Govt Gave Millions To Top Reproductive Health Org To Promote COVID Vaccines To Pregnant Women

 by Megan Redshaw, J.D. via The Epoch Times (emphasis ours),

The premier professional membership organization for obstetricians and gynecologists accepted $11.8 million from the Department of Health and Human Services (HHS) to promote COVID-19 vaccines to pregnant women, despite the exclusion of pregnant women from clinical trials and regulatory data showing the vaccine had not been tested for safety during pregnancy.

To learn more about COVID-19 funding received by the American College of Obstetricians and Gynecologists (ACOG) during the pandemic and what prompted the organization’s guidance on COVID-19 vaccines for pregnant women, Dr. James Thorp, a board-certified obstetrician-gynecologist and maternal-fetal medicine physician made a Freedom of Information Act (FOIA) request in 2022 to HHS.

“My request was simple: It sought only to obtain documents involving the three ‘Cooperative Agreement’ grants HHS/CDC made to ACOG during the pandemic, one of which was for $11.8 million, listed on a publicly accessible open data source for federal spending, USASPENDING.gov,” Thorp told The Epoch Times.

Documents obtained by Dr. Thorp show ACOG, on Feb. 1, 2021, was awarded the first of three cooperative agreement grants by HHS and the CDC. The receipt of COVID-19 grant money was contingent upon ACOG yielding substantial control over projects funded by the CDC to the agency and ACOG’s full compliance with CDC guidance on COVID-19 infection and control.

“This is a cooperative agreement, and CDC will have substantial programmatic involvement after the award is made. Substantial involvement is in addition to all post-award monitoring, technical assistance, and performance reviews undertaken in the normal course of stewardship of federal funds,” the documents state.

ACOG also agreed to allow the CDC program staff to “assist, coordinate, or participate in carrying out effort under the award.”

The contracts further provided for the return of funding to the HHS if ACOG did not adhere to the federal government’s messaging that COVID-19 vaccines were safe and effective for pregnant women and new mothers.

HHS Funds ‘Trusted Messengers’ to Increase Vaccine Confidence

HHS, on April 1, 2021, launched the “COVID-19 Community Corps,” a “nationwide, grassroots network of local voices and trusted community leaders to encourage vaccinations,” with more than 275 founding member organizations, including ACOG, that had the “ability to reach millions of Americans.” An archived HHS webpage states the program provides resources and fact-based public health information through HHS in partnership with the CDC.

As part of the multibillion-dollar program, Vice President Kamala Harris and Surgeon General Vivek Murthy met with founding members to discuss the next phase of the “public education campaign from the White House” to encourage vaccinations and increase vaccine confidence.

Members received weekly updates on the “latest scientific and medical updates, talking points about the vaccine, social media suggestions, infographics, factsheets with timely, accurate information, and tools to help people get registered for an appointment and vaccinated.”

“As part of the COVID-19 Community Corps, HHS awarded billions of federal dollars to recruit what HHS referred to as ‘trusted community leaders’ who could push vaccines within our most private relationships,” Thorp said. “Much like modern-day trojan horses, these ‘trusted messengers’ would be unique in their ability to permeate all facets of private life.”

ACOG Encourages Members to ‘Enthusiastically Recommend Vaccination’

Former CDC Director Dr. Rochelle Walensky, on April 23, 2021, announced for the first time during a White House COVID-19 briefing the agency was recommending all pregnant women get vaccinated despite limited data on the safety of the shot, as pregnant women were not included in COVID-19 vaccine clinical trials.

Dr. Walensky said her decision was based on preliminary findings published in The New England Journal of Medicine on the use of COVID-19 vaccines during the first 11 weeks of the vaccine rollout.

“We know that this is a deeply personal decision, and I encourage people to talk to their doctors and their primary care providers to determine what is best for them and for their baby,” Dr. Walensky said.

ACOG, on July 30, 2021, along with the Society of Maternal Fetal Medicine (SMFM), began recommending COVID-19 vaccination in pregnancy.

ACOG, founded in 1951, is the leading organization representing physicians and specialists in obstetrical care, with over 60,000 members. ACOG sets the standard of care for pregnant women and obstetrician–gynecologists generally follow the recommendations made by ACOG, just as pediatricians follow the recommendations of the American Academy of Pediatrics.

The SMFM represents more than 5,500 individuals with additional years of formal training in maternal-fetal medicine, making them “highly qualified experts and leaders in the care of complicated pregnancies.”

