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An event is serious (FDA MedWatch definition) when the patient outcome is:

  • * death

  • * life-threatening

  • * hospitalisation

  • * disability

  • * congenital anomaly

  • * requires intervention to prevent permanent impairment or damage

A 74-year-old woman developed polyserositis during treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir [routes and dosages not stated].

The woman diagnosed with chronic hepatitis C virus (HCV) genotype 1b was treated with ombitasvir/paritaprevir/ritonavir and dasabuvir. She was hospitalised after 2 weeks of antiviral treatment, with malaise, vomiting, weakness, fatigue, shortness of breath with progressive worsening, oedema of the lower limbs and fever during last several days. On admission, she had tachypnoea and tachycardia with fever. Her laboratory investigations showed hypoxaemia and leucocytosis. Her chest X-ray revealed bilateral interstitial infiltration and her trans-thoracic echo-cardiogram confirmed pericardial effusion. The patient was admitted to ICU with a diagnosis of polyserositis.

The woman was started on broad-spectrum antibiotics and her ombitasvir/paritaprevir/ritonavir and dasabuvir were stopped. She received pulse corticosteroids for 3 days, with progressive improvement. She was discharged from hospital after resolution of respiratory difficulty. She continued her home medication and decreasing doses of corticosteroids.

Author comment: To evaluate the possible link between polyserositis and the administration of antiviral treatment, the modified Karch-Lasagna algorithm was applied. The score of 6 was obtained, concluding that this reaction was "probable".