Sickle cell patients and others who need long-term blood transfusions provided by clinical laboratories and others would benefit most from successfully lab-grown blood
Administering lab-developed red blood cells in humans in a clinical study conducted in the United Kingdom (UK) is being hailed as a significant step forward in efforts to supplement the supply of whole blood through the development of synthetic blood products. Of interest to those clinical laboratory managers overseeing hospital blood banking services, researchers were able to create this new blood product from normal blood pints collected from donors.
What caused this clinical study to gain wider attention is the fact that previous attempts to create synthetic whole blood products have proved to be unsuccessful. For that reason, this new research has raised hopes that lab-grown blood may be just around the corner.
The initiative, known as RESTORE, is a joint research project conducted by scientists from the UK’s:
According to the researchers, it is the first such clinical trial performed in the world. Partial funding for this clinical study was provided by an NIHR grant, according to an NHS press release.
Most hospital laboratories also manage a blood bank. Thus, this breakthrough will be of interest to many clinical laboratory managers and blood bankers who are concerned about the shortage of blood products. Plus, blood products are quite expensive. This research could develop solutions that both ease the tight supply of blood and lower the cost of these critical products while improving patient care.
“This research, backed by government investment, represents a breakthrough for patients and means treatment could be transformed for those with diseases including sickle cell,” said Neil O’Brien (above), Minister of State for Health, in an NHS press release. “Once again this shows the UK is leading the world when it comes to scientific innovation and collaboration while delivering high quality care to those who need it the most,” he added. If the lab-grown products prove clinically viable, medical laboratories in the UK may soon suffer less from a shortage of available blood. (Photo copyright: UK Parliament.)
Manufacturing Blood from Stem Cells
“This world-leading research lays the groundwork for the manufacture of red blood cells that can safely be used to transfuse people with disorders like sickle cell,” hematologist Farrukh Shah, MD, Medical Director Transfusion, NHS Blood and Transplant, told BBC News. “The need for normal blood donations to provide the vast majority of blood will remain. But the potential for this work to benefit hard-to-transfuse patients is very significant.”
The process of manufacturing blood cells starts with a normal donation of a pint of blood. The researchers then use magnetic beads to single out flexible stem cells that can become red blood cells. Those flexible stem cells are grown in large quantities in the lab and then guided to transform into red blood cells.
“This challenging and exciting trial is a huge stepping stone for manufacturing blood from stem cells,” said Ashley Toye, PhD, Professor of Cell Biology at the University of Bristol in the NHS press release. “This is the first-time lab grown blood from an allogeneic donor has been transfused and we are excited to see how well the cells perform at the end of the clinical trial.”
The process to create the lab-grown blood cells takes about three weeks, and a pool of approximately half a million stem cells can result in 50 billion red blood cells. These cells are then clarified further to reap about 15 billion red blood cells that are at the optimum level to transplant into a human patient.
“Some blood groups are extremely rare, to the point that only 10 people in a country can donate blood,” Toye told BBC News. “We want to make as much blood as possible in the future, so the vision in my head is a room full of machines producing it continually from a normal blood donation.”
Transforming Care for Patients Who Need Long-term Blood Transfusions
To date, only two patients have taken part in the clinical trial. Next, the researchers plan to perform two mini transfusions on 10 volunteers at least four months apart. One transfusion will contain traditional donated red blood cells and the other will consist of the lab-grown cells. This experiment will show which blood cells last longer in the body. The findings could ultimately allow a patient to receive fewer transfusions and prevent iron overload, which can be a side effect of blood transfusions.
“We hope our lab-grown red blood cells will last longer than those that come from blood donors,” said Cédric Ghevaert, MD, Senior Lecturer in Transfusion Medicine at the University of Cambridge, in the NHS press release. “If our trial—the first such in the world—is successful, it will mean that patients who currently require regular long-term blood transfusions will need fewer transfusions in the future, helping transform their care.”
More research and clinical trials will be necessary to validate the efficacy and safety of these lab-grown blood products. However, such a breakthrough could potentially revolutionize treatments for patients with blood disorders, complex transfusion needs, and rare blood types, as well as reduce healthcare costs and curb blood shortages.
At the same time, this technology would also contribute to expanding the supply of useful blood products, a development that would be welcomed by those pathologists and clinical laboratory professionals overseeing the blood banks in their respective hospitals and integrated delivery networks (IDNs).
