Maribavir in SOT recipients with R/R CMV or intolerance to anti-CMV therapy: ARISE interim results

Interim results from the retrospective ARISE study (NCT06615921), evaluating the real-world effectiveness and safety of maribavir in adult solid organ transplant (SOT) recipients with refractory/resistant cytomegalovirus (CMV) infection (R/R subgroup) or intolerance to anti-CMV therapy (I subgroup), were presented by Nassim Kamar at the 31st International Congress of The Transplantation Society (TTS), September 20–23, 2026, Sydney, AU. The analysis included 124 SOT recipients (R/R, n = 99; I, n = 25) and the median observation period was 22 months. The primary outcome was CMV clearance at maribavir discontinuation.

Key data: Overall, CMV clearance was observed in 67.1% of patients at maribavir discontinuation (R/R, 61.9%; I, 87.5%). The Kaplan-Meier (KM) estimates for recurrence of CMV at Day 56 after maribavir initiation were 0.36 (95% confidence interval [CI], 0.27–0.47) overall, 0.39 (95% CI, 0.28–0.52) in the R/R subgroup, and 0.27 (95% CI, 0.13–0.51) in the I subgroup. A total of 74.2% of patients required ≥2 treatment sequences to manage their index CMV episode; maribavir was mostly used as a second-line agent in the R/R subgroup (56.6%) and as a first-line agent in the I subgroup (44.0%). CMV episode resolution was the most common reason (60.4%) for discontinuation of maribavir. Lower rates of myelosuppression and CMV-related inpatient hospitalization were observed after maribavir initiation.

Key learning: These interim results from the ARISE study suggest that maribavir may be an effective and well-tolerated treatment option for SOT recipients with R/R CMV or intolerance to anti-CMV therapy, with longer-term follow-up warranted to confirm these findings.