Maribavir effective against CMV infection in Hematopoietic Cell Transplant Patients

A recent phase 3 study found maribavir to effectively treat individuals with cytomegalovirus (CMV) infection following the hematopoietic cell transplant (HCT), with fewer treatment-limiting toxicities when compared to the commonly used valganciclovir. The findings were published in the Clinical Infectious Diseases.

This multicenter, double-blind study included patients with first asymptomatic CMV infection post-HCT and were randomized to receive either maribavir (400 mg twice daily) or valganciclovir (dose-adjusted for renal clearance) for 8 weeks, followed by an observation period of 12 weeks. The primary endpoint was to achieve confirmed CMV viremia clearance at week 8, with a noninferiority margin of 7.0%.

Maribavir did not meet the primary noninferiority endpoint (69.6% clearance compared to valganciclovir's 77.4%), but it showed comparable CMV viremia clearance during post-treatment follow-up. At week 16, the patients treated with maribavir (52.7%) and valganciclovir (48.5%) maintained CMV viremia clearance without tissue-invasive disease.

Substantial reduction in neutropenia was associated with maribavir treatment. Neutropenia occurred in only 16.1% of maribavir-treated patients when compared to 52.9% in the valganciclovir group. Also, few patients discontinued treatment due to treatment-emergent adverse events (TEAEs) with maribavir (27.8%) and valganciclovir (41.2%). Most discontinuations were linked to neutropenia, which was markedly lower in the maribavir group (4.0%) compared to valganciclovir (17.5%).

These outcomes suggest that maribavir could be a safer alternative for patients undergoing HCT who develop CMV infections. The comparable efficacy coupled with significantly fewer instances of neutropenia and discontinuations due to adverse events suggest maribavir as a promising option in the treatment of CMV post-transplantation.

Source:

Papanicolaou, G. A., Avery, R. K., Cordonnier, C., Duarte, R. F., Haider, S., Maertens, J., Peggs, K. S., Solano, C., Young, J.-A. H., Fournier, M., Murray, R. A., Wu, J., Winston, D. J., Singhal, D., Sasadeusz, J., Maertans, J., Georgala, A., Selleslag, D., Verlinden, A., … for the AURORA Trial Investigators. (2023). Treatment for first Cytomegalovirus infection post–hematopoietic cell transplant in the AURORA trial: A multicenter, double-blind, randomized, phase 3 trial comparing maribavir with valganciclovir. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America. https://doi.org/10.1093/cid/ciad709