Spotlight Series on Hepatitis C

Investigational Hep C Drug Shows Good Results

January/February 2013

Janssen Pharmaceuticals reported high levels of sustained virologic response (SVR) in study participants using its investigational hepatitis C medication simeprevir (TMC435). The once-daily pill was given with pegylated interferon (PEG-IFN) and ribavirin, the current standard of care.

Participants in the Phase 2b studies had Metavir scores (a method for assessing liver damage) F3 and F4, signs of advanced liver disease. An F3 score means the patient has numerous septa (fibrous tissue bands that can decrease the flow of blood through the liver), while an F4 score means the patient has cirrhosis (the final phase of chronic liver disease). All had genotype 1 HCV, the hardest to treat.

In the PILLAR study with treatment-naive (never before on hep C therapy) participants, 79% of those with an F3 score taking the simeprevir regimen saw an SVR at 24 weeks vs. 72% of those on PEG-IFN and ribavirin alone.

In the treatment-experienced patients seen in the ASPIRE study, however, the difference was much greater: 48% of the F3 participants on the simeprevir regimen saw an SVR at 24 weeks compared to 8% of those on PEG-IFN and ribavirin. For those with cirrhosis, 62% achieved SVR on simeprivir vs. none of the patients on the dual therapy.

While none of these patients had HIV, hep C advancements are important because a large percentage of people with HIV are estimated to be co-infected with HCV. Fortunately, a slew of new, and more tolerable, hepatitis C treatments are on their way. Simeprevir is an NS3/4A protease inhibitor. It is also being studied in all-oral, interferon-free regimens.

The results came from post hoc (done after the study) analyses of patients on 150 mg of simeprevir and were presented at the annual Liver Meeting of the American Association for the Study of Liver Diseases (AASLD) in November.

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