Efficacy of prophylactic letermovir for cytomegalovirus reactivation in hematopoietic cell transplantation: a multicenter real-world data

Safety and Effectiveness of Letermovir in Allogenic Hematopoietic Stem Cell Transplantation Recipients: Interim Report of Post-marketing Surveillance in Japan

“…The interim results of this real-world survey demonstrated that letermovir is safe and effective in the prevention of CMV infection in Japanese patients. The interim safety and effectiveness data from the survey are consistent with the results of a Phase III clinical trial of letermovir [16] and previous real-world studies [17][18][19][20][21]25]. The median age of the patients in the survey was 53 years, which is consistent with study patient characteristics in the letermovir arm in Phase III trial, with a median age of 53 years [16], and a previous retrospective cohort study by Johnsrud et al with a median age of 55.5 years in the letermovir arm [17].…”

“…In the letermovir Phase III trial [ 16 ], there were only 58 Asian patients (40 in the letermovir arm and 18 in the placebo arm) and 36 Japanese patients (25 in the letermovir arm and 11 in the placebo arm) in spite of the number of HSCT cases in Japan (excluding autologous transplant cases) totaling 3688 in 2014 and 3724 in 2015 [ 24 ]. A recent real-world analysis published by the Japanese investigator group reported the prophylaxis data of letermovir in 114 patients [ 25 ]; however, no nationwide data on letermovir have been published to date. The post-marketing surveillance (PMS) to evaluate the safety and effectiveness of letermovir for prophylaxis of CMV infection in Japanese allo-HSCT recipients was conducted at multiple registered institutions during the survey period.…”

Assessment of the association between cytomegalovirus DNAemia and subsequent acute graft‐versus‐host disease in allogeneic peripheral blood stem cell transplantation: A multicenter study from the Spanish hematopoietic transplantation and cell therapy group

“…Likewise, data from the phase III letermovir trial do not support such a direct relationship, since the incidence of all grade aGvHD was comparable in the letermovir (39.1%) arm, in which CMV DNAemia was dramatically suppressed, and in the placebo group (38.5%). 22 Moreover, in a non-randomized reallife study reporting on the efficacy of letermovir for CMV reactivation, Mori et al 23 found a comparable incidence of all grade or grade II-IV but not grade III-IV aGvHD in the letermovir and non-letermovir groups, even though letermovir notably reduced the occurrence of clinically significant CMV infection.…”

Cytomegalovirus gastroenteritis in patients with acute graft-versus-host disease

“…After approval of letermovir, several real-world experiences have been reported on its use in primary 46,47 and secondary prophylaxis 48,49 , and these have demonstrated a significant reduction in CMV reactivation. Recently, Johnsrud et al reported a single-center experience in which 114 patients received letermovir prophylaxis.…”