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This article is sponsored by Gilead Sciences, Inc.
In this special sponsored episode from Gilead, I’m joined by Anu Osinusi, an infectious disease physician and Vice President of Clinical Research for Hepatitis, Respiratory, and Emerging Viruses at Gilead, to discuss navigating COVID-19 today. We look back on the early days of the COVID-19 pandemic and the development of treatments that helped get us to where we are today.
The first days: Navigating the COVID-19 pandemic
Like most of us, Dr. Osinusi remembers the first day she heard of COVID-19: December 2020 in an email about the mystery cases of pneumonia in the Wuhan district in China. Just a week later, these mystery cases were confirmed as a novel coronavirus, and Anu and her team at Gilead were off to the races.
“There were a lot of unknowns, but I think one thing that I was really proud of the team for is that we were never paralyzed by that fear, or the fear of the unknown,” Dr. Osinusi says, “We just kept pushing ahead, recognizing that if we could be part of the solution, we would want to be part of the solution.”
Gilead was one of the first pharmaceutical biotech companies to commit to addressing the pandemic, an accomplishment Dr. Osinusi credits to the company’s 30 plus years of experience and expertise in viral diseases.
COVID-19 treatment options available today
In terms of where we are today with COVID-19, Dr. Osinusi emphasizes the tireless efforts by researchers across the globe that have yielded what she defines as remarkable treatment approaches and guidelines for the disease.
These developments have led to COVID-19 vaccines, antiviral therapies, and immune modulators, including corticosteroid therapies. All these tools continue to play a critical role in the treatment of COVID-19 patients, especially those who are at the highest risk of complications or who are hospitalized for COVID-19.
On the topic of COVID-19 treatment, Dr. Osinusi emphasizes the importance of avoiding a one-size-fits-all approach when treating viral infections.
“I think rather than us touting one treatment as superior to the other, it’s important to explore how different drugs and medications can be used in tandem to enhance the effectiveness of each individual treatment, and customized for each individual patient,” Dr. Osinusi says.
Unmet needs in the COVID-19 landscape
Even today, there are still unmet needs in COVID-19 treatment.
Gilead continues to pursue multiple approaches to transform and bring to the fold innovative medicines and science into transformative therapies to really address the unmet needs that remain with COVID-19, such as treating immunocompromised patients.
“I think real-world evidence increasingly offers this really crucial information on how the treatment is working in the actual clinical settings, which can then be used to supplement the clinical trial results,” Dr. Osinusi says. “And then it also gives us insights to populations maybe that weren’t necessarily greatly represented in the early treatment trials, especially I would think, for instance, immunocompromised patients who continue to be at higher risk of severe disease from COVID-19.”
Looking ahead
“Even as we see this shift to this endemic phase of the virus, it’s not going away,” Dr. Osinusi says.
COVID-19 has evolved in many ways, including greater awareness and interest in Long-COVID and its impact on patients and providers.
“And so, for us, the patients they are our North Star, it’s a focus for us on the Gilead research and development team,” Dr. Osinusi says. “With that commitment, we’ve been working very closely with regulatory agencies across the globe as well as researchers and academia to really learn about the unmet needs that remain in COVID-19.”
Backed by a strong heritage in virology and research and development, Dr. Osinusi is confident Gilead is built to continue to address unmet needs in the COVID-19 pandemic, as well as future pandemics because as Dr. Osinusi puts it, the next pandemic is not a matter of if, but rather of when.
“We need to definitely stay extremely vigilant because I think as we’ve seen since the very start of the pandemic, many variant lineages have continued to emerge,” Dr. Osinusi says. “Each variant brings very different transmissibility or different disease outcomes severity. And despite the tremendous progress, the impact of what the future variants will bring remains unclear. So, I think it’s important for the field as a whole for us to keep optimizing, adhering to the treatment recommendations, prioritizing antiviral treatment for hospitalized patients at high risk, but also continuing to innovate.”
Anu Osinusi is an infectious disease physician and Vice President of Clinical Research for Hepatitis, Respiratory, and Emerging Viruses, Gilead.
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Transcript
Kevin Pho: Hi, and welcome to the show, where we share the stories of the many who intersect with our health care system but are rarely heard from. Subscribe at KevinMD.com/podcast. Today we have a special sponsored episode from Gilead. We welcome Anu Osinusi, an infectious disease physician and VP of clinical research for hepatitis, respiratory, and emerging viruses at Gilead. Today we’ll be discussing navigating COVID: why it still matters. Anu, welcome to the show.
Anu Osinusi: Thank you, Kevin, for having me.
