AbbVie announces results of TURQUOISE-III study in hepatitis C

NORTH CHICAGO, Ill.—AbbVie Inc. is ending the week on a high note, having seen promising results from its TURQUOISE-III study, a multi-center, open-label Phase 3b study evaluating the safety and efficacy of VIEKIRAX and EXVIERA without ribavirin (RBV) in adult patients with genotype 1b chronic hepatitis C virus infection and compensated liver cirrhosis who were treatment-naïve or treatment-experienced (failed previous treatment with pegylated interferon and RBV). The primary endpoint for the study is the rate of sustained virologic response 12 weeks after treatment, and AbbVie saw that in spades, reporting a 100-percent sustained virologic response. The company plans to present these results at the 15^th Annual International Symposium on Viral Hepatitis and Liver Diseases in Berlin.

"In the TURQUOISE-III study, GT1b patients with compensated liver cirrhosis achieved a 100 percent cure rate with VIEKIRAX + EXVIERA without ribavirin," Dr. Scott Brun, vice president of pharmaceutical development at AbbVie, said in a press release. "TURQUOISE-III is part of our Phase 3b program, which aims to further enhance our understanding of AbbVie's regimen in HCV populations seen in clinical practice, and supports our commitment to continued investigation in this field."

In addition to the encouraging response rates, the trial did not see any treatment discontinuations due to adverse events. The most commonly reported adverse events were fatigue, diarrhea and headache, which occurred in 22, 20 and 18 percent of patients, respectively.

Genotype 1 is the most common type of HCV genotype, according to the World Health Organization website, and accounts for 60 percent of cases worldwide. Genotype 1b represents the most prevalent genotype in Europe, accounting for 47 percent of cases. Some 160 million people are infected with HCV globally.

"Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens," Dr. Jordan J. Feld, research director and clinician scientist at the Toronto Center for Liver Disease, said in a press release. "The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks."

This announcement comes just over a week after AbbVie reported updated results in another of its current studies. In a Phase 1b study of patients with relapsed/refractory chronic lymphocytic leukemia treated with venetoclax in combination with rituximab, patients saw an overall response rate of 84 percent, with six patients halting treatment after achieving either a complete response or complete response with incomplete marrow recovery. Three patients maintained a response after a median of 12 months.

"Potentially, the most interesting part of these initial results is the data regarding the patients who have been able to come off treatment and who continue to maintain their complete response," noted Prof. Andrew W. Roberts, the Royal Melbourne Hospital Department of Clinical Hematology and Bone Marrow Transplant Service and head of Clinical Translation at the Walter and Eliza Hall Institute of Medical Research. "The fact that this investigational venetoclax combination achieved these response rates suggests this treatment may offer patients another option and warrants further investigation."

SOURCE: AbbVie press release