The First Interferon-Free Regimens for Treatment of Hepatitis C Virus Are Expected to Launch in 2014 in the United States and Europe and Will Experience Aggressive and Widespread Uptake Through 2021
Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of hepatitis C virus (HCV), the elimination of interferons (IFNs) from treatment regimens is highly desirable owing to their side effects, which prevent a significant number of HCV-infected individuals from receiving antiviral therapy. Interviewed physicians expect that all-oral, IFN-free regimens will be more efficacious, better tolerated and enable treatment of patients who are contraindicated to IFN-alpha. The first IFN-free regimens are expected to launch in the United States and Europe by 2014 and, once available, Decision Resources anticipates aggressive and widespread uptake of these therapies in patients who are treatment-naive as well as treatment-experienced.
Until recently, the standard of care for HCV infections was peg-IFN-alpha and ribavirin, a nearly year-long treatment that cured only about 50 percent of patients and was associated with severe side effects. In 2011, the first two protease inhibitors—telaprevir (Vertex’s Incivek, Johnson & Johnson’s Incivo, Mitsubishi Tanabe Pharma’s Telavic) and boceprevir (Roche/Merck’s Victrelis)—entered the HCV market and were quickly adopted, in combination with peg-IFN-alpha and ribavirin, to treat genotype 1-infected HCV patients.
The upcoming Pharmacor advisory service entitled which will be published soon, also finds that interviewed physicians generally consider telaprevir a more potent antiviral than boceprevir, but also report that telaprevir is associated with higher rates of adverse events, including rash and anemia. Additionally, treatment providers have found both protease inhibitors less effective in difficult-to-treat patients, such as those with cirrhosis or advanced liver fibrosis.
The findings also reveal that the HCV market offers large but time-limited commercial opportunity in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
“Although the incidence of HCV has declined dramatically after the introduction of prevention measures such as blood donor screening in the early 1990s, prevalence is still high owing to the large cohort of aging, HCV-infected patients, many of whom have failed prior treatment and are awaiting new therapeutic options,” said Decision Resources Analyst David Holman, Ph.D. “As the treatment paradigm of HCV changes and additional highly efficacious and curative antivirals become available, the size of the prevalent HCV population will shrink.”
The HCV pipeline is dynamic and competitive owing to the large commercial potential that has been well recognized by pharmaceutical developers. Agents in late-stage development, which include protease inhibitors such as Johnson & Johnson/Medivir’s simeprevir; nucleoside polymerase inhibitors such as Gilead’s sofosbuvir and Bristol-Myers Squibb’s NS5A inhibitor daclatasvir, among others—are expected to drive dramatic HCV market growth through 2021. These emerging direct-acting antivirals (DAAs) are being evaluated in all-oral, IFN-free regimens consisting of one to three DAAs in combinations with and without ribavirin. Overall, the HCV market will grow from about $3 billion in 2011 to nearly $21 billion in 2018 and will then drop to $17 billion in 2021, owing to a decline in the size of the treatment-eligible population.
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