Kevin Pho: Anu, you grew up in Nigeria, where viral hepatitis and other infectious diseases represent a sizable burden, and later cared for patients as a physician. How did your own background lead you to where you are today, and also help you prepare for the last three years?
Anu Osinusi: Thanks, Kevin. That’s an excellent question. So yes, I grew up in Nigeria, and I think for me, just seeing firsthand the significant burden of infectious diseases across every age group, whether you’re an adult or a child, viral hepatitis, tuberculosis, malaria, and just the significant morbidity, mortality, and the social and economic impacts of those diseases, where you also had very limited treatment options, I think really spurred not only a curiosity to try and solve for some of those problems but also this sense of purpose and impact on a larger scale.
And so I think for me, then moving over to the U.S., where you still see the same burdens from infectious diseases, just maybe with different socioeconomic determinants of health, but still a huge impact from HIV and viral hepatitis, really led me into this career that I’ve had as an infectious disease physician, as a clinician researcher, and also as a public health specialist. I think over the last few years, that’s come together nicely for me in my current role, where I work in drug development, trying to put together all these different interests to try and solve for a common good with a larger impact. And so I think in many ways that had helped prepare me for what has happened in the last few years.
Kevin Pho: At the start of the pandemic, everyone was working at breakneck speed to deliver antivirals and vaccines. Can you briefly tell us what it was like at Gilead during those frantic early days? What kept your team motivated?
Anu Osinusi: Yeah, now we all know a lot more about COVID-19, but when the world first heard about this novel coronavirus, there was very little known. In fact, there was nothing known. I recall the first time I heard an inkling about this was December 2019, when we got this email about the mystery cases of pneumonia in the Wuhan district in China, but nobody even knew that it was a coronavirus. I don’t think anyone was fully prepared for a pandemic, let alone for a newly identified virus.
But I think at Gilead, what our motivation was, was that we were determined to be part of the solution right from the start. There was a lot of uncertainty; there were a lot of unknowns. But I think one thing that I was really proud of the team for is that we were never paralyzed by that fear, or the fear of the unknown. We just kept pushing ahead, recognizing that if we could be part of the solution, we would want to be part of the solution. And so I think that was why we were one of the first pharmaceutical biotech companies to commit to addressing the pandemic, really relying on our 30-plus years of experience and expertise in viral diseases.
Kevin Pho: Can you elaborate on what kind of treatment options are available for patients who are hospitalized with COVID-19?
Anu Osinusi: Yes. So I think, as I stated earlier, there have been tireless efforts by researchers across the globe that have really yielded, I think, remarkable treatment approaches and guidelines in a very compressed manner, and I think the entire health system needs to be applauded for that. These novel approaches have really helped health care providers make the best decisions for their COVID-19 patients.
And I think it’s been multifactorial, right? So in addition to the lightning-speed development of effective and safe COVID-19 vaccines, you then have the antiviral therapies, and you have immune modulators, especially including corticosteroid therapies, that continue to play a critical role in the treatment of COVID-19 patients, especially those who are at the highest risk of complications or who are hospitalized with COVID-19.
Kevin Pho: How would you describe the current treatment landscape for COVID-19, especially with new and emerging variants? Are we where we need to be?
Anu Osinusi: I think we need to definitely stay extremely vigilant, right? Because I think, as we’ve seen since the very start of the pandemic, many variant lineages have continued to emerge. Each of them brings very different transmissibility or different disease outcome severity, and despite that tremendous progress, the impact of what the future variants will bring remains unclear. So I think it’s important for the field as a whole for us to keep optimizing, adhering to the treatment recommendations, prioritizing antiviral treatment for hospitalized patients at high risk, but also continuing to innovate.
I keep getting asked a lot, “Is COVID-19 over?” It’s like it’s done, and it’s not. I mean, I think there’s that misconception that it’s no longer an issue because we’re not seeing the height of the numbers that we definitely saw in the early days. I think we’re all thankful that the worst days of the worst pandemic in our lifetime, the worst pandemic in the last 103 years, are over. However, we still see substantial mortality and morbidity due to COVID-19, not only in the U.S. but in other parts of the world as well, and there is sometimes this lack of urgency to actually diagnose or treat people hospitalized with COVID-19.
I think when you look at the numbers, just last year, in 2022, COVID was actually still the fourth leading cause of death in the U.S. And I think many experts, including those at the Fred Hutchinson Cancer Center, where they actually see people who are a lot more immunocompromised, estimate that we will reach almost 100,000 deaths by the end of 2023 from COVID this year. So this level of mortality is honestly nearly three times higher than the average numbers of deaths that we see from influenza, even dating back to 2010.
