Enter Note
732 - Real World Effectiveness and Safety of Maribavir in Solid Organ Transplant (SOT) Recipients with Refractory/Resistant Cytomegalovirus or Intolerance to Anti-Cytomegalovirus Drugs: Interim Results from ARISE
View session detail
Author Block: N. Kamar1, M. Helleberg2, M. Morton3, I. Pulido González4, T. Veit5, I. Albieri6, T. Bo7, F. Cassanelli8, B. Milovanović6, O. Witzke9, 1Toulouse Rangueil University Hospital, Toulouse, France, 2Rigshospitalet, Copenhagen, Denmark, 3Manchester Royal Infirmary, Manchester, United Kingdom, 4Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas, Spain, 5LMU University Hospital, Munich, Germany, 6Takeda Pharmaceuticals International AG, Zürich, Switzerland, 7Takeda Development Center Americas, Inc., Cambridge, MA, 8IQVIA Solutions Italy S.r.l, Modena, Italy, 9University Medicine Essen, Essen, Germany
*Purpose: Assess maribavir use, effectiveness and safety for the treatment of post-transplant cytomegalovirus (CMV) infection/disease in routine practice.
*Methods: ARISE is a retrospective cohort study evaluating maribavir use in adult transplant recipients with refractory/resistant (RR) CMV or intolerance (I) to anti-CMV agents in 10 European countries. Primary outcome is CMV clearance at maribavir discontinuation. Secondary outcomes include safety and healthcare resource utilization (HRU). Interim data are reported.
*Results: The analysis included 124 SOT recipients (RR, n=99; I, n=25; median observation 22 months). Mean (SD) age at transplant was 57 (13) years, 59% were male; 59% received kidney, 21% lung, 15% heart. Overall, 47 patients experienced ≥1 CMV episode before the index episode (first maribavir-treated episode). In patients with available viral load (N=79), CMV clearance at maribavir discontinuation was achieved by 39/63 (62% [95% CI: 49-74]) RR and 14/16 (88% [62-98]) I patients. During the index episode maribavir monotherapy was the first treatment agent in 35 (28%) patients and second in 66 (53%). Median (Q1-Q3) duration of maribavir treatment course (N=139) was 57 (42-83) and 56 (44-57) days in RR and I patients, respectively, with 60% of treatment course discontinuations (N=134) due to CMV episode resolution. Maribavir was initiated at home in 84/118 (71%) and 11/25 (44%) treatment courses in RR and I patients, respectively. In patients whose index episode ended (regardless of clearance confirmation), Kaplan-Meier estimates of recurrence ≤56 days from maribavir discontinuation were 39% and 27% in the RR and I groups. Adverse events and HRU are shown in the Table.
| RR (n=99) | Intolerance (n=25) | |||
| Prior to maribavir initiationa | After maribavir initiationb | Prior to maribavir initiationa | After maribavir initiationb | |
| Adverse events of special interest | 29 (29.3) | 16 (16.2) | 13 (52.0) | 3 (12.0) |
| Myelosuppression | 25 (25.3) | 5 (5.1) | 13 (52.0) | 1 (4.0) |
| Myelosuppression, PPY | 0.18 | 0.05 | 0.58 | 0.04 |
| Nephrotoxicity | 4 (4.0) | 7 (7.1) | 2 (8.0) | 1 (4.0) |
| Nephrotoxicity, PPY | 0.03 | 0.08 | 0.13 | 0.04 |
| Taste disturbance | 1 (1.0) | 10 (10.1) | 0 | 1 (4.0) |
| Taste disturbance, PPY | 0.01 | 0.1 | 0 | 0.04 |
| CMV-related ER visits | 6 (6.1) | 1 (1.0) | 2 (8.0) | 1 (4.0) |
| CMV-related ER visits, PPY | 0.05 | 0.02 | 0.1 | 0.13 |
| CMV-related inpatient hospitalizations | 55 (55.6) | 33 (33.3) | 11 (44.0) | 6 (24.0) |
| CMV-related inpatient hospitalizations, PPY | 0.6 | 0.59 | 0.57 | 0.25 |
| Table reports number (%) of patients with ≥1 events. aMedian (Q1-Q3) time from transplant to maribavir initiation was 284 (171-471) days for the overall population. bMedian (Q1-Q3) time from maribavir initiation to end of observational period was 374 (200-591) days for the overall population. CMV, cytomegalovirus; ER, emergency room; HRU, healthcare resource utilization; PPY, per patient year; RR, refractory/resistant CMV | ||||
*Conclusions: The results support real world effectiveness and safety of maribavir in adult SOT recipients with RR and I CMV. The observed CMV clearance rates, and lower incidence of myelosuppression and hospitalizations after than prior to maribavir initiation, align with previous studies.