For a quarter century, hepatitis C was a dreaded diagnosis, linked to long, grueling treatment regimens and poor outcomes. Dramatic gains, however, have been witnessed since the approval in 2011 of the protease inhibitors boceprevir and telaprevir – the first of the “directly acting antiviral agents.”
“With the addition of boceprevir or telaprevir to interferon and ribavirin, cure rates of about 70 percent were seen after only six months of treatment,” says Ian Schreibman, M.D., of Penn State Hershey Gastroenterology and Heptology. The fast pace of successful drug development has not slowed, and now interferon-free regimens are being studied, with cure rates of more than 90 percent. “We’ve turned the tables on hepatitis C. The potential to completely eliminate it is now on the horizon, similar to what occurred with polio during the twentieth century,” says Schreibman.
Among the game-changing drugs are the protease inhibitor simeprevir and the polymerase inhibitor sofosbuvir. While each is FDA-approved for use in combination with interferon and ribavirin for patients with genotype 1 HCV, the physician community has been riveted on their potential use together as an interferon-free combination as studied in the COSMOS trial, which enrolled treatment naïve-cirrhotic or non-cirrhotic patients who failed to respond to interferon and ribavirin. The COSMOS trial demonstrated high levels of sustained virologic response among some of the sickest, most difficult to treat patients using an interferon-free regimen. Over 90 percent of prior null responders without cirrhosis who took the combination treatment once daily for either twelve or twenty-four weeks showed a sustained virologic response. For treatment-naïve patients with advanced fibrosis or cirrhosis, nearly 100 percent showed a sustained virologic response.
This data has led to the recent FDA approval for these two drugs to be used in combination. Another drug, Harvoni, has also been recently approved by the FDA, consisting of antiviral agents ledipasvir and sofosbuvir. Schreibman notes: “So far, we’ve treated approximately fifty patients with these directly acting antiviral drugs in combination.”
The patients will be followed carefully to better characterize the durability of their response to treatment. “There are several interesting unknowns for patients successfully treated and cured with these new drugs. Over the long-term, we intend to evaluate whether the risk of liver cancer is decreased, or whether cirrhosis can reverse, possibly preventing the need for liver transplant. What can be accomplished for patients with hepatitits C seems more promising now than it’s ever been,” says Schreibman.
Ian R. Schreibman, M.D.
Associate Professor of Medicine
Program Director: Gastroenterology and Hepatology Fellowship
Penn State Hershey Gastroenterology
Fellowships: Transplant Hepatology, Penn State Milton S. Hershey Medical Center; Gastroenterology & Hepatology, University of Miami, School of Medicine
Residency: Internal Medicine, Penn State Milton S. Hershey Medical Center
Medical School: New York University Medical Center