ACOG’s former president, Dr. J. Martin Tucker, in a statement on the organization’s website, encouraged members to “enthusiastically recommend vaccination” to their pregnant patients and to emphasize the “known safety of the vaccines and the increased risks of severe complications associated with COVID-19 infection, including death, during pregnancy.”

“It is clear that pregnant people need to feel confident in the decision to choose vaccination, and a strong recommendation from their obstetrician–gynecologist could make a meaningful difference for many pregnant people,” Tucker added. “Pregnant individuals should feel confident that choosing COVID-19 vaccination not only protects them but also protects their families and communities,” he added.

Dr. William Grobman, president of SMFM, said experts in high-risk pregnancy should “strongly recommend” pregnant women get vaccinated and that vaccination is “safe before, during, or after pregnancy,” despite the absence of clinical trial data.

https://www.zerohedge.com/medical/government-gave-millions-top-reproductive-health-org-promote-covid-19-vaccines-pregnant

Biden officials ‘likely violated First Amendment’ in Big Tech COVID censorship efforts: appeals court

 The Biden administration likely infringed upon the First Amendment when it leaned on social media companies to remove false or misleading COVID-19 content, a federal court of appeals ruled Friday — narrowing a bombshell district court order that barred several officials and agencies from communicating with the platforms.

The White House, surgeon general, Centers for Disease Control and Prevention and the FBI “likely coerced or significantly encouraged social-media platforms to moderate content” and in doing so, “likely violated the First Amendment,” the New Orleans-based Fifth US Circuit Court of Appeals determined.

The three-judge panel, however, adjusted the scope of US District Judge Terry Doughty’s July 4 order, which had been temporarily stayed on July 14, removing officials from the National Institute of Allergy and Infectious Disease, the Cybersecurity and Infrastructure Security Agency and the State Department from the injunction. 

The appeals court called parts of Doughty’s preliminary injunction “vague and broader than necessary.” 

Doughty, a Trump appointee, had determined that the Biden administration likely colluded with Big Tech to censor protected speech during the COVID-19 pandemic and that the plaintiffs, led by the states of Missouri and Louisiana, were likely to succeed in their court battle.

His preliminary injunction restricted dozens of Biden administration officials and agencies from attempting to coordinate with social media giants to remove content.

US District Judge Terry Doughty determined that the Biden administration likely colluded with Big Tech to censor protected speech during the COVID-19 pandemic and that the plaintiffs were likely to succeed in their court battle.

The Fifth Circuit vacated nine of the 10 provisions in Doughty’s order that prevented Biden administration officials from “urging, encouraging, pressuring” or “inducing” social media companies from removing content, arguing that those requests do not violate the Constitution “unless and until such conduct crosses the line into coercion or significant encouragement.” 

Similarly, the appeals court determined that “following up with social-media companies” about content moderation, “requesting content reports from social-media companies” or asking platforms to “Be on The Lookout” for certain types of material does not violate individuals’ First Amendment rights. 

“There would be no way for a federal official to know exactly when his or her actions cross the line from permissibly communicating with a social-media company to impermissibly ‘urging, encouraging, pressuring, or inducing’ them ‘in any way,’” the judges wrote. 

“The injunction’s language must be further tailored to exclusively target illegal conduct and provide the officials with additional guidance or instruction on what behavior is prohibited,” they argued, modifying the language of the one provision left in place to bar only actions that “ coerce or significantly encourage social-media companies to remove, delete, suppress, or reduce, including through altering their algorithms, posted social-media content containing protected free speech.” 

“That includes, but is not limited to, compelling the platforms to act, such as by intimating that some form of punishment will follow a failure to comply with any request, or supervising, directing, or otherwise meaningfully controlling the social-media companies’ decision-making processes.”

The opinion was handed down by Circuit Judges Edith Clement, Jennifer Walker Elrod and Don Willett — all Republican appointees. 

The order is on pause for 10 days pending a Supreme Court appeal. 

https://nypost.com/2023/09/08/biden-officials-likely-violated-first-amendment-over-covid-court/

Proton beam therapy may shorten breast cancer treatment

 In a randomized trial, published in The Lancet Oncology, Mayo Clinic Comprehensive Cancer Center researchers uncover evidence supporting a shorter treatment time for breast cancer patients.

The study compared two separate dosing schedules of pencil-beam scanning proton therapy, the most advanced type of proton therapy known for its precision in targeting cancer cells while preserving healthy tissue to reduce the risk of side effects.

