▎ WuXi AppTec content team editor
Recently, a new antiviral drug, letimovir tablets, was approved by the State Drug Administration of China (NMPA) for marketing, suitable for the prevention of cytomegalovirus (CMV) infection and related diseases.
Screenshot source: NMPA official website
According to public information, letmovir oral tablets and intravenous solutions were approved by the U.S. Food and Drug Administration (FDA) in November 2017 for the prevention of cytomegalovirus infection and related diseases, and the drug became the first new drug approved for CMV infection in the United States in 15 years.
Common spore virus infection
CYTOME is a common herpes virus that infects people of all ages and lasts for life once infected.
The main routes of cmV transmission are:
It is transmitted through contact with the saliva, urine, feces, blood, tears, semen and breast milk of an infected person.
If the pregnant woman is infected with CMV, the virus may also be transmitted to the fetus through the placenta or during childbirth.
Through transplantation of organs and blood transfusions, cmV transmission can also occur.
After the first infection with CMV, most healthy people have almost no symptoms, and the virus usually remains inactive or latent in the body for a lifetime. A small number of healthy people may also develop symptoms such as fatigue, fever, sore throat, or muscle pain.
However, for some special groups, such as fetuses and newborn babies, the first infection with CMV will cause a variety of symptoms and even serious complications.
Fetuses infected with CMV may experience developmental delays in the mother's body, and even miscarriage, stillbirth, and neonatal death.
Fetuses infected with CMV or infants infected with CMV at birth (acquired by the birth canal route) may develop symptoms such as enlarged liver and spleen, persistent jaundice, petechiae of the skin, microcephaly, hepatitis, etc., and may also cause hearing loss and even complications or sequelae such as deafness, intellectual disability, vision loss, movement disorders, and seizures.
In addition, for immunocompromised people, such as AIDS patients and organ transplant recipients, whether they are initially infected with CMV or reactivated with latent viruses in the body, it can lead to symptomatic diseases or secondary infections caused by other pathogens, affecting eye, lung, liver, esophagus, gastrointestinal and intestinal health.
Clinically, CYTOME infection is one of the common complications of allogeneic hematopoietic stem cell transplantation (HSCT), which can lead to gastrointestinal diseases, pneumonia or retinitis, increasing the risk of transplant failure and death.
Image credit: 123RF
Novel non-nucleoside CMV inhibitors
Letermovir is a novel non-nucleoside CMV inhibitor. Public information shows that letmovir has a new anti-cytomegalovir effect, by inhibiting the activity of the terminal enzyme complex of CMV, preventing the processing and packaging of viral DNA, thereby exerting antiviral effects. Unlike DNA polymerase inhibitors, lettmulfa is more selective for CMV and significantly more intense.
In a Phase 3 clinical trial, researchers evaluated the efficacy and safety of lettmvir in CMV-susceptible populations (adult patients who are serum positive for CMV after receiving allogeneic hematopoietic stem cell transplantation).
The results of the study show that:
Patients in the letmovir group had a clinically significant CMV infection at 24 weeks post-transplantation was 18%, compared with 42% in the placebo group;
Within 14 weeks after transplantation, the proportion of clinically significant CMV infections was 8% and in the placebo group was 39%;
In high- and low-risk populations of CMV reactivation, the efficacy outcomes were consistent;
The all-cause mortality rate was 12% in the Letmovir group, compared with 17% in the placebo group.
We expect that the approval of letmovir tablets in China will bring effective prevention measures to patients susceptible to CYTOME in China.