Interferon-free regimens advance in treatment of hepatitis C virus

In December 2013, a new era dawned for patients with hepatitis C virus infection. That’s when the FDA granted approval for use of the nucleoside polymerase inhibitor sofosbuvir.

Sofosbuvir (Sovaldi, Gilead Sciences) became the first oral drug to demonstrate safety and efficacy in treating patients with specific HCV genotypes without the need for interferon.

Long considered a component of the gold standard, pegylated interferon has been partnered with ribavirin with or without a protease inhibitor to treat patients with HCV for more than a decade. Interferon therapy, however, has several adverse effects that preclude it for treatment in some patients.

High cure rates, reduced treatment duration, wider patient candidacy and other factors determined in clinical studies have tilted the advantages toward sofosbuvir as treatment for HCV in the future. Along with other nucleoside/nucleotide polymerase inhibitors; NS5A inhibitors; protease inhibitors, including recently FDA-approved simeprevir (Olysio, Janssen Therapeutics); and drug combinations, many researchers believe interferon-free therapy for HCV is only a matter of time.

“Sofosbuvir could become the backbone for future all-oral therapy moving forward,” Donald M. Jensen, MD, professor of medicine and director of the Center for Liver Diseases at the University of Chicago Medical Center, told HCV Next.“It is potent, with a high genetic barrier to resistance, minimal drug-drug interactions, a good safety profile, and it leads to virtually no resistance to variants.”

With recent data that have shown sustained virologic response using various interferon-free treatments, plus the FDA granting expedited approval processes for some drug combinations, HCV drug development has made larger strides than in the past.

“The time factor has allowed for big breakthroughs and has opened the door for a number of combinations to be still in the game — not on the sideline,” Jensen said.