Imagine facing this choice: Take medication so debilitating that your entire life could be put on hold for a year, or allow the disease to continue destroying your liver while awaiting a better treatment option.
For the last several years, many individuals across the country infected with Hepatitis C have faced this exact situation. Large numbers of persons with the disease were opting to delay life-saving treatment while hoping that a less incapacitating medication would soon hit the market.
Last week, these hopes became a reality. The FDA gave final approval to a revolutionary new treatment that physicians can now prescribe.
The medication – Sofosbuvir – is a first-in-class drug that signals a dramatic improvement over older forms of Hepatitis treatment. Traditional Hepatitis treatments require up to one year of daily Ribavirin pills and Interferon injections, resulting in an approximate cure rate of 40-45 percent, Sofosbuvir is a once-a-day pill that has been proven to effectively treat 93-95 percent of hepatitis C cases in as little as eight weeks.
While Sofosbuvir was developed by Gilead Sciences in California, some of the most critical research proving its efficacy took place at the Texas Liver Institute in San Antonio, conducted by a team of researchers led by Dr. Fred Poordad and Dr. Eric Lawitz.
Why was their research so important?
“The study, which has been published in the New England Journal of Medicine, showed that Sofosbuvir was able to cure 93-95 percent of even the most challenging patient populations over the course of 8 to 12 weeks,” said Dr. Poordad, vice president of academic and clinical affairs at The Texas Liver Institute and a clinical professor of medicine at the San Antonio University of Texas Health Science Center.
“Many individuals chose to wait to receive treatment primarily because of the relatively low cure rates of Interferon and Ribavirin treatments, coupled with their debilitating side effects and lengthy treatment time,” Poordad said. Side effects include chronic fatigue, flu-like symptoms, depression, nausea, and diarrhea.
While some of these symptoms are difficult to live with, they often are accompanied by what Poordad calls, “Interferon fog,” that causes incapacitating mental sluggishness that makes it impossible for the patient to hold a job.
Simply put, Sofosbuvir represents a foray into a golden age of Hepatitis treatment. The research that took place at the Texas Liver Institute is helping to draw attention to the Alamo City as one of the major worldwide players in liver research.
“We are moving from an Interferon era to a pills-only era with very high cure rates and minimal side effects,” Poordad said.
San Antonio and the Liver Institute currently has a hand in “developing all emerging therapies for Hepatitis C … with at least two more ground breaking treatments hitting the market over the next year, 2014 is expected to be an extremely pivotal year in both Hepatitis C awareness and research,” Poordad added. “This 22,000 square foot center institute is not only the site location for liver research in Texas, but it represents the first of its kind in the entire U.S., and its presence has placed San Antonio at the forefront of all liver research moving forward.”
According to Poordad, more than prestige and research dollars are at stake. A major benefit is improving the lives of those in the city who suffer from Hepatitis C.
Hepatitis C is an infection that, according the World Health Organization, chronically afflicts 150 million individuals worldwide. It is typically passed through the transmission of blood and it is famous for causing severe disease and inflammation of the liver leading to cirrhosis, cancer, transplantation, and death. Studies suggest that four million Americans are currently infected with Hepatitis C, but Poordad said the unofficial number is probably closer to six million.
“The commonly stated numbers fail to accurately account for inmates and veterans, of whom about 40 percent and 10 percent have hepatitis C, respectively,” he said.
To put it all in perspective, each year in this country more Americans die from Hepatitis C than HIV/AIDs (15,000 to 13,000) with 73 percent of the deaths being reported in those 45-65 years old. Roughly one of every 33 baby boomers suffers from the disease, and about 75 percent do not know that they are infected, according to the CDC.
The new waves of drugs like Sofosbuvir literally represent a new chance at life for those who chose to wait for the treatment or were unaffected by more traditional approaches. The only downside?
Sofosbuvir comes with a prohibitive cost. At nearly $80,000 per treatment cycle, this latest treatment is significantly more expensive than the less effective traditional treatment. That cost should go down in time.
While Sofosbuvir is expensive for now, Poordad said it’s important to weigh the cost of medication against the cost of failed Interferon treatment: hospital stays, potential liver transplant surgery, and end of life care, all of which can add up to hundreds of thousands of dollars.
What’s next for the researchers?
“We’ve started some promising research on reversing long-term cirrhosis of the liver,” Poordad said. “This work is meant to address the needs of those who, in the process of waiting for the new waves of Hepatitis C treatment, may have seen an extreme degradation of their liver due to cirrhosis or cancer. “
Such treatments are likely years away, but the research into their development will help solidify San Antonio as a city known for its growing medical research industry.
John Burnam is the Associate Director of the Louise Batz Patient Safety Foundation and a nonprofit consultant currently working with The San Antonio Christian Dental Clinic, I Care San Antonio, and The Big Give SA. Interested parties can learn more at his website: www.johnburnamconsulting.com.