Single-center, open-label, randomized controlled trial comparing the tolerability of maribavir 400 mg twice daily versus standard-dose valganciclovir for cytomegalovirus prophylaxis in high-risk kidney transplant recipients.

In 30 seconds

This 12-month, single-center, open-label randomized trial compared maribavir 400 mg twice daily with valganciclovir 900 mg daily for CMV prophylaxis in 70 adult kidney transplant recipients at high CMV risk. Clinically significant leukopenia incidence did not differ significantly between groups (22.9% vs 5.7%, P = .084). However, valganciclovir recipients spent more prophylaxis days below each reported white blood cell threshold. Exploratory CMV outcomes appeared similar, and no CMV breakthrough, disease, or resistance occurred. The authors conclude that maribavir was associated with a lower overall leukopenia burden, while calling for confirmation in larger multicenter studies.

Key findings

• Clinically significant leukopenia occurred in 22.9% with maribavir and 5.7% with valganciclovir (P = .084).
• Time below white blood cell thresholds was lower with maribavir: <3000/μL, 2.4% vs 12.2%; <2000/μL, 0.2% vs 3.0%; <1000/μL, 0.1% vs 0.3%.
• Exploratory CMV outcomes appeared similar, including any viremia (37% vs 43%, P = .626); no breakthrough, disease, or resistance occurred.

Why it matters

Valganciclovir prophylaxis can be limited by leukopenia, an important consideration after kidney transplantation. This trial suggests maribavir may reduce the duration of low white blood cell counts, although it did not show a significant difference in clinically significant leukopenia incidence. The findings add comparative evidence on prophylaxis options but remain preliminary given the study’s size and single-center design.

What to keep in mind

The trial was single-center and included 70 recipients; the authors state that the findings should be confirmed in larger multicenter studies. CMV outcomes were exploratory.