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Thursday, December 2, 2021

Truepill preps launch of virtual COVID-19 service for oral antivirals

 Telehealth, diagnostics and pharmacy business Truepill will launch a new virtual care platform in the coming weeks that it says will provide “end-to-end” care for people with COVID-19.

The on-demand, online service will combine virtual consultations and next-day delivery of oral antiviral medicines – assuming those become available to patients in the US.

Closest to emergency use authorisation (EUA) and launch is Merck & Co and Ridgeback’s molnupiravir, which was narrowly backed by an FDA advisory committee yesterday, with Pfizer’s Paxlovid (PF-07321332/ritonavir) following closely behind.

Oral antivirals are highly anticipated because they could be given to patients at home and prevent them developing more severe symptoms, reducing the burden on hospitals during the crisis.

Truepill’s service consists of a landing page for patients that serves as a portal for sharing test results and symptoms, and a booking system for telehealth consultations. Any prescribed COVID-19 medication will be dispensed with overnight shipping or routing to a patient’s local pharmacy.

There will be on-demand patient support from the off, and Truepill also said it plans to add follow-up visits via telehealth early next year. It says the whole process from reporting symptoms to receiving the medicines should take 24-48 hours.

That’s crucial, as antiviral therapy needs to be administered early on in the course of infection to have an impact. In Merck’s molnupiravir trials, patients were only eligible for participation if they were within five days of symptom onset.

Truepill’s senior vice president for telehealth, Andy Rink, said that authorisation of oral antivirals “has the potential to significantly reduce the devastating impacts of the pandemic.”

However, he went on to say that in order for that to happen “there needs to be a system in place for rapid, mass distribution to impacted populations.”

Molnupiravir seems likely to be granted an EUA, despite a worrying fall-off in efficacy in its phase 3 trial, as it will be the only option for a few weeks at least.

The drug’s ability to prevent hospitalisations and death in mild-to-moderate COVID-19 patients at risk of severe disease fell from 48% midway through the study to 30% will additional follow-up. In contrast, Paxlovid’s trial showed an efficacy of 89%.

The latest venture isn’t Truepill’s first foray into COVID-19 care. Earlier this year it launched a COVID-19 wellness programme that combines testing, contact-tracing and digital healthcare tools aimed at the employer market.

Last month, the company closed a $142 million fourth-round financing that swelled its value into unicorn territory at $1.6 billion.

https://pharmaphorum.com/news/truepill-preps-launch-of-virtual-covid-19-service-for-oral-antivirals/

Virtual care companies rush to ease access to Covid-19 antivirals

 As two new antiviral pills for Covid-19 approach emergency authorization, experts are concerned that a lack of public health infrastructure — especially easy access to fast-turnaround testing and quickly filled prescriptions — will prevent them from making a meaningful dent in the pandemic.

“We know that these antivirals are going to have a window of opportunity where their effectiveness is optimal, and it can be difficult to get an appointment and get a prescription,” said infectious disease specialist Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

Virtual care companies think they could speed up the process of getting patients the antivirals in the three to five days from symptom onset when they are most effective. This week, digital health company Truepill announced it would soon launch a platform to support telehealth consultations, prescriptions, and next-day delivery of the new drugs, from Merck and Pfizer, when authorized. Carbon Health, which has both brick-and-mortar clinics and virtual care, plans to extend its acute Covid care program to include the oral antivirals. And direct-to-consumer company Ro says it has the capability to prescribe and deliver the drugs and expects to make them available through its platform.

“I do think there could be a great opportunity here to leverage all the telehealth that’s developed over the pandemic, and even was going on before the pandemic, to be able to get prescriptions into the hands of people much faster than the traditional route,” said Adalja.

But that opportunity hinges on all the rest of the pieces falling into place at the right time. For the pills to live up to their full potential, people need to be able to procure and pay for tests, receive their results quickly, and connect right away with a health care provider if they test positive for Covid.

