Hepatitis C Virus

Genelabs has an established reputation in the hepatitis virus field based on its discovery of the hepatitis E and G viruses (HEV and HGV) as well as considerable work with hepatitis B and C viruses (HBV and HCV). Our research has led to the development of marketed diagnostic products for three hepatitis viruses and an investigational HEV vaccine currently in clinical trials.

Our drug discovery efforts are currently targeted against the hepatitis C virus (HCV), a therapeutic area that represents significant unmet medical need. Chronic infection with HCV can cause potentially life-threatening liver disease. The World Health Organization has estimated that 170 million people worldwide are chronically infected with HCV, including 4 million in the United States, where HCV is the most common chronic blood-borne virus.

Patients with chronic HCV infection can be virtually symptom-free for decades but may eventually progress to life-threatening complications. The continued presence of active HCV infection in the liver over a number of years can lead to serious liver disease, such as cirrhosis (scarring of the liver), or hepatocellular carcinoma (liver cancer). According to the CDC (U.S. Centers for Disease Control), approximately 85% of HCV infected individuals will develop chronic infections, of which 60-70% will progress to chronic liver disease. Furthermore, it is estimated that the incidence of cirrhosis in individuals with chronic HCV infection is 20%, while hepatocellular carcinoma will occur in approximately 5% of people infected with HCV. In the United States, chronic HCV infection is now the leading cause of liver failure requiring liver transplantation and leads to death in approximately 10,000 individuals annually.

Significant and Growing HCV Patient Population

This delay in the occurrence of symptoms as well as approximately 36,000 new HCV infections annually in the U.S. (according to the American Medical Association), represents a significant and increasing patient population. Because current therapies are effective only in a limited number of cases, there is a need for improved treatment options for HCV.

HCV Treatments

Treatment of chronic HCV infections is characterized by a dual objective: preventing the progression of liver disease by reducing the amount of virus in the body to low levels, and ameliorating the process of liver inflammation. In the U.S., the only currently approved treatments for chronic HCV infections are interferon alpha and the combination of interferon alpha with the nucleoside analog ribavirin. Unfortunately, these treatments are only effective in reducing viral loads in approximately 50-60 % of patients infected with HCV genotype 1, the genotype most prevalent in developed countries. As a result, approximately half of the HCV genotype 1 infected population is without effective treatments for a disease which may eventually progress to life threatening complications. In addition, it has been demonstrated in well controlled clinical trials that re-treatment of HCV infected patients with interferon-based therapies was not effective, leaving them with no treatment options to control their disease.

This relatively low response rate and the inability to successfully re-treat patients infected with HCV genotype 1, is producing each year a sizable, accumulating base of non-responding HCV infected patients.
Currently approved HCV treatments are also associated with significant toxicities and can cost over $30,000 per year, creating further potential barriers to treatment.

HCV Market Potential

The need for innovative HCV treatments will increase each year due to the following reasons:

• Large pool of undiagnosed HCV-infected individuals, many of whom will proceed to symptomatic disease

• Newly infected individuals

• Accumulating number of previously treated HCV-infected individuals who are non-responders to existing therapies

These dynamics have created a pharmaceutical treatment market that is projected to exceed $10 billion by 2010.

Chronic HCV infection remains an important public health problem throughout the world and there is an urgent need for new therapies with even modest improvements over existing treatments.

Genelabs is taking a targeted approach to HCV drug discovery with the goal of producing best-in-class compounds that demonstrate an advantage over competitive approaches and can be advanced into preclinical and clinical development.

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