FDA Links Serious Liver Injury—in Rare Cases—Linked with HCV Drugs

During the last week of August, the United States Food and Drug Agency (FDA) warned that three direct-acting antiviral drugs have been linked with rare cases of severe liver injury among patients who are presently being treated for chronic hepatitis C viral infection.  

So far, the FDA has been able to identify 63 cases of liver decompensation—including but certainly not limited to liver failure and death—among patients who have been, and are being, treated with glecaprevir/pibrentasvir, elbasvir/grazoprevir, and sofosbuvir/velpatasvir/voxilaprevir.  You may know these treatments by their drug brand names Mavyret, from AbbVie, Zepatier, from Merck & Co, and Vosevi, from Gilead, respectively. 

Each of these cases have been reported to the FDA Adverse Event Reporting System (FAERS) database, or have been identified in appropriate medical literature through January 8 of this year. 

All three of these drugs have been approved for the treatment of chronic HCV infection in patients who do not have mild-to-moderate liver impairment. However, the study found that these cases do appear to be concentrated among patients who had evidence of more advanced liver disease; at least, at the baseline.  

At the same time, they also found that some of these cases occurred among patients who had been incorrectly classified as having no cirrhosis or compensated cirrhosis with only a mild liver impairment before receiving treatment but also had evidence of more severe liver disease. This includes traits like decreased platelet level, portal hypertension, alcohol abuse, or other serious medical conditions typically associated with serious liver issues. 

Essentially, these next-generation hepatitis C medicaitons tend to cure the disease relatively quickly and with very little—if any—side effects.  And surely, 63 noted cases of this severe side effect is miniscule when compared with the 72,000 total people who used these drugs last year, but the result is so drastic that the FDA feels it necessary to advise on the it.