Glecaprevir/Pibrentasvir Is Safe, Effective in Treatment of HCV in Real-World Setting

The efficacy and safety of glecaprevir/pibrentasvir (G/P, sold as Mavyret) in the treatment of hepatitis C virus (HCV) has previously only been investigated in clinical trials. Thus far, no real-world data had been available until a group of researchers looked to investigate the efficacy and safety of G/P in a real-world setting in Italy.

The study enrolled 723 patients with HCV and began treatment between October 2017 and January 2018. Overall, 88% of patients were treated for 8 weeks, 11% of patients were treated for 12 weeks, and 1% of patients were treated for 16 weeks. Genotypes included 1, 2, 3, and 4, and 57 participants had compensated cirrhosis, while 116 were interferon-experienced.

Researchers found that 97% of patients in all treatment duration groups achieved sustained virologic response (SVR). The rate of SVR by intention-to-treat was 94% (95% CI, 92%-96%) and by per-protocol analysis, SVR was 99.3% (95% CI, 98.6%-99.9%).

However, 35 patients were lost to follow-up and 3 patients passed away during the study due to causes unrelated to treatment. Furthermore, 4 patients discontinued treatment early due to adverse events, which were only experienced in 8.4% of patients, but all 4 achieved SVR.

“We demonstrated for the first time the excellent effectiveness and safety of [G/P] in a large cohort of HCV patients treated in a real-life setting,” wrote the study investigators.

Across all centers, researchers noted that therapy compliance was excellent, although 10 patients were undertreated. Of these 10 patients, 9 achieved SVR and 1 was lost to follow-up.

In relation to patients with genotypes 1a and 3, advanced fibrosis, high HCV RNA, and a high body mass index, “even in the relatively limited subgroup of patients carrying clinical features usually associated with lower chances of achieving an SVR, G/P treatment resulted in optimal effectiveness,” wrote the study authors.

Reference

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.