New Treatments for Hepatitis C Virus: Strategies for Achieving Universal Access

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Background: the HCV pandemic
185 million people across the world are infected with HCV; 150 million are chronically infected. The HCV pandemic is concentrated in middle-income countries (MICs); while 15% of the 150 million people with chronic HCV live in high-­income countries (HICs), 73% live in MICs and 12% in low-income countries (LICs). It is estimated that HCV-related liver complications kill 350,000 people annually. Currently, the standard of care is injectable peg-interferon (PEG-IFN) used in combination with ribavirin (RBV). The cure rate is 50-75%, and the treatment is associated with strong side effects. Worldwide, only a tiny percentage of people with HCV have access to treatment.

2014, a turning-point in the history of the pandemic
New treatments recently approved or soon to be authorized will offer a range of advantages compared with their predecessors: multigenotypic activity, fewer side effects, and higher cure rates, including for those in advanced stages of infection.
These direct-acting antiretrovirals (DAAs), are bringing with them great hope for millions of people, as their use may lead to excellent cure rates. Gilead’s new nucleotide polymerase inhibitor/DAA sofosbuvir (SOF) was approved by the European Medicines Agency (EMA) in November 2013 and by United States Food and Drug Administration (FDA) in December 2013. The cure rate with sofosbuvir is close to 90% according to recent clinical trials results. Janssen’s simeprevir also received FDA approval in November 2013. Bristol-Myers Squibb (BMS) has submitted daclatasvir to the FDA. Sofosbuvir will be most likely be followed by other DAAs marketed by AbbVie, Janssen, and BMS before the end of 2014.

The issue of access
Although these new molecules will improve the quality of life of people with HCV and increase the number of people cured, their price will be out of reach of most of the people who need it. Gilead, like the other firms, is planning to apply different marketing strategies: “standard prices” in HICs, “tiered pricing” in MICs, and voluntary licencing in LICs. This analysis, using epidemiological data specific to HCV, tries to determine whether the strategies employed by pharmaceutical companies would be good for access.
While experts estimate that the production cost of sofosbuvir is USD68-136 (per person for 12 weeks), in HICs, sofosbuvir is sold USD1,000 per pill or USD84,000 per person for 12 weeks in the United States - where it is estimated that 5,367,834 persons are infected with HCV. As a comparison, the median household income in the country is USD51,017 per year, and while it is estimated that 48 million of Americans do not have any health insurance. In France, the cost of sofosbuvir is set at USD913 per pill (USD76,720 per person for 12 weeks). According to calculations made on InVs/ANRS epidemiological data, to provide sofosbuvir to 55 percent of the 232,196 people affected by chronic HCV in France and who need treatment rapidly, it would be slightly more than the 2014 budget of the Assistance Publique des Hôpitaux de Paris or 4 times what France has paid into the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) since 2001. In MICs, Gilead plans to sell sofosbuvir for at least USD2,000 (for a 12-week course). In Egypt, at a minimum price of USD2,000, the cost of sofosbuvir alone for 100% of people with HCV would represent five times the country’s total 2011 public health expenditures. In Indonesia, it would be a little bit more than the total annual health budget in 2011. More generally, at the prices set by pharmaceutical companies, universal access would be practically unachievable, even in countries who have strongly committed to access to HCV care, such as Georgia, Thailand and Egypt.

During the first HCV World Community Advisory Board (CAB) that took place between February 22 and 25 2014 in Bangkok, Gilead gave more precisions on the scope of the sofosbuvir voluntary license and the countries covered. Excluding the most affected countries in terms of number of people with HCV, this license is failing to address the issue of access to sofosbuvir in LICs and MICs. Theoretically, this license leaves out 77,4 millions people with HCV from the access in LICs and MICs. But, does the license give any guarantee to provide to the 57,1 millions other covered by the scope of the license a real access to treatment? Given the fact that there is no Global Fund on HCV to purchase treatments, diagnostics, and monitoring for LICs and MICs, there are really little chance that countries such as DRC or Cameroon, who are covered in the scope of the license, will start treating people with sofosbuvir anytime soon. Given its very limited scope, the Gilead’s 60 countries voluntary license on sofosbuvir brings out the fact that its main objective is not to provide access to the people living in the countries included in the territory but to bind generic producers, mostly based in India, to prevent them to supply any excluded MICs (including China, Brazil, Thailand, Egypt, Indonesia, etc.). As for the other VLs signed in the case of HIV and projections made based on details of the HCV pandemic, they also fail to provide an appropriate answer to the HCV pandemic in LICs and MICs. Voluntary licensing will thus fail to respond to the HCV pandemic in the most affected countries and hinder the generic drug competition.

Learning the lessons from the fight against HIV/AIDS
If none of these strategies (standard pricing, tiered pricing, and voluntary licensing) are good in terms of access, what other possibilities exist? In the case of HIV/AIDS, the use of TRIPS flexibilities has shown great results for opening access and reducing drug prices. In India, the opposition and revocation of abusive patents have increased the competition and considerably helped to drive down drugs’ prices. In countries such as Thailand and Brazil, the use of compulsory licensing in the case of HIV/AIDS has led to a substantial drop of the price of medicines.