High viral load predicts virologic failure in chronic genotype 2 hepatitis C virus-infected patients receiving glecaprevir/pibrentasvir therapy

J Formos Med Assoc. 2020 Nov;119(11):1593-1600. doi: 10.1016/j.jfma.2020.08.010. Epub 2020 Aug 21.

Abstract

Background: The real-world data of glecaprevir/pibrentasvir (GLE/PIB) therapy for patients with chronic hepatitis C virus (HCV) genotype 2 infection remained limited. We aimed to evaluate the possible predictors of virological failure and side effects of GLE/PIB therapy for chronic genotype 2 HCV-infected patients in a real-world setting.

Methods: A total of 326 compensated HCV genotype 2 patients treated with GLE/PIB 12 weeks for cirrhotic patients (n = 56) and 8 weeks for non-cirrhotic patients (n = 270) were enrolled.

Results: The sustained virological response 12 weeks off therapy (SVR12) was 98.1%, 100%, and 97.7% in overall, GLE/PIB 12-week, and 8-week group, respectively. There were 6 (1.8%) patients with early withdrawal, and 14.1% patients had pruritus, the major adverse effect. In multivariate analyses, end-stage renal disease (odds ratio (OR) = 4.056, 95% confidence interval (CI) = 1.477-11.14, p = 0.007) and hypertension (OR = 2.325, 95% CI = 1.171-4.616, p = 0.016) were two significant factors associated with pruritus. There were 6 patients with virologic failure. In patients receiving 8-week GLE/PIB therapy, the SVR12 rate was significant lower in high baseline viral load (≥107 IU/ml) group compared to low viral load group (90.6% v.s 98.7%, p = 0.025). Multivariate analyses showed that HCV RNA≥107 IU/ml was one of the independent factors (OR = 0.134, 95% CI = 0.024-0.748; p = 0.022) associated with SVR12.

Conclusion: GIE/PIB is an effective, tolerable and safe agent to treat genotype 2 HCV infected patients. However, high viral load (≥107 IU/ml) may predict virologic failure in non-cirrhotic patients receiving 8 weeks GIE/PIB treatment. This result should be further validated in a large cohort in the future.

Keywords: Glecaprevir/pibrentasvir; Hepatitis C virus; Pruritus; Sustained viral response; Virological failure.

MeSH terms

  • Aminoisobutyric Acids / therapeutic use*
  • Antiviral Agents / adverse effects
  • Benzimidazoles / therapeutic use*
  • Benzimidazoles / urine
  • Cyclopropanes / therapeutic use*
  • Genotype
  • Hepacivirus / genetics
  • Hepatitis C, Chronic* / drug therapy
  • Humans
  • Lactams, Macrocyclic / therapeutic use*
  • Leucine / analogs & derivatives*
  • Leucine / therapeutic use
  • Proline / analogs & derivatives*
  • Proline / therapeutic use
  • Pyrrolidines
  • Quinoxalines / therapeutic use*
  • Sulfonamides / therapeutic use*
  • Viral Load

Substances

  • Aminoisobutyric Acids
  • Antiviral Agents
  • Benzimidazoles
  • Cyclopropanes
  • Lactams, Macrocyclic
  • Pyrrolidines
  • Quinoxalines
  • Sulfonamides
  • pibrentasvir
  • Proline
  • Leucine
  • glecaprevir