Welcome to our series, 1 Big Question, which asks 1 question to the medical community and we get their feedback on an important infectious disease topic.

In this episode, our 1 Big Question is: Will PrEP have a prominent role and significant impact in HIV prevention?

We interviewed Gary Spinner, DMSc, PA, MPH, AAHIVS, medical director of the HIV/AIDS Program, Southwest Community Health Center, Randy Matthews, PhD, MD, senior principal scientist, Merck, and Carl Schmid, executive director, HIV+Hepatitis Policy Institute.

Check out our video to hear their insights.

Videos

HIV Stakeholders weigh on the future of PrEP. 

The Long-Term Prognosis of PrEP 

7:10 Jacinda Abdul-Mutakabbir, PharmD, MPH, AAHIVP

In this episode, our 1 Big Question is: One of the things that is being reported is that during the first year of the pandemic antibiotics were over prescribed. Do you agree with that assessment and do you think we are seeing a return to normal prescribing practices now?

We interviewed Priya Nori, MD, director, Antibiotic Stewardship, Montefiore Health System, Cornelius (Neil) Clancy, MD, associate professor of Medicine and director of the Mycology Program at the University of Pittsburgh, and Jacinda Abdul-Mutakabbir, PharmD, MPH, AAHIVP assistant professor of Pharmacy Practice at Loma Linda University School of Pharmacy.

As providers were challenged to care for patients with severe COVID-19 In the first year of the pandemic, antibiotic usage increased. Listen to clinicians talk about this specific challenge and how prescribing practices evolved over time.

Antibiotic Prescribing Practices During COVID-19

In this episode, our 1 Big Question is: Do you get the sense that the overall medical community understands the magnitude of the problem of antimicrobial resistance from a big picture standpoint?

We interviewed Cornelius (Neil) Clancy, MD, an associate professor of medicine and director of the Mycology Program at the University of Pittsburgh, David Hyun, MD, project director, Antibiotic Resistance Project, 

, and Guy Palmer, DVM, PhD, regents professor, Washington State University and committee chair on the  National Academies report, 

Combating Antimicrobial Resistance & Protecting the Miracle of Modern Medicine

Providers and key stakeholders weigh in on this significant topic.

What is the Medical Community’s Awareness on Antimicrobial Resistance? 

Venatorx Pharmaceuticals Cofounder and CEO Christopher Burns, PhD, likes to say he started the company with two other longtime friends, Daniel Pevear, PhD, senior vice president, Biology and Grants Development, and Luigi Xerri, PhD, senior strategic advisor and head of Scientific Affairs, at a well-known, corporate bakery and restaurant. The 3 pharmaceutical veterans laid the groundwork for the company there, which was started in 2010, and is headquartered in suburban Philadelphia, PA. The company name comes from the Latin word venator, which means hunter, and rx is the medical symbol for drugs.

Venatorx is a private, clinical-stage pharmaceutical company with a focus on multi-drug-resistant bacterial infections and hard-to-treat viral infections.

The current pipeline has 2 lead antibacterial clinical-stage therapies, which includes the intravenous therapy, cefepime-taniborbactam, that is in phase 3 trials and ceftibuten/VNRX-7145 which is in phase 1 trials. The company also has its VNRX-9945, which is a Hepatitis B virus inhibitor and is in phase 1. 

Earlier this month, they signed a research collaboration and license agreement with Roche to discover, characterize, and develop new small molecule inhibitors of the penicillin binding proteins in gram-negative bacteria focused on agents active against carbapenem-resistant 

Burns says they expect a readout of data for cefepime-taniborbactam by late February.

“If it makes it to the market, it will be the first agent to cover the 2 main sub classes of resistance for gram-negatives,” Burns said.

Burns recently presented a keynote speech at the World Antimicrobial Resistance Congress and one of the major themes of his speech was the debate on what innovation means in the development of antibiotics. He says there are 3 categories of drugs: new, first in-class; true innovation around known mechanisms; and copycat drugs.

He explains everyone wants the first, they don't understand the value of the middle category, and no one wants the third category.

“There has been a misunderstanding of what can be innovative versus what’s considered derivative,” Burns said. “I think part of that misunderstanding is that the world really doesn’t want copycat drugs.”

Pharmaceutical companies have been trying to develop new, first in-class antibiotics, says Burns, but he makes the distinction that improvements in current classes of therapies are treating people today.

Burns says that for gram negative infections there haven’t been any new, first in-class antibiotics in decades. And with bacterial infection resiliencies it is very difficult to make efficacious therapies that will last for a long time. And even in spite of this knowledge, drug development continues to look for new therapeutic agents.