If all those steps go according to plan, online platforms, by virtue of their distributed workforce of virtual providers, could get prescriptions in some hands faster while allowing Covid-positive patients to quarantine. When a patient enrolls in Carbon Health’s Covid-19 program online, “we make sure they have a thorough virtual assessment within 24 hours of showing symptoms,” said medical director of program development Aaron Weinberg, also national director of Carbon for Research. “The clock starts as soon as someone contacts us.”

Once patients meet with a Carbon Health provider and receive a positive test result, they might receive a prescription for monoclonal antibodies, a pulse oximeter to self-monitor their symptoms, or soon, an antiviral prescription.

Truepill is making an even more explicit guarantee of speed, with plans to offer its teleconsultation and delivery services as a plug-and-play tool for existing healthcare systems, providers, and payers, said Andy Rink, vice president of telehealth at Truepill. “We will basically allow any patient that has tested positive for Covid and qualifies for these medications under the [emergency use authorization] guidelines to get the medication within 24 hours,” he said.

How quickly digital pharmacies can get the antivirals to a patient’s door will depend significantly on supply. The drugs, like vaccines and other Covid-19 therapeutics, will be distributed state-by-state according to need. To ensure timely delivery after a teleprovider prescribes the drug, Truepill will arrange for access in one of two ways: shipping them overnight through one of the company’s own pharmacy centers, or arranging pickup or delivery from a retail pharmacy, using publicly available information to determine which locations have the drugs in stock. “We can take that information and get it to the provider at the point of that visit, so we can get it to the right location, the first time,” said Rink.

Truepill expects to complete its platform within two weeks, and is talking with groups that may implement it. “We have groups of providers that are interested in taking our existing solution and using it for their patients, even patients that have a primary care doctor already,” said Rink — primarily with the advantage of finding a reliable supply of the drug. They’re also talking with payers, employer groups, and existing direct-to-consumer companies.

Until those partnerships are solidified, it’s unclear what the impact will be on increasing access in underserved patient groups — particularly older adults and lower-income individuals, who are less likely to have access to or use telemedicine. Telehealth has also seen lower use among non-white, uninsured, and rural patients.

“I worry that we have this tendency to herald technological breakthroughs, while really setting ourselves up for breakdown in delivery to those who are going to need it most,” said Alyssa Bilinski, a public health policy expert at Brown University.

It’s possible that telehealth companies could, if not increase access for the most underserved patients, lighten the burden for some in-person providers or shorten wait times for certain patients. Direct-to-consumer pharmacy companies like Ro, Nurx, and Hims & Hers — many of which started by providing convenient online prescriptions for erectile dysfunction medications or birth control — have increasingly expanded their offerings, including Covid-19 testing, and added telehealth services. These companies could capitalize on their own network of teleproviders to support antiviral access, or deploy a platform like Truepill’s.

“Companies that have been successful doing it with other medications, lifestyle medications, I think they’re perfectly poised to do it,” said Adalja.

But each of these routes to digital prescription and delivery could run into obstacles. Not every virtual care network has teleproviders licensed in every state; someone looking for a quick prescription might hit a dead end when they realize a platform doesn’t serve them. And while platforms will typically require users to fill out an intake survey that asks questions about the antiviral drugs’ indications, patients with complex medical histories should be especially careful to make sure a new teleprovider takes any contraindications or potential drug interactions into consideration.

“Given their potential advantage in terms of access, one could see direct to consumer telemedicine companies playing a more substantial role,” said Mehrotra. “However I suspect that the vast majority of people will still turn to their usual PCP or go to a local urgent care or retail clinic.”

Primary care offices are capable of writing prescriptions after virtual visits, too, of course. In a study led by Michael Anne Kyle, postdoctoral fellow in the Department of Health Care Policy at Harvard Medical School, researchers found that many primary care offices offered testing and virtual visits during the pandemic. “But the wait times to get an appointment were usually outside the window … needed to start antivirals,” Kyle wrote in an email.

