New Guidelines Good News for Kidney Disease Patients
- Revised KDIGO clinical guidelines highlight how sofosbuvir and other antiviral drugs have changed the treatment of hepatitis C and severe kidney disease.
- The guidelines now encourage kidney transplants from donors who had hepatitis C to organ recipients who do not.
- The authors believe the guidelines could increase the organ supply for kidney transplants and simplify treatment of hepatitis C.
Revised clinical practice guidelines from Kidney Disease: Improving Global Outcomes (KDIGO) highlight the impact sofosbuvir and other antiviral drugs on hepatitis C (HCV), curing the disease in many patients.
The new rules, published in the journal Annals of Internal Medicine, show the relatively new treatment has dramatically changed how clinicians approach kidney disease, kidney transplantation and liver biopsies.
“In the past few years, there has been an exponential increase in the amount of data from clinical trials and general clinical experience,” said Paul Martin, M.D., professor of medicine in the Division of Digestive Health and Liver Diseases at the University of Miami Miller School of Medicine and a contributor to the guidelines. “We felt it was appropriate to update the guidelines to include all this new information.”
A Change to Kidney Transplants
One significant guideline change encourages surgeons to use transplant kidneys from HCV-positive donors, which could dramatically increase the number of available organs. Before sofosbuvir, this practice would have been disastrous for most kidney recipients.
“Prior to 2015 and the introduction of powerful antiviral drugs, transplanting an HCV-positive organ into an HCV-negative patient would not go well,” said David Goldberg, M.D., a Miller School associate professor of medicine in the Division of Digestive Health and Liver Diseases and guideline contributor. “There was really no good way to treat them.”
That changed dramatically with the introduction of anti-HCV drugs. Dr. Goldberg co-authored a groundbreaking study in 2017 that showed these medications could effectively treat patients receiving HCV-positive kidneys. Since then, additional studies have proven these transplants are safe.
Non-invasive Approaches for Kidney Disease
The revised guidelines also encourage clinicians to use anti-HCV medications in patients with severe kidney disease.
“Since the advent of direct antiviral agents, there were concerns whether sofosbuvir-based therapies would be safe in people with severely decreased kidney function,” said Michael Cheung, Ph.D., KDIGO’s chief scientific officer. “Sufficient evidence has now demonstrated that these therapies are not only effective, but they can be safely used without dosage adjustment for people across all severities of kidney disease.”
Another guideline change allows clinicians to prescribe sofosbuvir without performing a kidney biopsy. Biopsies are unnecessary because the drugs are proven effective and the procedure would not necessarily improve care.
The new guidelines, in fact, encourage clinicians to use noninvasive techniques to measure HCV impact on the liver, again avoiding biopsies.
“That’s important because it was long thought that, if a patient already had cirrhosis due to hepatitis C and needed a kidney transplant, maybe they should have both organs replaced,” said Dr. Martin. “Now we know that, if a patient does have cirrhosis but their liver function is well-preserved, they’ll probably do fine just getting a kidney instead of kidney and liver.”
The authors believe the guidelines, last revised in 2018, will have an important impact on donor organ availability.
“The KDIGO guidelines increase the organ supply for kidney transplants, simplify hepatitis C management in this population and reduce the risk the disease will be transmitted in dialysis units,” said Dr. Martin. “Also, by treating infected patients, we’re reducing the risk of progressive liver disease and transmitting hepatitis C.”