By Thresa Giles, CEO — Hope & Help of Central Florida
The emergence of pre-exposure prophylaxis treatments (PrEP) for the prevention of HIV was a watershed moment in the history of the HIV/AIDS epidemic. However, for some people, remembering to take a daily pill can be a struggle. In addition, a stigma still exists surrounding HIV, even as preventative measures improve and rates of HIV infection continue to decline.
Now, a new twice-yearly injectable called lenacapavir has been approved by the FDA under the brand name Yeztugo. The emergence of this groundbreaking pre-exposure prophylaxis could very well revolutionize HIV prevention going forward, leading us even closer to eliminating HIV completely.
Those who stand to benefit from lencapavir
Early trial data for lenacapavir are encouraging. Phase III PURPOSE 1 and PURPOSE 2 trialsin Africa, the Americas, and Europe found that twice‑yearly lenacapavir PrEP dramatically reduced HIV infections compared with standard daily oral PrEP regimens. Unlike a vaccine, lenacapavir does not train the immune system; instead, it keeps proactive drug levels in a person’s system so that if HIV is introduced, it is not able to establish a permanent infection.
In the United States, some communities stand to benefit greatly from the approval of lenacapavir. For example, Black and Latino gay and bisexual men shoulder a disproportionate share of HIV diagnoses, yet reports show that their adherence to current daily PrEP regimens may be low. Lenacapavir could close the gap for this at-risk community, lowering incidents of HIV and increasing wellness throughout the community overall.
Additionally, young adults who test positive for HIV, even those who are not in high-risk communities, still often have unstable schedules, housing, or insurance coverage that can make preventing HIV challenging. A twice-yearly visit can be a great option for this group, helping them manage healthcare fatigue and the ongoing costs that can often accompany prevention methods that must be taken more frequently.
Lenacapavir has been designed to alleviate the “pill burden” that hinders much of HIV prevention, allowing a high level of protection for people who may have struggled with medication adherence. Many people may experience medication fatigue, including those in higher-risk communities who are dealing with a lack of stable housing, mental health issues, or juggling other medication needs.
The ripple effect on public health
Once scaled, the use of lenacapavir could significantly affect the curve of new HIV infections. Models reflect this hope, suggesting that this highly effective, twice-a-year, low-burden prevention option could accelerate progress toward eventually eradicating HIV and ending AIDS as a widespread public health threat.
The ripple effect can be seen with the easing of the stigma that still exists around HIV as well. By making PrEP an occasional health service, similar to a flu shot, instead of a daily reminder that one has been identified as “high risk” for HIV, people may feel less shame. Lenacapavir is helping reframe PrEP treatments as routine sexual health care and less as a symbol of suspicion or a moral failing.
Compare and contrast: Lenacapavir and PrEP pills
PrEP pills that are meant to be taken daily emerged in 2012, absolutely changing the HIV and AIDS prevention game. However, as technology has evolved, new and better options are available.
Studies show that twice-yearly lenacapavir achieved nearly 100% protection among one study cohort and a 96% reduction in risk compared with a daily PrEP pill. This success is largely due to adherence to a twice-yearly shot being far easier than remembering a daily pill.
Lenacapavir requires a clinic visit roughly once every six months following a brief oral start-up course. Between visits, there is nothing to remember, carry, or take daily. While some daily pills can offer some flexibility with start and stop, the demand for ongoing attention, refills, and integration into the daily routine that the pills require can deter many from adhering to the regimen, lessening effectiveness.
Cost may be an initial deterrent to lenacapavir use, prompting global agencies to call for cost containment. In the United States, the list price for the twice-yearly injection has been set at $28,000 per person, per year — a staggering amount that could be a massive roadblock for many of the most vulnerable populations. However, once a generic version is widely available, affordability will likely improve.
Reframing prevention as routine care
There is no argument that PrEP absolutely revolutionized HIV treatment. Now, with a twice- yearly option available, we are one giant step closer to eliminating HIV. Lenacapavir now sits with daily pills and the injectable cabotegravir as available prevention options that reinforce the idea that HIV prevention can be personalized and become part of routine sexual health care.
For communities long marginalized and those in high-risk cohorts, the approval of lenacapavir can reinforce dignity, choice, and hope. With the hope of bringing new HIV infections to historically low levels in sight, we are close to transforming HIV into a routine part of staying well.
— Thresa Giles, CEO of Hope & Help of Central Florida (dba Hope & Help), has an extensive background in business and operations in both the for-profit and non-profit sectors. Her impeccable experience spans over 30 years and is punctuated by an impressive array of achievements, including industry-recognized certifications, academic accomplishments, and numerous awards, including the Jacksonville Women of Influence Award, the Ultimate CFO Award, and the State of Delaware Outstanding Leader Award. Thresa’s vision for Hope & Help
includes addressing total health and wellness with enhanced community partnerships and expanded access to care. This will be facilitated by strategic growth and expansion fostered by diversification of funding, investing in new technologies, and supporting the team with development, efficiency, and sustainability.