As 3D printing technology gains acceptance with pharmaceutical companies, clinical laboratories could see increased demand for pharmacogenomic testing
Will physicians someday “print” prescription drugs for patients in-office? It sounds like science fiction, but research being conducted at the University College London (UCL) indicates the capability may be closer than we think, and it could bring about a new type of collaboration between clinical laboratories, ordering physicians, and pharmacies.
UCL’s new 3D technique, which it calls “volumetric 3D printing,” is intended to enable the pharmaceutical industry to tailor drug dosage, shape/size, and release to an individual patient’s needs and preference. A key element of precision medicine.
According to GlobalData Healthcare, 3D printing also can “significantly reduce cost, wastes, and economic burden as printers only deposit the exact amount of raw materials required.”
3D printing may enable pharmaceutical companies to address gender and racial disparities in prescription drug manufacturing through a developing technology that could have implications for clinical laboratory testing. Fred Parietti, PhD (above), co-founder and CEO of Multiply Labs, a technology company that develops robotics for precision medicine pharmaceuticals, told 3D Natives, “Currently, medications are developed especially for white adult men, which means that all women and children have an excessive prescription for their bodies. This fact underlines the importance of the advent of personalized medicines, as well as highlighting the individuality of each patient, since the error in the dosage of certain active ingredients can even lead to the malfunctioning of some treatments.” (Photo copyright: Multiply Labs.)
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Increased Demand for Pharmacogenomic Testing
Though 3D printing of prescription drugs is not directly in the clinical laboratory/pathology space, it is noteworthy because it shows how technological advancements are progressing that actualize the ability to deliver precision medicine care to individual patients.
In turn, this could increase physician/patient demand for pharmacogenomic tests performed by clinical laboratories. The test results would be used by treating physicians to determine proper dosages for their individual patients prior to ordering 3D-printed drugs.
Being able to provide medication tailored to patients’ specific needs could bring about a revolution in pharmaceutical manufacturing. If 3D printed prescription drugs become mainstream, the demands could affect the clinical laboratory and pathology industries as well.
How Far Are We from Mass Production of 3D Printed Drugs?
The first and only 3D printed pharmaceutical drug on the American market is Spritam (levetiracetam) an anti-epileptic drug developed by Aprecia Pharmaceuticals, according to Medical Device Network. It received FDA clearance under the name Keppra in 1999.
Headquartered in Blue Ash, Ohio, Aprecia’s patented ZipDose manufacturing process allows 3D-printed pills to hold a larger dosage and dissolve rapidly. They currently have the only FDA process-validated 3D printing platform for commercial-scale drug production. They are leading the way on this new 3D technology and others are following suit.
FabRx, a start-up 3D printing company developed by academic researchers in 2014 at the University College London, released its first pharmaceutical 3D printer for personalized medicine called M3DIMAKER according to LabioTech.eu. The system is “controlled by specialized software, allowing the selection of the required dose by the pharmacist according to the prescription given by the clinician,” the company’s website notes.
The technology also allows for additional customization of pills, including the application of Braille for visually impaired patients, and printing of Polypills, which combine more than one drug into a single pill.
Other company’s developing 3D printing of pharmaceuticals, according to LabioTech.eu, include:
Germany’s Merck: currently in clinical trials of 3D printing medication with the goal of reaching large scale production.
China’s Triastek: which holds “41 patents that account for more than 20% of global 3D printing pharmaceuticals applications.”
We are still far away from large scale production of drugs using 3D printing, but that doesn’t mean it should not be on clinical laboratory leaders’ radar.
The rise of 3D printing technology for precision medicine could lead to big changes in the pharmaceutical world and alter how patients, providers, and clinical laboratories interact. It also could increase demand for pharmacogenomic testing to determine the best dosage for individual patients. This breakthrough shows how one line of technology research and development may, as it reaches clinical use, engage clinical laboratories.
Studies could lead to new prognostic biomarkers and clinical laboratory diagnostics for cancer
Might fungi be involved in human cancers? Two separately published studies have found fungal DNA in various cancers in the human body. However, the researchers are unclear on how the fungi got into the cancer cells and if it is affecting the cancers’ pathology. Nevertheless, these discoveries could lead to utilizing tumor-associated fungal DNA as clinical laboratory diagnostics or prognostic biomarkers in the fight against cancer.
“The finding that fungi are commonly present in human tumors should drive us to better explore their potential effects and re-examine almost everything we know about cancer through a ‘microbiome lens,’” said Ravid Straussman, MD, PhD (above), a principal investigator at Weizmann Institute of Science and one of the authors of the study in a UCSD press release. These findings could lead to new clinical laboratory diagnostics and prognostic biomarkers. (Photo copyright: Weizmann Institute of Science.)
