CMX001 to Prevent Cytomegalovirus Disease in Hematopoietic-Cell Transplantation

Abstract

Treatment with oral CMX001 at a dose of 100 mg twice weekly significantly reduced the incidence of CMV events in recipients of hematopoietic-cell transplants. Diarrhea was dose-limiting in this population at a dose of 200 mg twice weekly. (Funded by Chimerix; CMX001-201 ClinicalTrials.gov number, NCT00942305.).

Human herpesvirus-6 encephalitis after allogeneic hematopoietic cell transplantation: What we do and do not know

“…A phase 2 trial showed that brincidofovir effectively prevented cytomegalovirus diseases without myelosuppression and nephrotoxicity in allo-HCT recipients. 91 Diarrhea was the most common adverse event. 91 Clinical trials will be required to assess the safety and efficacy of new agents to suppress HHV-6 reactivation and prevent HHV-6 encephalitis.…”

“…91 Diarrhea was the most common adverse event. 91 Clinical trials will be required to assess the safety and efficacy of new agents to suppress HHV-6 reactivation and prevent HHV-6 encephalitis.…”

Treatment of CMV infection after allogeneic hematopoietic stem cell transplantation

“…Three multicenter, randomized, placebo-controlled phase II, proof of concept studies [60,61,62] led to the identification of three new compounds with anti-CMV activity (Table I).…”

“…Its lipophilic nature, obtained with the addition of a lipidic side chain to the parent compound, allows the absorption through plasma membranes, reducing the amount of circulating drug and avoiding damage to renal tubules [82]. In a multicenter double blind, placebo-controlled, phase II dose-escalation study on a cohort of 230 allogeneic HSCT patients, BDF reduced incidence of CMV infection and CMV disease in those patients who received BDF at doses of 100 mg weekly or higher as compared with those who received placebo [62]. Of 15 patients in the study cohort who developed GvHD and required systemic steroid treatment, only one developed CMV reactivation.…”

Immunotherapy for viral and fungal infections

“…CMV reactivation/disease has a major negative impact on the outcome of SCT. 1,2 Inspite of novel anti-CMV drugs (CMX001 and letermovir) with promising activity and good safety profile, 3 CMV infection remains a life-threatening complication and a major cause of infection-related mortality in recipients of an allo-SCT, especially in patients undergoing cord blood or haploidentical SCT as well as patients with severe acute or extensive chronic GvHD.…”