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.  

Is Long-Lasting, Injectable Medication the Future of HIV Therapy?

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

Long-lasting medication to treat patients living with HIV/AIDS has been a goal of the medical field since the early days of the epidemic. Currently, most HIV therapies include daily medication involving multiple pills, which has proven to be expensive for the average patient, as well as potentially challenging for medication adherence. That could be changing, because an investigational, long-acting, injectable, 2-drug regimen of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) for the treatment of HIV is showing promise.

At the 2020 Conference on Retroviruses and Opportunistic Infections, ViiV Healthcare announced results from its 96-week global phase III FLAIR study. The results demonstrated the injectable therapy "continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC)." Also, compared to their previous, oral treatment, patients who participated in the study expressed a high level of treatment satisfaction at week 48, as well as week 96 (ViiV Healthcare).

Photo Source: Christian Today

"Our focus on creating innovative treatment options for people living with HIV is further supported by these long-term findings of a long-acting injectable HIV treatment regimen. The efficacy and safety data of cabotegravir and rilpivirine at 96 weeks, as well as a high level of treatment satisfaction for the long-acting regimen, further encourage us as we work to bring this treatment option to people living with HIV," said Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare.

"Seeing the longer-term data is really exciting. It confirms that the long-acting, two-drug regimen of cabotegravir and rilpivirine has maintained its efficacy and has the potential to be a generally well-tolerated alternative to the standard-of-care, daily, oral pill. For some people living with HIV, reducing their dosing schedules from 365 days per year to 12 may be a realistic option in the future," said Chloe Orkin, M.D., Consultant Physician and Clinical Professor at Queen Mary University of London (ViiV Healthcare).

The use of cabotegravir has implications broader than HIV therapy, too. Injectable cabotegravir is also being evaluated for pre-exposure prophylaxis (PrEP). Whereas the aforementioned news of cabotegravir’s (in combination with and rilpivirine) initial effectiveness in treating patients is new to celebrate, questions still remain as it relates to its use in HIV prevention - one being its effectiveness in women living with HIV.

As it relates to PrEP, Molly Walker wrote in MedPage Today on May 19 that she worries this drug will be approved for only one HIV positive population.

"While results for the long-acting HIV prevention medication cabotegravir are promising in men who have sex with men (MSM), there is still no data on this drug in women, begging the question of whether this will be another HIV prevention option that ends up being approved for only one population," said Walker (MedPage Today).

Mitchell Warren is executive director of AVAC: Global Advocacy for HIV Prevention. He described the experience with another drug, F/TAF as 'completely dropping the ball early on in the process'. According to Walker, the experience with cabotegravir is not similar to F/TAF.

Thousands of women are getting cabotegravir injections and the same data safety monitoring board oversees both studies," he noted, adding HPTN 083 data has not been fully analyzed and yet to be peer reviewed. "It's still a long way from submission to the FDA and other regulators," said Warren.

Unlike F/TAF trials, the test trials for cabotegravir is almost 'fully enrolled' among women, which is promising. Warren also noted that if cabotegravir is effective in HIV positive women or at-risk women, it could be good news to those who still carry the social stigma of taking multiple pills a day.

"While PrEP has been "normalized" in the gay community, he added, the idea of carrying "a large pill bottle" still imparts a great deal of stigma for at-risk women," Warren said.

Warren emphasized that having more options with HIV medications is helpful to those around the world, citing that many women are comfortable getting injections every 3 months for contraception.

Cabotegravir is still in the testing stages, but the initial results of effectiveness in trail patients has been positive. The hope is that this new drug will be effective for both men and women, while also lessening the social stigma of taking large dosages of pills to treat and prevent HIV.

References:

• ViiV Healthcare (2020, March 9). ViiV Healthcare presents positive long-term data from phase III study demonstrating efficacy and safety of cabotegravir and rilpivirine, its investigational, long-acting injectable treatment regimen in adults living with HIV-1. Retrieved from https://viivhealthcare.com/en-gb/media/press-releases/2020/march/viiv-healthcare-presents-positive-long-term-data-from-phase-iii-/#:~:text=Cabotegravir%20is%20being%20developed%20by,prior%20to%20long%2Dacting%20injection
• Walker, Molly (2020, May 19). HIV Injectable Tx May Work in Men -- But What About Women? MedPage Today. Retrieved from https://www.medpagetoday.com/hivaids/hivaids/86580.

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.