Preferred HIV treatment among patient populations is diversified; among housing-compromised persons, even more factors come into play.

As described in a new study presented at the 

International AIDS Society (IAS) 2021 Conference on HIV Science

 last week, homeless or people with unstable housing living with HIV provided varied feedback on care models preference, physician continuity needs, telehealth resourcing, and incentive-based care.

The findings, presented by Elizabeth Imbert, MD, MPH, associate professor at UCSF and clinical lead of the trial’s POP-UP Program at Ward 86 in San Francisco, suggest the need for more focused care toward the homeless HIV population.

In the second segment of an interview with 

 during IAS 2021, Imbert explained the observed populations’ HIV care preference particularities, such as that with Telehealth.

“I think one of the take-home messages from this is that folks who are homeless or unstably housed with HIV, during COVID-19, did not prefer telehealth, even when we said, ‘Someone can come to you,’” Imbert said. “To me, as a provider, that says we should keep our doors open, because these folks are vulnerable.”

Imbert also discussed the need for personable, tailored care from consistent caregivers dedicated to this HIV population.

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A discussion as to why people with unstable housing living with HIV may not prefer telehealth versus consistent in-person care.

Can We Provide Tailored Care for Homeless HIV Patients?

 last week showed COVID-19 severity risks were not more significantly associated with hospitalized people living with HIV.

The findings, presented by author Matthew S. Durstenfeld, MD, Assistant Professor of Medicine in the UCSF Division of Cardiology, dissented from previously-held beliefs that people living with HIV—particularly those receiving therapy—may be at a greater risk of COVID-19 severe illness or even death due to their status.

during IAS 2021, Durstenfeld discussed the early-pandemic uncertainty as to whether immunosuppressed patients on antiretroviral therapy would be compromised in COVID-19 risks.

“I think now we know that’s not the case—that we can treat people living with HIV, at least in the states where the vast majority are, I think we can treat just like any other person,” Durstenfeld explained. “They don’t need a special kind of observational status while we figure that out anymore.”

Durstenfeld additionally discussed the surprising lack of data available for the team’s research.

“The fact it took us including over 21,000 people to find 220 people living with HIV is pretty remarkable and speaks to the fact if people living with HIV were hospitalized at dramatically higher rates, then we would have expected that number to be higher,” he explained.

The risk of COVID-19 severity in people living with HIV may be less than previously anticipated.

Shifting COVID-19 Concerns in the HIV Community

New trial data from Merck showed investigative once-monthly 

 islatravir was associated with good tolerability and predominately mild adverse events versus placebo among patients at low-risk of HIV-1 infection, in 24-week, phase 2A trial data.

The findings, presented this week at the 

, alluded to the therapeutic potential of a longer-duration PrEP option among a broad patient population.

But ongoing phase 3 trials may better inform its absolute potential among other available PrEP.

during IAS 2021, study author Sharon Hillier, PhD, director of Reproductive Infectious Disease Research at UPMC Magee-Womens Hospital in Pittsburgh, discussed the 2 ongoing phase 3 studies for islatravir, in which the agent is being observed for HIV incidence versus available once-daily, fixed-dose marketed PrEP, as well as in populations such as men who have sex with men and transgender women.

As Hillier explained, the trials will help inform investigators as to whether a once-monthly PrEP is as good, if not better, than once-daily combinations.

“And ‘better’ can be a number of things,” Hillier explained. “Better at blocking HIV, or more tolerable, or easier to adhere to.”

Hillier also shared perspective on the aging HIV-risk population, and how research can continue to assure therapeutic prophylaxes are tailored to their needs.

Phase 3 trials for islatravir are underway. What are investigators considering with the Merck investigative drug?

Once-Monthly PrEP May Become a Viable HIV Option

In the country of Belgium, the provision of 

 therapy is currently mostly centralized within specialized 

 clinics. In order to help scale up the delivery of PrEP and to reach underserved populations, it is important to engage family physicians due to their broad range of person-centered healthcare.

Recently, investigators from the Institute of Tropical Medicine of Belgium, in collaboration with the University of Antwerp, set out to understand family physicians’ perceptions of their role in providing PrEP therapy.

Data from the study was presented at the 

11th International AIDS Society Conference on HIV Science.

For the study, the team of investigators initiated online discussion groups of family physicians. In total, there were 81 participants between November and January of 2021.

The participants also completed an online questionnaire which assessed socio-demographics and experience with sexual health.

Findings from the study showed that the majority of the respondents had little PrEp-related knowledge and exposure through their practice. However, it was observed that they were interested in receiving more information on the therapy.

Although the physicians agreed that identifying and referring high-risk patients was important, they disagreed about their perceptions of how to operationalize that role.

Additionally, most participants described a lack of clinical guidelines, absence of a formal referral mechanism, and perceived discomfort in proactively conducting sexual behavior risk assessments as main barriers to identify and refer clients for PrEP.

“Despite limited PrEP experience, Belgian FPs in our study clearly saw a role for them in linking clients to PrEP and in ensuring good-quality follow-up, particularly for clients not reached by specialized HIV clinics,” the authors wrote. “Providing additional training and creating FP-specialist collaborations were suggested to increase FPs' engagement.”

