The Medical Letter on Drugs and Therapeutics
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ISSUE
1481
In Brief: Hepatic Injury with Hepatitis C Drugs
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 Select a term to see related articles  dasabuvir   Drug Safety   Harvoni   Hepatitis C   Holkira Pak   ledipasvir   ombitasvir   paritaprevir   Ritonavir   sofosbuvir   Viekira Pak 

The FDA recently announced labeling changes for the combination antiviral products Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir)1 and Technivie (ombitasvir/paritaprevir/ritonavir)2 warning of a risk of serious, potentially fatal liver injury.3 Viekira Pak, approved in December 2014 for treatment of hepatitis C virus (HCV) genotype 1 infection, including patients with compensated cirrhosis, and Technivie, approved in July 2015 for treatment of HCV genotype 4 infection without cirrhosis, have been identified as "possible" or "probable" causes in 26 postmarketing cases of hepatic decompensation, including 10 cases (mostly in patients with preexisting advanced cirrhosis) that resulted in death or liver transplant. Hepatic injury generally occurred within 1-4 weeks of treatment initiation.

All therapies for chronic HCV infection have been associated with cases of hepatic decompensation in patients with advanced fibrosis or cirrhosis, but cause and effect are difficult to determine. Viekira Pak and Technivie are now contraindicated in patients with moderate to severe (Child-Pugh B/C) hepatic impairment. Ledipasvir/sofosbuvir (Harvoni), another recently approved treatment for HCV genotype 1 infection,4 is still indicated for treatment of patients with any degree of compensated hepatic impairment (Child-Pugh A/B/C). The efficacy and safety of all three combinations in patients with decompensated cirrhosis have not been established.

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