Interferon-alpha-2b/oseltamivir/umifenovir

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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 26-year-old woman developed worsening of liver function impairment following off label use of interferon-α-2b, oseltamivir and umifenovir for COVID-19 during pregnancy.

The woman was admitted due to fever at 26 weeks of gestation in late January 2010. She presented with a history of fever and myalgia for 10 days followed by dry cough and dyspnoea for 3 days. On admission, she her vital signs were normal except for elevated body temperature. She was noted to have elevated ALT and AST. Her serum albumin level decreased slightly (liver function impairment). Following clinical investigations, she was diagnosed with COVID-19. Subsequently, she received off label treatment with umifenovir [arbidol] interferon-α-2b [recombinant human interferonα-2b] and oseltamivir [routes and dosages not stated]. Additionally, she received azithromycin and cefdinir. She had been receiving IV infusion of magnesium isoglycolate injection to improve hepatic function since her admission. She received oxygen inhalation through nasal cannula for dyspnoea with other supportive care. Eventually, her underlying COVID-19 infection started to improve, however, on day 7, her hepatic dysfunction worsened despite continuous liver protection treatment [duration of treatments to reaction onset not stated].

The woman's hepatic function improved on day 9 following modification of dose of magnesium isoglycolate and addition of glutathione injection. On day 12, significant improvement in her liver function was noted and she was discharged on day 13 with prescription of oral polyenylphosphatidylcholine. By the end of observation, she recovered well without any discomfort [pregnancy outcome not stated].