Telaprevir can be successfully and safely used to treat older patients with genotype 1b chronic hepatitis C

J Hepatol. 2013 Aug;59(2):205-12. doi: 10.1016/j.jhep.2013.03.020. Epub 2013 Mar 28.

Abstract

Background & aims: This study was performed to evaluate the efficacy of a triple therapy in older Japanese patients; telaprevir (TVR) was added to pegylated interferon α2b and ribavirin.

Methods: This prospective study enrolled 120 genotype 1b patients with chronic hepatitis C who received 12 weeks of triple therapy followed by a 12-week dual therapy that included pegylated interferon α2b and ribavirin. Patients were categorized according to age: group A, 64 patients aged >60 and group B, 56 patients aged ⩽60. Serum HCV RNA levels were monitored by COBAS TaqMan HCV test.

Results: The rates of undetectable HCV RNA at week 4 (rapid virological response, RVR) were 73.4% in group A and 73.2% in group B. No significant difference in sustained virological response (SVR) was found between groups A (76.6%) and B (83.9%) (p=0.314). The SVR rates for patients with interleukin 28B (IL28B) (rs8099917) TT allele (89.4% and 91.9% for groups A and B) were significantly higher than for those with the IL28B TG/GG allele (41.2% and 68.4%, respectively) (both p<0.05). Multivariate analysis extracted IL28B TT and RVR as independent factors associated with SVR. Adverse effects resulted in treatment discontinuation by 12.5% in each group. Hemoglobin decrease significantly differed between groups A and B: the decrease to ≤100 g/L, to 85 - <100g/L, and to <85 g/L, was 9.4%, 40.6%, and 50% in group A patients, respectively, and 41.1%, 25%, and 33.9% in group B patients, respectively (p=0.0006).

Conclusions: TVR-based triple therapy can be successfully used to treat older patients with genotype 1b chronic hepatitis C.

Keywords: ALT; AST; Chronic hepatitis C; DAA; EOT; HCC; HCV; IL28B; ITPA; KULDS; NS3/4A; Older patients; PCR; PegIFN-α; Pegylated interferon α; RBV; RVR; Ribavirin; SNP; SVR; TVR; Telaprevir; The Kyushu University Liver Disease Study; alanine aminotransferase; aspartate aminotransferase; cEVR; complete early virological response; direct-acting antiviral agent; eGFR; end-of-treatment response; estimated glomerular filtration rate; hepatitis C virus; hepatocellular carcinoma; inosine triphosphate pyrophosphatase; interleukin 28B; non-structural 3/4A; pegylated interferon α; polymerase chain reaction; rapid virological response; ribavirin; single-nucleotide polymorphism; sustained virological response; telaprevir; γ-glutamyl-transpeptidase; γGTP.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / adverse effects
  • Drug Therapy, Combination
  • Female
  • Genotype
  • Hepacivirus / classification
  • Hepacivirus / drug effects*
  • Hepacivirus / genetics*
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / virology*
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / administration & dosage
  • Interferon-alpha / adverse effects
  • Male
  • Middle Aged
  • Oligopeptides / administration & dosage*
  • Oligopeptides / adverse effects
  • Polyethylene Glycols / administration & dosage
  • Polyethylene Glycols / adverse effects
  • Prospective Studies
  • RNA, Viral / blood
  • RNA, Viral / genetics
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Ribavirin / administration & dosage
  • Ribavirin / adverse effects
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • Oligopeptides
  • RNA, Viral
  • Recombinant Proteins
  • Polyethylene Glycols
  • Ribavirin
  • telaprevir
  • peginterferon alfa-2b