Survival rates for breast cancer continue to improve due to advances in diagnosis and treatment, leading to increasing emphasis on reducing the long-term toxicity of cancer treatment, including radiotherapy.

Prior to this study, all patients treated with proton postmastectomy radiotherapy (PMRT) had received a conventional 25- to 30-day course delivered five days per week over five to six weeks. The researchers hoped to demonstrate that condensing the course of proton beam therapy, a form of particle therapy that could spare the heart and lungs from radiation damage, may result in a similar side effect profile.

Eighty-two patients with indications for PMRT, many of whom had prior breast reconstruction, were randomized to either conventional fractionation (fractions of radiation dose) administered in 25 days, or a condensed 15-day hypofractionated schedule.

With hypofractionation, a larger dose of radiotherapy is delivered with each treatment, allowing all radiotherapy to be completed in just three weeks. The investigators found that both conventional and hypofractionated proton therapy resulted in excellent control of the cancer while sparing surrounding normal tissue. Further, complication rates were comparable between the two study groups.

"The study provides the first prospective data supporting the use of shorter-course proton PMRT, including in patients with immediate breast reconstruction, and the first mature results of a randomized trial in the field of breast particle therapy," says Robert Mutter, M.D., a radiation oncologist and physician-scientist at Mayo Clinic Comprehensive Cancer Center.

"We can now consider the option of 15 days of therapy with patients based on the similar treatment outcomes observed as the longer conventional course. Of note, the short course actually resulted in reduced skin side effects during and after treatment."

Importantly, the researchers noted that the new schedule spares patients additional inconvenience, cost, and other burdens associated with the longer regimen. As there are a limited number of proton therapy facilities in the United States and the world, Dr. Mutter adds that demonstrating the safety and feasibility of the shorter treatment course could result in greater access to proton beam technology for difficult-to-treat breast cancer cases.

The researchers say additional investigation into the optimal PMRT dose and fractionation is warranted. The team plans additional research, investigating the delivery of PMRT in as few as five days.

"Ultimately, our goal is to personalize radiotherapy based on tumor biology," Dr. Mutter says. "We want to identify the best possible radiotherapy schedules or drug-radiotherapy combinations to eliminate cancer while minimizing side effects."

More information: The Lancet Oncology (2023). www.thelancet.com/journals/lan … (23)00388-1/fulltext

https://medicalxpress.com/news/2023-09-reveals-proton-therapy-shorten-breast.html

Study: Vaping may render frontline immune cells unable to move to meet threats

 Inhaling vapor from an e-cigarette may be stopping frontline immune cells from working typically, as a new study shows that even moderate smoke exposure suppresses cell activity.

The findings are published in the Journal of Allergy and Clinical Immunology and suggest that inhaling e-cigarette smoke could be damaging neutrophils, the first line of defense in the human immune system. The findings are important as previous research has shown that damage caused to neutrophil by cigarette smoking can lead to long-term lung damage.

Researchers from the University of Birmingham took blood samples from healthy donors who had never smoked or vaped. The team then exposed neutrophils taken from the blood to 40 puffs of unflavored vape, which previous studies have shown is a low daily exposure; with half of the samples were exposed to nicotine-containing vapor while the rest to nicotine-free alternatives.

Results of the tests showed that in both the nicotine and non-nicotine groups, the neutrophils remained alive but were stuck in place, rendering them incapable of effectively tackling threats to the body.

Dr. Aaron Scott, associate professor in respiratory science at the University of Birmingham and lead author of the study said, "We found that after short, low-level exposure to e-cigarette vapor, the cells remain alive but can no longer move as effectively and are unable to carry out their normal protective functions. Interestingly, vapor from e-liquids which did not contain nicotine also had the same negative effects as vapor from e-liquids which did contain nicotine.

"E-cigarettes are a proven, lower harm, tool to help smokers quit smoking but our data adds to current evidence that e-cigarettes are not harmless and highlights the need for to fund longer-term studies in vapers."

Further experiments with neutrophils exposed to e-cigarette vapor suggest a build-up of a microfilament within the cells which are unable to re-arrange themselves properly is driving the suppression of the cells normal function.

Actin is usually found as small filaments within cells and rearrange themselves into a network to help a cell change its shape. This function is used by neutrophils so that they can move towards and surround threats to destroy them.

