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Treatment of infection with hepatitis C virus (HCV) has changed substantially in the last 3 years, with new therapies now reaching cure rates (defined by sustained virologic response) higher than 95%. As little as 3 years ago, treatment involved an arduous course of pegylated interferon and ribavirin, which caused serious adverse effects in more than 80% of patients; less than 50% of patients could finish the treatment course. Because HCV infection can be indolent, with slowly developing liver injury in the form of scarring and fibrosis, many patients were so-called warehoused by their physicians, followed up closely while waiting for more promising treatments.1
In 2011, introduction of the first generation of protease inhibitors, particularly telaprevir and boceprevir, heralded change. When combined with interferon and ribavirin, these medications produced much higher sustained viral responses in the HCV genotype 1 subclasses.1 However, these agents were much more expensive than standard therapy, at a cost of more than $80 000 per course of therapy, and were associated with high levels of viral resistance development if patients did not strictly adhere to therapy.
In 2014, the introduction of polymerase inhibitors set a new standard. The first in this class, sofosbuvir, manufactured by Gilead, has shown significant effectiveness when combined with ribavirin and interferon in patients with genotype 1 HCV. Sofosbuvir also can be combined with another new protease inhibitor, simeprevir, to treat patients in whom interferon-based therapy has failed. These regimens provide interferon-free treatment protocols that are shorter and well tolerated and have 80% to 95% cure rates.1 This fall, an oral combination of sofosbuvir and ledipasvir will be introduced that inhibits both the NS5B polymerase and NS5A polymerase and has been shown to reduce treatment to an 8-week course with cure rates of more than 95%.2 Now, a chronic disease that affects millions of Americans can be cured by well-tolerated oral medications.
Perhaps surprisingly, most media coverage of this important development in HCV treatment has not focused on the cure rates but, rather, on cost. The price of sofosbuvir is essentially $1000 per pill, or $84 000 for a standard 12-week course. The fact that pricing in the United Kingdom for a similar regimen is $54 000, and perhaps as low as $900 in Egypt and other developing countries,3indicates that the pricing in the United States is a purely financial decision by Gilead and has outraged many. Indeed, some pharmacy benefit managers are calling on their clients to boycott these products until alternatives are available late in 2014.4/.../