Victrelis (boceprevir) has been approved by the FDA for adults with hepatitis C who have either never been treated with medications before or have not responded well to drug therapy. The FDA (Food and Drug Administration) approval is for Victrelis use alongside peginterferon alfa and ribavirin.
The FDA evaluated two Phase III trials involving 1,500 adult patients with chronic hepatitis C. In both cases over 60% of patients administered Victrelis alongside the other two medications had no detectable hepatitis C virus 24 weeks after treatment stopped (24-week virologic response). This represented a much higher percentage when compared to patients on just the other two drugs (pegylated interferon and ribavirin).
When a virologic response is sustained so long after finishing drug treatment it usually means their hepatitis C infection has been cured. Such patients have a much lower risk of cirrhosis and liver disease complications, reduced liver cancer risk, and a much smaller chance of dying prematurely.
Director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, Edward Cox, M.D., M.P.H., said:
"Victrelis is an important new advance for patients with hepatitis C. This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy."
Chronic hepatitis C is an infection caused by a virus that causes liver inflammation that can eventually undermine liver function, and even result in liver failure. In the majority of cases, infected individuals have no symptoms until liver damage occurs many years after initial infection.
The majority of liver transplants in American are done to treat hepatitis C patients after the disease has progressed too far.
Most infected individuals eventually go on to develop chronic (long-term) hepatitis C. If cirrhosis of the liver develops, which can occur after some years, the liver can become damaged and the patient may experience liver cancer, fluid build up in the abdomen, bleeding, and jaundice.
You can become infected with hepatitis C by:
Being born to an infected mother
Being exposed to infected blood
Having unprotected sex with an infected partner
Having your skin pierced with unsterilized equipment, as may occur when having a tattoo or ear piercing
Sharing tainted needles (more common among addicts of illegal drugs)
Patients take Victrelis three times daily with food. It is a protease inhibitor - it binds to the virus, stopping it from multiplying.
In the trials, participants on the Victrelis combination therapy reported the following side effects: dysgeusia (impairment or dysfunction of the sense of taste), nausea, headache, anemia, and fatigue.
Pharmaceutical company Merck & Co Inc., the marketers of Victrelis, says it will be supplying pharmacies with Victrelis within the next seven days so that hepatitis C patients can have access to it as soon as possible. Merck's support of public awareness and education programs for chronic hepatitis C will be expanded, the company added, to include coupons to help with medication costs, reimbursement support to help better understand individual insurance coverage, plus a twenty-four hour nurse telephone support service.
Victrelis will also be added to Merck's patient assistance program - a significant number of individuals may be eligible to receive the medication at no charge.
View drug information on Victrelis.