Comparing Costs Associated to Letermovir Prophylaxis Vs Ganciclovir Pre-Emptive Therapy in HCMV-Seropositive Patients Who Undergone to Hemopoietic Stem Cells Transplantation

• Published in: Blood 2019-11, Vol.134 (Supplement_1), p.5643-5643
• Main Authors: Borsani, Oscar, Lilleri, Daniele, Gabanti, Elisa, Cassinelli, Gabriela, Colombo, Anna Amelia, Caldera, Daniela, Alessandrino, Emilio Paolo, Bernasconi, Paolo
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2019-124121

INTRODUCTION: Human cytomegalovirus (HCMV) infection is a significant cause of mortality and morbidity after hemopoietic stem cell transplantation (HSCT). Pre-emptive therapy with Ganciclovir (GCV) reduces the risk for HCMV disease but may be associated with significant toxicity. Letermovir (LTV) has been recently approved for prophylaxis of HCMV infection in HCMV-seropositive patients. AIM: to compare costs associated with GCV preemptive therapy or LTV prophylaxis within 100 days after HSCT. METHODS: A retrospective analysis of GCV preemptive therapy-related costs was performed on 63 HCMV-seropositive patients receiving allogeneic HSCT. For comparison, we estimated LTV prophylaxis-related costs according to dosage and duration reported in the phase 3 trial (Marty et al., NEJM 2017). According to definitions adopted in the LTV prophylaxis study, patients were considered at high risk for HCMV-disease if having one of the following: a mismatched (related or unrelated) or a haploidentical donor; umbilical cord blood as the stem-cell source; ex vivo T-cell-depleted grafts; and grade ≥2 GVHD. Clinically significant HCMV infection was defined as HCMV disease (i.e. HCMV end-organ infection in association with clinical symptoms) or HCMV DNAemia leading to pre-emptive treatment (i.e. ≥ 30.000 copies/mL in blood in the GCV-preemptive group; ≥ 150 copies/mL or ≥ 300 copies/mL in plasma for high-risk or low-risk patients in the LTV-prophylaxis study). All diagnostic and therapeutic procedures performed within 100 days post-HSCT were recorded. Costs associated to HCMV antiviral therapy and to the management HCMV infection (including also, but not limited to, diagnostic procedures, transfusions and hospitalizations) were calculated. RESULTS Study populations Baseline characteristics of the GCV-preemptive group in comparison with the LTV-prophylaxis group are shown in Table 1. A higher proportion of patients at high risk for HCMV disease has been observed in the preemptive group (49.2% vs 32.4%). HCMV infection and disease GCV-preemptive group: 39 patients (62%) developed a clinically significant HCMV infection and in all cases pre-emptive therapy resolved the infection. Drug switch due to GCV-induced neutropenia was not necessary in any case. Gastrointestinal HCMV disease occurred beyond day 100: in 2 patients (3.2%) occurred within 24 weeks post-HSCT and in additional 7 patients later on (median time: 314, range 144-387 days after HSCT). LTV-prophylaxis group: clinical