Rink said Truepill’s platform will allow users to order an at-home test online, but acknowledged that “given the five-day window, it’ll be hard to get all that done — get the test, get it delivered, have the visit, get the medication.” So patients who turn to virtual care companies for an antiviral prescription will likely have taken an at-home antigen test. That means the biggest beneficiaries of virtual platforms could be those who have had the means and ability to stock up on those tests. “We’re seeing a lot of people order tests ahead of time to have at home,” said Rink.

In a move to increase testing access, the Biden administration said it would soon require private insurers to reimburse Americans for the cost of rapid, at-home antigen tests. But access may still present a challenge for patients who don’t have the approximately $30 to pay for a test upfront, or for those who can’t find tests on shelves.

If telehealth is to play a role, then, it will have to be just one part of a systemic effort to enable access to rapid testing, diagnosis, and treatment with the new antivirals.

“So much less attention has been paid to the full cascade of steps,” said Bilinski. “That starts with educating people to get tested, then getting the test and the quick test turnaround, but then having to know that you want to seek a prescription, having some kind of consultation with someone who can prescribe, and then getting that prescription filled.” Any breakdown in that chain of events could be the one that keeps the pills from achieving their full impact.

https://www.statnews.com/2021/12/02/covid19-antivirals-carbon-truepill/

Twitter Slaps 'Unsafe' Label On American Heart Association mRNA Vaccine Warning

 Twitter has slapped an "unsafe link" warning on a study from the American Heart Association which found that mRNA vaccines dramatically increase risk of developing heart diseases from 11% to 25%.

As of this writing, when one clicks on the link in the below tweet...

This warning, which ZeroHedge followers are no stranger to, pops up, requiring one to click "Ignore this warning and continue" before they can proceed to the American Heart Association's website:

One Twitter user, however, noted that an "expression of concern" was filed over the AHA study, noting that there are "several typographical errors" and "no data in the abstract regarding myocardial T-cell infiltration" or "statistical analyses for significance provided."

That said, Twitter's warning says that the link was identified as being "potentially spammy or unsafe," and could contain:

  • malicious links that could steal personal information or harm electronic devices
  • spammy links that mislead people or disrupt their experience
  • violent or misleading content that could lead to real-world harm
  • certain categories of content that, if posted directly on Twitter, are a violation of the Twitter Rules

It's unclear as to which of these warrants the label. 

https://www.zerohedge.com/covid-19/twitter-slaps-unsafe-label-american-heart-association-mrna-vaccine-warning

United CEO estimates airline will see smaller financial hit from omicron than delta

 The chief executive officer of United Airlines during an interview with CNBC on Wednesday estimated that while the omicron variant might affect their bookings and revenue, the airline would ultimately suffer a smaller hit than it during the delta wave.

“We've said ... the recovery from COVID will never be a straight line ... Omicron is almost certainly — it's too early to really tell, but it's going to certainly have a near-term impact on bookings. Bookings are going to be lower than they otherwise would have been,” United CEO Scott Kirby told CNBC.

“But you know, I think this will be three steps forward, one step backwards. Delta was two steps forward, and one step back, and the next variable will be four steps forward and one back. We're much better at dealing with this as a society,” he continued.

Kirby estimated that the vaccines would likely be effective at curbing the spread of the new variant, and he noted that even though the airlines might see a small dip in revenue, “the dip will be much smaller than it was for delta.”

Kirby’s comments come as airlines determine how to tackle the emergence of the newly detected omicron variant, which has made its way into a number of countries within the span of days. Several countries have instituted travel restrictions to curb spread of the variant.

The first case of omicron found in the U.S. was detected on Wednesday in California. Health officials previously noted that the variant would likely make its way into the country given its prevalence in southern Africa, Europe and elsewhere.

Health officials have pleaded with Americans to get their vaccines if they have not done so already and to get their booster shots if they are eligible. 

