Tocilizumab

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

A 55-year-old man developed hepatitis-B viral (HBV) reactivation with acute hepatitis following an off-label treatment with tocilizumab for severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection.

The man, who had a history of inactive chronic hepatitis-B since childbirth, presented with progressive shortness of breath. He was diagnosed with SARS-COV-2 infection and was placed on supplemental oxygen with no favourable clinical response. Subsequently, he was admitted to the ICU and started receiving in high-flow ventilation followed by dexamethasone and apixaban due to acute respiratory disease syndrome. Thereafter, he received an off-label treatment with convalescent-anti-SARS-CoV-2-plasma [convalescent plasma] for SARS-COV-2 infection. Despite treatment, the symptoms persisted. Therefore, he received an off-label treatment with tocilizumab [dosage and route not stated]. As a result, signs of respiratory and functional status gradually improved. The supplemental oxygen was de-escalated to a nasal cannula, and he was discharged to acute rehabilitation. After discharge, the laboratory work-up showed elevated liver tests with normal bilirubin and INR. The HBV panel showed an increase in the DNA levels to 10 million IU/mL. Imaging was done to rule out hepatocellular carcinoma; however, cirrhosis was noted. Based on the clinical presentation and laboratory findings, HBV reactivation with acute hepatitis secondary to the tocilizumab therapy was considered.

The man was treated with tenofovir, which resulted in gradual improvement in liver enzymes and reduction in HBV viral load >1 log.