Hepatitis C drug teleprevir cures 75% virus infection, says Vertex

Anti-viral drug teleprevir has cured more than 75% of patients suffering from hepatitis C infection, first time in the history of the life-threatening liver disease treatment.

75% of people chronically infected with genotype 1 hepatitis C virus (HCV) who had not previously been treated achieved viral cure after a 12-week telaprevir-based combination therapy, according to Vertex Pharmaceuticals Incorporated.

Telaprevir was followed by treatment with pegylated-interferon and ribavirin alone, in the Phase 3 ADVANCE trial.

ADVANCE was a Phase 3, randomized trial that enrolled approximately 1,095 people infected with genotype 1 chronic HCV, the most common form of the virus in the U.S. and Europe, who had not previously been treated for their HCV infection.

The trial enrolled patients at 114 international clinical trial sites worldwide.

Approximately 60% of the patients in ADVANCE were enrolled at trial sites in North America. Additionally, approximately 20% of the patients in ADVANCE were African American, Black, Hispanic or Latino, and approximately 20% had advanced fibrosis or cirrhosis.

69% of people achieved viral cure after receiving an 8-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone. 44% of people in the control arm achieved cure after 48 weeks of treatment with the currently approved regimen of pegylated-interferon and ribavirin.

Telaprevir has been found safe for patients in the trials.

“These first Phase 3 results are important for people with hepatitis C, as they represent a potential new era of therapy where doctors may be able to use direct acting antiviral medicines to improve treatment and help patients potentially avoid life-threatening liver-related consequences associated with chronic hepatitis C,” stated Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, and an Investigator for the ADVANCE trial.

Fewer than half of people with genotype 1 hepatitis C achieve a viral cure with currently approved therapies.

Telaprevir is an investigational, oral pill that inhibits HCV protease, an enzyme essential for viral replication

Telaprevir is being developed by Vertex Pharmaceuticals in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma.

Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) for telaprevir in the second half of 2010 for both treatment-naïve and treatment-failure patients.

What is hepatitis C?

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). HCV is found in the blood of people with the disease.

While chronic HCV infection affects up to 3.9 million individuals in the United States, 75% of those infected are unaware of their infection.

Though many people with HCV infection may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.

Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved treatment regimen, do not achieve sustained viral response (SVR),or a virologic cure.

HCV is spread through direct contact with the blood of infected people.

Chronic HCV can lead to serious liver problems, including liver damage, cirrhosis, liver failure, or liver cancer.

If treatment is not successful and patients do not achieve an SVR, they remain at risk for progressive liver disease.

HCV infection is the leading cause of liver transplantations.

The majority of patients infected with HCV were born between 1946 and 1964, accounting for two of every three chronic HCV cases.