Monday, April 17, 2017

Glecaprevir and Pibrentasvir Yield High response Rates in Patients with HCV Genotype 1-6 without Cirrhosis

Available online 13 April 2017

Glecaprevir and Pibrentasvir Yield High response Rates in Patients with HCV Genotype 1-6 without Cirrhosis
Paul Y. Kwo1, Fred Poordad, Armen Asatryan, Stanley Wang, David L. Wyles, Tarek Hassanein, Franco Felizarta, Mark S. Sulkowski, Edward Gane, Benedict Maliakkal, J. Scott Overcash,

An all oral, once-daily, RBV-free, pangenotypic HCV treatment option is described.
8- or 12-week treatment with glecaprevir + pibrentasvir yielded high rates of SVR12
Treatment was well-tolerated with a favorable safety profile.

Background and Aims
Hepatitis C virus (HCV) therapy that is highly efficacious, pangenotypic, with a high barrier to resistance and short treatment duration is desirable. The efficacy and safety of 8- and 12-week treatments with glecaprevir (ABT-493; NS3/4A protease inhibitor) and pibrentasvir (ABT-530; NS5A inhibitor) was evaluated in non-cirrhotic patients with chronic HCV genotype 1–6 infection.

SURVEYOR-I and SURVEYOR-II were phase 2, open-label, multicenter, dose-ranging trials including patients with chronic HCV genotype 1–6 infection who were either previously untreated or treated with pegylated interferon plus ribavirin. Patients received once-daily glecaprevir plus pibrentasvir at varying doses with or without ribavirin for 8 or 12 weeks. The primary efficacy endpoint was the percentage of patients with a sustained virologic response at post-treatment week 12 (SVR12).

Of the 449 patients who received varying doses of glecaprevir plus pibrentasvir, 25%, 29%, 39%, and 8% had HCV genotype 1, 2, 3, and 4–6 infection, respectively. Twelve-week treatment achieved SVR12 in 97–100%, 96–100%, 83–94%, and 100% in genotypes 1, 2, 3, and 4–6, respectively. Eight-week treatment with 300 mg glecaprevir plus120 mg pibrentasvir in genotype 1–, 2–, or 3–infected patients yielded 97–98% SVR12 with no virologic failures. Three (0.7%) patients discontinued treatment due to adverse events; most events were mild (Grade 1) in severity. No post-nadir alanine aminotransferase elevations were observed.

Glecaprevir plus pibrentasvir was well tolerated and achieved high sustained response rates in HCV genotypes 1–6–infected patients without cirrhosis following 8- or 12-week treatment durations.

Lay Summary
The combination of direct-acting antivirals glecaprevir and pibrentasvir comprise a once-daily, all-oral, pangenotypic treatment for HCV genotype 1-6 infection. This article describes results from two Phase 2 trials investigating a range of doses at treatment durations of 8 or 12 weeks in 449 patients without cirrhosis. Efficacy of the optimal dose, as determined by rates of sustained virologic response at post-treatment week 12, ranged from 92%-100%; treatment was well-tolerated and significant laboratory abnormalities were rare.

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