Chapter 3: Unmet Needs for the HIV Disease State

Moderator: Dr Lopes, I'll turn back to you. How are we doing against that strategy, and what would you say the unmet need is?  

Dr Maria Lopes: Thank you, Eric, and thank you, Dr Cohen. So, while we have these goals… 

We still have a long way to go. And to meet the 2030 goals and if you look at the slide for 2030, the number of new HIV infections must be decreased by nearly six times the current rate. 

So, it's interesting, we're in 2025, and look how far we're gonna have to go.  

And we can't solve this epidemic without understanding what hurdles exist that need to be overcome. In this section, I'd like to outline some of the challenges and barriers that need to be addressed.  

Another challenge is increasing HIV prevention, and we know that HIV prevention with PrEP is grossly underutilized. 

So, we have 1.2 million estimates in the U.S. of individuals who are high risk and would benefit from PrEP. 

And these individuals are at substantial risk of contracting HIV and transmitting HIV.  

So, these include individuals with an HIV positive partner, people who inject drugs, men who have sex with men, people with a history of sexually transmitted infections, and individuals engaging in unprotected sex, especially with partners of unknown HIV status.  

So, of the 1.2 million eligible PrEP users, if you look at the graph on the left side, the pie chart, the opportunity is that 64% are high risk and not receiving PrEP. 

And unfortunately, only 36% are receiving PrEP. If you look on the right side, another hurdle is the inequity in PrEP use. So the bar chart illustrates that the blue bars outline the percent of new HIV diagnosis in 2023 by ethnicity and gender, and the red bars outline the percent of PrEP users in 2023. 

And you can see an inverse correlation. You can see that while Black and Hispanic populations have the highest percentage of new HIV diagnosis, they also have the lowest PrEP use, right? So an inverse correlation. Social determinants of health exacerbate this gap, and those that could benefit from PrEP are not receiving it. 

So, to compound the problem, not only are those indicated for PrEP not receiving it, there are access issues associated with PrEP. And even if someone overcomes the environmental, the social, and the individual barriers outlined in the previous slide, they may still face additional challenges. 2024 article published in Health Affairs looking at implications of real-world delays in receiving PrEP found that delays and disconnects can increase the odds of someone acquiring or spreading HIV. 

And these delays could be caused by a number of factors, and they include benefit design issues, typically from payers. And individuals with rejected PrEP claims had about two-fold higher incidence of HIV, demonstrating the urgency of removing barriers to PrEP to reduce new HIV infections. Furthermore, PrEP abandonment rates increase when costs of PrEP increase, right? So, no surprise in terms of affordability. 

As patient out-of-pocket costs increase, patients can no longer stay on the recommended therapy. And with that, HIV diagnosis were 2-3 times higher among people who abandoned PrEP prescriptions than those who filled them. And this demonstrates, again, the opportunity for the direct correlation cost and affordability and what that impact is on people who could benefit from PrEP. 

On a final note, it's not just access that matters. Adherence to treatment is also key. And of note, you see that 60% of people with new HIV infections had PrEP on hand at the time of their diagnosis. 

And this indicates that it's not just access to treatment, but reducing non-adherence of PrEP. And it's something that must be overcome if we're going to prevent disease and disease spread.  

So transitioning into unmet needs.  

In the treatment space, there are challenges that follow individuals that are diagnosed as HIV positive, and certainly for PrEP, this is true.  

So, once someone is diagnosed or at risk, stigma always plays a large role in fear of disclosure and fear of how others may react to their diagnosis or lifestyle. And this leads to many people living with HIV or at risk of HIV keeping their diagnosis to themselves. 

Often people don't want others to see their HIV pills or see them going into the Infectious Disease Office or clinic. And an individual with HIV is certainly concerned many times because of fear of friends or that if they come over to visit that they may not take their medications. This drives home the point that, of the extent that people will go to avoid sometimes the public's knowledge and scrutiny over their condition. 

Daily treatment can also lead to a daily reminder of their HIV status, which can lead to psychological impact and negative reinforcement for adherence as a constant reminder of their disease status. And finally, daily treatments can also lead of course to forgetfulness, to anxiety, especially for people living with HIV.  

So as demonstrated by ending the HIV epidemic indicators, achieving viral suppression is critical and not just for the person living with HIV but also to reduce new infections. And you can see from the chart on the left that therapy does work, right? Those who are virally suppressed contributed zero to new infections while the 15% that were undiagnosed contributed 38% to new HIV infections. The impact on cost to a payer, and this is seen on the right, the lifetime net cost per individual living with HIV is estimated to be $850,000 more than the cost of an individual without HIV. And this stresses the importance, which I think Dr. Cohen also mentioned, of prevention as those who are on prevention not only prevent acquisition for the disease themselves but also spread to others and save not only healthcare dollars but lower total healthcare resource utilization.