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 22 May 2018

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Glecaprevir–pibrentasvir for in HCV genotype 1 or 3 infection

This week's issue of the New England Journal of Medicine evaluates the efficacy and safety of 8-week and 12-week courses of treatment with glecaprevir plus pibrentasvir in patients without cirrhosis who had hepatitis C virus genotype 1 or 3 infection.

News image

Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity and a high barrier to resistance.

Dr Stefan Zeuzem and colleagues evaluated the efficacy and safety of 8-week and 12-week courses of treatment with 300 mg of glecaprevir plus 120 mg of pibrentasvir in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection.

The researchers conducted 2 phase 3, randomized, open-label, multicenter trials.

Patients with genotype 1 infection were randomly assigned in a 1:1 ratio to receive once-daily glecaprevir–pibrentasvir for either 8 or 12 weeks.

Patients with genotype 3 infection were randomly assigned in a 2:1 ratio to receive 12 weeks of treatment with either glecaprevir–pibrentasvir or sofosbuvir–daclatasvir.

Additional patients with genotype 3 infection were subsequently enrolled and nonrandomly assigned to receive 8 weeks of treatment with glecaprevir–pibrentasvir.

The team's primary end point was the rate of sustained virologic response 12 weeks after the end of treatment.

8 weeks of treatment with glecaprevir–pibrentasvir yielded a rate of 95%
New England Journal of Medicine

In total, 1208 patients were treated.

The researchers noted that the rate of sustained virologic response at 12 weeks among genotype 1–infected patients was 99% in the 8-week group, and 99.7% in the 12-week group.

The team found that genotype 3–infected patients who were treated for 12 weeks had a rate of sustained virologic response at 12 weeks of 95% with glecaprevir–pibrentasvir, and 97% with sofosbuvir–daclatasvir.

The research team found that 8 weeks of treatment with glecaprevir–pibrentasvir yielded a rate of 95%.

Adverse events led to discontinuation of treatment in no more than 1% of patients in any treatment group.

Dr Zeuzem's team concludes, "Once-daily treatment with glecaprevir–pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis."

NEJM 2018; 378:354-369
29 January 2018

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