Once-Daily, Ribavirin-Free, Pan-Genotypic Hepatitis C Regimen Shows Strong Results
Novel HCV regimen shows high SVR12 rates at 8 and 12 weeks of treatment.
After 8 weeks of treatment in a phase 2 trial with a ribavirin (RBV)-free, pan-genotypic, once-daily regimen of ABT-493 and ABT-530, 97 to 98% of chronic hepatitis C virus (HCV) genotype 1-3 (GT1-3) patients achieved sustained virologic response at 12 weeks post-treatment (SVR12).
Furthermore, 100% (n=34/34) of GT4-6 chronic HCV-infected patients without cirrhosis achieved sustained virologic response after 12 weeks (SVR12) of treatment.
“The recent evolution in hepatitis C treatment has resulted in high cure rates for many patients with specific genotypes, but there remain distinct areas of unmet need,” said Paul Kwo, MD, professor of medicine at the Indiana University School of Medicine. “These new data show us the potential of ABT-493 and ABT-530 in genotype 3 patients new to therapy even with the added complication of compensated cirrhosis.”
The new data came from the phase 2 SURVEYOR-1 and SURVEYOR-2 studies with a total enrollment of 531 HCV patients.
SURVEYOR-1 is an ongoing 2-part study that evaluates the safety and efficacy of AbbVie’s ABT-493 and ABT-530 with or without RBV for 8 to 12 weeks in adult HCV GT1 patients with or without cirrhosis and non-cirrhotic adult patients with GT4-6 HCV. The patients were new to therapy or did not respond to prior treatment with pegylated interferon (pegIFN)/FBV (null responder).
SURVEYOR-2 is an ongoing 4-part study that tests the safety and efficacy of ABT-493 and ABT-530 with or without RBV in adult patients with HCV GT2-6, who failed prior treatment with pegylated interferon (pegIFN)/FBV and were new to therapy.
The primary endpoint for both studies was the percentage of patients who achieved SVR12.
“These results move us closer to our ultimate goal of providing a treatment option for as many hepatitis C patients as possible,” said Rob Scott, MD, vice president, development and chief medical officer at AbbVie. “We will continue to examine our investigational, pan-genotypic regimen through our dedicated clinical trial program, including an 8 week duration across all genotypes.”
The results for GT1 (n=33/34), GT2 (n=53/54) and treatment-naïve GT3 (n=28/29) patients were based on an Intent-to-Treat (ITT) analysis.
The new data will be presented at The International Liver Congress 2016 in Barcelona, Spain.