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Peers and Perspectives

1rem

, where we delve into some of the social factors that create and widen healthcare disparities.

This Pride month, Contagion Community is highlighting the healthcare needs and disparities unique to the LQBTQ+ community. Joining us for June’s podcast are Steven Wolfe, DO, MPH, and Stuart A Fisk, CRNP, of the Allegheny Health Network (AHN).

Fisk and Wolfe work with LGBTQ people who are living with 

. In this episode, they delve into the intersectionality of the disease, emphasizing that HIV prevention and treatment is especially needed for transgender people of color.

Wolfe and Fisk both identify as gay men, and thus have a personal as well as professional stake in ensuring LGBTQ+ people have access to comprehensive healthcare.

“We need more physicians, like myself, out there who really understand what the community’s needs are,” Wolfe said.

Asked about the current state of the HIV epidemic, Wolfe said, “62% of people who are trans and Black have HIV…I think we’re going in the right direction, but I think that we need a lot more work when we’re thinking about the minority populations.”

Fisk added that 25-30% of people newly diagnosed with HIV are being diagnosed at the end stages of the disease. “We do not test people routinely for HIV,” he said. “To have the biomedical ability to end a pandemic as tragic as this one, and not do it because we’re failing to give people a $2 test, is really a bad thing.”

 is another HIV preventative measure that is vastly underutilized. Wolfe cited study data suggesting 96% of transgender women were aware of PrEP, “but the reality of it is only 32% of transgender women were actually using PrEP to prevent HIV. That’s a huge gap.”

Fisk pointed out that similar disparities exist for injection drug users, who are at high risk of getting HIV but are “rarely if ever” offered PrEP. “People of color in general who have risk of HIV acquisition are typically not being offered PrEP or do not take PrEP.”

“The problem is that HIV carries the stigma of the populations that it most impacts,” Fisk said, noting that our society’s criminalization of queerness, homelessness, and injection drug usage exacerbates HIV disease disparities. “The HIV pandemic has always been as much a social and political pandemic as it’s been a medical pandemic. Until we deal with those political and social issues that create risk, we will not see the end to this pandemic.”

Fisk has been working with marginalized people since the beginning of his nursing career, which he says has helped him become a better healthcare provider and a better human.

Wolfe noted that caring for people living with HIV is often not only about providing healthcare, but also mitigating the stigma these patients may have experienced throughout their lives. “The HIV pandemic has always been as much a social and political pandemic as it’s been a medical pandemic. Until we deal with those political and social issues that create risk, we will not see the end to this pandemic.”

The experts emphasized that HIV and LGBTQ+ healthcare should not be seen as specialized care. “This is care that should be integrated with regular primary care,” Fisk said, with Wolfe adding, “A transgender person should not have to go to an endocrinologist to get their hormones.”

Allegheny Health Network’s Positive Health Clinic has 3 different locations in the Pittsburgh area of western Pennsylvania. You can find out more by calling 

Missed Episode 4 of Contagion Community? 

Listen in on the conversation and feel free to offer your feedback on this episode, interest in participating in the podcast, or suggest ideas for future episodes. Please email your correspondence to Nina Cosdon: 

Joined by Steven Wolfe, DO, MPH, and Stuart A Fisk, CRNP, of the Allegheny Health Network, we discuss the populations most at risk of HIV infection, as well as advice for making healthcare spaces more inclusive and accessible for LGBTQ+ people.

"A Social and Political Pandemic”: HIV Disparities in LGBTQ+ People

Traditional healthcare systems can be inhospitable to people who use drugs. The Montefiore-NYHRE Clinic is an alternative academic medical center that promotes the holistic health and dignity of marginalized people who use drugs.

Today, associate editor Nina Cosdon interviews Brianna Norton, DO, MPH, an assistant professor in the Montefiore Einstein Department of Medicine (General Internal Medicine) and the medical director of New York Harm Reduction Editors (NYHRE).

Norton founded the Montefiore-NYHRE Clinic, which cares for people struggling with substance use disorders.

