HCV TREATMENT COST RISES

Large-scale manufacture of drugs used to treat patients infected with the hepatitis C virus (HCV) can be accomplished at much lower costs than current pricing schemes, according to a studypublished online January 6 in Clinical Infectious Diseases.

The US Food and Drug Administration (FDA) recently approved new drugs for HCV, including sofosbuvir and simeprevir. The drugs are expected to dramatically improve care for patients with HCV.

However, the cost of these game-changing drugs may put them out of reach of many patients. At this time, in the United States, the cost of 12 weeks of HCV therapy with simeprevir is $66,000, and with sofosbuvir it is $84,000.

In a new study, Andrew Hill, PhD, from the University of Liverpool, United Kingdom, and colleagues, estimated the cost of HCV treatment, using similar market dynamics as those used to dispense antiretroviral therapy to patients with HIV in developing countries.

Given their similar chemical structure and mechanism of action, the researchers compared 5 direct-acting antiviral HCV drugs (DAAs) — daclatasvir, sofosbuvir, simeprevir, faldaprevir, and ribavirin — with their closest analogues used in the treatment of HIV and used these data to estimate manufacturing costs per gram of drug.

The authors determined that the cost of a 12-week course of HCV therapy could be as little as $100 to $250 a person. These estimated treatment costs were based on an intended treatment population of at least 1 million patients and included a 40% margin for finished production.

The authors note that 12 of the 20 countries with the largest HCV epidemics are classified as low- or lower-middle-income countries and point out that their results demonstrate that more affordable therapy is possible. "These low prices coupled with the high [sustained virological response] rates established in several trials [show] the potential for large-scale, low cost HCV treatment in developing countries, with the potential to repeat the model of low-cost HIV treatment that has benefitted millions of people," write Dr. Hill and colleagues.

In an interview with Medscape Medical News, Dr. Hill said, "We need the health authorities in the highest-burden countries to work with the World Health Organization for a plan for large-scale treatment of hepatitis C. Eradication of this disease is possible, if there is the political will."

When asked whether he felt the current price for new DAAs for HCV therapy is justified, Dr. Hill responded: "We need to separate the cost of treatment in North America and Europe from the cost in low- and middle-income countries. There should be large-scale access programs set up to treat people with hepatitis C at minimum cost in high-burden countries such as India, Egypt, Indonesia, and Nigeria."

Already, legal initiatives have been filed in India in an effort to prevent a major pharmaceutical company from obtaining a patent on one of these new HCV drugs. This would allow for production of a low-cost generic formulation and drastically reduce the cost of treatment in that country.

Dr. Hill and colleagues acknowledge there are limitations to their analysis, including a lack of detailed production information about specific DAAs and the fact that these estimates assume no patent restrictions on production. They note that voluntary or compulsory licenses that allow for the production of generic formulations will be necessary to make these cost estimates a reality.

"Every company developing drugs for hepatitis C needs a plan for ensuring access to their drugs in low- and middle-income countries," concluded Dr. Hill. "In the future, access to treatment for hepatitis C should be available together [with] treatment for HIV," he said.

One author has received consultancy payments from Janssen Pharmaceuticals that are not connected with this project. Another author has received consultancy and travel grants from other pharmaceutical companies that are also not associated with this project. The other authors have disclosed no relevant financial relationships.

Clin Infect Dis. Published online January 6, 2014. Full text