In patients with chronic hepatitis C virus (HCV) genotype 3 (GT3) infection, glecaprevir coformulated with pibrentasvir (G/P) is well-tolerated and effective, regardless of cirrhosis status and prior treatment experience, according to study results published in the Journal of Viral Hepatology.
The researchers included data from five phase 2 or 3 trials that evaluated 8-, 12-, and 16-week G/P in participants with chronic HCV GT3 infection (n=693). They included participants with or without cirrhosis and patients who were treatment naïve or experienced with interferon- or sofosbuvir-based regimens. The researchers assessed safety and sustained virologic response at 12 weeks post-treatment (SVR12).
A total of 95% of participants who were treatment-naïve without cirrhosis achieved SVR12 while receiving 8-week (198/208) and 12-week (280/294) G/P. Treatment-naïve participants with cirrhosis had a 97% (67/69) rate of SVR12 with 12-week G/P.
Of treatment-experienced participants, patients without cirrhosis had SVR12 rates of 90% (44/49) and 95% (21/22) with 12- and 16-week G/P, respectively. Patients with cirrhosis had SVR12 rates of 94% (48/51) for 16-week G/P.
The researchers found that serious adverse events occurred in 3% of participants, but none that were attributed to G/P. The rate of study discontinuation due to adverse events was low (0.4%).
“The data from this integrated analysis support the label-recommended durations of 8 and 12 weeks of G/P for treatment-naïve patients without and with cirrhosis, respectively, and 16 weeks of G/P for treatment-experienced patients, regardless of cirrhosis status,” the researchers wrote.
Disclosure: AbbVie sponsored the 5 trials described in this study, contributed to their design, collection, analysis, and interpretation of the data, and participated in the writing, review, and approval of the content of the manuscript. Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.
Flamm S, Mutimer D, Asatryan A, et al. Glecaprevir/pibrentasvir in patients with chronic HCV genotype 3 infection: an integrated phase 2/3 analysis [published online November 12, 2018]. J Viral Hepatol. doi:10.1111/jvh.13038