By Steven Rogers, MD
The Food and Drug Administration recently approved an extremely promising new treatment for hepatitis C virus. This new medication, sofosbuvir, marketed under the name Sovaldi, is considered a major breakthrough for two reasons: it is much more easily tolerated by patients than previous treatment protocols, and it has proven to be 80-90 percent effective in curing hepatitis C, representing a significant increase over previous approaches to treatment. Sofosbuvir, which works by blocking the ability of the hepatitis C virus to replicate, is a pill that is taken once a day. It received final approval in December 2013 and is available now locally.
What is hepatitis C?
Hepatitis C is a virus that affects the liver. An estimated 3 million people in the United States and over 100 million people worldwide have it. This is a virus that often does not disappear on its own; in most people, if you have acquired hepatitis C, it will infect your liver for the span of your life and may progress to liver cancer or cirrhosis of the liver if not successfully treated. Hepatitis C is the most common cause of liver failure.
Viruses are typically difficult to treat and hepatitis C is no exception. While it is true that treatment for hepatitis C has evolved and improved over the past 25 years, it has historically been difficult for people to tolerate the treatment. An additional serious drawback has been that many people undergoing treatment for hepatitis C were not cured.
How does sofosbuvir compare to previous treatment methods?
For the past 25 years, hepatitis C has been treated with interferon. This is a drug that stimulates the body’s immune system and can cause many uncomfortable side effects. Patients treated with interferon had to inject themselves once a week for months (and in some cases up a year) and many suffered with flu-like symptoms for the duration of treatment. After all was said and done, the cure rate was only 30 percent. About 15 years ago, we began prescribing an oral medication called ribavirin, to be taken along with interferon. This combination of medications increased the cure rate for hepatitis C to around 50 percent. In 2011 two new medications that directly attack the virus, teleprevir and boceprevir, were added to the mix and the cure rate climbed to 65 percent. However, a major drawback that remained was the need to take these new medications along with interferon. Treatment was long (up to a year) and for many, very difficult to tolerate.
What are the factors that influence the cure rate for hepatitis C?
A cure for hepatitis C has been greatly influenced by the particular strain or genotypes of the virus. The most prevalent type of hepatitis C is genotype 1. In the United States, 70 percent of the people infected with hepatitis C have genotype 1, which is the hardest to cure. Genotypes 2 and 3 are much easier to cure.
What are the new treatment recommendations issued by the FDA?
Since the majority of people infected by hepatitis C have genotype 1, the new recommendations will be for 12 weeks of interferon, ribavirin, and sofosbuvir. This treatment regimen, when studied in clinical trials, has resulted in a 90 percent cure rate. Although this combination still includes interferon, individuals would only need to be treated for three months (instead of up to one year, as previously required). For those infected with either genotype 2 or 3, treatment would require the medications ribavirin and sofosbuvir only. This represents the first interferon-free treatment and leads to a 90 percent cure rate. Side effects associated with the new medications are quite minimal. Additionally individuals with hepatitis C who were previously treated but not cured have nearly as good cure rates with these new agents. One major concern among physicians is the cost of these medications, with estimates as high as $28,000 a month.
Who should get tested for hepatitis C?
The virus is blood borne. If you had a blood transfusion before 1992, when testing for hepatitis C in blood donors became standard practice, you should be tested. You should also be tested if you have shared a hypodermic needle or razor blade, or engaged in any activity that exposed your blood to that of someone else. The U.S Preventive Services Task Force is recommending that everyone born between 1945 and 1965 (members of the Baby Boomer generation) be tested for hepatitis C.
This virus often goes undetected for many years after the initial exposure. By the time symptoms appear, you may have sustained liver damage. A blood test is quick and easy. With this new treatment breakthrough, hepatitis C virus can be cured before it causes potentially fatal illness.
Dr. Rogers is board certified in gastroenterology and internal medicine. He serves on the medical staff of Cayuga Medical Center and is in practice with Gastroenterology Associates of Ithaca, where he can be reached at (607) 272-5011.