Sofosbuvir (sold under the brand name Sovaldi from Gilead Sciences, among others) significantly reduces the risk of death and the need for liver transplant in patients with hepatitis C who suffer from advanced stages of liver disease.
Researchers at Intermountain Healthcare’s Intermountain Medical Center in Salt Lake City studied almost 1,900 patients with hepatitis C and found that the number of patients needing a liver transplant was reduced by 40 percent after they were treated with sofosbuvir.
The study results were recently presented at the 2017 International Joint Congress of ILTS, ELITA & LICAGE May 24-27 in Prague, Czech Republic.
An estimated 2.7 million to 3.9 million people in the United States have chronic hepatitis C, according to the Centers for Disease Control and Prevention (CDC). Chronic hepatitis C is a serious disease that causes liver inflammation and can lead to serious liver problems like cirrhosis. There is no vaccine against the hepatitis C virus (HCV).
Currently, the standard of care in the U.S. for hepatitis C is pegylated interferon alpha and ribavirin, which have increased sustained virological response (SVR; having an undetectable hepatitis C virus load) rates from 50% to 80%.
These response rates have been further increased with the introduction of sofosbuvir, a nucleotide analogue inhibitor of the HCV NS5B polymerase, a protein important for viral replication. The drug was approved by the U.S. Food and Drug Administration in December 2013 for the treatment of adults infected with HCV.
Now, researchers analyzed new data, including results of clinical trials, to determine the effects of sofosbuvir in treating patients with hepatitis C with advanced stages of liver damage.
They compared the clinical outcomes of 1,857 patients with hepatitis C before the FDA’s approval of sofosbuvir with those from 623 patients who were treated with the drug after the FDA’s approval and were on the United Network for Organ Sharing (UNOS) waitlist for a liver transplant between 2008-2013.
The team found that only 3 percent of patients on sofosbuvir needed a liver transplant compared to 40 percent of patients who were not treated with the drug.
“Prior to FDA approval of sofosbuvir, patients with the most advanced stages of cirrhosis either died from their disease or ended up receiving a transplant,” Michael Charlton, MD, lead researcher and associate director of the Intermountain Medical Center Transplant Program, said in a news release.
“We found that by treating those patients, who were on the verge of needing a transplant, with sofosbuvir-based therapies, we greatly reduced the liver transplant and mortality rates.”
The researchers suggest that HCV treatment with sofosbuvir should be considered in all HCV patients with cirrhosis, even those in advanced stages.
“We found the sicker a patient was, the more benefit they experienced by using sofosbuvir,” Charlton said. “However, many people around the world who might benefit most from this therapy don’t have access to it because the regulatory authorities haven’t felt it safe for use in patients with advanced stages of liver disease due to hepatitis C.”
“Our research shows the benefits of this drug include significantly improving the health of even the sickest patients, allowing them to return to their normal life sooner,” he added.