Glecaprevir/pibrentasvir demonstrated high rates of efficacy and safety for the treatment of patients with hepatitis C virus (HCV) in the first large real-world trial, according to study results published in the Journal of Hepatology.
The study included participants with HCV in the NAVIGATORE-Lombardia Network who were starting glecaprevir/pibrentasvir between October 2017 and January 2018 (n=723). Participants took glecaprevir/pibrentasvir according to the drug label for 8, 12, or 16 weeks. The researchers staged fibrosis histologically or by liver stiffness measurement, and defined sustained virologic response as undetectable HCV-RNA 12 weeks after the end of treatment.
Overall, 89% of participants were treated with glecaprevir/pibrentasvir for 8 weeks; 49% of participants had HCV genotype 1 (32% of whom had genotype1b), 28% had genotype 2, 10% had genotype 3, and 13% had genotype 4.
A total of 680 participants achieved sustained virologic response, with a rate of 94% at intention-to-treat and 99.3% at per-protocol analysis.
Due to post-treatment relapse, 5 participants did not respond to therapy, with 1 case of post-treatment NS5A variant resistance-associated substitutions. Mild adverse events were reported in 8.3% of participants, with 0.7% of participants withdrawing from treatment prematurely. The most commonly reported events were fatigue, nausea, and pruritis, with no differences between treatment duration.
The researchers found that sustained virologic response rates were lower in males and participants with HCV genotype 3 who were treated for 8 weeks (P =.022), but independent of treatment duration, HCV genotype, fibrosis stage, baseline HCV-RNA, body mass index, or chronic kidney disease stage.
“Whether these results do effectively reflect lower effectiveness of glecaprevir/pibrentasvir in these specific subgroups of patients need to be further investigated, due to the overall very high [sustained virologic response] rates obtained in our study,” the researchers wrote.
Unrestricted grant for NAVIGATORE-Lombardia web-based platform (AbbVie, Gilead, MSD)
D’Ambrosio R, Pasulo L, Puoti M, et al. Real-life effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C [published online November 22, 2018]. J Hepatol. doi:10.1016/j.jhep.2018.11.011