“We have all been looking for something brand new: new classes of drugs; new targets; new mechanisms of action. For some of the key areas of need, which is in gram-negative infections, we have not been very successful.”

Still, Burns makes the point that therapeutic improvements in the beta lactam antibiotics have been saving people’s lives for nearly a century since the discovery of penicillin.

“Improvements in penicillin have been going on every year for almost the last 90 to 100 years,” Burns said. “And each time you improve penicillin into newer drugs that all bare the same beta lactam but have other new improvements you meet a patient’s needs. So while you are waiting for that brand new thing...the patient’s laying in a hospital bed and needs to look up and see the IV bag has something going into their arm that is going to cure them.”

And this mindset of finding innovative new agents is how the federal government wants to apply its incentives to pharmaceutical companies. “There is a policy making its way through Congress that could create a subscription model like Netflix, where the government will reward innovators in this space,” Burns said. “By this mistaken use of words like innovation, it can only be a brand new drug to qualify. If we haven’t had one in 60 years, you might have to wait another 60. So, you will have this pool of money that no one will be able to access if the future is like the past.”

 spoke to Burns about his company’s investigational therapies, and long-term plans, as well as his experience at the World Antimicrobial Resistance Congress.

CEO Christopher Burns spoke about their investigational therapy pipeline, the long view perspective for the company, and how the federal government’s use of the nomenclature innovation might actually hinder incremental improvements in antibiotic development.  

Venatorx Pharmaceuticals is Developing Therapeutic Improvements to Fight Gram Negative Bacterial and Viral Infections

Betsy Wonderly Trainor, Alliance Director for Combating Antibiotic Resistant Bacteria (CARB-X), sat down with 

 to discuss CARB-X’s mission and new sponsored projects.

Wonderly Trainor gave the presentation, “Innovative Technologies: Fighting AMR” at the 

2021 World Anti-Microbial Resistance Congress

 last week. During her talk, she highlighted various technologies in CARB-X’s portfolio.

Wonderly Trainor has a broad interest in infectious disease, and worked to support development and commercialization of drugs to combat viral diseases before joining CARB-X. She said there is a lot of overlap in the product development for bacterial and viral diseases.

“Antibiotic resistance is becoming more and more of a problem as the days go on, and so I think making sure that we’re planning ahead, and we have the tools that we need when we need them…hopefully to help prevent the problem from getting any worse.”

She said a primary function of CARB-X is “looking at the infrastructure that’s in place and how we can best leverage that for multiple disease areas.”

CARB-X is still in its first 5 years of funding and is currently in negotiations for future funding, and Wonderly Trainor said, “We are hopeful that the companies that are currently in the portfolio will be successful, and we will see a lot of novel technology coming out across the 3 pillars of antibiotics, preventatives, and diagnostics…I’m excited about some of the new initiatives that we might have coming out in the future.”

Betsy Wonderly-Trainor discusses CARB-X's mission to fund novel antibiotics, preventatives, and diagnostics in the fight against antimicrobial resistance. 

CARB-X Funds New Technologies to Combat Antimicrobial Resistance

As pathogens develop resistance to antibiotics and other therapies, we must turn to new solutions—or, as Leonard Friedland, MD, puts it, old solutions: vaccines. “The best treatment of a disease is to actually not have to treat it at all but to prevent it, and that’s the role of vaccines. Vaccines are, after 

, the most effective public health tool that’s ever been introduced,” Friedland said.

Leonard Friedland, MD, is the Vice President of Scientific Affairs and Public Health Vaccines at GlaxoSmithKline (GSK). Last week, Friedland gave a presentation entitled, “Vaccines as an essential tool in the fight against AMR” at the 

Friedland said both he and GSK are passionate about the development of vaccine to fulfill unmet medical need, describing antimicrobial resistance (AMR) as “a global health security problem” and “the silent pandemic.”

Friedland expressed concerns that if antimicrobial resistance continues, the practice of medicine will be under threat: “If we don’t have ways to treat infections, we won’t be able to do many of the things that are part of modern medicine, such as organ transplants, safe Cesarian section deliveries, the ability to treat common infections.”

Vaccines save lives, but Friedland says they are underappreciated. To ensure they remain at the forefront of preventative healthcare, Friedland follows the development of vaccines at GSK and beyond, encouraging the extension of bacterial and viral vaccines to drive down the use of antibiotics.

Friedland stressed that low- and middle-income countries will be most affected by continued AMR. “We all recognize through the COVID pandemic now how important it is to address access to care, equitably, for people all around the world…as we address this issue we need to make sure we’re thinking globally, not just locally.”

