AbbVie’s investigational hepatitis C virus (HCV) regimen, glecaprevir (ABT-493)/pibrentasvir (ABT-530), known as G/P, cured virtually all those with genotype 1 of the virus in a recent trial in Japan.
The Phase III CERTAIN-1 study included 181 people with genotype 1 of hep C who did not have cirrhosis and had not been treated for HCV before. They were tested for a hep C resistance mutation called Y93H. The 158 people who did not have the mutation were randomized two-to-one to receive eight weeks of G/P or 12 weeks of AbbVie’s Technivie (ombitasvir/paritaprevir/ritonavir). The 23 people with the mutation received eight weeks of G/P.
Ninety-nine percent (105 of 106) of those without the mutation who received eight weeks of G/P achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). The one person not cured was lost to follow-up. The 52 people who received Technivie were cured. Consequently, the researchers concluded that G/P was non-inferior to Technivie, meaning, essentially, that G/P is as good as Technivie.
The 23 people with the resistance mutations were cured.
No one in substudy 1 who took G/P stopped taking it because of adverse health events, compared with one person who took Technivie. The most common adverse health events among those taking G/P, occurring at a rate greater than 5 percent, were inflammation of the throat and nasal passages and itchiness.
To read a press release about the study, click here.