Patients undergoing any kind of surgery face many worries. Whether it be fear of infection following the procedure, worries about what the recovery process will look like, financial concerns, or just general medical procedure fear, all patients have worries. There is a certain subgroup of patients, however, who have a particularly difficult journey. Patients undergoing transplantation surgery face long term risks not associated with many other procedures. Patients who undergo an organ transplant have many immediate and long term risks, including risk of rejection, risks associated with immunosuppression, diseases associated with transplanted organs, and major blood loss. One of the scariest parts for patients is what kind of organisms they are at risk for on long-term immunosuppressants. One of the most common infectious agents associated with transplant-related morbidity and mortality is cytomegalovirus.1 Cytomegalovirus is a virus that can appear as a latent virus, as an active virus, or it can be an invasive virus. It is often associated with people who have a weaker than normal immune system, which is the case in patients with immunosuppression following transplant. It is a significant cause of morbidity and mortality in patients who are receiving a transplant. Cytomegalovirus is a virus that can be controlled with prophylaxis. Typically, prophylaxis is administered to patients for three to six months following transplant. At that point, the risk of reactivation is low. Standard care of treatment includes oral valganciclovir. When there is an activation of a latent cytomegalovirus infection, standard care includes hospitalization and infusion with intravenous ganciclovir. Valganciclovir, however, has significant adverse effects for patients. There was recently a new medication brought to market by Takeda Pharmaceuticals, which helps to address some of the patient concerns regarding cytomegalovirus reactivation.2
Maribavir is a novel agent that was recently approved by the Food and Drug Administration (FDA) for the treatment of cytomegalovirus reactivation. In the open-label, dose blinded, phase 2 trial that helped maribavir gain FDA approval, patients found significant benefit. Patients were assigned randomly to receive maribavir 400 mg, 800 mg, or 1200 mg twice daily for no more than 12 weeks. This was compared against the standard of care, valganciclovir. Patients were dosed for no more than 12 weeks, which aligns with the minimum interval for cytomegalovirus prophylaxis. Sixty two percent of patients in the maribavir group had a positive response to treatment as compared to just fifty-six percent in the valganciclovir arm. There was also a higher amount of serious adverse events as well as discontinuations in the maribavir group when compared to the valganciclovir group. There was a higher percentage of gastrointestinal related adverse events in the maribavir group, while the valganciclovir arm had a higher incidence of neutropenia. Although different, these adverse events can help clinicians determine which patients would benefit from each kind of prophylaxis. This represents new hope for a group of patients who previously had limited treatment options. Previously, patients had limited options, and could be left susceptible to cytomegalovirus reactivation. With this new hope for transplant patients, we will see a revolution in the way we care for transplant patients.3
References:
Center UCDT. Potential risks of transplant surgery. UC Davis Health. https://health.ucdavis.edu/transplant/about/potential-risks-of-transplant-surgery.html. Accessed November 30, 2021.
Azevedo LS, Pierrotti LC, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics (Sao Paulo). 2015;70(7):515-523.
Maertens J, Al. E, Department AAFthe H, et al. Maribavir for preemptive treatment of cytomegalovirus reactivation: Nejm. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa1714656. Published November 25, 1970. Accessed November 30, 2021.