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Due to limited familiarity with providing antiretroviral medication, many participants were hesitant to initiate PrEP.

Increasing Family Physician Engagement with PrEP Therapy

 market is emerging as different medications and treatment options are being studied, there are 2 therapies that are Food and Drug Administration (FDA) approved currently: emtricitabine and tenofovir alafenamide (F/TAF), and emtricitabine and tenofovir disoproxil fumarate (F/TDF). Each of these medications are indicated for a once-daily oral regimen.

Investigators at Howard Brown Health in Chicago wanted to study real-world use patterns and HIV seroconversion for F/TAF and F/TDF.

Laura Rusie, ScM Director of Data, Evaluation, and Epidemiology, Howard Brown Health led the study and presented the oral abstract, Comparing Adherence to HIV PrEP Among New, Male PrEP Users Initiating F/TAF vs. F/TDF, at the 

“Because of the fairly recent approval of F/TAF, there is a need for real-world contemporaneous data comparing outcomes among users using these two different regimens,” Rusie said in her presentation. “This work aims to be among the first to use real-world claims data to analyze two outcomes: adherence and HIV seroconversions for each regimen.”

They study had a total of 1113 F/TAF users and 1961 F/TDF users who met the criteria. The investigators performed a retrospective analysis of data from medical and pharmacy claims. The study looking at adult males with their first PrEP prescriptions written between October 2019 through January 2020.

According to the findings—using multivariate analysis—the investigators found that at 180 days, F/TAF users had 1.67 higher odds of adherence as compared to F/TDF users. They also noted that adherence odds increased with older populations and those with private insurance.

When looking at seroconversion, rates were not statistically different, but there was a numerical difference. “F/TAF showed a numerically lower incidence of seroconversion at all time points compared to F/TDF,” Rusie explained in her presentation. The differences in seroconversion demonstrated rates of 1.24/100 person-years for F/TAF users, and 1.80/100person-years in F/TDF users.

 spoke with Rusie about her study, insights on upstream barriers to PrEP initiation, and what motivates people to stay engaged in their therapy.

Investigators wanted to study usage of F/TAF vs F/TDF in clinical practice and HIV seroconversion.

Evaluating Adherence of PrEP Therapies

 usage in men who have sex with men (MSM), and measuring event-driven usage vs daily dosing, the former increased and the latter decreased over a 1 year period.

The data from the study, Effectiveness and Medication Adherence of Daily and Event-Driven Pre-Exposure Prophylaxis Regimens among Chinese Men who have Sex with Men: a Real-world CROPrEP study was presented at the 

From December 2018 to October 2020, Chinese investigators offered PrEP to MSM with a self-chosen regimen of daily or event-driven TDF/FTC in 4 cities including Beijing, Shenyang, Chongqing, and Shenzhen.

The PrEP users were followed up with every 3 months up to 1 year. The investigators reported PrEP adherence by measuring the proportion of covered sex acts by PrEP.

In the study, 520 MSM chose using a daily dosing regimen and 503 decided upon an event-driven regimen. In addition, 507 other MSM were PrEP non-users. In terms of the 12-month follow-up, 88% of PrEP users and 89% of the non-users completed it. 

Contrary to what some might expect in thinking that daily dosing would have greater adherence, the results showed that event-driven regimens increased and people using daily dosing decreased. 

“The proportion of covered sex acts by PrEP increased over time in event-driven PrEP users (from 57% to 78%), while the opposite trend was observed in the daily group (75% to 72%),” the investigators reported.

Still the two regimens remain important. “This real-world study showed that PrEP can effectively reduce HIV risk among MSM,” investigators wrote. “Compared with the traditional daily medication regimen, the event-driven regimen has increased trend of medication adherence and a better HIV protective effect.”

Adherence for daily dosing decreased and event-driven PrEP usage increased in a Chinese study.

How Does Adherence of Daily Dosing vs Event-Driven PrEP Regimens Compare?

 pandemic brought an onslaught of stressors to many individuals, including people living with 

 (PLWH). The term that defines an individual’s positive adaption to stressors like the pandemic is called Resilience.

Recently, investigators from the Department of Surgical, Medical, Dental and Morphological Sciences at the University of Modena and Reggio Emilia, conducted a study which set out to understand the relationship between frailty and resilience and how it can impact quality of life.

The team of investigators conducted an observational study of PLWH attending the Modena HIV Metabolic Clinic. Using a 37-item frailty index (FI), they assessed frailty in 2019 prior to the start of the pandemic.

The score from the index was categorized as either fir or frail. Then, in January of 2021, they offered a set of electronic questionnaires, including the CD-RISC-25 for resilience and EQ-5D5L for QoL, to PLWH.

Findings from the study showed that out of the 575 respondents, the median age was 54.5 years with a median HIV duration of 24.3 years. Impaired resilience was associated with loneliness, but age, sex, HIV risk and duration were not.

Additionally, predictors for EQ-5D5L were phenotypes 'frail/non-resilient' and 'fit/non-resilient'.

