Letermovir prevents CMV disease in kidney transplant patients — a ‘less toxic’ alternative
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WASHINGTON — Letermovir effectively prevented cytomegalovirus disease among kidney transplant patients with fewer side effects than valganciclovir, according to a study presented at IDWeek.
Although valganciclovir is effective against CMV in transplant patients, its toxicities make it more challenging to use, researchers said. The drug was approved by the FDA in 2001 for specific solid organ transplant patients, including kidney patients.
According to the new study, letermovir is at least as effective and could be preferable in some indications, but the drug has not been approved for solid organ transplant patients. It already is approved and in use for allogeneic hematopoietic stem cell transplant patients.
“This medication seems to be as effective — not a lot better, not a lot worse — basically comparable to the current approved standard. The big claim to fame [here] is that it is significantly less toxic,” Ajit P. Limaye, MD, professor of medicine and director of the solid organ transplant infectious diseases program at the University of Washington, told Healio.
For the study, Limaye and colleagues randomly assigned 601 patients within 7 days of a kidney transplant to receive either letermovir or valganciclovir for 28 weeks after their transplants and followed them for 52 weeks after transplant. The primary endpoint was the proportion of patients who developed CMV disease.
Researchers found that, through week 52, 10.4% of patients treated with letermovir developed CMV, compared with 11.8% of patients treated with valganciclovir.
The proportion of patients treated with letermovir who experience drug-related adverse events, however, was 19.9%, whereas 35% of patients treated with valganciclovir experienced adverse health events linked to the treatment.
Additionally, more patients completed the letermovir treatment course, with 4.1% withdrawing from the study due to an adverse event, compared with 13.5% who withdrew from the valganciclovir arm of the trial.
According to the CDC, up to half of adults by age 40 years have been infected with CMV — a member of the herpesvirus family that is largely symptomless in those with healthy immune systems. The virus can reactivate, however, when the immune system is weakened, like when a person is receiving a solid organ transplant.
The incidence of CMV in kidney transplant recipients ranges from 8% to 32%, according to researchers, and it usually occurs in the first 6 months after transplantation.
Limaye said it is important to have a second medication to prevent CMV with fewer side effects because there is a high risk for “getting a kidney full of CMV.” Other second-line medications for CMV in transplant patients have been approved in recent years, but finding an appropriate drug for kidney transplant patients have been slow to come.
With valganciclovir having been developed and approved more than 2 decades ago, Limaye noted that “just looking at the timeline of other drugs and how few have been approved in this setting ... I think it’s a testament to how challenging [it is].”
References:
- CDC. Cytomegalovirus (CMV) and congenital CMV infection. https://www.cdc.gov/cmv/index.html. Accessed Oct. 26, 2022.
- Einollahi B. Int J Organ Transplant Med. 2012;3:74-78.
- Simon DM, Leven S. Infect Dis Clin North Am. 2001;doi:10.1016/s0891-5520(05)70158-6.
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Limaye A, et al. Abstract LB2307. Presented at: IDWeek; Oct. 19-23, 2022; Washington (hybrid meeting).
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