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Phase II Study Finds Maribavir Decreases Cytomegalovirus Levels

December 30, 2021

A phase II study found that maribavir was effective in eradicating cytomegalovirus (CMV) infection in transplant recipients who were resistant or refractory to the antiviral drugs ganciclovir or foscarnet. Sixty-seven percent (n=80) of patients who were treated with varying doses of maribavir for up to 24 weeks had no detectable levels of CMV in their plasma within six weeks of starting treatment (primary endpoint).

"Cytomegalovirus infection that is resistant or refractory to standard therapy in transplant patients is associated with significant complications and high mortality," said Genovefa Papanicolaou, MD, from Memorial Sloan Kettering Cancer Center, who presented the study's findings at the 2016 Infectious Diseases Week. "The phase II findings support further research to confirm these results among patients who have limited options to combat the infection."

A total of 120 patients (median age = 55 years; range = 18-74 years) with CMV infection (defined as ≥1,000 DNA copies/mL of blood plasma) were included in the study. Forty-seven patients received a hematopoietic cell transplantation, while 73 patients had a solid organ transplant.

Patients were randomized to receive 400, 800, or 1,200 mg of maribavir for up to 24 weeks.

Among  patients were found to have no detectable CMV, 70 percent (n=28) were in the 400 mg group, 63 percent (n=25) were in the 800 mg group, and 67 percent (n=27) were in the 1,200 mg group.

CMV infection recurred in 30 patients, including in seven receiving 400 mg of the drug, in 11 receiving 800 mg, and in 12 receiving 1,200 mg.

Adverse events (AEs) occurred in 78 percent of patients (n=93), with dysgeusia being the most common treatment-related AE (n=78; 65%). Twenty-seven percent of patients died due to an AE, one of which (multi-organ failure) was deemed possibly related to maribavir. Forty-one patients (34%) discontinued treatment with maribavir due to an AE, including 17 patients who discontinued treatment due to CMV infection.

Other treatment-related AEs included nausea, vomiting, diarrhea, fatigue, and anemia.

Source: Maertens J, Cordonnier C, Jaksch P, et al. Maribavir versus valganciclovir for preemptive treatment of cytomegalovirus (CMV) viremia: a randomized, dose-ranging, phase 2 study among hematopoietic stem cell transplant (SCT) and solid organ transplant (SOT) recipients. Abstract #2287. Presented at the 2016 IDWeek, October 29, 2016; New Orleans, Louisiana.


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