The introduction of Gilead Sciences’ hepatitis C virus (HCV) Sovaldi (sofosbuvir) to the market in December 2013 was associated with improvements in the health outcomes of those living with the virus who were on the liver transplant waiting list.
Sovaldi ushered in the current era of highly effective direct-acting antiviral (DAA) treatment. The drug was incorporated into Gilead’s Harvoni (ledipasvir/sofosbuvir), which was approved in October 2014 and became a blockbuster drug. Various other DAAs from other pharmaceutical companies emerged from the pipeline during this time, leading to today’s healthy crop of numerous, highly effective hep C regimens.
Publishing their findings in the Journal of Viral Hepatology, researchers analyzed data on U.S. adults with and without hep C who were on the liver transplant waiting list according to the United Network for Organ Sharing registry. The study authors looked at two eras: Era 1 covered January 2002 through May 2014 (six months after Sovaldi’s approval, allowing time for the drug’s use to pick up); Era 2 covered June 2014 through December 2016. The study included follow-up data through March 2017.
Between 2002 and 2016, 158,045 people were on the liver transplant waiting list, including 128,307 during Era 1 and 29,738 during Era 2. The number of people with hep C on this list began to decrease in 2012. During Era 1, 20.1% of those on the waiting list had HCV, compared with 16.2% during Era 2. Between the two eras, the proportion of those with HCV who had hepatocellular carcinoma (HCC, the most common form of liver cancer) increased from 28.4% to 53.8%.
After adjusting the data to account for various differences between the cohort members, the study authors found that those in Era 2 were 9% less likely than those in Era 1 to undergo a liver transplant. Among those with HCV, the corresponding reduction in the likelihood of liver transplantation was 17%, compared with just a 7% decline among those without HCV.
The respective six- and 12-month survival rates after individuals were put on the transplant waiting list were 90.3% and 85.7% among those in Era 1 compared with a respective 88.3% and 81% among those in Era 2. Those in Era 2 had a 5% higher likelihood of dying while on the waiting list than those in Era 1.
While people with HCV had an overall 8% higher likelihood of dying while on the waiting list compared with those who did not have the virus, this difference was only statistically significant (meaning not likely to have been driven by chance) during Era 1; during that earlier period, those with HCV, compared with those without the virus, had a 9% higher likelihood of dying while on the waiting list.
To read the study abstract, click here.