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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

Gilead’s HIV-1 capsid inhibitor, which is a twice-yearly injection, was more effective than a daily Truvada pill in a phase 3 trial. 

Lenacapavir Reduces HIV Infections by 96%, Demonstrates Superiority Over Another HIV Prophylactic

Our panel discusses this patient group and the challenges associated with their care.

HIV Roundtable: Addressing Adherence and Privacy Issues in Adolescent Management

In this episode, clinicians discuss challenges associated with these topics and offer management insights on them.

HIV Roundtable: Aging with HIV, Multidrug Resistance, and Vaccine Development

In this case study, clinicians review a challenging case. 

Multidrug Resistance in a Patient With HIV

In the current state of the mpox outbreak, individuals with advanced HIV face a higher risk of severe illness, making vaccination and targeted public health measures essential.

HIV and Mpox: Risks, Prevention, and Vaccine Access

‘Vampire Facials’ and HIV Transmission

The CDC provided an update on their ongoing investigation of the link between a spa treatment for customers who received platelet-rich plasma with microneedling, or what is also referred to as vampire facials, and the transmission of HIV. The latest findings were published last week in the CDC’s 

According to the federal agency, there has been multiple HIV infections among people with no known HIV risk factors who received these vampire facial procedures at 1 spa in New Mexico. CDC confirmed that 4 spa customers, and 1 sexual partner of a spa customer, all received HIV diagnoses during 2018–2023.

It is important to note these cases were linked to just 1 facility, the VIP Spa, which was located at 809 Tijeras Avenue, NW Suite B, Albuquerque, New Mexico.

The spa was closed down back in 2018, shortly after the New Mexico Department of Health (NMDOH) was made aware of the potential connection between these facials and HIV.

“This is the first instance that we're aware of, of HIV transmission due to unsterile cosmetic injection services, so we would say the risk is generally very low,” Anna M. Stadelman-Behar, PhD, MPH, epidemiologist, CDC, and an investigator on the case. Stadelman-Behar credits local clinicians who quickly alerted public health officials of the potential medical issue.

“The strong relationship between the New Mexico Department of Health and the providers within New Mexico who were alerting the Department of Health of these patients was such a defining characteristic of this investigation,” Stadelman-Behar said. “The providers were the reason we kick started the investigation.”



The Investigation and Infection Prevention


Although the investigation began back in 2018, the CDC has kept the investigation open due to the lack of records maintained by the spa owner as well as the patient population who contracted HIV and the possibility more people may get diagnosed. The last known diagnosis was in 2023.

"It is important to remember that this is a group of individuals that did not have risks or behaviors associated with HIV acquisition,” Stadelman-Behar said. “So they weren't regularly testing. [They] were in monogamous relationships. They didn't have injection drug use and they had no risks—so this was a total shock to them.”

Stadelman-Behar points to the lack of infection control that likely led to the infections.

The spa owner did not have the appropriate licenses, and did not know how to uphold infection control practices. And that was really the main thing that led to transmission of HIV at this spa,” Stadelman-Behar said.

She also says there are steps for people who are seeking these procedures to feel more safe. “If they're seeking cosmetic injection services, they can check that their provider is licensed to perform those services,” Stadelman-Behar said. “Another thing that people can do if they're getting a cosmetic injection service is observing the [cosmetic] provider opening the needles in front of them, opening the vials, making sure the vials are labeled appropriately with their name and date of birth in case any specimens are collected. And then lastly, if there's any doubts or concerns, I always encourage people to ask their provider about the procedure or any infection control practices that they're doing.”



1. Stadelman-Behar AM, Gehre MN, Atallah L, et al. Investigation of Presumptive HIV Transmission Associated with Receipt of Platelet-Rich Plasma Microneedling Facials at a Spa Among Former Spa Clients - New Mexico, 2018-2023. 

. 2024;73(16):372-376. Published 2024 Apr 25. doi:10.15585/mmwr.mm7316a3

2. NMDOH Recommends Clients of VIP Spa in Albuquerque Receive Testing for Blood-Borne Infections. NMDOH news statement. September 18, 2024. Accessed May 1, 2024

A Centers for Disease Control and Prevention (CDC) investigator offers insights into their investigation of customers receiving vampire facials (a spa cosmetic procedure) and contracting the virus afterwards. 

The first-in-class entry inhibitor delivered therapeutic benefits over a long study period for patients with chronic infection. 

