There are between 130 million and 150 million people worldwide who suffer from chronic hepatitis C infection, according to the World Health Organization (WHO). The hepatitis C virus (HCV) is a bloodborne virus that can be transmitted through poorly sterilized needles used for injections, unscreened blood transfusion or similar contact with bodily fluids. The virus mainly attacks the liver and can lead to cirrhosis or even liver cancer and while there are antiviral medications which can cure a large number of those infected with HCV, access to those treatments around the world is limited and 500,000 die each year across the globe from liver disease related to hepatitis C infection.
Even in countries with advanced healthcare systems, like America, hepatitis C is still a major problem. A fact sheet on hepatitis C published online by the Centers for Disease Control and Prevention (CDC) indicates that 3.5 million Americans live with chronic HCV infection. As recently as 2013, there were almost 30,000 cases of acute HCV infection, a short-term illness occurring in the first six months of contracting HCV which may lead to chronic infection.
In early May, the CDC published new data which indicates that hepatitis C now kills more Americans than all other infectious diseases combined, killing 19,659 Americans in 2014. That means that the number of people killed by HIV-AIDS, tuberculosis and other types of infection are dwarfed by this disease, which can be debilitating even when it’s not fatal. About 75 percent of Americans living with HCV infection are baby boomers born before 1965 and although it’s not known why baby boomers are five times more likely to be carrying HCV, it’s thought that contaminated blood products before HCV screening techniques were widely implemented between 1991 and 1992.
Treatment approved by the U.S. Food and Drug Administration (FDA) for those suffering from hepatitis C infection is sofosbuvir, marketed as Sovaldi by American biopharmaceutical firm Gilead Sciences Inc. (NASDAQ:GILD), headquartered in Foster City, CA. Sofosbuvir works as a nucleotide analog inhibitor of HCV NS5B polymerase, a major enzyme involved in HCV RNA replication processes. Recently, the company earned a patent from the Indian Patent Office for Sovaldi; reports indicate that Gilead will not increase the Indian market price of $13.71 per pill, which is what Sovaldi cost as a generic in that country.
One reason cited as to why mortality rates for hepatitis C-related illnesses are so high is a current lack of effective and widespread testing for the virus. Just this February, WHO began work on creating the world’s first guidelines on hepatitis C testing that could be used by countries and organizations developing testing programs for populations. That month, WHO announced that it had partnered with the China-based Social Entrepreneurship for Sexual Health for a month-long Hepatitis Testing Innovation Contest to identify forward-thinking HCV testing methods that could be employed. Winning entries will be included in the hepatitis C testing guidelines that WHO will be releasing.
In America, where high drug prices have been attracting a lot of attention in the nation’s capital, it’s possible that many fail to seek treatment due to the high cost of Sovaldi, which costs $1,000 per pill, much greater than its cost to Indian consumers. Harvoni, another Gilead HCV treatment, costs $1,125 per pill, but it works faster than Sovaldi and doesn’t need to be taken with other drugs to increase its efficacy. Reports of pharmacological developments in Egypt indicate that at least the global market may have access to a low-cost alternative treatment in two years’ time. Pharco Pharmaceuticals of Alexandria, Egypt, is working on developing a combination treatment of sofosbuvir and ravidasvir, an NS5A enzyme inhibitor, which it has agreed to produce for a maximum cost of $3.50 per pill, or $300 for an entire regimen. Last November, Pharco announced a 100 percent cure rate for HCV among a specific population of hepatitis C patients as a result of the combination treatment. Development of this combination drug treatment was aided by the non-profit Drugs for Neglected Diseases Initiative (DNDi), headquartered in Geneva, Switzerland.
Antivirals like sofosbuvir may be expensive, but they’re pretty effective at eliminating HCV from the body and stopping the liver damage which this disease does. Research presented by German researchers this April at the International Liver Congress in Spain that a combination treatment of sofosbuvir and ledipasvir, another NS5A inhibitor, essentially eliminated HCV in patients after a six-week regimen. Patients were tested for HCV at 12 weeks and researchers found the same undetectable viral loads in patients that they saw when administering 12 weeks of the combination treatment.
The FDA has been quite active this year in approving new tests and treatments designed to help identify and eliminate the hepatitis C virus in patients. Swiss healthcare developer Roche (VTX:ROG) received FDA approval this March for a new quantitative RNA test which can help physicians see exactly what level of HCV exists in a patient’s blood instead of simply confirming an active infection. Earlier this year, in late January, the FDA granted approval to Merck & Co. (NYSE:MRK) for a once-daily single tablet treatment branded as Zepatier. Zepatier is another combination drug therapy which incorporates elbasvir and grazoprevir, both HCV RNA inhibitors, and is designed to treat patients having one of two strains of HCV, including the most common strain. A 12-week regimen of the treatment costs $54,600.
Gilead has a pretty tight hold over the drug market for hepatitis C treatments but Merck is starting to grab some of Gilead’s pie thanks to a patent infringement case that wrapped up in late March. A jury at a federal court in San Jose agreed that a pair of patents held by Merck and a partner, Carlsbad, CA-based Ionis Pharmaceuticals (NASDAQ:IONS) were being violated by Gilead’s Sovaldi and Harvoni drugs. The federal judge in the case awarded royalties of four percent, or about $200 million, on sales of both drugs between 2013 and 2015, and a separate hearing will decide royalties on sales going back to January 1st of this year. It’s reported that Gilead plans on appealing the decision.
The next few years are likely to see sizable growth in the market for viral infection medications. Market research published on RnR Market Research’s directory forecasts that the market for viral infection treatments should increase by a compound annual growth rate (CAGR) of 6.8 percent between 2014, when the global market was valued at $74 billion, through 2021, when it’s believed the market will hit $117.6 billion. The report notes a total of 1,848 pipeline products currently in development for infectious diseases, only 222 of which were focused on HCV. That’s good for third place behind HIV (419 pipeline products) and influenza (333 pipeline products). Of course, news of hepatitis C’s higher rates of mortality could very well refocus research and development initiatives focused on infectious diseases, at least here in America.