Express To benefit more patients with chronic hepatitis B, Gilead Antiviral Therapy has been approved by the FDA to expand its scope

Gilead Sciences today announced that the US FDA has approved a supplemental new drug application (sNDA) for its drug Vemlidy (tenofovir alafenamide) for the treatment of children with
chronic hepatitis B.
These patients are at least 12 years of age and have liver disease
that affects liver function.

Hepatitis B is one of the world's most significant infectious disease threats, with more than 290 million
people infected worldwide.
Hepatitis B virus infection is the leading cause of liver disease, and current treatments are difficult to cure, and many patients develop secondary liver cancer
.
Currently, there are an estimated 90 million chronic hepatitis B patients in China, of whom 28 million require treatment and 7 million require urgent treatment
due to the risk of severe liver disease and cancer.
Currently available antiviral treatments can control chronic hepatitis B but do not cure the disease
.
Even with long-term treatment, patients still have a high chance of developing cirrhosis and liver cancer
.

Vemlidy is an oral ingot, tenofovir targeted procurate, a novel nucleoside reverse transcriptase inhibitor (NRTI).

In 2016, Vemlidy received FDA approval to treat adults with chronic hepatitis B with liver disease that affects liver function
at once-a-day doses (25 mg).
According to guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the European Society of Liver Diseases (EASL), this drug is recommended as a first-line treatment
for these diseases.
According to research, Vemlidy reduces the viral load of hepatitis B in the body and improves the function of
the liver.

Image source: 123RF

The approval of Vemlidy for pediatric patients is based on a 24-week Phase 2 trial
of Trial 1092.
This trial compared the efficacy and safety of 25 mg Vemlidy with placebo in a total of 70 children aged 12 years but under 18 years who weighed at least 35 kg
.
The trial achieved the primary endpoint of less than 20 IU/mL viral DNA levels in people with hepatitis B at 24 weeks of the trial
.
Data analysis showed that 21% (10/47) of patients in the Vemlidy group met this clinical criterion, compared with 0% (0/23)
in the placebo group.

"Although the prevalence of children with hepatitis B has declined significantly in the United States, chronic hepatitis B infection in children following acute infection can have long-lasting health effects throughout their lives," said Dr.
Merdad Parsey, Gilead's Chief Medical Officer.

Based on known safety and once-a-day dosages, Vemlidy offers doctors a treatment option to meet the needs of
pediatric patients with hepatitis B.
”