March 26, 2014

The Promise of New HCV Therapies

HCV Next, January/February 2014

Your guide to the age after interferon

NewDrug

The future of treatment for hepatitis C virus infection is exciting. Many new drugs and combination therapies are moving rapidly through clinical trials and are becoming part of the conversation for FDA approval. The most recently approved tools at the disposal of clinicians are sofosbuvir and simeprevir, oral therapies that are associated with high cure rates.

The fast pace of development begs the question of whether an interferon-free future is near. Interferon has been the backbone of HCV treatment since it was approved by the FDA in 1991 for the treatment of HCV. In 1998, the addition of ribavirin to interferon was approved. Since the approval of pegylated interferon in 2001, the gold standard of treatment has been pegylated interferon with ribavirin with or without a protease inhibitor. However, the downsides associated with interferon, including adverse effects, need for careful monitoring and the fact that some patients are ineligible for treatment, and have left many desiring an interferon-free regimen.

Yet, interferon therapy is not quite a thing of the past. The approach figures into several recommended treatment options featured on HCVguidelines.org, the website recently launched by the American Association for the Study of Liver Diseases and Infectious Diseases Society of America, in collaboration with the International Antiviral Society-USA, which will serve as the clinical guidelines for HCV treatment in the United States (See Feature). However, a range of non-nucleoside polymerase inhibitors, nucleoside/nucleotide polymerase inhibitors, NS5A inhibitors, protease inhibitors and combinations thereof have demonstrated such overwhelmingly encouraging cure rates across genotypes in clinical trials that many believe the days of interferon are numbered.

The FDA has acted accordingly and provided accelerated 6-month approval status for several combination therapies. The speed with which new therapies are evolving has raised some eyebrows in the clinical community, but Donald M. Jensen, MD, said the development process is working exactly as it should.

“The duration of therapy is shorter with many of these drugs,” said Jensen, who is professor of medicine and director of the Center for Liver Diseases at University of Chicago Medical Center. Most combinations are being studied for 8 to 12 weeks of therapy and 12 weeks of follow-up.

“This has made the development of agents much quicker than with pegylated interferon and ribavirin-based therapies,” Jensen, a co-chair on the HCVguidelines.org panel, said. “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.”

Andrew J. Muir, MD, MPH, associate professor of medicine and clinical director of hepatology at Duke University, put the issue in clinical terms: “The concern is not the pace of the FDA-approval process. The concern is that patients are dying of cirrhosis and liver cancer. We now have the tools to stop this disease and end pain and suffering.”

HCV Next spoke with several experts about the current drug pipeline. Their insights may help clinicians who treat this disease prepare for 2014 and beyond.

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