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Three Drugs Better Than Two (or One) in Cystic Fibrosis

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“A three-drug combination for a certain form of cystic fibrosis (CF) not addressed with other therapies met its efficacy and safety endpoints in a phase III trial, researchers said.

Elexacaftor, tezacaftor, and ivacaftor (Trikafta) together improved forced expiratory volume in one second (FEV1) and lowered chloride levels in sweat in CF patients with Phe508del-gating or Phe508del-residual function genotypes, relative to a control regimen of ivacaftor either alone (Kalydeco) or with tezacaftor (Symdeko), reported Peter J. Barry, MD, of Manchester University NHS Foundation Trust in England, and colleagues in the New England Journal of Medicine.”

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Heart Transplant: A Slightly More Level Playing Field Under New UNOS System

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“Recent changes to U.S. donor heart allocation were followed by a narrowing of racial disparities in listing and transplant, though much more work remains to eliminate inequality, researchers warned.

Black patients listed for cardiac transplantation in 2011-2020 were less likely than white peers to die while waiting (adjusted HR 0.88, 95% CI 0.78-0.98). However, they ultimately had lower odds of undergoing transplant (adjusted HR 0.87, 95% CI 0.84-0.90) and a higher risk of post-transplant death (adjusted HR 1.14, 95% CI 1.04-1.24), reported P. Elliott Miller, MD, of Yale School of Medicine in New Haven, Connecticut, and colleagues.”

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For 2 Ga. Couples, a Transplant Created an Unbreakable Bond: ‘We’re the Kidney Warrior Family’

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“Tia Wimbush and Susan Ellis were coworkers for years at Children’s Healthcare of Atlanta, and while friendly to each other at work, they rarely interacted in the large IT department. But in March, the two became bonded for life when Tia donated her kidney to Susan’s husband Lance, and Susan donated her kidney to Tia’s husband Rodney.   

It all began with a chance encounter in the company restroom, and an introduction through another woman at work who knew that Tia’s husband Rodney had experienced sudden kidney failure in 2019 and that Susan’s husband Lance, who had long battled the disease, was in the same situation. Soon, they began to share what Ellis calls “a connection of sisterhood” after learning both their husbands had end-stage kidney disease and were on dialysis.”

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FDA OKs New Drug for CKD-Related Pruritus

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“The FDA approved difelikefalin (Korsuva) on Monday for treating pruritus in chronic kidney disease (CKD) patients, Cara Therapeutics and Vifor Pharma announced.

Difelikefalin is a first-in-class kappa opioid receptor (KOR) agonist that targets the peripheral nervous system, according to the two companies. Administered as an injection (0.5 μg/kg three times per week), the drug is indicated for moderate-to-severe pruritus in CKD patients on hemodialysis — the first therapy approved in this setting.”

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Can Liver Donor Biomarker Predict Liver Transplant Rejection?

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“The biomarker, class I human leukocyte antigen (HLA) evolutionary divergence (HED), was tied to liver transplant rejection in adults and children, French researchers found.

In a retrospective study, adult-donor class I HED was associated with acute liver transplant rejection (HR 1.09, 95% CI 1.03-1.16) and chronic rejection (HR 1.20, 95% CI 1.10-1.31), in addition to 50% or greater ductopenia (HR 1.33, 95% CI 1.09-1.62), reported Cyrille Feray, MD, PhD, of the Hôpital Paul-Brousse in Villejuif, France, and colleagues.”

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U.S. on pace to top 40,000 transplants in a single year for first time

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“In just the first half of 2021, 21,061 organ transplants have been performed in the U.S. according to data from United Network for Organ Sharing (UNOS), which serves as the Organ Procurement and Transplantation Network under federal contract.

Organ donation from deceased donors is up 15% over last year. There were 900 more deceased donors — people who provided one or more organs to save and enhance the lives of others — between January 1 and June 30 of 2021 than there were during the same period in 2020. The drop in donors caused by the pandemic beginning in the middle of March last year was offset enough by high numbers early in the year that there were still 242 more donors in the first half of 2020 than in the first half of 2019.

Organ transplants from deceased donors are also up — by 11%. A total of 17,821 deceased donor transplants were performed in the U.S. in the first half of 2021 compared to 15,933 in the first six months of last year. 2020 marked the 10th consecutive record breaking year for organ donation from deceased donors and the 8th in a row for deceased donor transplants.”

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The Science Supporting the U.S. Case for COVID Boosters

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“U.S. health officials laid out the scientific rationale for a third dose of the COVID-19 mRNA vaccines for all U.S. adults on Wednesday, relying on published and unpublished CDC data, as well as a preprint study.

Overall, they said that there is evidence that vaccine effectiveness against infection — both symptomatic and asymptomatic — has been decreasing over time, but that protection against severe disease, hospitalization, and death remains relatively high.

In anticipation of further waning of immunity amid the ongoing Delta variant-fueled surge — which is posing additional challenges — pulling the trigger on booster shots could help the U.S. stay ahead of the virus, they said.”

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Kidney Transplant Outcomes Improved Over Past Quarter-Century

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“Things have looked up for U.S. kidney transplant recipients over the past few decades, according to a review article.

In adult kidney transplant recipients, the total number of transplants from living and deceased donors in the U.S. jumped from 45,008 in 1996-1999 up to 76,885 in 2016-2019, reported Sundaram Hariharan, MD, of the University of Pittsburgh School of Medicine, and colleagues.

This uptick was largely driven by a rise in the number of transplants from deceased kidney donors, from 29,823 in 1996 to 53,139 in 2019, they stated in the New England Journal of Medicine.”

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Equity means providing a transplant for every single patient that needs one

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“Recently, I joined UNOS President-Elect Jerry McCauley, M.D. at a meeting organized by the National Academies of Sciences, Engineering and Medicine (NASEM) focused on equity. We were honored to share UNOS’ work in this space and lend our voices to this vital national discussion – a discussion we look forward to continuing.

UNOS is acutely attuned to issues of equity. As the mission-driven non-profit serving as the nation’s transplant system, we work with our community partners to ensure equitable policies and outcomes in multiple ways, including:”

Read the full article, here.

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Pfizer-BioNTech COVID-19 vaccine becomes first to win FDA’s full approval, paving way for boosters, mandates

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“Eight months after authorizing the Pfizer-BioNTech COVID-19 vaccine for emergency use in the USA, the Food and Drug Administration issued its full stamp of approval.

Now that the companies’ detailed, so-called biologics license application has been granted, it’s likely that vaccination will be required by many companies, schools and other entities. 

Monday, President Joe Biden called on companies, nonprofit groups, government agencies and schools to “step up vaccine requirements that will reach millions more people.” 

Vaccinations allowed people in this country to stop worrying about diseases such as smallpox, polio, measles, mumps and rubella, he said, and vaccines can help do the same for COVID-19.”

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