“Resilience characterizes well-being of PLWH during COVID crisis, highlighting that this construct is complementary to frailty in the identification of clinical phenotypes with different impacts on relevant clinical outcomes including QoL,” the authors wrote. “Loneliness in PLWH requires further attention and dedicated interventions.”

Impaired resilience was found to be associated with loneliness. 

Resilience in People Living With HIV During the COVID-19 Pandemic

 pandemic hit, it caused significant interruptions in routine care services. A substantial amount of pressure was placed on 

 programs in Nepal due to mitigation efforts like social distancing and movement restrictions. Many people no longer had access to the in-person services that they were so used to.

However, Nepal had been delivering online HIV services for the past 5 years with the PEPFAR and USAID-supported LINKAGES and EpiC programs.

Investigators from EpiC Nepal 360, in collaboration with EpiC/FHI 360 in Washington DC, supported a dramatic shift toward virtual client support and online HIV service access during the COVID-19 pandemic to continue providing the necessary care.

They presented what they learned at the 

Between March and October of 2020, the investigators procured new devices and mobile data packages for workers and community based supporters so that they could ensure contact with key populations and people living with HIV.

New messages on HIV and COVID-19 prevention, care and treatment were delivered through virtual and online support services. Individuals were able to make online reservations through an upgraded portal.

Popular social media influencers were also contacted to promote treatment and care channels.

The investigators learned that 40,230 individuals received information on HIV and COVID-19 prevention through their virtual efforts, which was 5 times higher than the period between July 2019 and February 2020.

A total of 11,744 people living with HIV were reached virtually for treatment, monitoring and education support. Testing was conducted on 906 individuals, of which 141 were diagnosed with HIV.

Additionally, of those 906, 16% received positive results at a rate that was 3 times higher than the previous period.

“Our findings suggest that online approaches provided continued service access for key populations and PLHIV,” the authors wrote. “Institutionalizing virtual solutions in Nepal helped safeguard gains made in the HIV response from the ongoing COVID-19-related service disruptions and other future threats. Our experience helped facilitate formal adoption of online interventions in Nepal.”

Virtual support services were crucial for providing continued care and education.

Providing Online HIV Services During the COVID-19 Pandemic

Medical counseling remains paramount to offering education to the general public. Long considered one of the most 

 in their occupation, pharmacists have a unique opportunity to have health conversations with people and counsel them when appropriate.

 therapy is one area within HIV prevention that has been increasing overall, but still needs help in greater utilization amongst appropriate populations.

As of 2019, Kenya had 1.5 million people living with HIV, a 4.5% prevalence rate in adults aged 15-49, and 42,000 new infections, according to 

. With that country’ high prevalence, yet people dealing with issues of stigma and long wait times in clinics, public health officials were looking for other potential solutions in the possibility of understanding HIV-associated behaviors and offering another option for PrEP counseling.

Investigators in Kenya set up a pilot program where they engaged customers at four retail pharmacies who were there seeking sexual and reproductive health (SRH) services, such as family planning. These customers were screened for PrEP eligibility, use the PrEP RapidAssessmentScreeningTool(RAST), which is used in public HIV care clinics in Kenya.

From November 2020 to February 2021, 227 customers completed RAST so as to determine PrEP eligibility.

“The majority (80%) of clients reported some behavior associated with HIV acquisition risk,” the investigators wrote. “Over half of clients (55%) reported inconsistent condom use, more than half (51%) reported not knowing the HIV status of their sexual partner(s), and almost a third (28%) reported multiple sex partners.”

With these findings, the investigators believed there was an opportunity for pharmacies to play a role with PrEP utilization.

“The prevalence of behaviors associated with HIV risk was high among clients accessing SRH services at retail pharmacies in Kenya,” investigators reported. “These findings suggest that the delivery of PrEP at retail pharmacies has great potential to expand the reach of PrEP to populations at HIV risk in Kenya and similar settings.”

In a pilot project, customers were surveyed about HIV risk behaviors to gain further insights and assessed for potential PrEP utilization.

Screening for Potential PrEP Users at Retail Pharmacies

New phase 2A trial data suggest once-monthly pre-exposure prophylaxis (PrEP) islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, was generally well tolerated and associated with mostly mild adverse events versus placebo in patients at low risk of contracting HIV-1 infection.

The new 24-week data, presented by Merck at the 

 this week, also showed islatravir levels in peripheral blood mononuclear cells (PBMCs) remained above investigators’ pre-specified efficacy pharmacokinetic threshold at both 60 mg and 120 mg doses, 8 weeks following the final trial dose.

In an interview regarding the findings at IAS 2021, study author Sharon Hillier, PhD, director of Reproductive Infectious Disease Research at UPMC Magee-Womens Hospital in Pittsburgh, discussed the implications of a tolerable and potentially efficacious one-month PrEP.

“Bottom line, pretty stellar safety profile for this drug at either concentration,” Hillier said.

Hillier also discussed ongoing phase 3 trial assessment of islatravir for HIV-1 PrEP, the benefit of these findings toward prescriber confidence, and the role of emerging preventive agents in the evolving HIV response capability.

New 24-week findings from Merck highlight the potential of a 1-month PrEP option for low-risk patients.

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