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.