So I think for us at Gilead, what we try to do is continue to innovate, driven by this relentless pursuit of safe and effective treatments against antiviral threats, not only COVID but including COVID. While I think there’s been a lot of progress, there still need to be more options for people who have COVID-19.
Kevin Pho: Can you speak to the benefits of antivirals in comparison to other treatments available, like corticosteroids?
Anu Osinusi: Thanks for that question. So I think our experience with COVID, and I think with other viral infections, highlights the importance of avoiding a one-size-fits-all approach when treating viral infections. I think rather than us touting one treatment as superior to the other, it’s important to explore how different drugs and medications can be used in tandem to enhance the effectiveness of each individual treatment, and customized for each individual patient.
I think the latest data and the guidance from the treatment guidelines support foundational antiviral intervention to help reduce that risk of disease progression, with the addition of steroids and other immune modulators to help mitigate the life-threatening inflammatory symptoms that are farther down the cascade of the disease. And so I think when you look at the NIH treatment guidelines, they encourage early intervention with FDA-approved antivirals for patients who are hospitalized due to COVID-19, particularly those at high risk of progressing to severe disease.
The guidelines also note that these FDA-approved antivirals should remain foundational treatment, with or without steroids and other immune-modulatory approaches, for people who have actually now progressed to severe COVID-19. That’s because steroids and those immune modulators are really designed to suppress the oftentimes life-threatening inflammatory symptoms that emerge from a wide array of conditions, including viral infections like COVID. But unlike the antivirals, the steroid treatments or the immune modulators do not target the virus itself. They do not target its function, but rather the subsequent cascade of inflammation that results from the viral replication and propagation.
I think as this body of evidence evolves alongside the treatment landscape and the options for patients, all health care providers need to ensure that each treatment decision aligns with the latest COVID treatment guidelines.
Kevin Pho: How does the timing of treatment impact the progression of COVID-19?
Anu Osinusi: Yeah, I think we’ve learned this over decades, and not only with COVID-19: With any viral infection, the earlier you treat, the better the outcomes. You reduce disease progression and prevent some of the complications that you see. And so I think when we look at the COVID-19 landscape as well, when you look at the many different trials examining the effectiveness of antiviral medications for COVID-19 patients, treatment is most effective when you initiate it early in the course of the illness. The severity of COVID-19 progression is often lessened as a result of the advantages of treating people early.
When you treat people early, what we see in the treatment course, even when they’re hospitalized, is that it has led to shorter hospital stays and shorter recovery times. This is because antivirals are designed to really slow viral replication, which begins when the patient is infected and continues largely through the disease course. So the earlier you treat, the better.
Kevin Pho: What role does real-world evidence play in the treatment of COVID-19?
Anu Osinusi: I think it plays a really important role, actually, and I think even more so than maybe we’ve seen with other diseases in the past. I think it’s very, very critical with COVID-19, really, when you think about not only the pace of how drug development was accelerated during that time frame, but also when you recognize that, as we said earlier, there are new variants, and the disease course itself keeps evolving. So it’s really important to continue to generate that data in the real-world space.
I think real-world evidence increasingly offers this really crucial information on how the treatment is actually working in the actual clinical settings, which can then be used to supplement the clinical trial results. I think what we’ve seen coming out of the real-world evidence is that it can tell us if treatments are working consistently across all these different stages of COVID-19 disease. And then it also gives us insights into populations that maybe weren’t necessarily greatly represented in the early treatment trials, especially, I would think, for instance, immunocompromised patients, who continue to be at higher risk of severe disease from COVID-19.
And so I think it’s been very useful during this pandemic, where not only are the treatments changing and the variants changing, but clinical care itself continues to evolve as we learn new things. And so that real-world evidence could actually outpace the new clinical trials and now actually assume increased, incremental importance. We also know that the field, our frontline health care workers and physicians, are really eager to see real-world evidence to guide their practice and to strengthen their treatment decisions in real time.
And I would say, for us at Gilead, we continue to pursue multiple approaches to transform and bring to the fold innovative medicines and science, into transformative therapies, to really address the unmet needs that still remain with COVID-19. And so, all of that being said, clinical trials and real-world data should be considered carefully in the context of all available data, looking at the type and the size of the data sets and making sure we’re examining the methodologies to mitigate confounding and bias. But I think they definitely play an important role.
Kevin Pho: You brought up immunocompromised patients. Go into more detail. How has COVID-19 impacted those who are immunocompromised, and does an unmet need still exist in these patients?
