A clinical trial conducted by the Research Division of Premier Medical Group has contributed to the development of a new combination of drugs for the treatment of Hepatitis C that not only promises a cure for many patients but brings eradication of the disease into view.
This April, an article co-authored by Premier Medical Group’s Dr. Peter M. Varunok was published in the prestigious New England Journal of Medicine. The article’s title, “Retreatment of HCV with ABT-450/r Ombitasvir and Dasabuvir with Ribavirin,” provides a hint of how technical it is. PremierHealth magazine interviewed Dr. Varunok and asked him to help us understand the article’s significance.
The clinical trial described in this paper is a game-changer. We don’t have that many events in medicine that effect a sea change, where you see, in a very short time, an absolute, significant improvement in the quality of medicine and the quality of people’s lives as a result. When I graduated from medical school in 1988, the hepatitis C virus had not yet been identified. It was called “non-A, non-B hepatitis” and we knew it was IV-transfusion related. So I’ve witnessed the disease from when it was an unknown entity, to its identification in 1991, through initial treatments, and now to the point of potential eradication.
Initially, with the standard early treatment of Peginterferon and Ribavirin—anti-viral drugs that ramp up the immune system and immune response—studies showed a “cure rate” of about 40 to 50 percent. With the initiation of the first generation of protease inhibitors—drugs which attacked the virus directly, studies showed potential response rates of 60 to 70 percent. But in the real world, cures were significantly fewer because the side effects of these treatments were so brutal and so difficult to manage that many patients dropped out of treatment.
To this day, despite incremental improvements in the treatment of hepatitis C, there remains a vast number of patients who have been diagnosed and know they have hepatitis C, but are unable to be treated with standard care due to contraindications, or just the fear of the side effects, which have been very profound… and word spreads like wildfire. Now, with this new combination of drugs used in the trial described in the NEJM article, we are achieving a response rate of about 96 percent, in just 12 weeks. On its own, that’s a significant improvement, going from 70 to 96 percent. But that percentage difference doesn’t tell the whole story. The new medications are so well-tolerated that the total number of people who will take it for its full course and who will be cured is almost exponential compared to the number that we have treated so far.
We are finding more and more information about this virus and what it does. We know about its risk of progression to cirrhosis, liver cancer, ascites and bleeding and, eventually, to the need for transplantation. But there’s also a significant increase in all-cause mortality, dying from anything, in people with hepatitis C. So we know there’s something this virus does outside the liver. This effect on cardiovascular, renal and pulmonary disease will eventually figure into the number of lives saved by conquering hepatitis C.