"[T]he fact is that people should wind up getting vaccinated and boosted if they’re eligible for a boost. I keep coming back to that because that’s really the solution to this problem," President Biden’s chief medical adviser Anthony Fauci said at a White House press briefing on Wednesday.

https://thehill.com/policy/transportation/583878-united-ceo-estimates-airline-will-see-smaller-financial-hit-from

TSA extending mask mandate for domestic travel through March

 The Biden administration will extend the requirement that passengers on domestic flights, trains and public transportation wear face masks through mid-March amid concerns about the new omicron coronavirus variant.

President Biden will announce the policy on Thursday as part of a broader effort to combat the COVID-19 pandemic during the winter months.

The Transportation Security Administration (TSA) plans to extend the mask requirement through at least March 18, according to a White House fact sheet. The TSA last extended the mask mandate in August through January 2022.

Under the rules, individuals who do not comply with the mandate will face a minimum fine of $500 with repeat offenders facing fines as high as $3,000.

The Centers for Disease Control and Prevention currently recommends people wear face masks in areas of high transmission of the coronavirus. Public health officials have urged mask use, particularly in crowded indoor settings, especially in light of the new omicron variant.

The administration has not instituted testing or COVID-19 vaccine requirements for domestic travel, as it has for international flights, though officials have indicated such requirements are not off the table.

As part of Biden’s announcement on Thursday, the administration is also implementing stricter requirements for pre-travel testing for international travelers.

Under the new rules, international travelers coming into the U.S. will need to present a negative COVID-19 test within one day of the flight regardless of vaccination status or nationality, rather than the current policy of three days. 

https://thehill.com/homenews/administration/583943-tsa-extending-mask-mandate-for-domestic-travel-through-march

States Didn't Follow CDC Recs to Prioritize COVID Vaccine for Cancer Patients

 Nearly two-thirds of states did not follow CDC guidelines to prioritize patients with cancer for the COVID-19 vaccine, a researcher reported, thereby "risking unnecessary morbidity and mortality, as this population is particularly vulnerable to COVID-19."

While 43 states included cancer patients as a priority subpopulation for COVID-19 vaccination during the initial rollout, only 8 precisely defined a qualifying cancer diagnosis and just 17 states (34%) gave patients with cancer the same immunization priority as those ages 65-74, according to Rahul Prasad, MD, MBA, a radiation oncologist at the Ohio State University Comprehensive Cancer Center in Columbus.

The problem was most likely that the CDC's definition of high-risk medical conditions was too broad, he noted.

"Although the CDC recommended that all states consider people with significant medical conditions to have equal vaccination priority with people over the age of 65, we found that nearly two-thirds of states did not give equal vaccination priority to patients with cancer," Prasad said in a presentation at the Radiological Society of North America annual meeting.

"I don't think anyone intended to push people to the back of the line," Rahul stated. "The [prioritization] efforts were well intentioned."

While the presentation may seem out of place at a radiology meeting, imaging is a major part of the cancer care continuum, and the imaging community this year played an integral role in identifying certain side effects from COVID-19 vaccines, such as post-vaccine myocarditis or lymphadenopathy, and axillary adenopathy on breast imaging.

In March, the American College of Radiology released a a list of resources to help radiologists care for recently vaccinated patients during screening or diagnostic imaging studies.

For their study, Prasad and colleagues conducted a search of every states' COVID vaccination webpage through a keyword-based internet search in order to identify data on vaccination for cancer patients. They pointed out that "Finding detailed vaccination information required significant computer literacy, as it routinely required navigation through multiple webpage subdomains."

Elliott Fishman, MD, professor of radiology, oncology, and surgery at Johns Hopkins University in Baltimore, commented that when vaccine rollouts take place, "you should always make sure that you take care of the highest risk patients first. I think we would all be comfortable saying that. Obviously, cancer patients are high-risk patients, although not every cancer patient is at the same risk."

