The OSIRIS trial Phase II a, Janssen-Cilag has conducted investigating once daily OLYSIO (simeprevir) in combination with sofosbuvir in hepatitis C virus (HCV) genotype 4 infected patients, with and without liver cirrhosis, demonstrated treatment to be safe and generally well tolerated, with Sustained Virological Response (SVR12) rates of up to 100% in patients treated for 12 weeks regardless of fibrosis stage and treatment history.
Janssen-Cilag International announced the preliminary results from the Phase IIa OSIRIS trial, at the Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.
Professor Waked, Professor of Medicine, National Liver Institute, Egypt and lead OSIRIS study investigator, shed some light on the trial:
“Genotype 4 is the most common HCV genotype within the Middle Eastern region and is especially prevalent in Egypt where 8%-10% of the population are infected with HCV, and almost all infections are due to genotype 4,” Waked said.
Waked said that studies such as the OSIRIS trial could aid our understanding of how best to treat genotype 4 infected patients.
As Janssen explained, the OSIRIS trial assessed genotype 4 infected patients (n=63) both treatment naïve and treatment experienced, with and without liver cirrhosis, who were treated with 150mg of simeprevir in combination with 400mg sofosbuvir once daily. According to the Johnson Johnson’s pharmaceutical company, patients without liver cirrhosis were randomized to receive either 8 or 12 weeks of treatment while patients with cirrhosis were assigned to receive 12 weeks of treatment.
Providing more details about the results, the company said that results demonstrated 100% SVR12 rates in patients (n=43) treated for 12 weeks, and 75% in patients (n=20) treated for 8 weeks. Out of the five patients who relapsed in the 8 week arm, all were non-responder to other therapies with IL28B non-CC genotype. The most common adverse events (≥10%) were increased lipase, pruritus, and headache. One patient reported treatment-emergent serious adverse events (pleural effusion and pulmonary hypertension;) neither considered to be related to simeprevir. There were no discontinuations due to adverse events.
Middle East and North Africa have some of the highest prevalence of HCV in the world.
Isabelle Lonjon-Domanec, European Therapeutic Area Leader Infectious Diseases, Janssen Pharmaceuticals, said:
“The results of the OSIRIS trial presented at the Liver Meeting show simeprevir in combination with sofosbuvir to be an effective interferon free treatment option for patients infected with genotype 4 HCV.”
She added that the Middle East and North Africa have some of the highest prevalence of HCV in the world and it’s important to find treatment options that are effective in the fight against HCV in these countries.
Janssen notes that HCV continues to be a major public health burden in Egypt, where an estimated 7.5 million people are living with the disease. Treatment of HCV is complex because of the unpredictable course of the infection and the heterogeneous population of patients it affects. Treatment efficacy is also highly dependent on the genotype of the virus, the company concludes.
“Janssen remains committed to investigating and providing effective treatment solutions for patients, particularly in the geographies where high unmet needs continue to demand attention,” it has been said in the company’s press release.