Glecaprevir/Pibrentasvir Highly Efficacious and Well-Tolerated for HCV Infection

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Less than 1% of overall patients had direct-acting antiviral-related serious adverse events or discontinuations.
Less than 1% of overall patients had direct-acting antiviral-related serious adverse events or discontinuations.

Glecaprevir plus pibrentasvir (G/P) is a pangenotypic, all-oral, once-daily, ribavirin-free, direct-acting antiviral that is highly efficacious and well-tolerated in the majority of patients with hepatitis C virus (HCV) infection when taken for 8 weeks, according to an integrated analysis published in the Journal of Hepatology.1

Recent guidelines for the treatment of HCV infection without cirrhosis have treatment durations of 12 weeks or more; however, shorter treatment durations have been associated with improved adherence.2-7 Therefore, researchers conducted an integrated efficacy analysis by pooling data from 9 phase 2 and 3 trials that included 2041 patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis who received G/P (300 mg/120 mg) for either 8 or 12 weeks.1

They found that in the intent-to-treat population, 943/965 (98%) and 1060/1076 (99%) of patients achieved a sustained virologic response 12 weeks posttreatment (SVR12) when treated for 8 and 12 weeks, respectively, and that the difference in rates was not significant (P =.2).

These high SVR rates were also achieved irrespective of key patient or viral characteristics that are traditionally associated with lower efficacy, and consistent in patients with HIV-1 coinfection (99% SVR12) and severe renal impairment (98% SVR12), with no virologic failures in either subgroup.

G/P was well-tolerated, and safety was similar between the groups with less than 1% of overall patients (and none in those treated for 8 weeks) having direct-acting antiviral-related serious adverse events or discontinuations.

"Treatment with all-oral, once daily G/P for 8 or 12 weeks demonstrated high SVR12 rates (≥97%, [modified intention-to-treat]) across all six major HCV genotypes, with a less than 1% rate of relapse regardless of treatment duration," concluded the study authors.

References

  1. Puoti M, Foster GR, Wang S, et al. High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir: integrated analysis of HCV genotype 1-6 patients without cirrhosis [published online March 15, 2018]. J Hepatol. doi: 10.1016/j.jhep.2018.03.007
  2. American Association for the Study of Liver Diseases/Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C virus. https://www.hcvguidelines.org/. Accessed April 6, 2018.
  3. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C 2016. J Hepatol. 2017;66:153-194.
  4. Hatzakis A, Chulanov V, Gadano AC, et al. The present and future disease burden of hepatitis C virus (HCV) infections with today's treatment paradigm - volume 2. J Viral Hepat. 2015;22:26-45.
  5. Razavi H, Waked I, Sarrazin C, et al. The present and future disease burden of hepatitis C virus (HCV) infection with today's treatment paradigm. J Viral Hepat. 2014;21:34-59.
  6. Younossi ZM, Kanwal F, Saab S, et al. The impact of hepatitis C burden: an evidence-based approach. Aliment Pharmacol Ther. 2014;39:518-531.
  7. Lafferty L, Treloar C, Guthrie J, et al. Social capital strategies to enhance hepatitis C treatment awareness and uptake among men in prison. J Viral Hepat. 2017;24:111-116.
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