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%).