Diario de Farmacovigilancia

Abstracto

Acute Hepatic Failure with Hyperbilirubinemia in a Cirrhotic Patient Receiving Glecaprevir and Pibrentasvir (Mavyret^®) For Hepatitis C Infection

Germin Fahim1 2, Harshil Fichadiya2, Mohamad Hamad2, Dana Ahmad2, Hardik Fichadiya3*, Farah Heis, Ahmad Al-Alwan2

The Hepatitis C Virus (HCV) causes both acute and chronic hepatitis C infection, requiring treatment with Direct Acting Antiviral (DAA) therapy for 8-24 weeks. Glecaprevir/pibrentasvir (Mavyret^®) is a fixed-dose combination of an NS3/4A protease inhibitor and NS5A inhibitor, respectively, targeted to decrease replication of the Hepatitis C Virus (HCV). Since its initial approval in 2017, it has gained indications to include management of pan-genotypic HCV with or without compensated cirrhosis in treatment-naïve or treatment-experienced individuals from children 3 years of age and older. The most common reported adverse effects are headache and fatigue; however, the FDA recently published a warning about rare occurrence of serious liver injury with the use of glecaprevir/pibrentasvir in some patients with advanced liver disease.

We discuss a patient with compensated liver cirrhosis who presented with shortness of breath and fatigue four weeks after initiation of therapy with glecaprevir/pibrentasvir for hepatitis C infection (genotype 1a), and was found to have progressively elevated bilirubin level. However, after discontinuation of glecaprevir/pibrentasvir, the patient’s bilirubin normalized with significant improvement in fatigue. Close monitoring of liver function is advised when prescribing glecaprevir/pibrentasvir to patients with advanced liver disease.