0
   SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of:
    
    

 - Adult patients with genotype 1, 2, 3 or 4 chronic hepatitis C virus
   (HCV) infection without cirrhosis or with compensated cirrhosis as a
   component of a combination antiviral treatment regimen. 

       

 - Pediatric patients 12 years of age and older or weighing at least 35
   kg with genotype 2 or 3 chronic HCV infection without cirrhosis or   
   with compensated cirrhosis in combination with ribavirin.

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=b66d2de5-8550-4015-9c2c-d7a9150926b4&type=display

Is this drug, a contraindication in cirrhosis, pharmacokinetically speaking?

1 Answer 1

1

TL;DR: No, decompensated cirrhosis is not a contraindication.

However, the safety and efficacy of Sovaldi have not been established in patients with decompensated cirrhosis:

Hepatic Impairment

No dosage adjustment of Sovaldi is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B or C) [see Clinical Pharmacology (12.3)]. Safety and efficacy of Sovaldi have not been established in patients with decompensated cirrhosis. See peginterferon alfa prescribing information for contraindication in hepatic decompensation.

(Emphasis mine)

It appears the concern is that since Sovaldi is primarily metabolized by the liver, decompensated cirrhosis could be dangerous. But that hasn't been established, so it's not being recommended, but it's not contraindicated.

Your Answer

By clicking “Post Your Answer”, you agree to our terms of service and acknowledge that you have read and understand our privacy policy and code of conduct.

Not the answer you're looking for? Browse other questions tagged or ask your own question.