Maribavir for refractory cytomegalovirus infection (with or without resistance) in solid organ transplant recipients: subgroup analysis of the phase 3 randomized SOLSTICE study.
Blumberg, E. A., et al.Journal of Heart & Lung Transplantation 2024 [record in progress].
Aims
This subgroup analysis of the SOLSTICE study aimed to assess the safety and efficacy of maribavir compared with investigator-assigned therapy (IAT) for cytomegalovirus (CMV) viremia clearance in the solid organ transplant group.
Interventions
Participants in the SOLSTICE trial were randomised to either the maribavir group or the IAT group.
Participants
211 solid organ transplant recipients from the SOLSTICE trial.
Outcomes
The primary outcome was CMV viremia clearance. The secondary outcome was a combination of confirmed CMV viremia clearance along with CMV infection symptom control.
Follow-up
16 weeks
CET Conclusions
The SOLSTICE trial demonstrated that Maribavir, a novel agent for treating refractory CMV infection, has superior efficacy to investigator assigned therapy (IAT) following hematopoietic cell transplant (HCT) and solid organ transplant (SOT). This subgroup analysis of the SOT cohort assessed the efficacy and safety data following kidney, pancreas, lung and heart transplantation. The analysis showed broadly similar results to those of the overall trial, with Maribavir achieving a higher rate of CMV clearance at 8 weeks than IAT. The rate of adverse events was higher in the Maribavir group, but this was due to a very high rate of dysgeusia. The more serious adverse events of acute kidney injury and neutropaenia were lower in the Maribavir group. Treatment resistance developed in 28% of patients, but recurrence rates beyond the 8-week treatment period were not reported. Although the efficacy and safety of Maribavir has been demonstrated by the SOLSTICE trial, long term outcomes and real-world benefit outside of trial conditions have yet to be determined.
Trial registration
ClinicalTrials.gov - NCT02931539