2287. Maribavir Versus Valganciclovir for Preemptive Treatment of Cytomegalovirus (CMV) Viremia: A Randomized, Dose-Ranging, Phase 2 Study Among Hematopoietic Stem Cell Transplant (SCT) and Solid Organ Transplant (SOT) Recipients
Session: Poster Abstract Session: Transplants: CMV and Transplantation
Saturday, October 29, 2016
Room: Poster Hall

Background: CMV is associated with morbidity and mortality among SCT and SOT recipients. Current anti-CMV therapy is associated with side effects including myelosuppression and renal toxicity. Maribavir (MBV) is a potent and selective orally bioavailable anti-CMV agent. This Phase 2 study (EudraCT 2010-024247-32) assessed safety, tolerability and anti-CMV activity of preemptive MBV versus valganciclovir (VGC) among hematopoietic SCT or SOT recipients.

Methods: SCT/SOT recipients aged ≥18 years with 1000–100,000 CMV DNA copies/mL in blood/plasma and no documented CMV organ disease were randomized 1:1:1:1 to receive oral MBV 400, 800 or 1200 mg twice daily (BID), or VGC (Weeks 1–3: 900 mg BID, after Week 3: 900 mg once daily; adjusted for renal function), for up to 12 weeks. Primary safety analysis focused on incidence of treatment-emergent adverse events (TEAEs). Primary efficacy endpoint was proportion of patients with confirmed undetectable plasma CMV DNA within 3 and 6 weeks of treatment (‘responders’). Treatment effect estimates were calculated for the pooled MBV group versus VGC and compared statistically; no statistical tests were performed on safety endpoints.

Results: Between May 2012 and July 2014, 159/161 randomized patients received study drug (119 MBV [58 SOT], 40 VGC [19 SOT]); median (range) age 58 (18–76) years. Efficacy results are shown in the table.

Most TEAEs were mild–moderate in severity. Gastrointestinal AEs (nausea/vomiting/diarrhea) occurred more frequently in those receiving MBV (20–23%) versus VGC (10–15%); dysgeusia occurred more frequently with MBV (40%) versus VGC (3%) but with no apparent dose effect. Neutropenia (ANC <1000/mm3) occurred less frequently with MBV (5%) versus VGC (18%).

Conclusion: MBV 400–1200 mg BID had similar efficacy to VGC at clearing CMV viremia among SCT/SOT recipients, with a similar treatment effect across MBV doses. MBV was generally well tolerated with a safety profile similar to previous studies.

Johan Maertens, MD, PhD1, Catherine Cordonnier, MD2, Peter Jaksch, MD3, Xavier Poiré, MD4, Jingyang J Wu, MS5, Anna Wijatyk, MD5, Faouzi Saliba, MD6, Oliver Witzke, MD7 and Stephen Villano, MD8, (1)UZ Leuven, Leuven, Belgium, (2)Henri Mondor Hospital and University Paris-Est-Créteil, Créteil, France, (3)Medical University of Vienna, Vienna, Austria, (4)Cliniques Universitaires Saint-Luc, Brussels, Belgium, (5)Shire, Lexington, MA, (6)AP-HP Hôpital Paul Brousse, Villejuif, France, (7)University Hospital Essen, Essen, Germany, (8)Shire (at time of study), Wayne, PA


J. Maertens, None

C. Cordonnier, None

P. Jaksch, None

X. Poiré, None

J. J. Wu, Shire: Employee , Salary

A. Wijatyk, Shire: Employee , Salary and Stock

F. Saliba, Viropharma: Investigator and Scientific Advisor , Speaker honorarium

O. Witzke, None

S. Villano, Shire (at time of study): Employee , Salary

Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.