Norton describes NYHRE as “a drop-in center, a syringe service program, and an overdose prevention center.” The clinic is located in East Harlem, but also has vans throughout the Bronx. “We reduced the barriers to access to healthcare by embedding a clinic within the community-based organization,” Norton explained.

“The focus,” Norton says, “is on the dignity and health of people who use drugs and sex workers.” NYHRE serves patients who are typically marginalized by society, and even by healthcare workers, with the goal of giving them a safe space to get the care they need from physicians they can feel comfortable trusting.

Norton said that some of the barriers her patients face are logistical, and stem from 

. Many normalcies of traditional American healthcare systems, like strict appointment times or copays, are impenetrable for marginalized populations. Norton says, “On top of the social determinants of health, there is a tremendous amount of stigma in the traditional healthcare system when it comes to people who use drugs.”

The Montefiore-NYHRE Clinic seeks to alleviate some of these challenges by seeing their patients as equal human beings, as people not defined by their substance use. “There’s this stigma that if you’re using drugs, you don’t care about your whole body,” Norton said, “and it’s just not true.”

“If you combine syringe service programs with substance use disorder treatment, which is what we’re doing, you can actually reduce HIV and Hep C by two-thirds.”

Norton also discussed the importance of addressing the reason the patient came into the office, rather than focusing on getting the person to stop using drugs. The Montefiore-NYHRE Clinic focuses on keeping people safe until they are ready to enter substance use disorder treatment. Norton emphasized, “I always say, you cannot get someone into treatment if they are not alive.”

“The whole philosophy of Osteopathic Medicine is seeing the patient as a whole, rather than in individual parts…It’s an asset in my practice today, because I’m open to a spectrum of treatments.”

Some of the specialized services the clinic provides are pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and HepC, HIV, and opioid use treatment.

The long-term goal is to offer wholistic care that makes patients feel safe seeing and trusting a doctor, so that as they age and require medical attention beyond what the clinic can provide, they will feel comfortable navigating traditional healthcare systems.

“What we’re saying is if you’re currently not going to stop using drugs at this very moment, let’s just give you the tools to use in a way that is safer, than can reduce harm…This is not a new concept, it’s just that people stigmatize the concept when it’s related to drug use.”

Missed Episode 2 of Contagion Community? 

People who use drugs face obstacles, like homelessness and stigma, that hinder their access to healthcare. Dr. Brianna Norton opened the Montefiore-NYHRE Clinic, a first-of its kind academic medical center, to serve marginalized people holistically and respectfully. 

“We Treat People With Dignity”: An Alternative Healthcare Clinic for People Who Use Drugs

Novavax’s COVID-19 vaccine, Merck’s RSV antibody, and Innoviva’s gonorrhea antibiotic await regulatory decisions this quarter.

Infectious Disease Treatments on FDA’s Watchlist for Q2 2025

The Visby Medical Women’s Sexual Health Test can screen for chlamydia, gonorrhea, and trichomoniasis.

FDA Grants Marketing Authorization For First Home Test for STIs

Carl Schmid, executive director, HIV + Hepatitis Policy Institute, explains how a Supreme Court case could have far reaching implications for greater health screenings and preventative services beyond HIV and hepatitis.

The Case for HIV Prevention and Screening: Pay Today or Pay Tomorrow

In a small study, investigators found they could reduce the antiretroviral therapy (ART) dosing to longer durations and the treatment remained safe and efficacious.

Exploring Novel Dosing Strategies by Reducing Once Daily Biktarvy

A recent study emphasizes the genetic diversity within the ompA-genotype L2b clade, enhancing our understanding of sexually transmitted infections and how they are transmitted.

New insights into Chlamydia trachomatis LGV diversity may help curb STI spread

A coalition of employers, the US Business Action to End HIV, sent a letter to Congress outlining the continued need for support from the federal government.

Why it’s Crucial to Maintain Funding for HIV Prevention, Research, Treatment 

This is the second in a series on the state of HIV today.

