It is a disease that an estimated 150 million people worldwide live with, that causes the deaths of at least 1,000 people a day, and that affects virtually every country of every income level, many of them without accessible diagnostic tools. The current standard of care brings harsh side effects and only a 50-to-75-percent cure rate. Yet, the report New Treatments for Hepatitis C Virus: Strategies for Achieving Universal Access notes, international responses have yet to reflect the severity of the threat posed by hepatitis C.
The report, from the international humanitarian nonprofit Médecins du Monde calls 2014 a “turning point” in the history of the pandemic disease that was discovered in 1989. That is because new treatments with fewer side effects and cure rates close to 90 percent are on the horizon, having been approved, or readied for approval in the last year. The report, then focuses on a familiar obstacle, noted here before: the costs of the new treatments put them almost universally out of reach. In the United States, the cost of a 12-week course of sofosbuvir, the new treatment from Gilead approved by the U.S. Food and Drug Administration last year, runs from $80,000 to $90,000 per person. Gilead plans to make a round of treatment available in middle income countries, including Egypt, the report says, for a minimum price of $2,000 per person, but in Egypt, the report notes, the cost of medicine alone for everyone with hepatitis C would amount to five times what the country spent on all of its public health services in 2011. Gilead is making a deal through voluntary licensing to make cheaper versions of the drug available to 60 lower income countries, but noting “there is no Global Fund on HCV to purchase treatments, diagnostics, and monitoring,” for low and middle income countries, the report contends that the deal’s impact on actual access, let alone on Gilead’s bottom line, will be minimal.
Pointing to patent refusal, revocation and compulsory licensing as tools that made possible the 10 million people on antiretroviral treatment for HIV today, the report advises it is time to learn “the lessons from the fight” against that pandemic, and questions the eligibility of sofobuvir for a patent.
At the same time, an article in the current Clinical Infectious Diseases breaks down the cost of manufacturing the drugs and concurs that the “situation of HCV treatment today is reminiscent of treatment for HIV/AIDS in the year 2000.” The article, Minimum Costs for Producing Hepatitis C Direct Acting Antivirals for Use in Large-Scale Treatment Access Programs in Developing Countries, found that a 12-week course of sofosbuvir, for example, costs from $68 to $136 to manufacture. This article, too, suggests that legal measures, including compulsory licensing, to overcome patent barriers will be necessary to make the drugs accessible. Until the drugs are widely accessible, the authors add, “current death rates from HCV of 500,000 per year will continue for many years to come.” Noting the “high cost of drugs is often justified by the need to recover costs of research and development,” the authors add that in the case of HIV antiretroviral drugs, “many of these costs were assumed by the public sector, where parts of the drug discovery and development occurred.”