Select your timezone:

P16.38 Healthcare resource utilization in transplant recipients with cytomegalovirus infection refractory to prior treatment with/without resistance receiving maribavir versus investigator-assigned therapy: Exploratory analysis of the Phase 3 SOLSTICE trial

Abstract

Healthcare resource utilization in transplant recipients with cytomegalovirus infection refractory to prior treatment with/without resistance receiving maribavir versus investigator-assigned therapy: exploratory analysis of the phase 3 SOLSTICE trial

Ishan Hirji1, Kim Cocks2, Alejandro Moreno-Koehler3, Aimee Sundberg1.

1Takeda Development Center Americas, Inc., Lexington, MA, United States; 2Adelphi Values, Bollington, United Kingdom; 3Adelphi Values, Boston, MA, United States

Introduction: Increased healthcare resource utilization (HCRU) has been associated with cytomegalovirus (CMV) infection following transplantation, in particular in patients (pts) requiring >1 antiviral course. In the Phase 3 SOLSTICE study (NCT02931539), maribavir (MBV) was superior to investigator-assigned therapy (IAT; val/ganciclovir, foscarnet, cidofovir) for CMV clearance at Wk 8 and clearance plus symptom control Wk 8 maintained through Wk 16 in transplant recipients with refractory CMV infection with/without resistance (R/R). This exploratory analysis of SOLSTICE evaluated HCRU for the MBV and IAT arms.

Methods: Transplant recipients with CMV R/R to prior treatment (failure to achieve >1log10 decrease in CMV DNA after ≥14 days, with/without genotyped resistance) were randomized 2:1 to MBV 400 mg BID or IAT for 8 wks with 12 wks of follow-up. After ≥3 wks of treatment, pts in the IAT arm with pre-specified criteria could enter a MBV rescue arm (8 wks’ MBV treatment, 12 wks’ follow-up). Data on hospital admissions were collected at each study visit and analyzed by treatment during the treatment and follow-up phases. Analyses included the number of pts with ≥1 hospitalization and length of hospital stay (LOS). Hospitalization rates and LOS (per person/year) were estimated using negative binomial models adjusting for exposure time. Adjusted incidence rates (IR), 95% CIs, IR ratios (IRR) and percent reduction in IRRs were calculated. Supplementary analyses described hospitalizations and LOS for the rescue arm and individual IAT groups.

Results: In total, 352 pts were randomized (MBV: 235; IAT: 117), of whom 22 (18.8%) entered the MBV rescue arm. While on treatment, pts on MBV versus IAT had reductions of 34.8% in hospitalizations (p=0.021) and 53.8% in LOS (p=0.029; Table). Hospitalization rates were lower during the follow-up than treatment phase, with no differences between treatments in the follow-up (off-treatment) period (Table). The hospitalization rate in the IAT group pre-rescue with MBV (IR=6.98; 95% CI: 4.06, 12.03) was 2.54 times higher (IRR=2.54; 95% CI: 1.28, 5.04; p=0.008) than on or after rescue with MBV (IR=2.75; 95% CI: 1.81, 4.18); increased LOS pre-rescue was also noted (IRR=2.25; 95% CI: 0.72, 7.01) but not statistically significant. In the IAT arm, foscarnet pts tended to have higher hospitalizations (5.5 admissions/person/year) and longer LOS (51.7 days/person/year) during the treatment phase compared with patients on val/ganciclovir or maribavir (Figure).

Conclusion: Results from this analysis quantify the HCRU experience of pts requiring treatment for post-transplant CMV. Hospitalizations and LOS were lower for pts on MBV than IAT. Pts who received MBV rescue reported lower hospitalization rates on or after rescue than pre-rescue. Reducing hospitalizations is critical for alleviating disease burden to healthcare systems.

TCT2022 encore; DOI pending

This study was funded by Takeda Development Center Americas, Inc. Writing and editing support was provided by Caudex (UK), funded by Takeda Development Center Americas, Inc.

Social Media Promotion Image

right-click to download

© 2022 TTS 2022