There’s great news in the treatment of hepatitis C, as several new drugs have been approved by the Food and Drug Administration and even more are in the pipeline. But the news can also be confusing for patients and their physicians because the huge demand for these drugs has created waiting lists for them.
More than 3.2 million people in the U.S. have Hepatitis C, and many have never been treated for it or may not even know they have it. The waiting lists are expected to expand further as the next generation of drugs, known as directly acting antivirals (DAAs), are approved, leading doctors and researchers to determine the best method of prioritizing patients for these new treatments.
Researchers at the University ofPittsburgh School of Medicine and Pitt’s Graduate School of Public Health have created a mathematical model that would assess which patients have the greatest clinical need for treatment. The results of their study were presented by Jagpreet Chhatwal, Ph.D., at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases in Boston in November.
Their algorithm uses a patient’s current health state, progression of hepatitis C disease, sustained virologic response rates, patient demographics and polymorphism near gene IL28B (which predicts treatment response). Using data pulled from the registration trials of the first two DAAs (telaprevir and boceprevir) and the estimated rates of hepatitis C disease progress from several prior studies, their model projected how many years of good health could be gained by early access to treatment. In addition, the researchers also projected the number of decompensated cirrhosis, hepatocellular carcinoma, liver transplant and liver-related deaths that can be prevented per 1,000 patients.
They found that younger patients with advanced liver disease suffering from hepatitis C would benefit the most by early access to treatment with DAAs. When all other factors were equal, the projected gain in quality-adjusted life years due to immediate treatment as opposed to a one-year deferment was higher in younger patients. In addition to age, prior treatment history also played an important role in cirrhotic patients. With all other factors equal, treatment priority should be in the following order: people who have had a prior relapse, those who have had no prior treatment and those who previously partially responded. Finally, they found that age did not play any role in prioritization of patients in early stages of disease.
As drug development changes the way we treat patients with Hepatitis C, mathematical models like this are going to become increasingly more important as the medical community strives to maximize the value of new treatments.
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