HCV is a blood-borne, positive sense, ssRNA virus, primarily infecting cells of the liver. HCV is a leading cause of chronic liver disease and liver transplants and spreads via blood transfusion, hemodialysis, and needle sticks. In the US, injection drug use accounts for approximately 60% of all new cases of HCV. Diagnosis of HCV is made through blood tests, including molecular tests that allow for the detection, quantification and analysis of viral genomes and the classification of an infection into specific viral genotypes (GTs). Hepatitis C becomes chronic hepatitis C in 75% to 85% of acute cases, with an incubation period lasting from two to 26 weeks.
HCV is classified into seven genotypes and 67 subtypes, with genotype 1 being responsible for more than 70% of HCV cases in the US. Patients with HCV are also classified by liver function status: compensated cirrhosis (liver scarring) denotes those patients that do not yet have impaired liver function, while decompensated cirrhosis describes patients with moderate to severe liver function impairment.
According to the WHO, an estimated 50 million people globally have chronic HCV infection, with about 1 million new infections and 242,000 deaths occurring per year. Approximately 290,000 people die every year from HCV related liver diseases, with the majority of deaths related to cirrhosis and hepatocellular carcinoma. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan.
The most recently published CDC HCV surveillance report showed a continuing increase in HCV infections in the US as rising incidence from new and re-infections offset the number of patients being cured. In addition, it is widely accepted that the number of reported cases is likely significantly below the number of actual cases. Most individuals who become infected with HCV remain unaware that they are infected because HCV can go undetected until the condition progresses to symptomatic disease or until specific clinical tests are performed to confirm diagnosis. Consequently, cases are unreported, skewing actual disease prevalence rates. The burden of underreporting is realized when high medical expenditures (comorbid treatment costs, liver transplants) and mortality rates from advanced chronic liver disease do not proportionally align with reported prevalence rate
Despite the availability of direct acting antivirals, there remains a large, underserved, HCV patient population in the US. HCV continues to be a recognized healthcare crisis in the US with between 2.4-4.0 million people living with HCV. There are approximately 170,000 newly reported annual HCV infections each year and they exceed annual cures. A large portion of this incidence is attributable to the opioid crisis, IV drug use and HCV reinfection.
The US HCV prevalence is expected to continue to remain steady over the coming years as rising HCV incidence offsets the number of new patients treated. It is estimated that a substantial global market for HCV therapeutics will exist to 2050 and beyond. In 2024, reported global net sales revenue was approximately $3 billion, with approximately 50% attributable to the US.
The combination regimen of bemnifosbuvir and ruzasvir is in a global Phase 3 development program. This regimen has the potential to offer a differentiated treatment option with low risk of drug-drug interactions, short treatment duration, and convenience with no food effect for HCV-infected patients with or without compensated cirrhosis.
Atea is a clinical-stage biopharmaceutical company committed to addressing unmet medical needs through novel antiviral treatments.
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