Anu Osinusi: I believe it actually does. And so I think, with the pandemic-era protocols, we saw that in May the U.S. started relaxing some of those protocols, when we approached the end of the COVID-19 public health emergency in May. However, what we see is that COVID-19 is still a concern for many people. You look at folks who are immunocompromised and other vulnerable populations, those on dialysis, and those with different stages of liver disease. What we’ve seen over the last few years, which is consistent with what we’ve seen in many other diseases, is that the disease course and the severity vary among patients depending on a wide array of factors, leaving all these gaps that cannot be filled by vaccinations alone, because even in those populations, the vaccine efficacy might also be different.
So while many people who contract COVID-19 experience mild to moderate symptoms, some individuals with COVID-19 continue to progress to severe, critical illness, and that’s borne out by the data that we’re seeing from all the different reports. Those are particularly elderly people, those who are over 65, people with immunocompromising conditions, including those with renal impairment, pregnant women, and those with other comorbidities. These severe and critical COVID-19 cases typically require hospitalizations. Oftentimes there might be ICU admissions, and they might experience really significant respiratory damage from lung tissue damage caused by the infection-induced inflammation.
Kevin Pho: You’re listening to a special sponsored episode from Gilead. We’re talking with Dr. Anu Osinusi, an infectious disease physician and VP of clinical research for hepatitis, respiratory, and emerging viruses at Gilead. Today’s topic is navigating COVID: why it still matters.
As we shift to the endemic phase, why is it important to continue researching and innovating treatments for COVID-19?
Anu Osinusi: Yeah, I think COVID has had this very transformative effect on the health care landscape, and it will continue to have that transformative effect. Even as we see this shift to this endemic phase of the virus, it’s not going away. It’s just going to be here with us to stay, like many other viruses. Many patients are still not being adequately treated, and I still believe the death rate is still too high. It’s more than what it should be.
So I think for us at Gilead, why we want to continue to have this impact in the COVID treatment space is really because we have this commitment. We made this commitment to emerging viruses more than a decade ago, recognizing that significant unmet need, and recognizing that we were uniquely positioned, based on our three-plus decades of experience in antivirals, to be part of the solution in making sure that there are more treatments for emerging viruses.
And so, just as we’ve done with COVID right from the beginning of the pandemic, that commitment for us is not going to wane, even as we shift to this endemic scenario. As we see COVID-19 evolving, with new variants emerging, and as experts continue to learn about this virus, we feel like it’s important to relentlessly continue to pursue new treatment options that will be made available to doctors to add to their treatment arsenal, not only for the current population of patients but even for a larger, broader population of patients as well.
Kevin Pho: Is Gilead studying long COVID, post-COVID complications?
Anu Osinusi: Yes. I think as we continue to learn about this disease, long COVID is a growing concern, not only in the treatment space but among health care providers and among patients as well. And so for us, with patients as our North Star, it’s a focus for us on the Gilead research and development team. With that commitment, we’ve been working very closely with regulatory agencies across the globe, as well as researchers and academia, to really learn about the unmet needs that remain in COVID-19.
Kevin Pho: And my final question, Anu: What are some of the take-home messages that you want to leave with the KevinMD audience?
Anu Osinusi: Yeah, I think, first of all, thank you again for the time today. As I’ve spoken about during our time here together, at the core of Gilead really is this really strong heritage in virology and R&D that is really built to continue to address our unmet needs in the COVID-19 pandemic. I would like to say that not only that, but we have also tried to be part of the solution for some of the biggest public health challenges that we’ve had over the last few decades, whether that’s HIV or hepatitis C. So for us, we continue to build on that really strong heritage.
And then I think, in terms of the disease, COVID-19, while people might not recognize it, continues to create a burden not only on patients, individuals, and their communities but on health care systems across the globe. It is essential for us to continue to refine our treatment management approach to help improve outcomes for patients. It’s essential that the treatment options that exist are used for the right patients at the right time, to really help achieve better outcomes and substantial decreases in health care resource use, with savings for countries and payers, and of course, ultimately, much better outcomes for patients.
And so, to also just recap the priorities for us at Gilead, pandemic preparedness is a key part of who we are at Gilead, because for us, and I think as an ID physician, it’s not a matter of if there will be another pandemic; it’s a matter of when. So as we look, as a society, to the future in the COVID-19 space, we continue to make commitments and investments in that pandemic preparedness space that would allow us to leverage our strong internal expertise, but also recognizing we can’t do this alone, the external partnerships that we’ve built over many decades, to ensure that we’re not only well placed as leaders in virology but also forward-facing and staying ready to be leaders in pandemic preparedness as well.
Kevin Pho: You’ve been listening to a special sponsored episode from Gilead. Our guest was Dr. Anu Osinusi, an infectious disease physician and VP of clinical research for hepatitis, respiratory, and emerging viruses at Gilead. Anu, thank you so much for your time and for coming on the show.
Anu Osinusi: Thank you so much, Kevin, for having me.
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