Livtencity is the first drug to be approved by US FDA for the treatment of Cytomegalovirus. This approval is specifically for the use in patients with post-transplant cytomegalovirus (CMV) infection or disease, failing to respond to the available antiviral treatments. Livtencity’s FDA approval is awarded with Breakthrough Therapy and Priority Review Designations. Livtencity works by blocking the virus replication. CMV infections are very severe and turn out to be fatal in transplant recipients. Stem cell and solid organ transplant patients are always under the risk of encountering post-transplant infections; CMV is very common among them. The commonly available antiviral treatments may include treatment with Cidofovir and Foscarnet Sodium.
Post-Transplant Cytomegalovirus Infections and their severity
CMV as it is often referred in medical short forms, Cytomegalovirus infection is one of the common risk factors associated with using anti-rejection medications. Both in case of Stem Cell and Solid Organ Transplant procedures, the success rate would depend on recipient body’s acceptance of donor cells or organs. It is inevitable to recommend immunosuppressant drugs or anti-rejection medications to reduce the risk of rejection as per the standard protocols. Taking such medications can also carry the risk of CMV infection. Transplant recipients are prone to CMV or other viral infections due to reduced immunity because of immunosuppressant intake. In many cases, CMV infection reoccurs from any contraction during the pre-transplant phase. This is a reactivated CMV infection. It could also be carried from the transplanted organ or cells, if the donor is either exposed or infected by CMV. It is a nothing but a type of herpes virus in simpler terms. Such an infection can affect any organ of the patient’s body. CMV symptoms include fever, leukopenia, shortness of breath, blurred vision and abdominal pain, other than seizures and headache. In many cases it may remain asymptomatic.
Livtencity (maribavir) in the management of CMV Infection or Disease
In the clinical study involving 532 transplant patients who did not respond to one or two available antiviral treatments, 235 patients received Livtencity through randomization. The four well known antiviral drugs are ganciclovir, valganciclovir, foscarnet and cidofovir. CMV viremia clearance was the parameter for evaluation in this phase three randomized trial. Undetectable blood CMV DNA determines the rate of CMV viremia clearance. 56% of patients who received Livtencity have experienced undetectable blood CMV DNA. This is almost double when compared to outcome with the random drug assigned for patients on comparator arm. Only 24% of patients on comparator arm achieved CMV viremia clearance against 56% of patients on Livtencity. This confirms the efficacy of maribavir, which can soon become a drug of dependence in the management of post-transplant CMV infection in patients. This can indirectly increase the rate of transplant success as many patients reportedly succumb to the CMV disease after the procedure. Estimates suggest that over 200,000 adult transplant procedures are carried out in a year across the globe. Given this, the relevance and apparent demand for Livtencity is clearly obvious.
