April 26, 2013
More Good News From AbbVie's Five-Drug Hep C Combo
Confirming previous encouraging findings, AbbVie’s five-drug hepatitis C virus (HCV) combination therapy demonstrated cure rates in the mid-90 percent range when taken for as little as 12 weeks, the Chicago Tribune reports. The results of this Phase IIb study, called Aviator, were presented at the International Liver Congress, the 48th annual meeting of the European Association for the Study of the Liver (EASL) in Amsterdam.
“These new results from the Aviator study further demonstrate that this investigational all-oral therapy combination can achieve high sustained viral response after 12 weeks of treatment,” Kris Kowdley, MD, director of the Liver Center of Excellence and director of research at the Digestive Disease Institute at Virginia Mason Medical Center, said in a release. “The consistency of high sustained viral response rates that we have seen in clinical trials across populations is encouraging, especially given the proportion of patients with these characteristics who have failed with interferon plus ribavirin treatment.”
The study included 247 people with genotype 1 of hep C who were non-cirrhotic and either treatment-naive or null-responders to previous ribavirin/interferon-based treatment. The five-drug cocktail included ABT-450/r, a protease inhibitor taken with ritonavir; the NS5A inhibitor ABT-267; the non-nucleoside polymerase inhibitor ABT-333; and ribavirin. The combination was studied for 8, 12 or 24 weeks of treatment among the treatment-naive participants and 12 or 24 weeks among null responders.
Among the four groups of treatment-naive participants taking the therapy for 12 weeks, one group took all five drugs, and those in the three remaining groups eliminated one of three meds: ABT-267, ABT-333 or ribavirin. Among the two groups of null responders taking the therapy for 12 weeks, one took all five drugs while the other eliminated ABT-333.
The rate of sustained virologic response (SVR) 24 weeks after therapy, considered a cure, ranged between a low of 83 percent among the treatment-naive participants who took therapy for 12 weeks and eliminated ABT-267, to 95 percent for the null responders who took all five drugs for 24 weeks, and 96 percent for treatment-naive participants who took all five drugs for 12 weeks. The treatment-naive participants who took all five drugs for just 8 weeks had an 88 percent cure rate. There was a single relapse among those taking all five drugs.
Four of the participants (1.6 percent) discontinued therapy because of adverse reactions. Another four patients experienced serious adverse events, including a case of arthralgia (joint pain) that may have been drug-related. Other common side effects, reported in more than 10 percent of the participants, included headache, nausea, insomnia and diarrhea.
To read the Chicago Tribune story, click here.
To read the AbbVie release, click here.
Search: AbbVie, hepatitis C virus, hep C, HCV, Chicago Tribune, International Liver Congress, the 48th annual meeting of the European Association for the Study of the Liver, EASL, Kris Kowdley, Virginia Mason Medical Center, ABT-450/r, ABT-267, ABT-333, ribavirin
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