Published online Jul 18, 2016. doi: 10.4254/wjh.v8.i20.858
Peer-review started: February 29, 2016
First decision: April 15, 2016
Revised: June 1, 2016
Accepted: June 27, 2016
Article in press: June 29, 2016
Published online: July 18, 2016
The United States Food and Drug Administration recently warned that the direct acting antiviral (DAA) combination hepatitis C virus (HCV) treatment of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin (PODr + R) can cause severe liver injury in patients with advanced liver disease. Drug induced liver injury was observed in a small number of patients with decompensated cirrhosis treated with other DAAs, but has not been reported in patients with compensated cirrhosis. We report a case of a 74-year-old woman with chronic HCV and Child-Pugh class A cirrhosis (compensated cirrhosis) treated with PODr + R. The patient presented on day 14 of PODr + R therapy with jaundice and new-onset ascites. Her total bilirubin level increased to 23 mg/dL and international normalized ratio rose to 1.65, while aminotransferase levels remained relatively stable. Hepatitis C treatment was discontinued on day 24 and she gradually recovered. Follow-up testing showed that she achieved a sustained virologic response. In conclusion, hepatic decompensation developed within two weeks of starting treatment with PODr + R in a patient with Child-Pugh class A cirrhosis and was characterized by jaundice and ascites with stable aminotransferase levels. Careful monitoring is warranted in patients with HCV-related cirrhosis treated with PODr + R.
Core tip: To the best of our knowledge, this is the first report of hepatic decompensation in a hepatitis C patient with Child Pugh class A cirrhosis due to treatment with Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir and Ribavirin (PODr + R). Liver aminotransferase levels did not increase prior to decompensation, depriving us of our usual alarm signs heralding hepatic decompensation. The patient achieved sustained virologic response despite very early discontinuation of therapy (day 24).