Dr. Leonard Friedland calls antimicrobial resistance “the silent pandemic,” and says vaccines are how we prevent it.

Prevention is the Best Treatment: Vaccines and Antimicrobial Resistance 

The city of Bridgeport, CT, has seen a great reduction in HIV incidence rates and one of its medical centers, The Southwest Community Health Center, has been steeped in HIV care and prevention with its adoption of the Ryan White HIV/AIDS Program and its PrEP counseling services. Southwest has 6 medical practices throughout Bridgeport and has an intimate understanding of the city’s citizens as it sees hundreds of patients on a daily basis.

Bridgeport is the largest city in Connecticut. It is a historic seaport city at the mouth of the Pequonnock River on Long Island Sound. The city is in the southwest portion of the state and only 40 miles from New York City. It was once an industrial manufacturing hub in the 20th century and experienced challenging times in the latter part of that century. In recent years, Bridgeport has been creating projects to redevelop and rejuvenate the city.

The city’s health care as it relates to HIV care has been a shining example of a grassroots approach that can spark positive outcomes. The area has seen a reduction in the number of HIV cases diagnosed, and also has a high percentage of people who have engaged in care for HIV.

The Bridgeport-Stamford-Norwalk metropolitan areas reported 83 new cases of HIV per 100,000 people in 2016, and saw a decrease in new cases with just 41 people being diagnosed in 2019. This reduction has been the greatest in a metropolitan American city being studied, according to 

In addition, 92.7% of people had a visit with an HIV health care provider within one month of being diagnosed with HIV and 80.3% of people diagnosed HIV who have received medical care for HIV.

HIV treatment specialist Gary Spinner, DMSc, PA, MPH, AAHIVS, is the medical director of the HIV/AIDS Program, and leads the Southwest Center's initiatives on 

Spinner makes the distinction about access and how it falls differently along racial lines. He says that although the majority of the patients he sees are Black or Latinx, more White patients are initiating PrEP.

Underutilization of PrEP has been a major issue, and Spinner says he would like to see more primary care providers engaging in conversations with patients about their sexual health.

In many medical settings, there might be just 1 PrEP prescriber, which means there are lost opportunities to engage many more patients in counseling on this form of HIV prevention, according to Spinner.

At Spinner’s center, they not only have a PrEP navigator to help with these conversations and get the right candidates into the treatment funnel, but there are providers across specialities at Southwest who are having PrEP conversations with patients and prescribing the therapy as well.

“One of the things I’ve really focused on is offering numerous trainings to my colleagues in primary care in my community health center, so I am no longer the sole prescriber of PrEP.

In terms of which patients should be considered for PrEP conversations, Spinner says it's about picking up on clinical cues.

“One of the things I try to impress upon all the prescribers is that patients come in and don’t necessarily even know PrEP is something that they want, but patients give us cues,” Spinner said.

Some of these clinical cues might include patients who want to be tested for HIV or sexually transmitted infections, according to Spinner. “If we don’t pick up on that [the cues] then we miss potentially an opportunity to really identify somebody’s risk.”

 spoke to Spinner about his conversations with patients around PrEP, his involvement in the 

 organization, how telemedicine can play a role in PrEP counseling, and how medical peers can further embrace PrEP.

How 1 provider is training medical peers to offer PrEP education and prescribe it.      

Stemming the Tide: Getting More Providers Involved in PrEP Counseling to Reduce HIV Infections

Despite being at high risk for HIV infection, only 1-2% of people who inject drugs use preventative 

Suzan Walters, PhD, is a sociologist who takes special interest in health disparities among stigmatized populations, such as injection drug users. “We have wonderful biomedical interventions, tools to treat, tools to prevent, such as PrEP…What I’d like to bring to the table is thinking of social responses and collaboration to prevent HIV,” Walters said.

Walters describes syringe service programs (SSPs) as spaces where injection drug users can receive care in a safe, hygienic environment free of stigma. SSPs are also important because they provide injection drug users with education about harm-reduction tools, such as PrEP.

, “PrEP Care Continuum Engagement Among Persons Who Inject Drugs: Rural and Urban Differences in Stigma and Social Infrastructure.”

Like the rest of us, Walters said, healthcare providers are not exempt from the influence of stigma, and specifically the negative stigma toward people who inject drugs. However, the stakes of PrEP provider stigma are much higher, as these biases could be preventing injection drug users from receiving lifesaving care.

Walters advocated for thinking about stigma on the individual, community, and structural levels. “My dream and hope for this work is for there to be some real-world impact,” she said.

