Sofosbuvir (Sovaldi) significantly decreases the risk of death and the need for liver transplantation in patients with hepatitis C virus (HCV) who have advanced stages of cirrhosis, a new study found.
 
The investigators used an integrated database containing 4 separate, prospective, multicenter, multinational, randomized, controlled clinical trials of sofosbuvir-based therapy in patients with advanced stages of cirrhosis. The data were then compared with patients on the United Network for Organ Sharing waitlist for a liver transplant between 2008 and 2013.
 
The results of the study showed that of the nearly 1900 patients with HCV studied, the number of patients needing transplants reduced 40% after they received sofosbuvir.
 
“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,” said lead investigator Michael Charlton, MD. “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.”
 
Overall, only 3% of patients on the sofosbuvir regimen ended up needing a transplant, compared with more than 40% of patients who were untreated.
 
“We found the sicker a patient was, the more benefit they experienced by sofosbuvir,” Dr 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.”
 
The authors recommend that all patients with HCV, even those in advanced stages of liver disease, should be considered for treatment with sofosbuvir. In the United States, an estimated 3.3 million individuals are living with chronic HCV.
 
The findings were presented at the 2017 International Joint Congress of ILTS, ELITA & LICAGE in Prague, Czech Republic.