In a phase 3 clinical trial, Japanese patients with chronic hepatitis C (HCV) infection without liver cirrhosis were able to achieve high sustained viral response rates after taking an investigational HCV drug from AbbVie.
In a recent news release, AbbVie, a pharmaceutical company based in Chicago, announced that its investigational hepatitis C drug regimen led to high sustained viral response (SVR) in a phase 3, multicenter, clinical trial in Japanese patients with chronic hepatitis C infection without liver cirrhosis.
The clinical trial was a part of AbbVie’s clinical development program which aims to explore a more rapid approach to hepatitis C treatment, particularly in areas with outstanding needs such as in Japan. According to Michael Severino, MD, executive vice president of AbbVie, “Due to patient characteristics and virological considerations, people living with HCV in Japan have specific treatment challenges and needs.”
The clinical study was conducted on Japanese patients with genotype 1 (GT1) chronic hepatitis C infection, which is the most common HCV genotype in Japan, with 60% to 70% of those infected with hepatitis C being infected with the GT1 type. In addition, the study also matched the demographics of the HCV-infected population in Japan, where incidence of HCV infection increases with age, by including a large percentage of patients over the age of 65 years.
The clinical trial compared the effects of 8 weeks of AbbVie’s investigational ribavirin-free treatment combination of glecaprevir and pibrentasvir (G/P) with 12 weeks of ombitasvor/paritaprevir/ritonavir (OBV/PTV/r), also known as VIEKIRAX, on GT1 HCV-infected individuals. The main goal of this study was to assess the efficacy and safety of the G/P regimen which combines two antiviral drugs that are meant to be taken once a day in the form of three oral tablets. Glecaprevir is an NS3/4A protease inhibitor while pibrentasvir is an NS5A inhibitor. The results of the study demonstrated that 8 weeks of G/P treatment were not less efficacious than 12 weeks of OBV/PTV/r treatment.
According to the news release, patients with an SVR at 12 weeks after treatment are considered to be cured of hepatitis C. The clinical study examined 106 GT1 HCV-infected patients without liver cirrhosis and found that 99% of patients achieved SVR at 12 weeks following treatment with the G/P regimen. The one patient that did not have a documented SVR after 12 weeks failed to follow-up.
Moreover, AbbVie conducted a randomized, open-label, substudy in which GT1 patients who have not been previously treated with direct-acting antivirals (DAA) were treated with G/P. In those individuals receiving G/P, no patients discontinued treatment as a result of adverse events (AEs). However, in those patients treated with OBV/PTV/r, one patient discontinued treatment as a result of AEs. The most common AEs in patients receiving the G/P treatment was inflammation of the throat as well as itchiness.
AbbVie also conducted a second non-randomized, open-label substudy which evaluated different genotypes of HCV-infected patients, of which there are 6 distinct strains of the virus. This study included those with treatment challenges such as patients with liver cirrhosis, chronic kidney disease, as well as patients who were previously treated with DAAs. Data resulting from this second substudy has not yet been released.
Samar Mahmoud graduated from Drew University in 2011 with a BA in Biochemistry and Molecular Biology. After two years of working in industry as a Quality Control Technician for a blood bank, she went back to school and graduated from Montclair State University in 2016 with an MS in Pharmaceutical Biochemistry. She is currently pursuing her PhD in Molecular and Cellular Biology at the University of Massachusetts at Amherst.