Livtencity's introduction raises expectations in the field

Takeda Pharmaceuticals’ Livtencity rises as a new option in treating infections

Up to 88% of allogeneic hematopoietic stem cell transplants and 55% of solid organ transplants experience CMV infection

Sung-Han Kim, Professor of Infectious Diseases at Seoul Asan Medical Center, stressed the need for the management of infections in stem cell and solid organ transplantation

Livtencity received a positive response for reimbursement as a second-line treatment for CMV infections and diseases, an area that lacked treatment options

The introduction of Livtencity (maribavir), a drug that can be prescribed to manage infections in transplant patients following the use of existing treatments, has been met with positive reviews in the field due to a lack of treatment options.

 

Although the actual number of patients who will be prescribed the drug is limited, the drug is expected to play a role in the management of infections in patients who value their transplant opportunity.

 

Sung-Han Kim, Department of Infectious Diseases, Seoul Asan Medical Center

Sung-Han Kim, Professor of Infectious Diseases at Seoul Asan Medical Center, attended a media session organized by Takeda Pharmaceuticals Korea to discuss the paradigm shift in the treatment of patients with cytomegalovirus (CMV) infection.

 

CMV is a double-stranded DNA virus that is a member of the herpesvirus family and is mainly transmitted through body fluids, white blood cells, and tissues such as transplanted organs.

 

In Korea, about 94% of adults are known to be seropositive for CMV.

 

For this reason, allogeneic hematopoietic stem cell transplantation or solid organ transplantation patients, whose immune function is temporarily reduced to control the body's rejection during the transplantation process, may develop latent CMV, rendering it an essential condition to manage.

 

In Korea, up to 88% of patients after allogeneic stem cell transplantation and up to 55% of patients after solid organ transplantation experience CMV infection.

 

CMV infection may be initially asymptomatic, but if not successfully treated, it can progress to CMV disease.

 

CMV infection is also considered a major threat that increases the risk of graft rejection, opportunistic infections, and death.

 

“People can be infected with CMV during adolescence to about 25 years of age and remain latent,” said Professor Kim, “and it can cause a number of diseases when the immune system is suppressed following transplantation.

 

CMV infection in transplant patients is an indication of a poorer immune status, so it needs to be managed appropriately.” Currently, CMV treatment is divided into three phases: prophylaxis for those who do not have the virus, preemptive therapy for those who do have the virus but have not developed a disease, and treatment for those who have advanced to a disease.

 

For solid organ transplant and allogeneic stem cell transplant patients, who are at high risk for CMV, ganciclovir (intravenous) and valganciclovir (oral) are used as first-line treatments.

 

In the case of patients who show resistance or are refractory to antivirals and require second-line treatment, solid organ transplant patients are treated with ganciclovir or valganciclovir in combination with an adjusted dose of immunosuppressive agents.

 

Foscarnet and cidofovir may also be considered, but their use is limited due to their non-reimbursed status.

 

”Livtencity is expected to serve as a promising new weapon for treatment of CMV...changing the guideline protocols remains a challenge” Livtencity has emerged in this situation.

 

The drug was launched last year and has been granted reimbursement as a second-line treatment since April.

 

Although the number of transplant patients is limited in Korea, the significance of its arrival is that it brings additional options to the field.

 

Although several drugs are already used for CMV, there are patients who are refractory to the existing options, so Livtencity is expected to play a role as a later-line option.

 

Kim said, “Organ transplants and bone marrow transplants are expensive, and there are cases where CMV can ruin the transplant.

 

In an area where options are limited, Livtencity’s introduction is significant because it has a better effect and fewer side effects.” ‘As Livtencity is an oral pill, it can be taken as an outpatient treatment, which makes it more convenient for the patients,” added Kim.

 

However, Kim believes that guidelines for post-transplant infection control need to be contemplated.

 

While the growing options have improved patient access, it also comes with the risk of cuts.

 

For allogeneic hematopoietic stem cell transplantation, the current treatment sequence is to use conventional first-line treatments such as ganciclovir and valganciclovir followed by Livtencity as a second-line treatment.

 

MSD's Prevymis (letermovir) has also emerged as a prophylaxis for CMV infection, but it can only be used for up to 100 days after transplantation.

 

“Prophylaxis after allogeneic stem cell transplantation is done most of the time, but due to the high cost of the drug and concerns about reimbursement cuts, the treatment is sometimes terminated at the wrong time or the right dose not used,” said Kim.

 

“There is also a need for the hematology and infectious disease departments to discuss the treatment protocols to manage CMV after allogeneic stem cell transplantation.” “Various discussions need to be made to address these protocol issues, which is not easy in the current environment.

 

We would need to sort out these protocols after the overall healthcare situation improves in Korea.”