AbbVie’s investigational all-genotype hepatitis C virus (HCV) treatment glecaprevir/pibrentasvir, known as G/P, cured the virus in almost all those with compensated cirrhosis, the milder form of cirrhosis.
AbbVie applied for FDA approval of G/P in February. A decision is expected in late June.
The Phase III multicenter, open-label EXPEDITION-1 trial gave 12 weeks of G/P to 146 adults with genotypes 1, 2, 4, 5 and 6 and Child-Pugh A cirrhosis, also known as compensated cirrhosis. The trial included those who were being treated for HCV for the first time as well as those who had been treated before with interferon-based treatments.
Findings were presented at the 52nd International Liver Congress in Amsterdam.
A total of 145 of the participants, or 99 percent, achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). The one person who was not cured had genotype 1a and experienced viral relapse.
None of the participants experienced grade 3 or higher elevations of their ALT liver enzymes. Eleven participants (7.5 percent) experienced serious adverse health events, but the researchers did not judge that any were related to treatment.
To read a press release about the study, click here.
For a Hep Magazine feature on the 2017 hep C drug pipeline, click here.