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Cytomegalovirus infection and disease Clinical criteria: Patient must have received a hematopoietic stem-cell transplant; OR Patient must have received a solid-organ transplant, AND Patient must have a cytomegalovirus infection or cytomegalovirus disease that is resistant, refractory or intolerant/contraindicated to appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; OR Patient must have received and is intolerant to continued use of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, AND The treatment must be used as monotherapy for this condition under this restriction, AND Patient must not have previously demonstrated resistance to this drug, AND Patient must not have cytomegalovirus disease that involves the central nervous system, AND Patient must not have cytomegalovirus retinitis. For the purpose of administering this restriction: (i) A patient is determined to be refractory if after at least two weeks of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, they fail to achieve a greater than 1log10 decrease in cytomegalovirus DNA level. (ii) A patient is determined to be resistant by the identification of a genetic alteration that decreases susceptibility to ganciclovir, valganciclovir, cidofovir or foscarnet. (iii) A patient with Grade 3 neutropenia (an absolute neutrophil count less than 1000 cells per cubic millimetre) or impaired renal function (creatinine clearance less than 50 mL/min) is determined to be intolerant/contraindicated.
“The antiviral activity of maribavir is mediated by competitive inhibition of the protein kinase activity of HCMV enzyme UL97, which results in inhibition of the phosphorylation of proteins; an effect achieved at low concentrations of maribavir.”
“Half-life (t 1/2 ) in transplant patients (h), mean 4.32”
“Maribavir is primarily eliminated by hepatic metabolism via CYP3A4 (primary metabolic pathway fraction metabolised estimated to be at least 35%), with secondary contribution from CYP1A2 (fraction metabolised estimated at no more than 25%).”
Working under the parallel aged-care framework? Aged-care equivalent →
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.