In late February, The US Business Action to End HIV, the largest coalition of employers dedicated to ending the HIV epidemic in the United States, sent a letter to Congress urging them to prioritize sustained federal funding for HIV prevention and treatment and underscoring the business sector’s commitment to advancing public health and ensuring progress in the fight against HIV.

“We have two goals, one to get people who are living with HIV on treatment, and two, to prevent new acquisition of HIV,” said Carl Schmid, Executive Director, HIV + Hepatitis Policy Institute.

The letter warns that funding freezes and grant delays could threaten hard-won progress, reversing declines in new HIV infections and exacerbating health disparities. Business leaders are calling on Congress to maintain investments in HIV research, prevention, and access to care, emphasizing that ending the epidemic is both a moral and economic imperative.

More specifically, the Coalition urges Congress to:

Maintain federal funding and state HIV prevention and treatment programs to safeguard decades of hard-won progress

Advance policies that sustain and expand life-saving public health efforts to keep the momentum going

Expand access to essential HIV services like testing, prevention, and treatment so everyone can stay healthy - regardless of where they live or their circumstances. (HIV continues to affect some communities more than others, particularly in parts of the US South, where access to prevention and care remains a challenge)

Strengthen public-private collaboration to close gaps in care, especially in communities most impacted by HIV.

“We saw a pretty steady decrease in the number of new HIV infections in this country between 2018 and 2022 but this progress is fragile, and reductions in funding or rollbacks and policy efforts could really risk a resurgence in new HIV infections and in preventable deaths, which would undermine all of the hard won gains that we've made,” said Stephen Massey, co-founder and co-CEO of the US Business Action to End HIV.

In terms of the business sector and their role in addressing these issues, Massey says companies have an opportunity to create a comfortable environment, to be able to have employers communicate with their employees about HIV, as well as what types of health plans they offer.

“There is an opportunity for employers to share trusted information about HIV, including how to prevent infection. There's an opportunity for employers to create workplaces where employees feel comfortable talking about HIV, asking questions, and also workplaces where employees have access to the very best care and prevention,” Massey said. “Employers play a really important role in determining health care plans that employees are offered for employees who might not be covered by their insurer. They could also provide information to employees about how they can access the social safety net of services that are available.”

“The community can advocate for ourselves, but I think it's really helpful, particularly in this time period, to have additional voices, including those of the business community,” Schmid said. “They can go into congressional offices and places where perhaps the community doesn't have the same footing.”

The Business Sector's Advocacy to Maintain Funding for HIV Prevention, Research, Treatment 

New data at CROI 2025 show zero cases of HIV acquisition reported with Apretude (cabotegravir long-acting (CAB LA) for PrEP) in varied clinical settings and populations in two implementation studies in the U.S. and Brazil

Apretude PrEP Shows High Efficacy, Safety in 2 Diverse Studies

At this week’s CROI conference, ViiV Healthcare presented real-world data on its long-acting injectable PrEP, cabotegravir long-acting (CAB LA), (Apretude). In it’s PILLAR study, there was zero HIV acquisition through 12 months and high persistence with CAB LA for PrEP. These new 12-month findings from the examined the effectiveness, diagnostic testing, persistence (time that an individual continued to receive injections), safety and tolerability of CAB LA in 201 participants. PILLAR is a phase 4 implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the US among a diverse population of men who have sex with men and transgender men, 26% of whom were Black and 38% Hispanic/Latino.

Persistence on CAB LA was high, at 85% (n=171/201) at six months and 72% (n=142/196) at 12 months; excluding five participants who completed the study post-data cutoff. Five participants missed an injection and received either oral CAB or alternative PrEP. Adverse events (AEs) related to CAB LA were uncommon, with injection site pain the most frequently reported (3%, n=6). Five percent of participants (n=11) had AEs leading to discontinuation, most commonly due to injection site pain.

“This study really has demonstrated that long-acting HIV prevention is acceptable, tolerable, again, highly effective,” said ViiV Healthcare Chief Medical Officer Harmony Garges, MD, MPH. There were no new acquisitions of HIV in the trial, and is showing that the persistence rate, meaning how long people remain on their PrEP with long acting, is very high.”

