Week Ending November 22, 2021

FDA In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II
“Today’s action allows manufacturers of certain types of Hepatitis C virus (HCV) tests to seek marketing clearance through the less burdensome premarket notification (510(k)) pathway rather than submitting a premarket approval application (PMA), the most stringent type of FDA medical device review.”

Direct-acting antiviral therapy correlates with lower risk of ESKD in patients with HCV
“When treated with direct-acting antiviral therapy, patients with chronic hepatitis C virus infection were at a lower risk for end-stage kidney disease and the composite of ESKD or death, according to a speaker at ASN Kidney week.”

Liver Cancer Risk Lingers Even After HCV Eradication
“Although the risk for liver cancer diminishes for patients with hepatitis C virus (HCV) infections for whom virus is eliminated with direct-acting antiviral (DAA) drugs, these patients are not out of the woods, and those who do not have a sustained viral response (SVR) are at substantially higher risk of developing hepatocellular carcinoma (HCC), results of a large study show.”

New York State sets plan to eliminate Hepatitis C fueled by opioid epidemic
“The New York State Department of Health has come up with a plan to eliminate Hepatitis C.”

Number of elderly on U.S. liver transplant list rising
“The proportion of U.S. elderly patients in need of liver transplant (LT) is sharply increasing, according to a study presented at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases, held virtually from Nov. 12 to 15.”