The FDA has approved Victaralis, a new drug for hepatitis C

Merck succeeded in developing the first new drug for jaundice after 20 years: the drug binds to an enzyme in the virus - and prevents the replication of the virus

The US Food and Drug Administration (FDA) over the weekend approved a new drug from the pharmaceutical company Merck, for the treatment of hepatitis C. The new drug, Victrelis (boceprevir), is intended for patients whose liver is still functioning at a certain level, and who have not previously been treated with any drug for the disease Jaundice, or after failure of previous treatments, with other drugs. The drug is approved for use in combination with peginterferon alfa and with ribavirin only. The approval of the FDA was given after clinical studies proved significantly higher efficacy than the treatments that existed until now.
According to the American Center for Disease Control and Prevention, about 3.2 million people in the US suffer from chronic hepatitis C. This viral disease causes inflammation of the liver, which may lead to a decrease in liver function or its complete failure, which may require a liver transplant. Most hepatitis C patients do not suffer any symptoms of the disease - until the damage to the liver itself occurs, which may come even years after infection with the virus.
Most of the liver transplants performed in the US are required for patients with type C jaundice, which has worsened to terminal liver damage. After the initial infection with the hepatitis virus - HCV - most of those infected develop chronic hepatitis C. Some will develop cirrhosis of the liver over the years. Cirrhosis can cause liver damage and complications such as bleeding, jaundice of the eyes and skin, fluid retention, infections or liver cancer.
Professor Ziv Ben Ari, an expert in liver diseases at the Beilinson Medical Center and the chairman of the Israeli Society for Liver Research said, "Victoralis belongs to a new group of drugs, protease inhibitors, for the treatment of chronic infection with the hepatitis C virus, which is a significant breakthrough in treatment. The drug significantly increases the percentage of cure from the disease compared to the existing treatment. I expect that Citralis will help many more hepatitis C patients get well. We are waiting for the moment when the drug will be approved for use in Israel as well."
Hepatitis C virus infection occurs in several possible ways, including exposure to blood infected with the virus, giving birth to children to mothers who carry the virus, transferring contaminated syringes, having sex with a person infected with the virus, sharing personal items such as a razor or toothbrush, or using a tattoo needle or tool Piercings that were not sinned properly after being used to treat a person suffering from the disease.
Victrilis, manufactured by the American pharmaceutical company Merck, which operates outside the US under the name MSD, is a pill that must be taken three times a day. The new drug belongs to a family of drugs known as protease enzyme inhibitors: the molecule of the drug binds to the enzyme of the virus, preventing it from reproducing.
The safety and efficacy of VictarlisTM were tested in two clinical trials in phase 3 of the development process, which included 1,500 adult patients. In two trials, two-thirds of patients who received VictarlisTM in combination with other drugs showed a significantly better virological cure: no hepatitis virus was detected in the blood 24 weeks after the end of treatment. These results are significantly better compared to the treatment that was accepted until now, with only peginterferon and ribavirin.
When the body continues to show an immune response to the HCV virus, the cause of jaundice, after completing the treatment - in a way that prevents the appearance of the virus in the blood - the virus infection is actually cured.
A stable virological response, of the type generated by the new drug, may lead to a reduction in the risk of liver cirrhosis or complications of liver disease, a reduction in the rate of liver cancer cases, and a reduction in mortality.
With the approval of the new drug, Dr. Edward Cox, Director of Antimicrobial Products at the FDA, stated that "VictoralisTM is an important new advance for hepatitis C patients. The new drug offers an effective treatment for a serious disease, and a greater chance of curing certain patients in jaundice, compared to the drugs that were available until today"
Safety information about VictarlisTM
The most common side effects of treatment with CitralisTM in combination with other drugs include fatigue, low red blood cell count (anemia), nausea, headaches and disturbances in the sense of taste.