|The following article features coverage from the 62nd Annual Scientific Meeting of the British Society for Haematology. Click here to read more of Hematology Advisor‘s conference coverage.|
The use of maribavir appeared effective as a rescue treatment for refractory or resistant (R/R) cytomegalovirus (CMV) infection in a clinical trial involving hematopoietic stem cell transplant (HCT) or solid organ transplant (SOT) recipients. This is according to study results presented at the 62nd Annual Scientific Meeting of the British Society for Haematology by Marcus Pereira, MD, MPH, of Columbia University in New York, New York, and colleagues.
The phase 3 SOLSTICE study (ClinicalTrials.gov Identifier: NCT02931539) evaluated use of maribavir in comparison with investigator-assigned therapy (IAT) for treatment of R/R CMV infection in HCT/SOT recipients. Patients were randomized 2:1 to receive either maribavir (400 mg twice daily) or IAT for 8 weeks, and then they underwent a 12-week follow-up phase. Possible therapies in the IAT arm included valganciclovir, ganciclovir, foscarnet, and cidofovir.
Patients randomized to IAT could switch to a maribavir rescue arm after receiving IAT for at least 3 weeks. In the maribavir rescue arm they were treated for 8 weeks with maribavir before a 12-week follow-up. Eligibility criteria for switching to the rescue arm included worsening or lack of improvement on IAT or a failure to reach viremia clearance plus IAT intolerance.
In their presentation, Dr Pereira and colleagues focused on study end points related to CMV viremia clearance beginning at week 8, as well as safety, in patients in the maribavir rescue arm. CMV viremia clearance was defined by a plasma CMV DNA level of <137 IU/mL during 2 consecutive tests that occurred at least 5 days apart.
From an overall population of 352 patients, 235 patients were randomized to maribavir, and 117 patients were randomized to IAT. CMV viremia clearance was confirmed in 55.7% of patients receiving maribavir and in 23.9% of patients in the IAT arm at week 8. A total of 22 patients, reflecting 18.8% of patients in the IAT arm, moved to the maribavir rescue arm. On entry, 6 (27.3%) of these patients had neutropenia, and 9 (40.9%) had increased serum creatinine levels.
When assessed at week 8 of rescue therapy, CMV viremia clearance was seen in 11 patients (50.0%). Symptom control was demonstrated through week 16 for 6 patients (27.3%) in the rescue arm who had achieved CMV viremia clearance at week 8.
Treatment-emergent adverse events were seen in all 22 patients who entered the maribavir rescue arm. Nausea, vomiting, diarrhea, and dysgeusia were the most common treatment-emergent adverse events. Reportedly, no patients had neutropenia, and 3 patients experienced acute kidney injury.
The study investigators concluded that treatment with maribavir had efficacy with R/R CMV infection as a rescue therapy in HCT/SOT recipients who had not shown sufficient response to IAT. In the maribavir rescue arm, the safety profile was also reportedly similar to that of the maribavir arm.
Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
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Pereira M, Cervera C, Kotton C, et al. Efficacy and safety of maribavir as a rescue treatment for investigator assigned therapy in transplant recipients with refractory or resistant cytomegalovirus infections in the SOLSTICE study: phase 3 trial results. Presented at: 62nd Annual Scientific Meeting of the British Society for Haematology; April 3-5, 2022. Abstract OR05.