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Microbiome Key to Cancer Biology and Detection
To perform their research, the team examined 17,401 samples of patient tissues, blood, and plasma across 35 different types of cancers in four independent cohorts. They discovered fungal DNA and cells in low abundances in many human cancers.
“The existence of fungi in most human cancers is both a surprise and to be expected,” said biologist Rob Knight, PhD, founding Director of the Center for Microbiome Innovation and Professor of Pediatrics and Computer Science and Engineering at UC San Diego in a UCSD press release. “It is surprising because we don’t know how fungi could get into tumors throughout the body. But it is also expected because it fits the pattern of healthy microbiomes throughout the body, including the gut, mouth and skin, where bacteria and fungi interact as part of a complex community.”
The main highlights of this study include:
Fungi detected in the different cancer types were often intracellular.
Multiple fungal-bacterial-immune ecologies were detected across tumors.
Intratumoral fungi stratified clinical outcomes, including immunotherapy response.
Cell-free fungal DNA found in both healthy and cancer patients in early-stage disease.
Fungi found on the human body appear as either environmental fungi, such as yeasts and molds, and commensal fungi, which live either on or inside the body. Both are typically harmless to most healthy people and can provide some benefits, such as improving gut health, but they may also be a contributing factor in some disease.
The researchers found that there were notable parallels between specific fungi and certain factors, such as age, tumor subtypes, smoking status, immunotherapy responses, and survival measures.
“These findings validate the view that the microbiome in its entirety is a key piece of cancer biology and may present significant translational opportunities, not only in cancer detection, but also in other biotech applications related to drug development, cancer evolution, minimal residual disease, relapse, and companion diagnostics,” said Gregory Sepich-Poore, MD, PhD, one of the study’s authors and co-founder and chief analytics officer at biotechnology company Micronoma, in the UCSD press release.
New Clinical Laboratory Tests to Identify Fungal Species in Cancer
Researchers from Duke University and Cornell University uncovered compelling evidence of fungi in multiple cancer types and focused on a detected link between Candida and gastrointestinal cancers.
They found that “several Candida species were enriched in tumor samples and tumor-associated Candida DNA was predictive of decreased survival,” according to their paper.
Their analysis of multiple body sites revealed tumor-associated mycobiomes in fungal cells. The researchers found that fungal spores known as blastomyces were associated with tumor tissues in lung cancers, and that high rates of Candida were present in stomach and colon cancers.
The Duke/Cornell researchers hope their work can provide a framework to develop new tests that can distinguish fungal species in tumors and predict cancer progression and help medical professionals and patients chose the best treatment therapies.
“These findings open up a lot of exciting research directions, from the development of diagnostics and treatments to studies of the detailed biological mechanisms of fungal relationships to cancers,” said Iliyan Iliev, PhD, Associate Professor of Microbiology and Immunology in Medicine, Weill Cornell Medicine, and one of the authors of the study, in a Weill news release.
More research is needed to determine if fungal DNA plays a role in disease pathology or if its presence does not have any causal link.
“It’s plausible that some of these fungi are promoting tumor progression and metastasis, but even if they aren’t, they could be very valuable as prognostic indicators,” Iliev said.
The insights gleaned from these two studies will be of particular interest to microbiologists, clinical laboratory professionals, and anatomic pathologists. Additional research could answer questions about how and if fungi infect tumors and if such fungi is a factor that increases cancer risk and outcomes.
Technologies developed by Pääbo to sequence Neanderthal DNA are being widely used in many clinical laboratory settings, including to study infectious disease outbreaks
Pääbo is considered to be the founder of paleogenetics. This field of science studies the past through examination of preserved genetic material found in remains of ancient organisms. It was his development of pioneering technologies that allowed for the genomic sequencing of Neanderthal DNA.
“[Pääbo’s] work has revolutionized our understanding of the evolutionary history of modern humans,” said German electrochemist Martin Stratmann, PhD, President of the Max Planck Society for the Advancement of Science (MPG), in a press release. “Svante Pääbo, for example, demonstrated that Neanderthals and other extinct hominids made a significant contribution to the ancestry of modern humans.”
“The thing that’s amazing to me is that you now have some ability to go back in time and actually follow genetic history and genetic changes over time,” Svante Pääbo, PhD (above), director of the Max Planck Institute for Evolutionary Anthropology, stated in a news conference, Reuters reported. “It’s a possibility to begin to actually look on evolution in real time, if you like.” Development of modern clinical laboratory techniques for identifying and tracking disease outbreaks have already evolved due to these findings. (Photo copyright: Max Planck Institute for Evolutionary Anthropology.)
