A study published in Gastroenterology found that using generic antiviral drugs to manage chronic hepatitis B virus (HBV) resulted in an increase in prescriptions as well as significant savings to Medicare—about $300 million annually.
Worldwide, more than 2 billion people have been infected with HBV, and 257 million people have chronic infections, according to Hep’s Health Basics on HBV. In the United States, the number of people with chronic hepatitis B is estimated to be 2.2 million. Chronic HBV can cause fibrosis (mild to moderate liver scarring), cirrhosis (serious liver scarring), liver cancer, liver failure and death.
There is no cure for chronic hepatitis B, but some medications can suppress the virus and slow liver damage, according to a Weill Cornell Medicine news release. However, the high cost of brand-name medications for HBV, which usually must be taken for life, keeps many people from accessing them.
“One of the biggest concerns in the U.S. health care system is its ever-increasing spending, which accounts for almost 20% of our national gross domestic product,” said Arun Jesudian, MD, an associate professor of clinical medicine and director of liver quality at Weill Cornell Medicine, in a Healio article. “Almost 10% of that spending is on prescription medications.”
Researchers from Weill Cornell Medicine and NewYork-Presbyterian analyzed publicly available Medicare Part D data to determine whether the Food and Drug Administration’s (FDA) decision to approve generic versions of entecavir in 2014 led to lower costs and better uptake and adherence among people with HBV.
Researchers found that prescriptions for brand-name drugs such as Baraclude (entecavir) and Viread (tenofovir disoproxil fumarate) dropped significantly after the generic drugs were approved. What’s more, between 2013 and 2020, the number of people on HBV treatment increased by more than 50%.
“As physicians, we need to be mindful of our health care utilization while still providing the best care for our patients,” Jesudian said. “As we found in our study, a majority of patients were switched to generic versions a year after their approvals.”
Chronic hepatitis B is not curable, but it is treatable. The goal of therapy is to reduce the risk of complications, including premature death. Treatment can help to prevent cirrhosis, liver failure and liver cancer by halting HBV replication and reducing viral load. Many medications that aim to cure hepatitis B are under study.
It is important that people with chronic hepatitis B take their medications exactly as prescribed. Missing doses can cause HBV to become drug resistant. Stopping medications can also cause HBV viral load and liver enzymes to increase quickly, which can damage the liver and cause severe symptoms. It is important for people with chronic hepatitis B who are receiving treatment to be monitored regularly by a health care provider.