In the other trial, the ImPrEP CAB Brazil study (The Choice Cohort), assessed PrEP coverage and HIV incidence among 1,447 participants who were given the choice of CAB LA or oral PrEP (TDF/FTC) for HIV prevention. The Choice Cohort included PrEP-naïve, cisgender men who have sex with men, non-binary and trans people aged 18 to 30. As a comparison group, the study assessed 2,263 people of a similar demographic, initiating oral PrEP through the Brazilian public health system during the same period.

The results show that offering CAB LA injections significantly improved PrEP coverage and HIV prevention for young key populations, reinforcing the role of CAB LA in addressing adherence challenges some people face with oral PrEP.

Eighty-three percent of the 1,447 participants who were free to choose either CAB LA or oral PrEP chose CAB LA (1,200 participants) and there were zero HIV acquisitions reported over 798.4 person-years in The Choice Cohort. There were eight HIV acquisitions over 408.52 person-years reported in the comparison group (incidence rate 1.96 [95% CI 0.98-3.92] per 100 person-years).

“It demonstrated that if you gave people a choice of either oral prep or a long acting PrEP, you had more people accessing HIV prevention,” Garges said. “And that's really important in terms of ending the epidemic. And again, it also showed in that study that for those who chose the long acting therapy, there were no new cases of HIV, so high rates of effectiveness, and it was it was well tolerated.”

Apretude is PrEP that was FDA approved in 2021, and is used for preventing sexually transmitted HIV infection in adults and adolescents weighing at least 35kg who are at high risk of being infected. Individuals must have a negative HIV test prior to initiating the PrEP (with or without an oral lead-in with oral cabotegravir).

Garges discusses some of the feedback around taking daily PrEP including stigma and compliance. “Roughly 50% of people taking HIV medicines do have some sort of psychological burden with daily pills. So having a long acting injectable is a real benefit for them, because our medicine only needs to be dosed once every 2 months for treatment or prevention, and so you're taking someone who for treatment was having to take a medicine 365 days a year to now they only have 6 times a year.”

Reference
1. ViiV Healthcare Announces New Implementation Study Data Showing Zero Cases of HIV With Apretude, the only long-acting injectable approved for HIV PrEP. March 12, 2025. Accessed March 14, 2025. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/march/new-implementation-study-data/

New data at CROI 2025 shows zero cases of HIV acquisition reported with Apretude (cabotegravir long-acting (CAB LA) for PrEP in varied clinical settings and populations in 2 implementation studies in the US and Brazil.

Conferences

Apretude PrEP Shows High Efficacy, Safety in Diverse Studies

Colleen Kelley, MD, MPH, offers some insights on where we are today with the state of HIV prevention including  PrEP and PEP, as well as why HIV vaccines are challenging to develop. 

Expanding PrEP Options and the Role of  Broadly Neutralizing Antibodies in Vaccine Development 

Here is the first in a news series on the state of HIV today including prevention, funding, and newer modalities.



HIV prevention in the form of pre-exposure prophylaxis (PrEP) continues to be a highly effective method of reducing the risk of contracting HIV. According to the Centers for Disease Control and Prevention (CDC), PrEP reduces the risk of getting HIV from sex by about 99%, when taken as prescribed.

CDC says there is less information about how effective PrEP pills are among people who inject drugs; however, it is reported that PrEP pills reduce the risk of getting HIV by at least 74% when taken as prescribed. Currently, PrEP injectables are not recommended for people who inject drugs.


One of the more exciting areas within PrEP is long-acting injectables. This modality is giving individuals new options to protect against infection. At this week’s CROI, investigators presented new data on these modalities for FDA approved and developmental PrEP. For example, ViiV Healthcare reported new data the 

long-acting injectable cabotegravir (Apretude) 

demonstrating its effectiveness in 3 years of real-world data. Right now this is the only long-acting injectable that is FDA approved.

Additionally, the investigational long-acting injectable, lenacapavir, has shown high efficacy in phase 3 trials for PrEP and has a PDUFA date for June 19.