Suzan Walters, PhD, is a Research Assistant Professor in the NYU School of Global Public Health, affiliated investigator at the 

Center for Opioid Epidemiology and Policy

This is the second of a 2-part interview with Suzan Walters, PhD. You can find the first segment of Walters’s interview 

, and the original coverage of Walters’s research 

Bias against injection drug users can inhibit them from receiving potentially lifesaving care, such as HIV pre-exposure prophylaxis (PrEP). Community-based responses like syringe service programs help combat this stigma.

Provider Stigma Can Prevent Injection Drug Users from Receiving HIV PrEP

According to the Centers for Disease Control and Prevention, “For both sexes, visits to a doctor or other health care professional increased with age, from 63.1% among men aged 18–29 years to 93.2% among men aged ≥65 years and from 82.4% among women aged 18–29 years to 94.3% among women ≥65 years.”

These statistics demonstrate that as people age, they seek professional medical help more frequently. Still, health communication remains vital for everyone at all ages, and for those people who are not currently engaged in medical care with a provider, they may be missing important information.

This also becomes a question of how people like to receive news and information. Certainly social media remains an important way younger people including millennials and Gen Z get the majority of their information and news.

“I can’t overstate the importance of social media for reaching folks who otherwise might not hear our messages,” Fenway Health’s Content Creation & Social Media Manager Bren Cole, said. And social media has morphed so that different age groups gravitate to different social networks, Cole explained. 

Another communication platform that is an emerging medium is podcasts. They are a place where people can listen in on conversations and learn about specific topics from experts. The medium is another complementary way health information is disseminated to the general public.

Podcasts are being utilized by younger people, and according to one 

 of listeners, 49% of monthly US podcast listeners are aged between 12-34, 40% between 35 and 54 years old, and 22% are aged over 55.

One of the nice features associated with podcasts is the ability to search specific topics listeners might be interested in. For example, Fenway Health’s Pride in Our Health examines issues related to HIV and 

, transgender health, and racial disparities. They speak to both people in the local community in Boston and their medical experts.

Cole is the host and producer of the podcast, and in addition to the aforementioned topics, podcast shows feature the clinic’s specialties and the research at the Fenway Institute.

Another distinction for podcasts is that they are first-person storytelling detailing people’s experiences. In fact, Cole really enjoys giving a voice to different types of people.

“I love to have conversations with folks, and hearing their stories is such an incredible opportunity to continue the tradition of oral history.”

 about how Fenway is communicating the messages of PrEP and HIV to the local community, addressing some common health challenges in the delivery of care of the LGBTQIA+ community, and what she enjoys about the podcasts.

1. QuickStats: Percentage of Adults Aged ≥18 Years Who Have Seen or Talked to a Doctor or Other Health Care Professional About Their Own Health in the Past 12 Months, by Sex and Age Group — National Health Interview Survey, United States, 2015. MMWR Morb Mortal Wkly Rep 2017;66:65. DOI: 

http://dx.doi.org/10.15585/mmwr.mm6602a12External

Fenway Health’s Pride in Our Health podcast is an example of new voices being heard, and an alternative means of getting health information to the general public. 

Podcasts: An Emerging Communication Medium for Storytelling, Disseminating Health Information 

On Tuesday, Gupta presented research entitled “Surveillance of multi-drug resistance organisms in India: Current work and why it matters,” at the World Anti-Microbial Resistance Congress.

Any discussion of antimicrobial resistance (AMR) would be incomplete without taking India, the world’s second most populous country, into consideration. Gupta explained that India has a very complex healthcare system, and is the world’s leading consumer of antimicrobials.

Gupta’s research found that the proportion of resistance to leading antibiotics (such as carbapenems) is 20 times higher in India than in the US. This large number of people and proportion of people with resistance has led to AMR becoming a cause of morbidity and mortality in adults and children.

Gupta discussed the many AMR questions that are still unanswered, including where these highly drug-resistant pathogens are coming from, and what can be done to prevent more resistance from emerging. AMR could be a result of people colonizing their gastrointestinal tract and carrying the bacteria. However, it may also be caused by one’s environment, water, food, or all the above. Beyond questions of etiology, Gupta said, “We want to have really good, robust surveillance systems in place so we can detect more readily and contain any new highly resistant variants.”

Amita Gupta, MD, is a Professor of Medicine and International Health at Johns Hopkins University. She received her MD from Harvard Medical School in 1997, and her MHS from the Johns Hopkins Bloomberg School of Public Health in 2006.

India is the world’s leading consumer of antibiotics, and Amita Gupta, MD, is researching how the country can best mitigate the spread of antimicrobial resistance.