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Comparing Neanderthal DNA to That of Modern Humans
Back in the mid-1990s, Pääbo and a team of researchers decoded relatively short fragments of mitochondrial DNA of a Neanderthal male. They discovered through their analysis that the DNA from the Neanderthal varied considerably from the genome of contemporary humans. This validated the belief that modern humans are not direct descendants of the Neanderthals.
Pääbo’s research team found nearly all (99.9%) of the Neanderthal DNA they studied to be heavily colonized by bacteria and fungi. That required them to create solutions for assembling the short components of mitochondrial DNA like a huge puzzle.
To accomplish this, the team had to:
Work under clean room conditions to prevent the accidental introduction of their own DNA into their experiments.
Establish more efficient extraction methods to enhance the output of Neanderthal DNA.
Generate complex computer programs that could compare the ancient DNA fragments with reference genomes of both humans and chimpanzees.
“Neanderthals are the closest relatives of humans today” said Pääbo in the press release. “Comparisons of their genomes with those of modern humans and with those of apes enable us to determine when genetic changes occurred in our ancestors. In the future, it could also be clarified why modern humans eventually developed a complex culture and technology that enabled them to colonize almost the entire world.”
Pääbo’s team succeeded in reconstructing their first version of the Neanderthal genome in 2010. Their comparisons between the genomes of Neanderthal and modern humans proved that the two groups had produced common offspring about 50,000 years ago and that this genetic contribution did influence human evolution.
The genome of modern non-African people still contains about 2% Neanderthal DNA.
“We have found around 30,000 positions in which the genomes of almost all modern humans differ from those of Neanderthals and great apes,” Pääbo added. “They answer what makes anatomically modern humans ‘modern’ in the genetic sense as well. Some of these genetic changes may be the key to understanding what distinguishes the cognitive abilities of today’s humans from those of now extinct hominids.”
Those with Neanderthal DNA More Susceptible to Severe COVID-19 Infection
Pääbo’s research also found that Neanderthal DNA may have affected the immune systems of modern people. During the COVID-19 pandemic, his work verified that individuals who carry a gene variant inherited from Neanderthals are more prone to severe forms of the illness than those who do not have that gene variant.
“We can make an average gauge of the number of the extra deaths we have had in the pandemic due to the contribution from the Neanderthals,” Pääbo said in a 2022 lecture, Reuters reported. “It is quite substantial, it’s more than one million extra individuals who have died due to this Neanderthal variant that they carry.”
Pääbo’s research team continues to develop new methods for reconstructing DNA fragments that are even more biodegraded, and which present in smaller amounts. Their ultimate goal is to investigate even older DNA and genetic material that is scarce due to climate conditions.
The DNA technologies pioneered by Pääbo to sequence Neanderthal DNA are being used widely in many clinical laboratory and research settings today. They include forensic science and the ability to collect DNA from human remains hundreds of years old to identify infectious disease outbreaks and study how today’s human genome has adopted new mutations.
Epidemiologists warn that elderly and other individuals may be at high-risk for co-infection by strains of both SAR-CoV-2 and influenza
As of October, the influenza (flu) season has begun in North America. With the COVID-19 pandemic still prevalent, clinical laboratories must be prepared not only for increased demand for SARS-CoV-2 tests, but also for an increased number of orders for flu tests as well. In fact, virologists are sounding the alarm that some patients may present with an uncommon double infection of both viruses.
The potential for contracting the co-infection was dubbed “flurona” by the Israeli Outbreak Management Advisory Team in 2020. The Israeli Team coined the term flurona to describe the potential of contracting both COVID-19 and influenza after two young Israeli pregnant women were diagnosed with influenza and COVID-19. Since then, cases of co-infections have been confirmed in multiple countries around the world, according to The Washington Post.
The symptoms of influenza and COVID-19 are extremely similar. According to the Centers for Disease Control and Prevention (CDC), symptoms for both influenza and COVID-19 include fever, cough, chills, sore throat, and body aches. However, without a clinical laboratory test it is nearly impossible to distinguish one virus from the other.
Therefore, during this cold and flu season, clinical laboratory testing will be extremely important. And though co-infection with COVID-19 and the flu is rare, lab leaders should be on the lookout for spikes in testing.
