AbbVie’s investigational hepatitis C virus (HCV) treatment glecaprevir/pibrentasvir, known as G/P, boasts high cure rates among those coinfected with HIV and multiple genotypes of HCV, including those with and without compensated cirrhosis.
The drug company applied for FDA approval of G/P in February. A decision is expected in late June.
The Phase III multicenter global EXPEDITION-2 trial tested eight weeks of G/P among 137 HIV/HCV-positive people without cirrhosis and 12 weeks of the treatment among 16 HIV/HCV-positive people with cirrhosis.
There were participants with genotypes 1, 2, 3, 4 and 6 in the trial, including those who had and had not been treated before (although those with genotype 3 had to be receiving treatment for the first time to enter the trial). All those with cirrhosis were taking antiretroviral (ARV) treatment for HIV, as were 93 percent (128 of 137) of those without cirrhosis.
Findings were presented at the 52nd International Liver Congress in Amsterdam.
Overall, 98 percent of the participants achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), including 99.3 percent (136 of 137) of those without cirrhosis and 93 percent (14 of 15 of those who finished treatment) of those with cirrhosis.
A respective three (2 percent) and 1 (6 percent) of those without and with cirrhosis experienced a serious adverse health event during the study, although none of the health events were judged related to G/P. The one person with cirrhosis who experienced such a health event stopped treatment as a result.