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.