“Co-infection is rare with COVID-19 and the flu, or COVID-19 and other types of infections that you might get as far as upper respiratory infections, because COVID-19 tends to take over,” Stephen McMullan, MD, a Mayo Clinic family medicine physician, told Mayo Clinic News. “Once COVID-19 is in your body, it’s going to be the predominant virus, but there are some rare cases where we have seen people getting both COVID-19 and the flu. So, it is possible, but it’s certainly not common.” Clinical laboratories should prepare for a spike in viral infections this winter that could indicate flurona. (Photo copyright: Mayo Clinic.)
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What Exactly Is a Flurona?
Although it is possible—albeit rare—to contract the flu and COVID-19 at the same time, flurona does not appear to be a “twindemic,” nor is it a distinct disease or a mutation of the two viruses, The Washington Post reported.
“The name seems to suggest that the viruses have somehow combined—and that’s not the case. It’s just that a person may get infected with two respiratory viruses at the same time or in short succession,” epidemiologist Judith O’Donnell, MD, Director, Department of Infection Prevention and Control, and Section Chief, Division of Infectious Diseases at Penn Presbyterian Medical Center, told an NPR affiliate in Pittsburg.
“It’s rare, but it’s not surprising that during a typical influenza season—which here in the northern hemisphere is right now during the winter months—that you will see multiple respiratory viruses circulating at the same time, and that people can get infected with more than one respiratory virus at the same time,” she added.
Though flurona may not be a hybrid virus, that does not mean it is of no concern.
“Although a low proportion of COVID-19 patients have influenza co-infection, the importance of such co-infection, especially in high-risk individuals and the elderly, cannot be ignored,” wrote the authors of a study published in Frontiers of Medicine titled, “COVID-19 and Influenza Co-infection: A Systematic Review and Meta-Analysis.”
Did COVID-19 Lockdowns, Social Distancing Cause Flurona?
According to the Washington Post, the US had record lows of influenza during the 2020-2021 flu season, however this was likely due to lockdown measures. With lockdown measures and social distancing even less prevalent this flu season, there is a risk of individuals being at risk for multiple respiratory viruses.
“We’re all a little bit more back together than we were a year ago,” McMullan told Mayo Clinic News. “The kids are back in school, and we have more events that people are attending, which could explain why we’re seeing flu cases rise.”
Thus, clinical laboratories should prepare for not only a higher number of flu tests, but also COVID-19 tests as well. That is because patients will not be able to distinguish which virus they are sick with based on symptoms alone. Further, because COVID-19 and the flu have similar symptoms, individuals may seek out multiple tests, or test for one virus and not the other.
McMullan asserts that a co-infection of the flu and COVID-19—though rare—is not impossible. For the best chance to avoid both diseases he suggests high-risk individuals “Get vaccinated against COVID-19, including your booster if eligible, and make sure to get your flu vaccine, continue to do the same strategies to protect yourself and others, such as wearing a mask in high-risk situations, washing your hands, and staying home if you feel ill.”
Meanwhile, clinical laboratory managers will want to track developments during this flu season. For example, flurona may be uncommon at this time, but emerging variants of SARS-CoV-2 and different strains of influenza might increase the number of patients diagnosed as infected with both COVID-19 and influenza.
These findings may be useful to clinical laboratory professionals when physicians want guidance in effective treatments for COVID-19 patients, particularly when there are concerns about a rebound of the infection
Drug interactions are a major concern for physicians and clinical laboratories. That is especially true given the push for nearly universal COVID-19 vaccinations and boosters. Now, a study conducted in Denmark may show that the use of Paxlovid as an antiviral drug to treat early SARS-CoV-2 infection could trigger drug-drug interactions (DDI) in some patients.
For clinical laboratory managers, insights into the issues associated with Paxlovid may be useful in helping client physicians diagnose their patients and anticipate possible negative drug reactions where other anti-viral drugs are involved.
Also of interest to medical laboratory leaders is the fact that the federal Centers for Disease Control and Prevention (CDC) in May released a Health Alert Network (HAN) Health Advisory about the potential for COVID-19 rebound after Paxlovid treatment.
COVID-19 Rebound, according to the CDC, “has been reported to occur between two and eight days after initial recovery and is characterized by a recurrence of COVID-19 symptoms or a new positive viral test after having tested negative.”