Gilead's Once-Yearly Lenacapavir Formulations Show Sustained Efficacy for HIV PrEP in Phase 1 Study



“Long acting injectables are a tremendous advancement, both for HIV prevention and treatment. So with respect to HIV prevention, we know that taking a pill every single day for the duration of the time where you may be exposed to HIV can be difficult for a lot of people,” said Colleen Kelley, MD, MPH, professor, Department of Medicine, Emory University School of Medicine. “We know that about half of people who start oral daily oral PrEP, stop it within the first year of taking it. And so what these long-acting injectables offer is the ability to have excellent HIV prevention without having to think about it, without having to take that pill every single day…and when you take daily oral adherence out of the equation, that's where we see these amazing efficacy results.” 


One area that is not discussed very often is post-exposure prophylaxis (PEP). Kelley says there are 3 challenges around it including the availability of the medication, the duration of the regimen, and potential insurance hurdles.

“It's difficult to access…And they don't know where to get it. They may go to an emergency room, they may go to a clinic, and there's no guarantee that clinic or emergency room will even offer you post exposure prophylaxis in the United States—even though it's recommended,” Kelley said. “And then the second step of how do you get the medication? Does your insurance cover it? Do you need to enroll in a patient assistance program if your insurance doesn't cover it? There's just too many logistical hurdles.”

“The current recommended post exposure prophylaxis regimen is actually 28 days, and that's long for some people who may have had a single exposure to continue taking that medicine every single day for 28 days.”
 

Long acting injectables are a tremendous advancement, both for HIV prevention and treatment. —Colleen Kelley, MD, PhD

Although there are HIV vaccines in development, there are no FDA-approved immunizations. Kelley says the primary challenges to developing such vaccines is the structure of HIV and the ability of the virus to hide away in the body.

“The human immune system makes a very strong antibody response to the SARS-CoV-2 virus, that then helped to attenuated people who had COVID from having severe disease,” Kelley said. That same thing cannot be said of HIV. The HIV antibodies that people get neither prevent them from acquiring HIV, nor prevent them from getting severe disease. And it's because of the structure of the virus, the way that it hides from our immune system, the various ways that it integrates into our cells and just lives there silently. These are all the reasons why we've not been able to create an HIV vaccine similar to the COVID vaccine.”

Although the traditional methodology of creating vaccines has not proven to be efficacious for HIV yet, there is a much newer approach that is starting to be studied for HIV vaccines that includes broadly neutralizing antibodies (bnAbs). The International AIDS Vaccine Initiative (IAVI) has been helping to drive this area of research.

“The origin of our work on a new approach to HIV vaccine design began with the discovery, beginning in 2009, of potent broadly neutralizing antibodies (bnAbs) from large cohorts of individuals living with HIV in Africa, India, Thailand, Australia, the UK, and the US. Researchers at IAVI’s Neutralizing Antibody Center (NAC), a partnership with Scripps Research, and partners isolated and studied these bnAbs, which develop in some people after they have lived with HIV for several years. Later, researchers showed in the lab that some of these bnAbs block HIV from infecting cells,” IAVI writes on its site.

 was reported at this week’s CROI conference by ViiV Healthcare as it relates to HIV management as part of a comprehensive treatment strategy.

The ability to prevent HIV continues to evolve, but it remains to be seen if the significant strides made in HIV prevention will continue, especially in today’s governmental policy environment.




References
1. Let’s Stop HIV Together. CDC. Last reviewed February 18, 2025. Accessed March 13, 2025.
https://www.cdc.gov/stophivtogether/hiv-prevention/prep.html
2. HIV Vaccines. IAVI. Accessed March 13, 2025.
https://www.iavi.org/our-work/hiv-vaccines/

Colleen Kelley, MD, MPH, offers some insights on where we are today with the state of HIV prevention including the expanding PrEP options, why PEP is underutilized, and the challenges behind HIV vaccine development.  

