Abstract
The novel cap-dependent endonuclease inhibitor baloxavir marboxil was approved for the treatment of influenza virus infection in Japan in February 2018. Two influenza A(H3N2) viruses carrying an I38T substitution in the polymerase acidic subunit (PA) were detected in baloxavir-treated children in December 2018. This mutation is known to confer reduced susceptibility to baloxavir, and the two mutant viruses exhibited 76- and 120-fold reduced susceptibility to baloxavir.
Highlights
The novel cap-dependent endonuclease inhibitor baloxavir marboxil was approved for the treatment of influenza virus infection in Japan in February 2018
The novel antiviral drug baloxavir marboxil was approved in Japan on 23 February 2018 for the treatment of influenza virus infection, in patients 12 years and older and children younger than 12 years weighing 10 kg or more; it became available on 14 March 2018 in Japan (Figure)
In Phase II and III clinical trials, I38T, I38F and I38M substitutions in the polymerase acidic subunit (PA) were detected in A(H1N1)pdm09 and A(H3N2) influenza viruses [2,3]. Patients infected with these mutant viruses exhibited prolonged virus shedding, and the median time to symptom alleviation was longer in baloxavir recipients infected with viruses bearing these substitutions than in those infected with viruses that lacked these substitutions [2,3]
Summary
The novel cap-dependent endonuclease inhibitor baloxavir marboxil was approved for the treatment of influenza virus infection in Japan in February 2018. Two influenza A(H3N2) viruses carrying an I38T substitution in the polymerase acidic subunit (PA) were detected in baloxavir-treated children in December 2018. The novel antiviral drug baloxavir marboxil was approved in Japan on 23 February 2018 for the treatment of influenza virus infection, in patients 12 years and older and children younger than 12 years weighing 10 kg or more; it became available on 14 March 2018 in Japan (Figure).
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