Simeprevir and Sofosbuvir Now Part of Hepatitis C Treatment Armamentarium

Until recently, treatments for hepatitis C were nonspecific, side-effect laden, and had a prolonged time course before patients were better, said Jacqueline G. O’Leary, MD, MPH, medical director, Inpatient and Transplant Unit, Baylor University Medical Center, Dallas. Now, recently approved medications have accelerated treatment time with fewer side effects.

“It’s incredibly gratifying that we’ve entered the future with antivirals,” O’Leary said.

O’Leary provided guidance on the use of recently approved treatments for hepatitis C during a presentation at the 2014 American Gastroenterological Association Clinical Congress of Gastroenterology and Hepatology in Miami Beach, FL.

The current buzz in hepatitis C surrounds two new treatments in particular, simeprevir and sofosbuvir. Simeprevir, a NS3/4A protease inhibitor, was approved for use in November 2013 by the US Food and Drug Administration (FDA) in genotype 1, Q80K-negative hepatitis C patients who use a combination regimen that includes pegylated interferon and ribavirin.

Patients take one 150 mg pill, once a day, with food. The data that supported approval of simeprevir came from the phase III QUEST-1 and 2 trials, which showed that 12 weeks after treatment ended, genotype 1 adult patients with hepatitis C had a sustained virologic response (SVR) of 80% (QUEST 1) and 81% (QUEST 2). The patients used simeprevir in addition to pegylated interferon and ribavirin. The SVR after 12 weeks in patients receiving only pegylated interferon and ribavirin was 50%.

Although patients in the simeprevir studies were slated to receive a 24- or 36-week course of pegylated interferon and ribavirin, 85% of patients in QUEST 1 and 91% in QUEST 2 were able to shorten their therapy of the two latter medications to only 24 weeks because they met response-guided treatment criteria.

The most common side effects in the QUEST trials were rash, pruritis, and anemia, but none of the rashes were life-threatening, O’Leary said.

In late 2013, the FDA also approved use of the drug sofosbuvir, a nucleotide analog NS5B polymerase inhibitor, for hepatitis C patients. According to FDA guidelines, genotype 1 or 4 patients should use sofosbuvir and pegylated interferon and ribavirin for 12 weeks, while genotype 2 patients should use sofosbuvir with ribavirin for the same amount of time.

Genotype 3 patients should take sofosbuvir with ribavirin for 24 weeks. O’Leary said that sofosbuvir is light on side effects compared with older hepatitis C medications, noting that trials showed fatigue and headache as the most common side effects.

Other hepatitis C medications with even stronger SVRs are on the horizon, O’Leary said. “There are numerous multidrug interferon-free 12-week cocktails in development with SVRs greater than 90%,” she said.