HIV Prevention: Discussing PrEP, PEP, and Vaccine Development

In a blinded phase 3 study, doravirine and islatravir was compared to BIC/FTC/TAF (Biktarvy) and there was no between-group differences 

Doravirine and Islatravir Combination Shown to be Noninferior to   Once-Daily Antiretroviral Therapy

At CROI today, Merck presented results of its investigational combination therapy of doravirine and islatravir (DOR/ISL) showing it was noninferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).

At week 48, HIV-1 RNA was ≥50 c/mL in 5 (1.5%) participants on DOR/ISL and 1 (0.6%) on BIC/FTC/TAF (difference 0.9%, 95% CI -1.9, 2.9; CI upper bound <4%), demonstrating non-inferiority of DOR/ISL to BIC/FTC/TAF. HIV-1 RNA was <50 c/mL in 91.5% of participants on DOR/ISL and 94.2% on BIC/FTC/TAF,” the investigators wrote in the abstract.

“At week 48, the proportion of individuals that maintain their viral suppression was the same between the 2 groups," said Luisa Stamm, MD, PhD, associate vice president, Infectious Disease Clinical Research, section head, HIV, Merck. "So we did meet our noninferiority primary efficacy endpoint with over 90% of individuals in both treatment groups maintaining viral suppression." 

In this double-blind, non-inferiority phase 3 study, adults with HIV, and viral suppression for approximately 3 months on BIC/FTC/TAF, and no history of treatment failure or known resistance to doravirine were randomized (2:1) to switch to doravirine and islatravir (100/0.25 mg) or continue BIC/FTC/TAF. Primary efficacy endpoint was the percentage of participants with HIV-1 RNA ≥50 c/mL at week 48). 

“Discontinuation was required for confirmed decline in total lymphocytes (≥30% and to <1.0 x109/L) or in CD4 T-cell count (≥30% and to <350 cells/mm3 from baseline ≥350 or to <200 from baseline ≤349),” the investigators wrote. “There were no between-group differences in mean change in CD4 T-cell or total lymphocyte count at week 48. Two participants on DOR/ISL (0.6%) and one on BIC/FTC/TAF (0.6%) discontinued due to decrease in CD4 T-cell or total lymphocyte count.”

Merck is also presenting data at CROI on an open-label phase 3 study examining doravirine and islatravir compared to a baseline antiretroviral therapy.

“Switching to DOR/ISL (100/0.25 mg) maintained viral suppression and was noninferior to continuing bART at week 48. DOR/ISL was well tolerated with a similar safety profile to bART and did not adversely affect lymphocytes,” the investigators wrote.

“The endpoint was similar, and we met noninferiority comparing doravirine/ islatravir to baseline antiretroviral therapy. And again, high rates of viral suppression, over 90% for both treatment groups, and similarly, the doravirine/islatravir group had comparable safety to the comparator group. And lastly, as we just discussed, we saw no impacts on total lymphocytes and CD-4 counts,” Stamm said.

In terms of next steps, Merck is working towards regulatory approval for the combination therapy.

“We are really excited about these positive results, and we're working furiously to put it together into our regulatory filing right now," said Stamm. “We'll have some updates on when we can anticipate that completion of the filing and the approval when they're available.”


Reference
1. Colson A et al. Switch to DOR/ISL QD from BIC/FTC/TAF: a blinded Phase 3 Study in Adults with HIV-1.” Oral abstract. Presented at CROI 2025. March 9-12, 2025, San Francisco, California. 
2. Orkin C et al.Switch to DOR/ISL (100/0.25 mg) QD from Oral ART: an Open-Label Phase 3 Study in Adults with HIV-1. Oral abstract. Presented at CROI 2025. March 9-12, 2025, San Francisco, California.

In a blinded phase 3 study, doravirine and islatravir was compared to antiretroviral therapy, BIC/FTC/TAF (Biktarvy), and it was shown that there was no between-group differences in mean change in CD4 T-cell or total lymphocyte count at week 48.  

Doravirine and Islatravir Combination Shown to be Noninferior to Once-Daily ART

In a long-acting dose regimen, an investigational antibodies treatment is a potent antiviral that can function as a component of a complete antiretroviral regimen. 

Sexually Transmitted Diseases

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