The team observed that there were high concentrations of the filament F-actin within the neutrophils that had been exposed to e-cigarette vapor, whether containing nicotine or not. The accumulation of the F-actin resulted in the immune cells being less able to move and function typically.

David Thickett, professor in respiratory medicine at the University of Birmingham, Clinical Lead for the University Hospitals Birmingham (UHB), NHS Foundation Trust, and a co-author of the paper said, "Neutrophils normally protect the lungs by moving from the blood to the site of possible harm before using a number of protective functions to protect the lung. The observed impact that e-cigarette vapor had on their mobility is therefore of significant concern, and if this were to happen in the body would make those who regularly use e-cigarettes at greater risk of respiratory diseases."

Professor Liz Sapey, director of the Institute of Inflammation and Aging at the University of Birmingham and honorary acute medicine and respiratory consultant physician at UHB, and a co-author of the paper said, "Smoking has a well-documented impact on neutrophils, and this study further shows the impact that e-cigarettes still have on the immune system. Neutrophils are heavily implicated in aging and chronic obstructive disease and their relationship with tissue damage, and the impact of vaping in suppressing neutrophil activity regardless of nicotine could have long term implications for health."

More information: Alice E. Jasper et al, E-cigarette vapour renders neutrophils dysfunctional due to filamentous actin accumulation, Journal of Allergy and Clinical Immunology (2023). DOI: 10.1016/j.jaci.2023.08.025

https://medicalxpress.com/news/2023-09-vaping-frontline-immune-cells-unable.html

Heart Failure Guidelines Update: What the ESC Got Right

 Hello. I'm Ileana Piña. I'm a professor of medicine at Thomas Jefferson University Hospital. This is my usual blog, except I am here from the absolutely beautiful city of Amsterdam, where the European Society of Cardiology (ESC) 2023 meeting has been going on.

SGLT2 Inhibitors for HFpEF and HFrEF

I'm going to review very briefly the 2023 focused update to the ESC heart failure guidelines. Theresa McDonagh was the first author of this and of the previous ESC or European guidelines. These are a little bit different than the American guidelines, which were presented in 2022. We know that we need an update. The Europeans have gotten ahead of us, and now we have the European update, which I find incredibly well written and it really highlights the areas that I think the takeaways are for the clinicians.

First, we have been seeing now for several years — since 2018 — the benefits of the sodium-glucose cotransporter 2 (SGLT2) inhibitors. Every time we lift the veil on something, there they are in a positive light. We have learned about heart failure with reduced ejection fraction (HFrEF) for both empagliflozin and dapagliflozin. There are very similar results. One population may be enriched with a little of this and a little of that, but the basic messages are the same. In HFrEF, both of these drugs improve outcomes and it happens quickly. You don't have to wait 1 or 2 years to see this. Within months, and actually within days, you start to see the curves split apart statistically.

The next logical ground was heart failure with preserved ejection fraction (HFpEF). The definition, when we started the HFpEF trials, was 45% or greater. I want the audience to realize that, in the midst of all these trials, we came out — we meaning the American Heart Association, the American College of Cardiology, and the Heart Failure Society — with the new definition of heart failure, which said that true HFpEF is 50% or greater. That in-between zone of 40%-50% or 41%-49% is mRF, or mid-range, what I call middle of the road. I think the Europeans have really emphasized that to us. I believe that those patients really behave much more like a HFrEF population.

Now that we have very positive findings with the SGLT2 inhibitors, both dapagliflozin and empagliflozin, in HFpEF — defined, as I said, as 40% or 45% or greater, not necessarily 50% —with excellent point estimates that just line up, one on top of the other. It doesn't matter if patients have diabetes or not; the results are exactly the same.

This has been so promising that I am not surprised that the Europeans elevated the SGLT2 inhibitors to a class 1A indication. In the US in 2022, we thought we were really way ahead by calling it a class 2A indication. Well, now it's a class 1A indication in Europe, and I have a feeling that the American Heart Association and the American College of Cardiology are going to start talking about an update because the data are so strong.

Now, we even have data on initiating these drugs in the hospital. EMPULSE was a very large trial, presented here, about the benefits of starting these drugs in the hospital. You do not have to wait until the patient is in the outpatient setting. You can start it in the hospital.

When? I have no specific day that I start it. I used to try to do a good diuresis first, get the patients somewhat decongested, and then start it. I don't want to deprive the patients of the benefits of these drugs that happen very early by waiting until the patients are in the outpatient setting.