Bulevirtide Demonstrates Efficacy, Safety for Hepatitis D Treatment

For patients who have chronic hepatitis Delta (HDV), which is the most severe form of viral hepatitis, the infection can often come with poor prognosis and high rates of mortality. And combined with the possible coinfections such as hepatitis B (HBV) and HIV, disease management can be extremely difficult.

“What we know is hepatitis delta prevalence in people living with HIV is actually higher than in people who do not have HIV,” Anu Osinusi, MD, vice president, Clinical Research for Hepatitis, Respiratory and Emerging Viruses, Gilead, said. “And so because of the common routes of transmissions of these diseases, HIV, hepatitis B, and hepatitis Delta, people who have triple infections, what we also know from the data is that there is a higher rate of liver-related outcomes such as developing cirrhosis, decompensated liver disease, liver cancer...larger rates of the need for liver transplantation and overall death, compared to individuals who just have hepatitis B or hepatitis D.”

With the potential severity of chronic hepatitis D and the coinfections and limited treatment options, there is an unmet need for therapies. Bulevirtide (Hepcludex, Gilead) is a first-in-class entry inhibitor that was approved in the European Union for chronic HDV infection in HDV RNA positive adult patients with compensated liver disease. The therapy is an investigational treatment in the United States. 

“What bulevirtide does is it essentially binds to and then inactivates the NTCP receptor, which then has the goal of preventing new infections in the hepatocytes, and then inhibits the propagation of hepatitis Delta itself,” Osinusi said.

At last week’s Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, CO, data was presented on bulevirtide in regards to those with chronic hepatitis D and also included results on 2 patients who had HIV, hepatitis B, and hepatitis D.




In this study, 150 participants with chronic hepatitis D were randomized (1:1:1) into 3 arms including Arm A, which was no active anti-HDV treatment for 48 weeks, followed by bulevirtide 10mg/d for 96 weeks (n=51), and Arms B or C: immediate treatment with bulevirtide at 2 mg/d (n=49) or 10 mg/d (n=50), respectively, each for 144 weeks, with follow-up of 96 weeks after end of treatment. Efficacy was measured by combined (undetectable HDV RNA or ≥2 log10 IU/mL decline from BL and ALT normalization), virologic and biochemical response rates.

“At week 96, 39% to 56% of patients responded with substantially reduced levels of HDV RNA and with normal levels of the liver enzyme alanine aminotransferase, a key marker of liver health. Through 2 years of treatment, bulevirtide was safe and well tolerated,” the study authors wrote.

Osinusi explained that for some participants it may have taken longer time to see a therapeutic benefit.

“Even in the patient participants who didn't have a virologic response at week 24, over time, many of those participants actually go on to have this improved response at week 96,” she said.

For the 2 individual patients in the subset who had HBV/HDV, they also saw a benefit. “At week 96, both patients achieved a combined response (virologic and ALT normalization) as well as improvements in HBV DNA, platelet levels, and liver stiffness measurements,” the investigators wrote. “Neither patient required changes to their anti-HIV regimen nor did they experience serious [adverse events] AEs related to [bulevirtide] BLV.”

 spoke to Osinusi who offered further insights on the study and the therapy.




Wedemeyer H, Aleman S, Brunetto M, et al. Efficacy and Safety of Bulevirtide 2 mg or 10 mg for 96 Weeks in Chronic Hepatitis Delta, Including in 2 Patients With HIV/Hepatitis B Virus/Hepatitis Delta Virus. Poster #735 presented at CROI 2024. March 3-6, 2023. Denver, CO.



Customizing treatment strategies for enhanced outcomes and longevity.

The Efficacy of New HIV Treatment in Older Adults

Age-associated health issues and the adverse effects of certain antiretroviral treatments (ART) restrict the treatment options for older individuals living with HIV.

Conference on Retroviruses and Opportunistic Infections (CROI)

 Loice Achieng Ombajo's, MBChB, MMED, study discussed assessing the effectiveness and safety of transitioning older adults to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) from a primary treatment regimen.

Transitioning to B/F/TAF has been proven effective and safe for individuals aged 60 years and older who are virally suppressed on a regimen containing Tenofovir Disoproxil Fumarate (TDF). This switch is linked to enhanced bone mineral density (BMD) and reduced need for treatment adjustments owing to declining kidney function, establishing it as a suitable therapeutic option for this demographic.

“We have an increasingly aging population of persons living with HIV,” stated Ombajo. “Half of the people living with HIV or AIDS are above 50, and with aging comes other complications and concerns. So largely, it's the accumulation of comorbidities, with terrible things like hypertension, diabetes, increasingly bone disease and kidney disease, the conditions that influence treatment, and influence patient outcome.”

