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

man pouring pills in hand
man pouring pills in hand
Glecaprevir plus pibrentasvir treatment results in high sustained virologic response rates irrespective of viral characteristics.

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.

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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.