December 11, 2014
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Simeprevir with PEG-IFN a-2a/Ribavirin Safely Treated HCV

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In a new study, treatment with simeprevir and a combination of pegylated interferon alfa-2a and ribavirin yielded noninferior response rates to treatment with telaprevir among patients with hepatitis C virus genotype 1 infection.

“HCV treatment has been a moving target, especially for those who do not have access to or the ability to pay for the latest treatment options,” researcher Rajender Reddy, MD, professor of medicine and director of hepatology at the Perelman School of Medicine at the University of Pennsylvania, said in a press release.  “With this study, we showed that simeprevir once a day was well-tolerated in genotype 1 infected previous non-responders, making it a viable alternative to telaprevir for a segment of patients with HCV.”

Rajender Reddy

Reddy and colleagues enrolled 763 patients from 169 clinical sites in 24 countries who had HCV genotype 1 infection. Patients received 150 mg simeprevir (Olysio, Janssen Therapeutics) once a day plus telaprevir (Incivek, Vertex) placebo three times a day between 7 and 9 hours apart or 750 mg telaprevir three times a day between 7 and 9 hours apart plus simeprevir placebo once a day combined with 180 mcg PEG-IFN a-2a and weight-based ribavirin for 12 weeks. After treatment ended, all patients continued treatment with only PEG-IFN a-2a and ribavirin for another 36 weeks. Of the patients, 379 received simeprevir and telaprevir placebo and 384 received telaprevir and simeprevir placebo. Sixty-two percent of all patients were previous null responders and 43% had HCV genotype 1a infection.  

Fifty-four percent of patients in the intention-to-treat population who received simeprevir reached sustained virologic response at 12 weeks compared with 55% in the telaprevir group (P=.0007). Also, 54% of patients in the pre-protocol population who received simeprevir reached SVR12 compared with 56% of patients who received telaprevir (P=.001). More patients in the simeprevir group reached rapid virologic response compared with the telaprevir group (55% vs. 49%), as well as completed treatment compared with the telaprevir group (87% vs. 82%).

Of all previous partial responders, 70% who received simeprevir achieved SVR12 compared with 68% of patients who received telaprevir; 44% of previous null responders reached SVR12 in the simeprevir group compared with 46% in the telaprevir group.

More adverse events were observed among patients who received telaprevir compared with simeprevir (86% vs. 69%), as well as serious adverse events (9% vs. 2%).

“The observations from the study present simeprevir, peginterferon and ribavirin as a good therapeutic option for regions of the world where all-oral therapies are unavailable or cost prohibitive,” Reddy said. “This is the only study we are aware of that directly compares telaprevir to simeprevir.”

Disclosure: The study was funded by Janssen. See the study for a full list of researchers’ financial disclosures.