Mavyret demonstrated 97% sustained virologic response in a large, real-world cohort of patients with hepatitis C over an 8-week course and extended 12-week to 16-week courses, according to recently published data.
“In clinical trials, restricted inclusion and exclusion criteria for the targeted patients may influence outcomes,” Roberta D'Ambrosio, MD, from the University of Milan in Italy, and colleagues wrote. “We demonstrated for the first time the excellent effectiveness and safety of [Mavyret] in a large cohort of HCV patients treated in an Italian real-life setting.”
The real-world cohort comprised 723 patients with hepatitis C who underwent treatment with Mavyret (glecaprevir/pibrentasvir, AbbVie) for 8 weeks (88%), 12 weeks (11%) or 16 weeks (1%). Fifty-seven participants had compensated cirrhosis and 116 were interferon-experienced. Genotypes included 1, 2, 3 and 4.
Thirty-five patients were lost to follow-up and three patients died during the study due to reasons unrelated to treatment.
At end of treatment, 97% of patients in all treatment duration groups achieved SVR. Specifically, the rate of SVR by intention-to-treat was 94% (95% CI, 92-96) and by per-protocol analysis was 99.3% (95% CI, 98.6-99.9).
The researchers noted that therapy compliance was excellent across all centers. Of the 10 patients who were undertreated, nine achieved SVR and one was lost to follow-up.
Four patients discontinued treatment early due to adverse events. However, all four achieved SVR.
Referring to patients with genotypes 1a and 3, advanced fibrosis, high HCV RNA, and high BMI, D’Ambrosio and colleagues wrote that “even in the relatively limited subgroup of patients carrying clinical features usually associated with lower chances of achieving an SVR, [glecaprevir/pibrentasvir] treatment resulted in optimal effectiveness.” – by Talitha Bennett
Disclosure: D’Ambrosio reports financial connections with AbbVie, Gilead and Merck Sharp & Dohme. Please see the full study for the other authors’ relevant financial disclosures.