In the United States, we've had some issues with coverage of some of these drugs. In my institution, we now have both on the formulary, and I pick the drug depending upon the patient's coverage. Medicare pretty much covers most of them. If the patient is older but not yet a Medicare patient, they may have a very large copay. I advise you to get your offices or your health system to look into this so that, when you give the prescription to the patient, whether they're leaving the hospital or are now in your clinics, they can actually get the drug.

Finerenone and Intravenous Iron

There is an additional recommendation in these guidelines for finerenone, the mineralocorticoid receptor agonist (MRA) that I've discussed before on this blog, that has some really promising data on type 2 diabetes with chronic kidney disease (CKD). They have called that a class 1A indication for finerenone. I think there is more to come.

One more: the iron deficiency. Giving intravenous (IV) iron actually does improve symptoms and quality of life. I have seen this in my own patients, so I have been very diligent at looking for iron deficiency.

It is a new era. We have more tools, obviously, for our patients. It means one more drug, and that's always a challenge. We've already been doing the pillars of care. This is the fourth pillar of care, but now with a class 1A indication.

Take a look. They're easy to read. Professor McDonagh is the first author, and I think they've been extremely well done.

I hope this helps, and I am looking forward to future blogs on perhaps some of the findings from this meeting.

I'm Ileana Piña, signing off. Have a great day.

Ileana L. Piña, MD, MPH, is a heart failure and cardiac transplantation expert. She serves as an advisor/consultant to the FDA's Center for Devices and Radiological Health and has been a volunteer for the American Heart Association since 1982. Originally from Havana, Cuba, she is passionate about enrolling more women and minorities in clinical trials. She also enjoys cooking and taking spin classes.

https://www.medscape.com/viewarticle/995808

GI Conditions May Predict Parkinson's

 Dysphagia, gastroparesis, constipation, and irritable bowel syndrome without diarrhea specifically predicted Parkinson's disease (PD) in a new study.

Early detection of these conditions might help identify patients at risk for PD, potentially prompting preventive strategies, the researchers suggest.

The results of previous experimental studies by the team supported the Braak hypothesis, which states that idiopathic PD originates in the gut in a subset of patients. However, no previous study had investigated a broad range of gastrointestinal (GI) symptoms and syndromes that might occur prior to a PD diagnosis.

Given their preclinical work, the authors were not surprised to find that certain GI syndromes were specifically associated with PD, even when compared with Alzheimer's disease (AD) and cerebrovascular disease (CVD), principal author Pankaj Jay Pasricha, MBBS, MD, of Mayo Clinic Arizona, Scottsdale, told Medscape Medical News. However, they were "impressed by the strength of the associations."

"Experts have known for a very long time that constipation is a potential risk factor for PD, so this study adds to the list of GI conditions that could potentially be risk factors," he said.

The study was published online August 24 in Gut.

Studies Converge

To determine the incidence of GI syndromes and interventions preceding PD, the investigators performed a combined case-control and cohort study using a US-based nationwide medical record network.

First, they compared 24,624 individuals with new-onset idiopathic PD with the same number of matched negative controls (NCs), as well as 19,046 people with AD and 23,942 with CVD to investigate the presence of preexisting GI conditions, which the researchers referred to as "exposures." Overall, the mean age was about 70, and about half of those studied were women.

Eighteen conditions covering the entire GI tract were investigated. These included achalasia, dysphagia, gastroesophageal reflux disease, gastroparesis, functional dyspepsia, paralytic ileus, diarrhea, irritable bowel syndrome (IBS) with and without diarrhea, intestinal pseudo-obstruction, fecal incontinence, Crohn's disease, ulcerative colitis, and microscopic colitis, as well as appendectomy and vagotomy.

All GI syndromes were significantly increased in the PD group compared with NCs (odds ratio [OR] > 1). However, only preexisting dysphagia (OR, 3.58), gastroparesis (OR, 4.64), functional dyspepsia (OR, 3.39), intestinal pseudo-obstruction (OR, 3.01), diarrhea (OR, 2.85), constipation (OR, 3.32), IBS with constipation (OR, 4.11), IBS with diarrhea (OR, 4.31), IBS without diarrhea (OR, 3.53), and fecal incontinence (OR, 3.76) produced ORs that were numerically greater than the upper limit of the negative exposures.

In addition, only gastroparesis, dysphagia, IBS with constipation, IBS without diarrhea, and constipation were specific for PD, compared with the AD and CVD groups (OR > 1). After correction for false discovery rate, though, gastroparesis and constipation did not remain significantly different compared with the AD and CVD groups.

