Treating patients who suffer from chronic Hepatitis C virus infection (HCV) with once a day protease inhibitor simeprevir along with interferon and ribavirin has been demonstrated to be as effective as administering them with telaprevir with interferon and ribavirin, which is the standard care recommended among developing countries. The conclusions are from a multi-center international research that included investigators from Penn Medicine, which were able to prove that simeprevir not only is simpler for patients to take, but also has fewer adverse events.
The study, which is going to be published in The Lancet Infectious Diseases in January 2015, was designed to assess the alternative therapy in comparison with standard therapy, since in the United States and other countries where there is access to more updated research and HCV treatments, physicians are favoring the use of all-oral therapy instead of interferon-based therapies, due to its side effects and low effectiveness levels.
“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,” explained the investigator Rajender Reddy, MD, who serves as professor of Medicine and director of Hepatology at the Perelman School of Medicine of the University of Pennsylvania. “This is the only study we are aware of that directly compares telaprevir to simeprevir.”
Simeprevir, manufactured by Janssen Pharmaceuticals, has less side effects and is more accessible than Telaprevir, which is a protease inhibitor administered three times per day. The phase 3 randomized, double-blind trial analyzed data from 763 patients suffering from chronic HCV genotype 1 infection, a form of the virus present in up to 75 percent of infections and compensated liver diseases. All of the participants had also previously not responded or only partially responded to at least one course of peginterferon and ribavirin.
“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,” Reddy said. “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.”
The group was randomly given either simeprevir plus telaprevir placebo or telaprevir plus simeprevir placebo in combination with peginterferon and ribavirin, during 12 weeks. After that, all of the patients received peginterferon and ribavirin alone for 36 weeks.
After 12 weeks of the end of the treatment, 54 percent of patients in the simeprevir group and 55 percent in the telaprevir group were able to achieve a sustained virologic response (SVR), which means that the amount of virus in the body was reduced. In prior partial responders, the SVR levels were 70, 68, and 44 percent, respectively, compared to 46 percent of previous non-responders following treatment with simeprevir and peginterferon and ribavirin and telaprevir and peginterferon and ribavirin treatment. In addition, 69 percent of the patients who took simeprevir suffered adverse events, compared to 86 percent, among the group that took telaprevir.