AbbVie’s investigational hepatitis C virus (HCV) regimen glecaprevir/pibrentasvir, known as G/P, has posted excellent cure rates for those with all genotypes of the virus who did not have cirrhosis, MedPage Today reports. A pooled analysis from major trials of the treatment found that cure rates were comparable between those treated for eight and 12 weeks.
The FDA currently has G/P under priority review. A decision is expected in late June.
Presenting their findings at the Digestive Disease Week conference in Chicago, researchers examined the results of seven major trials of the fixed-dose combination tablet of the NS3/4A inhibitor glecaprevir and the NS5A inhibitor pibrentasvir among 1,193 people without cirrhosis and genotype 1, 2, 3, 4, 5 or 6 of HCV. The regimen involves taking three tablets once daily.
Participants were treated for eight or 12 weeks.
Ninety-seven percent of those treated for eight weeks achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), as did 98 percent of those treated for 12 weeks.
Because of the similar results between the two groups, the investigators believe that eight weeks of G/P treatment should suffice for people with all genotypes of hep C who do not have cirrhosis.
The treatment was generally safe and well tolerated. Only one adverse health event experienced by the participants was deemed related to G/P. Four participants saw their hep C recur while on treatment (known as breakthrough viremia), 14 experienced a recurrence of the virus after the end of treatment (viral relapse) and 11 stopped treatment early. The remainder were all cured.
Few of the participants had either NS3 or NS5 resistance mutations upon entering the respective trials; such mutations may compromise the effectiveness of glecaprevir and pibrentasvir, respectively. Less than 1 percent had both resistance mutations; this was the only factor that the researchers identified as predictive of participants failing treatment.
G/P may prove particularly advantageous for people with genotype 3 and no cirrhosis, since these individuals were cured at high rates without the addition of ribavirin to their regimen, as is sometimes necessary to ensure such success with Gilead Sciences’ Epclusa (sofosbuvir/velpatasvir).
To read the MedPage Today article, click here.