New Direct-Acting Antivirals Promising for Hepatitis C Treatment

Antiviral hepatitis C drugs on the horizon could spur more people to accept treatment and improve patient outcomes, Andrew J. Muir, MD, MHS, associate professor of medicine and clinical director of hepatology at Duke University in Durham, NC, reported at Digestive Disease Week 2013, held May 18-21, 2013, in Orlando, Fla.

“It’s a great time in hepatitis C and for telling patients the great things that are going to come to help them,” Muir said.

According to Muir, approximately 3.2 million people have hepatitis C, and about half of the cases have been detected while one third have been referred to care. Only 5 percent to 6 percent of patients have been successfully treated, Muir said.

“I hope the new drugs and response rates will bring people out,” Muir said. “We need to be proactive to make that happen.”

The Centers for Disease Control and Prevention has recommended screening baby boomers for hepatitis C, but the U.S. Preventive Services Task Force has been less enthusiastic, issuing a Grade B recommendation for people at risk and a Grade C recommendation for people at average risk who were born between 1945 and 1965.

Muir indicated the field has been held back by the inability to prove treatment has saved lives. However, more recent studies have shown reductions in liver-related mortality and transplants.

“There is proof that effective treatment leads to improved clinical outcomes,” Muir said, later adding that “sustained virologic response rates show we can cure most people.”

But Muir noted there are still issues with side effects and treatment duration, which is currently 24 to 48 weeks. Muir called the infection rate found in the CUPIC (Compassionate Use of Protease Inhibitors in Cirrhotics) trial concerning, as more than half of the patients who had compensated cirrhosis and were taking the three drug regimen of pegylated interferon/ribavrin and telaprevir or boceprevir experienced a serious adverse event.

“The infection often began a cascade that led to their demise,” Muir said. He continues to use the therapies but indicated he has changed how he counsels patients to avoid scaring them off. Also, the U.S. Food and Drug Administration (FDA) has added a black box warning to telaprevir related to patients dying after a progressive rash and systemic symptoms.

The OPTIMIZE trial assessed whether a twice-daily regimen of telaprevir was as effective as a thrice-daily regimen when both are administered with pegylated interferon/ribavrin, and it found a similar outcome. Muir called twice-daily dosing a “reasonable option” for patients challenged by the thrice-daily regimen, though he cautioned that the FDA has not yet approved it.

Reporting on three new drugs — simeprevir, faldoprevir, and sofusbuvir — Muir noted, “We are starting to get more drugs demonstrating nice potency.” Clinical trials are also under way on interferon-free regimens. Since many patients continue to hold off on starting treatment because they are waiting for new options, Muir recommended educating them about liver wellness. For patients with significant liver disease, he suggested clinicians discuss benefits and risks and document the session.

With more treatment options in the pipeline, Muir called it an “amazingly wonderful time to be a physician in a liver clinic,” because patients have options and most who receive treatment can live well for years.

“Bottom line: Interferon-free treatments are at hand and just around the corner,” moderator Adrian M. Di Bisceglie, MD, FACP, FACP, Bander chair of internal medicine and chief of hepatology at the Saint Louis University School of Medicine, in Missouri, said after the session. He expects approvals for some uses as soon as the end of the year.

“When we have that, it will transform how we think about the treatment of hepatitis C,” Di Gisceglie added. “An easy, one- to two-drug treatment regimen — that’s what we are looking forward to.”