None of the participants experiencing protocol-defined virologic failure reached the ≥500 copies/ml level necessary for drug resistance testing. The average percentage change in lumbar spine BMD showed a significant increase of 2.17% for the B/F/TAF group compared to an increase of 0.61% for the control group, favoring B/F/TAF. Grade 3 or 4 adverse events (AEs) were rare, with no serious treatment-related AEs reported, and a smaller number of individuals in the B/F/TAF group stopped the medication due to AEs than those in the control group (CAR).

“We found that up to 60% of patients have osteoporosis, which is a significant bone disease that increases bone fragility and the risk of bones breaking,” Ombajo explains. “So that's a high proportion that's generally not reported. And that was quite concerning. The other concern laboratory noted earlier on in the studies that many of our patients up to about 40% had impaired kidney function.”

From February to May 2022, 520 people were split into 2 treatment groups, each with 260 people: one receiving B/F/TAF and the other CAR. Out of these, 296 were also monitored for bone density (143 in the B/F/TAF group and 153 in the CAR group). All participants were Black, with an average age of 64, and about half (267 or 51%) were women, ensuring comparable diversity in both groups from the start. By the 48th week, HIV levels were above the target in 5 (1.9%) individuals in the B/F/TAF group and 7 (2.7%) in the CAR group, indicating that the treatments were similarly effective.

“We're looking at the bones, we're looking at the kidneys, the liver, the sugar, the cholesterol,” explains Ombajo. “We haven't had too many safety concerns in the study. Because this is an older population, we saw a bit of a bit of mortality from things like malignancies, and cardiovascular diseases.”

Participants were evenly split to either transition to B/F/TAF or stick with their existing ARV regimen (CAR). The main outcomes measured were the percentage of subjects with an HIV-1 RNA level of 50 copies/mL or higher at the 48-week mark in the intention-to-treat-exposed group, as per the FDA Snapshot algorithm with a 4% non-inferiority margin, and the average change in lumbar spine BMD from the start of the study to week 48.

Ombajo's investigation addresses the needs of the aging HIV population by offering a safer, more effective option with low drug resistance and adverse events. The research underscores the importance of personalized treatments for older adults with HIV, indicating a change toward accommodating the changing health challenges of this demographic in future HIV treatment protocols.

Ombajo L, Penner J, Nkuranga J, et. al. A Randomized Trial Switching Adults ≥ 60 Years Old From First-Line ART to B/F/TAF: Week 48 Results. Poster #643 presented at CROI 2024. March 3-6, 2023. Denver, CO.

Conferences

The therapy, lenacapavir, showed sustained virological suppression and safety over a 2-year period in this treatment-challenged patient population. 

Examining a Newer Combination Therapy for Heavily Treated HIV Patients

People with multi-drug resistant (MDR) HIV have limited antiretroviral therapy (ART) options, which can leave their disease management very challenging.

“The patients who meet this definition tend to be very well known to us,” Onyema Ogbuagu, MBBCh, FACP, FIDSA, director of HIV Clinical Trials program at Yale School of Medicine, said. “I provide HIV care, and we all know many of these patients tend to be people who have long [been] in HIV care—it is typically not the newly infected.”

He says that these patients may have been diagnosed with HIV as children and now are adults or maybe they are older adults who had HIV for decades, and their ART regimens are less effective in keeping their HIV viral loads suppressed.

“Someone gave a talk today at CROI, [and the person] said that people don't fail drugs, but drugs fail people,” Ogbuagu said.

It is within this context, that treatment for these patients with multidrug resistance need an additional therapy to keep their viral loads down and prevent them from becoming vulnerable to other opportunistic infections.

There is a newer therapy, lenacapavir (Sunlenca), which has shown some promising data in addressing MDR HIV and as a potential complement to existing ART regimen in these aforementioned patients. Lenacapavir is a first-in-class, investigational long-acting HIV capsid that was 

 in late 2022 and is indicated for adult patients living with HIV, whose infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety consideration.

Lenacapavir is manufactured by Gilead, and at this week’s 

 in Denver, CO, new data was presented that demonstrated treatment benefits over a 2-year periodfrom the phase 2/3 CAPELLA trial evaluating the lenacapavir. Ogbuagu was at CROI, and is a principal investigator on the trial. 

CAPELLA is a double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir when administered every 6 months as a subcutaneous injection in heavily treatment-experienced (HTE) people with MDR HIV infection. The eligible participants had resistance to ≥2 ARVs in ≥3 of the 4 main ARV classes (NRTI, NNRTI, PI, INSTI).

