Hepatitis C is a blood-borne viral infection characterized by chronic inflammation of the liver. Although patients may be asymptomatic for a number of years or decades, chronic HCV infection can lead to liver fibrosis (formation of scar tissue) and ultimately liver cirrhosis, in which permanent fibrotic scar tissue replaces healthy liver cells. In severe cases, cirrhosis may lead to liver failure and death. In addition, hepatitis C patients are at an increased risk of developing liver cancer.
Hepatitis C has a high global prevalence, with the number of people living with the disease estimated at 130-170 million worldwide. Before the arrival of direct-acting antivirals (DAA) in 2011, the gold-standard of hepatitis C therapy consisted of the host-targeting drugs pegylated interferon-α and ribavirin, which were associated with significant side effects.
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After nearly a decade of minimal progress in the development of hepatitis C therapies, the treatment landscape of hepatitis C has evolved substantially in recent years. This has resulted in an increasingly competitive market landscape, and several oral regimens that combine DAAs from different nonstructural (NS) HCV protein families – NS5B polymerase inhibitors, NS5A replication complex inhibitors and NS3/4A protease inhibitors – have already been licensed. These new combination therapies have been highly commercially successful and are now regarded as the gold-standard within the treatment algorithm.
Despite the entry of these new therapies, there is a subgroup of patients that do not respond to current treatments, or relapse. In addition, HCV resistance to DAAs may also be a cause for concern, as the development of selection pressure by the host immune system in combination with DAA therapy may lead to outgrowth of resistant viruses. As such, the rationale for investment in first-in-class innovation remains strong.
First-in-class products account for a relatively small proportion of the hepatitis C pipeline. However, in comparison with historical hepatitis C trends, which saw virtually no first-in-class products approved over a large period up until 2011, the presence of a modest number of these products is promising. The first-in-class targets identified show considerable diversity, and the high number of novel pathways targeted by first-in-class products provides evidence of enhanced divergence in hepatitis C first-in-class innovation in recent years.
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