ATLANTA – In what is being hailed as a “landmark shift in the treatment of Hepatitis C,” the Food and Drug Administration has approved two new drugs to treat—and cure—Hepatitis C (HCV) in most patients. The newest drug, Sovaldi, is thought to have no side effects, work in a shorter amount of time, and be more effective than other Hepatitis C medicines.
Globally there is roughly five times the number of people with Hepatitis C as HIV, with the World Health Organization estimating that 150 million people have the disease. HCV kills roughly 500,000 people per year.
Previous medicines treating the disease required pills as well as weekly injections, which are infamous for causing severe flu-like side-effects, as well as anemia and depression. Sovaldi allows some patients with HCV to treat their illness with just pills, eliminating side effects completely.
Two years ago, the treatment for Hepatitis C cured only about 50% of patients. The cure rates associated with Sovaldi are much better at roughly 80%, depending on the genotype of the disease.
Genotype 1, roughly 70% of Hepatitis C cases in the United States, will still require the interferon shots. However, treatment time will be 12 weeks rather than the previous 24-48 weeks, and the cure rate is 90% for the newly treated.
For genotypes 2 and 3, 20-25% of American cases, use of Sovaldi will constitute the first all-oral treatment for HCV and will take 12 and 24 weeks, respectively, to cure.
Clinical trial results are expected to be released shortly, and, barring negative outcomes, Sovaldi could become available by the end of 2014.
As many as 3.3 million Americans are infected with Hepatitis C, with “baby boomers” thought to have the highest rate of infection. This is due to previous drug use and exposure in medical settings before testing for the virus was common practice.
Transmission of HCV is through blood contact, mostly by needles during intravenous drug use, blood transfusions, and more rarely through sexual contact and unsterile tattooing.
The country that has by far the highest rate of Hepatitis C infection is Egypt. More than 10% of the population has chronic HCV due to early and widespread use of improperly sterilized needles from Egyptian Public Health efforts. In people over the age of 50, the infection rate is as high as 25%.
Experts point out that innovations in HCV treatment do nothing if the drugs do not reach the people who need them.
Dr. John Ward, the director of the Division of Viral Hepatitis at the Centers for Disease Control, asserts, “The potential of these and other treatment advances hinges entirely on our ability to get more people screened and into care. Right now, most Americans with Hepatitis C don’t access treatment because they have no idea they’re infected.”
Roughly 80% of people with acute HCV are asymptomatic, but the disease can lead to severe liver disease in 10-20% of infected people. Hepatitis C is the top cause of liver transplants in the United States.
Another problem is that costs of the new medication is high. The wholesale cost of Sovaldi would be $1,000 per daily pill, putting the full treatment at a cost of $84,000 for most patients and $168,000 for those needing 24 weeks of treatment.
Experts fear that the high cost of the new drugs could be cripplingly high for those suffering in the developing world.
Initiative for Medicines, Access & Knowledge (I-MAK), an American patient rights group, reports that it is pursuing action to block Sovaldi’s creator Gilead Sciences’ bid for a patent on the drug in India. The country is known as the “pharmacy of the world” for their strict patent laws and a strong industry of generic medicines. I-MAK says that the drug is “old science.”
Andrew Hill, a pharmacologist at Liverpool University, published a study that shows that generic Sovaldi can be made for between $62 and $134 for the 12-week treatment.
Some analysts predict that Sovaldi will become one of the top-selling drugs globally, with sales potentially reaching over $100 billion in the next 10 years.
Dr. David Thomas, liver specialist at Johns Hopkins University, citing the importance of the interferon-free drug says, “[It’s] about as hot as I’ve ever seen…it’s the kind of thing where we did something that didn’t work that much and hurt people a lot. And then we go from that to something that’s…really an amazing transformation.”
– Kaylie Cordingley