However, patients on active cancer therapy, and those who have just completed therapy, should get vaccine priority, stated Fishman, who was not involved in the study. Regardless of the cancer patients' age, "it would make all the sense in the world that those patients should be prioritized first," he added.

Fishman noted that because this was a retrospective study, "you could say that this is water under the bridge...I think what we have to do is to figure out what to do with the next wave, or the next disease, and put in place knowledge of what went wrong [with vaccine rollout] to make sure that next time, things go right."

Prasad explained that initial limitations in vaccine supplies forced the CDC Advisory Committee on Immunization Practices to make difficult patient-prioritization decisions. People ages 16-64 with high-risk conditions were grouped into the final part of the first phase, along with people ages 65 to 74. However, this group encompassed 129 million people nationally, leading many states to sub-prioritize, he stated.

"You could have someone diagnosed with breast cancer at age 40, who is now 55 [and] in remission, and wondering if they're eligible," Prasad said. "On the other side of the spectrum, someone newly diagnosed with low-risk prostate cancer may not be particularly immunocompromised if they haven't started treatment yet."

Prasad's group stressed that policy interventions in future waves requiring boosters, or in other pandemics, should ensure timely vaccination of vulnerable populations to better mitigate disparities.


Disclosures

Prasad disclosed no relationships with industry.

Fishman disclosed relationships with Siemens and GE.

VBI Vaccines scores first FDA vaccine nod just as hep B market is set to expand

 VBI Vaccines has toiled a while to earn its first FDA approval. But for the Massachusetts-based company, the timing may be perfect.

In gaining a green light for its hepatitis B shot, VBI is poised to take advantage of what figures to be a growing market. A month ago, a CDC advisory committee voted unanimously to strengthen its recommendation for hepatitis B vaccination, saying that those aged 19 to 59 “should” receive shots. The current guidance for adults is that they “may” get the vaccine and only those deemed at risk “should” receive it.

With the FDA blessing, PreHevbrio joins three other hepatitis B shots on the market—Dynavax’s Heplisav-B, GlaxoSmithKline’s Engerix-B and Merck’s Recombivax HB.

Already approved in Israel, PreHevbrio is differentiated from the others as a three-antigen vaccine. In a head-to-head phase 3 trial, PreHevbrio provided higher seroprotection than the monovalent Engerix-B.

“The feedback we’re getting is that this is clearly a highly effective vaccine, which is safe and well-tolerated,” VBI CEO Jeff Baxter said during an investor’s call. “And particularly, statistically, significantly, we are better in adults age 45 and over.”

The next order of business for VBI will be to receive endorsement from the Advisory Committee on Immunization Practices.

“Just getting that recommendation alongside (the others) is a very important first step,” Baxter said. “That creates a level playing field for PreHevbrio to compete against those vaccines.”

Baxter expects a nod from the ACIP to come before the end of the first quarter of 2022, provided that COVID variants don’t “hijack” the work of the committee, he said.

The FDA based its approval on two phase 3 studies showing PreHevbrio elicited higher rates of seroprotection compared with Engerix-B in subjects age 18 and older (91% vs. 76%) and 45 and older (89% vs. 73%). The safety analysis of both studies demonstrated good tolerability with no unexpected reactions.

Hepatitis B has infected more than 290 million people globally. HBV is the leading cause of liver disease and, with current treatments, is difficult to cure. Many patients go on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.

Low awareness of HBV leads to increased risk of transmission, with 68% of chronically infected adults unaware of their infection status. With adult vaccination rates remaining persistently low at around 25% for adults 19 and older, approximately 200 million adults are left unprotected.

The World Health Organization has established a goal of eliminating HBV by 2030.

Baxter said he expects the recommendation from the CDC will expand the market from $320 million per year in the United States to more than $500 million a year, with Europe and China likely to follow.

“We could be launching into a very hot market for the next several years,” Baxter said.

https://www.fiercepharma.com/pharma/for-vbi-vaccines-timing-right-as-fda-nod-for-its-hepatitis-b-shot-comes-as-market-set-to