Other preexisting GI conditions not only were significantly associated with PD but also showed strong associations with the AD and CVD groups.

To validate the case-control analyses, the team set up a complementary cohort study. Eighteen cohorts — each diagnosed with one of the GI conditions in the case-control analysis — were compared with their respective NC cohorts for the prospective risk of developing PD, AD, or CVD within 5 years.

Gastroparesis, dysphagia, IBS without diarrhea, and constipation showed specific associations with PD vs NCs, AD, and CVD in the cohort analysis. Their relative risks (RRs) vs NCs were 2.43, 2.27, 1.17, and 2.38, respectively.

Functional dyspepsia, IBS with diarrhea, diarrhea, and fecal incontinence were not PD-specific, but IBS with constipation and intestinal pseudo-obstruction showed PD specificity in both the case-control (OR, 4.11) and cohort analyses (RR, 1.84).

Appendectomy decreased the risk for PD in the cohort analysis (RR, 0.48), but neither inflammatory bowel disease nor vagotomy was associated with PD.

"This study is the first to establish substantial observational evidence that the clinical diagnosis of not only constipation but also dysphagia, gastroparesis, and IBS without diarrhea might specifically predict the development of PD, whereas other exposures were less specific," the researchers write.

However, Pasricha said, "there is no need for alarm." Clinicians should reassure patients that "the overall risk for developing PD is low. The overwhelming majority of patients with these GI conditions will never develop PD."

His team will be doing experimental work on the biological mechanisms that might explain the current study's findings. "In addition, the US National Institutes of Health has issued a call for proposals to perform research in patients that could help understand these associations better," he said.

Body or Brain?

The Parkinson's Foundation's National Medical Advisor, Michael S. Okun, MD, called the study "fascinating."

The findings "confirm many other studies showing that GI symptoms can precede a Parkinson's disease diagnosis," he told Medscape Medical News.

Although the study was designed to test the Braak hypothesis, "the dataset really cannot confirm or refute Braak pathology, which can only be accomplished with comparison to postmortem samples," he added.

"The raging debate in the field of body-first vs brain-first Parkinson's may be somewhat artificial, especially if we consider that Parkinson's is not one disease," Okun noted. "It will take clinical data, pathology, and the collaboration of many researchers to solve the puzzle."

"The Foundation continues to monitor all the advancements in the 'gut' Parkinson field," he said. "We do not recommend at this time changing the approach to clinical care based on this data."

No funding or competing interests were declared. Okun has no relevant disclosures.

Gut. Published online August 24, 2023. Full text

https://www.medscape.com/viewarticle/996013

Vir cut to Neutral by B of A

 BofA Securities has downgraded Vir Biotechnology Inc 

VIR-4.84%+ Free Alerts

 to Neutral from Buy with a price target of $14, down from $23.

Analysts Geoff Meacham, Charlie Yang, Susan Chor, Hao Shen, and Alexandria Hammond note that VIR's stock performance YTD has been lackluster, with a decline of 54%, compared to the NBI index's marginal decrease of 4% primarily attributed to disappointing influenza A and HBV data. 

However, the analysts maintain a positive outlook on Vir's antibody platform and recognize its long-term potential.

In terms of its pipeline, Vir encountered some challenges in 2023. However, it's worth noting that Vir is actively developing a next-generation flu antibody. 

Additionally, several upcoming Hepatitis B virus trial readouts are featuring various combination regimens over the next 18 months. However, these are unlikely to change investor sentiment materially.

BofA anticipates results for the Vir-2218 + Vir-3434 + PEG-INF (triple combo) with 24 weeks of treatment data in HBV (March Part B) in Q4 2023.

Insights from key opinion leaders suggest that the triple combo must demonstrate a substantial functional cure rate to achieve commercial success, ideally exceeding 40-50% clearance. However, functional cure data won't be available until Q2 of 2024.

Also, initial data from the SOLSTICE trial of VIR-2218 + VIR-3434 in the Hepatitis D virus is expected. The analysts will monitor this combination's efficacy, aiming for results comparable to Gilead Sciences Inc's 

GILD+2.79%+ Free Alerts

 bulevirtide, which achieved a response rate of 45-48%. 

https://www.benzinga.com/analyst-ratings/analyst-color/23/09/34363871/infectious-disease-player-vir-biotech-has-limited-near-term-upside-analyst-downgrad