Why the FDA-approved drug label for sofosbuvir mentions "Without cirrhosis or with compensated cirrhosis" as indication?

Question

   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?

Answer 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.