General Information

Livtencity (maribavir) is a cytomegalovirus (CMV) pUL97 kinase inhibitor.

Livtencity is specifically indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

Livtencity is supplied as tablets for oral use. The recommended dose is 400 mg (two 200 mg tablets) orally twice daily with or without food.

Mechanism of Action

Livtencity (maribavir) an antiviral agent that targets and inhibits the pUL97 protein kinase and its natural substrates. 

Side Effects

Adverse effects associated with the use of Livtencity may include, but are not limited to, the following:

• taste disturbance
• nausea
• diarrhea
• vomiting
• fatigue

Clinical Trial Results

FDA approval was based on the TAK-620-303 (SOLSTICE) trial, a multicenter, randomized, open-label, active-controlled superiority trial to assess the efficacy and safety comparing treatment with either Livtencity (maribavir) or investigator assigned treatment, IAT, (conventional antiviral therapy) in 352 hematopoietic stem cell transplant and solid organ transplant recipients with CMV infection refractory, with or without resistance, to one or a combination of the conventional antiviral therapies: ganciclovir, valganciclovir, foscarnet or cidofovir. Adult patients underwent a 2-week screening period, followed by randomization 2:1 to Livtencity (n=235) (400 mg, twice daily) or IAT (n=117) (as dosed by the investigator) for up to 8-weeks. After completion of the treatment period, subjects entered a 12-week follow-up phase.

Overall, more than twice the proportion of patients achieved confirmed CMV DNA level <LLOQ (lower limit of quantification, i.e. <137 IU/mL) at Week 8 (end of treatment phase), the study’s primary endpoint, with Livtencity (56%; n=131/235), compared to those treated with conventional antiviral therapies (24%; n=28/117).