsure if they would be able to afford it or worried if their insurance would cover it.[9]

The PURPOSE 1 and 2 clinical trials and ongoing data indicate the promise of effective prevention that long-acting injectables can bring. Future results from PURPOSE 3, 4, and 5 will continue to strengthen proof of efficacy among even more diverse groups. It is imperative that education, policy, funding, and infrastructure be created and maintained to ensure access to those who are most in need of and desire to utilize not only long-acting injectable PrEP, but long-acting HIV treatment of all forms.

[1]  Mahobe, R. (2022, December 22). U.S. FDA approves Gilead's long-acting HIV drug Sunlenca. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-gileads-long-acting-hiv-drug-sunlenca-2022-12-22/#:~:text=By%20Raghav%20Mahobe,Licensing%20Rights%20%2C%20opens%20new%20tab 

[2] Manalac, T. (2024, September 13). Gilead touts 96% HIV risk reduction with twice-Yearly PrEP, eyes regulatory filings. Retrieved from https://www.biospace.com/drug-development/gilead-touts-96-hiv-risk-reduction-with-twice-yearly-prep-eyes-regulatory-filings

[3] Mundell, E. (2024, September 13). Twice-yearly injection cuts HIV risk by 96%, but will cost cut access? Retrieved from https://medicalxpress.com/news/2024-09-yearly-hiv-access.html#google_vignette

[4] Foster, Robin. (2024, June 24). Twice-a-year injection gives women full protection against HIV, trial finds. Retrieved from https://www.healthday.com/health-news/infectious-disease/twice-a-year-injection-gives-women-full-protection-against-hiv-trial-finds

[5] Edwards, G. G., Miyashita-Ochoa, A., Castillo, E. G., Goodman-Meza, D., Kalofonos, I., Landovitz, R. J., Leibowitz, A. A., Pulsipher, C., El Sayed, E., Shoptaw, S., Shover, C. L., Tabajonda, M., Yang, Y. S., & Harawa, N. T. (2023). Long-Acting Injectable Therapy for People with HIV: Looking Ahead with Lessons from Psychiatry and Addiction Medicine. AIDS and Behavior, 27(1), 10–24. https://doi.org/10.1007/s10461-022-03817-z

[6] Cairns, G. (2024, March 29). Why is the roll-out of injectable PrEP taking so long?. Retrieved from https://www.aidsmap.com/news/mar-2024/why-roll-out-injectable-prep-taking-so-long

[7] Wirth, D., Crowley, J. (2024, Sept 19). Medicaid must prepare to cover twice-yearly HIV prevention injection. Retrieved from https://www.statnews.com/2024/09/19/medicaid-prep-long-lasting-twice-yearly-prep-hiv-injection-cms/

[8] O'Neill Institute. (2024, July). Medicaid Leadership Must Ensure Access to Longer-Acting HIV Products. Retrieved from https://oneill.law.georgetown.edu/wp-content/uploads/2024/07/ONL_BIIB_Medicaid_Leadership_P5.pdf

[9] ADAP Advocacy. (2024, June). Patient access considerations for  Injectable HIV Therapies  & Injectable HIV Pre-exposure prophylaxis. Retrieved from https://www.adapadvocacy.org/pdf-docs/2024_ADAP_Project_Long_Acting_Injectables_Final_Report_06-25-24.pdf

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

New Study Dissects Efficacy of Lenacapavir

By: Ranier Simons, ADAP Blog Guest Contributor

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

Photo Source: sunlencahcp.com

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

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

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

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

Photo Source: European AIDS Treatment Group

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

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

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

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

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

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

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

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

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.  

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.