Available online 13 April 2017
Glecaprevir and Pibrentasvir Yield High response Rates in Patients with HCV Genotype 1-6 without Cirrhosis
Glecaprevir and Pibrentasvir Yield High response Rates in Patients with HCV Genotype 1-6 without Cirrhosis
Highlights
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.
Abstract
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.
Abstract
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.
Methods
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).
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).
Results
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.
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.
Conclusions
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.
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.
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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