In an article she penned for STAT, Joan Susan Bregstein, MD (above), a pediatric emergency medicine physician and professor of pediatrics at Columbia University Irving Medical Center in New York, wrote, “Is Paxlovid worth it? The CDC advisory states in black, bold, and no uncertain terms that, despite the risk of rebound COVID, ‘Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease.’ But the definition of ‘high risk’ in this situation has been a moving target since the first days of COVID-19.” Clinical laboratory leaders can attest to the accuracy of that statement. (Photo copyright: Columbia University.)
Do Anti-Viral Drugs Interact with Other Medications?
Paxlovid is the retail name for a combination of two anti-viral drugs: nirmatrelvir and ritonavir. The medication for COVID-19 was developed by American pharmaceutical company Pfizer (NYSE:PFE) and received Emergency Use Authorization from the US Food and Drug Administration in August of this year.
The drug is taken orally for five days by people who test positive for the SARS-CoV-2 coronavirus to head off disease progression as well as serious illness, according to the CDC advisory.
But a “sizeable proportion” of elderly people are on medications that could interact with Paxlovid, Reuters reported.
“Two oral antiviral drugs—nirmatrelvir/ritonavir (NMV/r) and molnupiravir—have been approved for early outpatient treatment of COVID-19 to prevent severe disease. Ritonavir, contained in NMV/r is known to have significant DDI with several drugs frequently used by the elderly. This communication puts the problem with DDI with oral antiviral COVID-19 treatment into perspective,” the study authors wrote.
Their analysis of prescription data from Denmark residents found “extensive use of drugs likely to interact with NMV/r” as follows:
Anticoagulants (blood thinners): used by 20% of people over age 65 and by 30% of people over 80.
Statins (cholesterol-lowering medications): taken by 15% to 18% of people over 65.
Analgesics (for pain), calcium channel blockers (used to decrease blood pressure in patients with hypertension), or digoxin (used to treat heart conditions): taken by 20% of those studied.
In their paper, the researchers offered guidance to physicians. “Before prescribing NMV/r, the patient’s full medical history, including herbals and over-the-counter and recreational drugs, must be known and co-treatment carefully managed by the treating physician or by a specialist to avoid detrimental effects.”
However, one infectious disease specialist told Scientific American it may just take the elderly who were taking Paxlovid more time to completely get over COVID-19.
“Being of an elderly age and then having other risk factors—like diabetes, heart disease, kidney disease, or some sort of cancer—does put you at higher risk of rebound,” Aditya Shah, MBBS, Mayo Clinic Infectious Disease Physician and Researcher, told Scientific American.
That study’s researchers retrospectively reviewed 92 million electronic health records (EHR) from US patients. They found most people (11,270) had been treated with Paxlovid. However, 2,374 patients took molnupiravir, which also was granted EUA status by the FDA and is marketed as Lagevrio.
That COVID-19-rebound study found:
After nirmatrelvir/ritonavir (Paxlovid) treatment: 3.53% had rebound infections, 2.3% with rebound symptoms, and .44% were hospitalized.
After molnupiravir (Lagevrio) treatment: 5.86% had rebound infections, 3.75% with rebound symptoms, and .84% were hospitalized.
“Patients who took molnupiravir were significantly older and had more comorbidities than those who took Paxlovid,” the researchers wrote. “Results further suggest that rebound was not unique to Paxlovid and may be associated with persistent viral infection in some patients treated with either of these two antivirals. There has been more attention to COVID-19 rebound following Paxlovid treatment than molnupiravir, which may be attributable to more people being treated with Paxlovid,” they concluded.
Clinical Laboratories Can Guide Doctors
In an article she penned for STAT, titled, “Paxlovid Rebound Happens, Though Why and to Whom Are Still a Mystery,” Joan Susan Bregstein, MD, a pediatric emergency medicine physician and professor of pediatrics at Columbia University Irving Medical Center in New York, wrote of COVID-19 rebound, “My emergency medicine physician colleagues are seeing tons of it. Although people tend to think of medical care as something that is certain, it is actually a real-time experiment. Paxlovid, like a lot of COVID-19 care, is a reminder of this.”
Similarly, Mayo Clinic’s Shah acknowledged difficulty in identifying a COVID-19 rebound case. “You need real documentation of three tests—a positive, a negative, a positive—and clear documentation of symptoms—all symptoms gone, symptoms come back,” Shah told Scientific American.
Thus, clinical laboratories play a vital role in diagnosing and treating COVID-19 rebound patients, because that is what clinical labs do: test, document, and report. And as the study of the Danish population pointed out, doctors need guidance as they prescribe oral antivirals to COVID-19 patients who are on other drugs and at possible risk of drug-drug interactions.
