Real-world effectiveness and tolerability of post solid organ transplant patients with CMV switching from valganciclovir treatment to maribavir: analysis using lab-linked claims data in the United States

Abstract

Background: Antiviral (AV) treatment options (e.g. Valganciclovir, VGCV) for cytomegalovirus (CMV) infections present a challenging benefit-risk profile (e.g. bone-marrow suppression) and potentially increased resistance and refractoriness. Maribavir (MBV), a new AV treatment approved for refractory/resistant post-transplant CMV infections, demonstrated superior viral clearance in SOLSTICE trial.

Research design and methods: A retrospective lab-linked claims analysis of solid organ transplant (SOT) patients on VGCV (≥900 mg BID) treatment who newly switched to MBV (i.e. index date) between 1 December 2021 and31 December 2023. MBV treatment effectiveness (CMV viremia clearance/no treatment switch) and tolerability (e.g. leukopenia) during 3-months pre- and post-index was examined.

Results: Of the 1,247 post-SOT VGCV-treated patients, 81 switched to MBV; the mean age was 55 years, and 73% had kidney transplant. Among 33 with follow-up labs, 88% (n = 29) achieved viral clearance. Of the remaining 48 without follow-up labs, 60.4% (n = 29) did not switch to other AV treatments. The combined treatment effectiveness was 71.6%. Tolerability issues decreased after MBV initiation: with leukopenia, neutropenia, nausea, and diarrhea decreasing by 14.29%, 3.57%, 14.29%, and 17.86%, respectively.

Conclusion: MBV-treated patients had 10-15% lower tolerability issues; over 7 in 10 demonstrated treatment effectiveness in this real-world analysis. MBV's favorable benefit-risk profile makes it a potentially valuable addition to the CMV treatment armamentarium.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT02931539.

Keywords: Antivirals; cytomegalovirus; effectiveness; switching; tolerability.