Welcome to the Chronic Kidney Disease Insider Newsletter. If you are living with chronic kidney disease (CKD) on dialysis, have had a kidney transplant or are helping care for someone who is, this newsletter was created for you! The content is meant to keep you and/or a family member up to date on the latest information to help you manage your health now and in the near future in consultation with your physician.
In this month’s CKD Insider: New FDA EUA for COVID-19 prevention, AKF Disaster Relief Fund, FDA approval for drug to help kidney transplant recipients, Advocacy Alert and Fun Tip of the Day!
COVID-19 Prevention Medication
The FDA issued an emergency use authorization (EUA) for a new drug to prevent COVID-19 for certain individuals including immunocompromised kidney transplant recipients. What it is: A new long acting monoclonal antibody treatment, Evusheld from AstraZeneca, that is intended as a preventative measure for those that are not currently infected with SARS-CoV-2 nor have they had a known recent exposure. It is a long-acting treatment that can offer protection for months.
Why it is important: This treatment is approved for those with compromised immune systems due to a medical condition or those taking immunosuppressive medications, such as following kidney transplantation, that results in an inadequate immune response to the COVID-19 vaccines. The treatment is also available for those who have had an adverse reaction to a COVID-19 vaccine, or component(s) of the available vaccines, as an alternative to vaccination. Reference: FDA News Release: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals
Tornado Disaster Relief Help
American Kidney Fund provides emergency grants to kidney patients affected by tornados. Apply by Dec 31st. The American Kidney Fund (AKF) has activated its Disaster Relief Program to provide emergency grants to dialysis and post-transplant patients who were impacted by the devastating tornadoes on December 10 and 11. Emergency grants of $250 are being made available for dialysis and post-transplant patients impacted by the tornadoes in Kentucky, Arkansas, Illinois, Mississippi, Missouri and Tennessee. Disaster relief grants from AKF help patients replace lost medications and special renal diet foods, pay for temporary housing and transportation to treatment, and replace clothing and personal essentials lost due to the natural disaster or the need to evacuate without notice. Dialysis and recent kidney transplant patients who need emergency financial help should contact a social worker at their dialysis clinic for information on applying for aid or apply directly at gms.KidneyFund.org. Applications will be accepted until Dec. 31. Reference: AKF News Release
Your Fun Tip of the Day!
Do the Unexpected!
If your feeling like all you do is the same thing over and over again and that this pandemic will never end, you are not alone, we all are experiencing this at different times. One way to change your state - try something new, something completely different that you have never done before. It doesn't need to be something big or expensive, just something unexpected.
If you’re a girl who never colors her nails, treat yourself get them done or pick up a color or design you wouldn't normally use just for fun. If your a person who has never been interested in dancing take a dance class. Try drawing or painting if you never have. Try anything that is the opposite of what you normally do day to day to change it up! Have fun!
FDA approved first treatment for CMV infection after transplant
What it is: The US Food and Drug Administration (FDA) approved a new drug from Takeda Pharmaceuticals, LivtencityTM (maribavir), as the first treatment for Cytomegalovirus (CMV) infection in transplant recipients for both adults and children over the age of 12. Livtencity is an antiviral that blocks viral replication. A Phase 3 trial included 352 transplant recipients with CMV infection that was resistant to other antiviral drugs such as Ganciclovir, Valganciclovir, Foscarnet, and Cidofovir. In this trial, 56% of the patients who received Livtencity had undetectable viral DNA after the 8-week trial compared to only 24% of the control group. Livtencity received Breakthrough Therapy designation, which is an expedited development and review process given to therapies intended to treat a significant medical condition where early data indicate significant promise.
Why it’s important to you: CMV is an infection that is common in kidney transplant recipients and is often resistant to other antivirals. Livtencity reduces the effectiveness of other antivirals and so should not be used in combination. If you or a loved one is undergoing or has recently undergone a kidney transplant and experiences post-transplant infection symptoms such as fever, chills, and muscle aches, speak with your nephrologist about these symptoms. Livtencity is an option to treat post-transplant CMV infection.
References: FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs Approval is for Cytomegalovirus, a Type of Herpes Virus, FDA Breakthrough Therapy, Takeda News Announcement
Bipartisan bill aims to block payment cuts to office-based vascular access procedures that are set to take effect as of January 1st.
What it is: Bipartisan bill supported by Dialysis Vascular Access Coalition aims to block payment cuts to office-based vascular access procedures that are set to take effect January 1st.
The 2022 Physician Fee Schedule, set to go into effect on January 1st, includes another round of cuts for office-based vascular access care. If the cuts go into effect, payment fees will be cut for vascular access procedures conducted by interventionalists & surgeons.
Why it's important: These cuts are being opposed by The Dialysis Vascular Access Coalition and other advocacy groups. The Medicare Stability for Patients and Providers Act (H.R. 6048) sponsored by U.S. representatives Bobby Rush (D-Ill) and Gus Bilirakis (R-Fla) would prohibit some of the cuts proposed in the upcoming Physician Fee Schedule. This bill is supported by The Dialysis Vascular Access Coalition.
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