May 07, 2014
1 min read

Letermovir reduced cytomegalovirus infection after HSCT

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Patients who underwent allogeneic hematopoietic stem cell transplantation were less likely to experience cytomegalovirus infection when treated with letermovir compared with placebo, according to phase 2 study results.

Researchers sought to evaluate the anti-cytomegalovirus (CMV) action of letermovir (AIC246, AiCuris), the novel mechanism of which targets the viral terminase subunit pUL56.

They randomly assigned 131 CMV-seropositive patients 3:1 to letermovir or placebo in 60-mg, 120-mg or 240-mg daily doses for 12 weeks after engraftment.

All-cause prophylaxis failure — defined as study drug discontinuation due to CMV antigen or DNA detection, end-organ disease or any other cause — served as the study’s primary endpoint.

Researchers observed a trend toward reduced all-cause prophylaxis failure among patients assigned the 60-mg dose of letermovir compared with those assigned placebo; however, the reduction was not statistically significant (48% vs. 64%; P=.32).

Incidence of prophylaxis failure was significantly reduced among patients assigned 120-mg (32% vs. 64%; P=.01) and 240-mg (29% vs. 64%; P=.007) doses of letermovir.

Time to onset of prophylaxis failure among patients who received 240 mg of letermovir ranged from 1 day to 8 days, which was significantly shorter compared to the 1-day to 21-day onset range among patients assigned placebo (P=.002).

Adverse events were mild or moderate, and they were comparable between treatment arms. A higher rate of patients assigned placebo experienced a serious adverse event (36% vs. 31%) and discontinued treatment due to an adverse event (58% vs. 26%).

“Overall, the incidence of virologic failure decreased with an increasing dose of [letermovir],” the researchers wrote. “In addition, letermovir at a dose of 240 mg per day significantly reduced the time to the onset of prophylaxis failure — that is, patients in whom the drug failed to prevent CMV infection were fewer but were identified earlier in the course of the study and were subsequently shown to have had active CMV infection before they received the study drug.”

Disclosure: The study was funded by AiCuris.