AT THE LIVER MEETING 2014

BOSTON (FRONTLINE MEDICAL NEWS)Since their approval in late 2013, the direct-acting antiviral agents sofosbuvir and simeprevir have taken over treatment of hepatitis C with real-world success that approximates clinical trial results, two separate and ongoing longitudinal, observational studies show.

Sofosbuvir-containing regimens produced sustained virologic response (SVR) rates of 85%-90% in patients with genotype 1 infection in one study and 79%-88% in the other.

In one study, researchers analyzed data for 2,063 patients who started and completed treatment for hepatitis C since January 2014 at 43 academic medical centers and 13 community medical centers in North America and Europe participating in the HCV-Target study , Dr. Donald M. Jensen and his associates reported at the annual meeting of the American Association for the Study of Liver Diseases.

Among patients with genotype 1 hepatitis C infection, 68% were treated with an off-label combination of sofosbuvir plus simeprevir with or without ribavirin, 23% received sofosbuvir plus pegylated interferon plus ribavirin, and 9% received sofosbuvir plus ribavirin alone, reported Dr. Jensen, professor of medicine and director of the Center for Liver Diseases at the University of Chicago.

Among patients with genotype 2 or 3 hepatitis C infection, 99% and 92% received sofosbuvir plus ribavirin, respectively.

The off-label combination of sofosbuvir plus simeprevir with or without ribavirin also was common in two subgroups, patients with cirrhosis and patients who had undergone liver transplantation.

That combination – sofosbuvir plus simeprevir with or without ribavirin – produced an SVR at 4 weeks in 89% of patients with genotype 1 hepatitis C, ranging from 92% in patients without cirrhosis to 87% in those with cirrhosis and 75% in patients with prior decompensation, he reported. And if they’d previously failed protease inhibitor therapy, the SVR rate at 4 weeks was 81%, ranging from 79% in those with cirrhosis to 85% without cirrhosis.

Treating patients with genotype 1 infection with sofosbuvir plus pegylated interferon plus ribavirin led to an SVR rate at 4 weeks of 85%, ranging from 70% in cirrhotic patients to 90% without cirrhosis.

In patients with genotype 2 infection, treatment with sofosbuvir plus ribavirin produced an SVR rate at 4 weeks of 90%, ranging from 88% in patients with cirrhosis to 91% without cirrhosis.

A secondary analysis suggested good concordance between SVR rates at 4 weeks and 12 weeks. The positive predictive value for SVR at 12 weeks if there was SVR at 4 weeks was 97% for patients treated with sofosbuvir and simeprevir with or without ribavirin, 94% for those treated with sofosbuvir, pegylated interferon, and ribavirin, and 98% for patients treated with sofosbuvir and ribavirin.

Rates of serious adverse events and premature discontinuation of therapy were “very low,” Dr. Jensen said.

In a separate study of patients who started treatment for hepatitis C between January and April of 2014 at 119 practices, researchers analyzed data on 955 patients who completed treatment. Because SVR rates at 12 weeks are pending for some patients, an intent-to-treat analysis included 822 patients and 743 patients who were in a per-protocol analysis.

Forty percent of patients were treated with sofosbuvir plus pegylated interferon and ribavirin, 24% received sofosbuvir and ribavirin, and 34% were treated with sofosbuvir and simeprevir with or without ribavirin, reported Dr. Douglas Dieterich and his associates.

SVR was achieved at 12 weeks by 79% of patients in the intent-to-treat analysis and by 88% in the per-protocol analysis, reported Dr. Dieterich, professor of medicine at Mount Sinai School of Medicine, New York.

“This is comparable to data reported in clinical trials,” he said. Notably, 72% of patients who previously failed treatment and then received sofosbuvir, pegylated interferon, and ribavirin achieved SVR at 12 weeks, “exactly as predicted by the Food and Drug Administration,” he added.

Dr. Dieterich reported ties with Merck, Idenix Pharmaceuticals, Janssen Pharmaceuticals, Gilead, and Bristol-Myers Squibb, and his associates reported ties with dozens of companies. Dr. Jensen reported ties with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech/Roche, and Janssen Pharmaceuticals, Gilead, Merck, Vertex, and GSK.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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