The optimized background regimen (OBR) participants were selected by individual clinicians, and other investigational drugs were permitted for the study.

The investigators wrote that the OBR overall susceptibility score was the sum of susceptibility scores for each OBR ARV; 0 (no susceptibility), 0.5 (partial susceptibility) and 1 (full susceptibility) and efficacy was assessed at Weeks 26, 52, and 104. Lenacapavir and OBR ARV resistance analyses were done at virologic failure (virologic rebound ≥50 copies/mL or <1 log10 decline vs baseline).

There were 72 patients enrolled, and of them, 12 (17%) had no fully active antiretrovirals in their OBR; 6 of 12 and 1 of 12 had 1 or 2 partially active (score 0.5 each) ARVs, respectively. The investigators report the median (range) number of OBR ARVs was 4 (2–6). Overall, OBR comprised NRTI (9 participants), INSTI (8), PI (7) or NNRTI (6); 5, 2, and 2 participants were on a CD4 post-attachment inhibitor (ibalizumab), CCR5 inhibitor (maraviroc), or attachment inhibitor (fostemsavir), respectively.

The trial was conducted over a 2-year period, and Ogbuagu says this was about looking at the modality of subcutaneous injections as it related to safety, but also the long-term efficacy of the therapy.

“We found even as far out as two years or the so called 104 [week] data, that about 82% of individuals—when we excluded those who are missing— were virologically suppressed…that's unheard of numbers for this kind of patient population,” Ogbuagu said. “We have other studies with other agents that have shown lower rates of treatment success with these kinds of patients.”

spoke to Ogbuagu during CROI about lenacapavir's mechanism of action, more insights around the CAPELLA study, and the value he sees in the addition of this HIV therapy.

Ogbuagu O, Ratanasuwan W, Avihingsanon A, et al. Lenacapavir Efficacy IN CAPELLA Patients With No Fully Active Agents In Optimized Background Regimen. Poster #630 presented at CROI 2024. March 3-6, 2023. Denver, CO.

Examining a Newer Therapy for Heavily Treated HIV Patients

When treating a chronic condition, adherence to therapy remains paramount. For people with HIV, the advent of antiretroviral therapy (ART) has greatly extended and improved people’s lives, but it comes with its own set of challenges. For example, it has been reported that for people with HIV having to take a daily pill can be an ongoing adherence issue.

ViiV Healthcare developed its long-acting, injectable therapy, Cabenuva. It is a combination of Cabotegravir plus long-acting Rilpivirine, and it looks to adress the adherence issue as well as other challenges. Specifically taking a daily pill can remind people of the stigma associated with having the virus. In feedback with ViiV Healthcare, people with HIV preferred a long-acting therapy over a daily oral regimen.

“Roughly two thirds preferred the long acting regimen because they didn't have to carry their HIV medications with them like they would if they had a daily oral pill,” ViiV Healthcare CMO Harmony P. Garges, MD, MPH, said of feedback from patients. She also said simple things like having medication sitting out at home can lead to unintended privacy issues, especially if the person with HIV has not openly disclosed their status.  

At 

the International AIDS Society (IAS) Conference 2023

, ViiV Healthcare is presenting additional 12-month patient preference data from the phase 3 SOLAR study. According to investigators, the data showed that 90% of participants who switched to Cabenuva preferred the long-acting regimen to the daily oral pill, Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy).  Garges also pointed out that Cabenuva was found to be non-inferior to Biktarvy.

As well as leading to improved adherence, there were also emotional and psychological benefits—83% and 61% of participants respectively who switched said they preferred the long-acting treatment as it was more convenient for them or because it stopped them from thinking about their HIV status every day. More than half (59%) cited not having to worry that others may see their pills as a reason they preferred the injections.

According to ViiV, patient reported outcomes like treatment satisfaction and convenience are particularly important for understanding how people living with HIV feel about their treatment and care. 

spoke to Garges who offered further insights on the therapy and the study.




A new study being presented at the ongoing IAS conference showed that people with HIV found the injectable therapy, Cabotegravir plus long-acting Rilpivirine (Cabenuva) is more conducive to today’s lifestyles, reduced stigma, and improved adherence.  

Long-Acting HIV Injectable Preferable to Daily Oral Regimen

June 27 commemorates National HIV Testing Day, a day that encourages everyone to get tested for 

HIV testing is for everyone, explains Dr. Uri Belkind, regardless of sexual orientation, race, or gender. 

HIV / AIDS

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