Course of hepatitis C virus (HCV) RNA and HCV core antigen testing are predictors for reaching sustained virologic response in liver transplant recipients undergoing sofosbuvir treatment in a real-life setting

Transpl Infect Dis. 2016 Feb;18(1):141-5. doi: 10.1111/tid.12475. Epub 2016 Jan 30.

Abstract

Background: Hepatitis C virus (HCV) infection is associated with reduced graft survival in orthotopic liver transplant recipients. Treatment with the new direct-acting antivirals (DAAs) is safe and efficient, but no reliable predictive factors for sustained virologic response (SVR) have been identified so far. The HCV core antigen assay (HCV-core-Ag) is a new, inexpensive, and efficient method to detect viral antigens, but the value of this technique to predict treatment response in orthotopic liver transplantation (OLT) patients is still unclear.

Methods: All OLT patients who were treated with a sofosbuvir-based antiviral regimen at our center between March 2014 and August 2014 were included in the analysis (n = 20). HCV-core-Ag and HCV RNA (polymerase chain reaction [PCR]) were determined at each visit. Primary endpoints of this study were SVR at 4 or 12 weeks after end of treatment (SVR 4 and SVR 12).

Results: HCV-core-Ag tested negative after a median of 2 weeks (range 1-16 weeks) while PCR tests became negative after a median of 4 weeks (range 2-12 weeks). Time until PCR negativity and until HCV-core-Ag negativity showed a good correlation (R = 0.711, P < 0.001, Fig. ). Seventeen of 20 patients (85%) achieved SVR 12. SVR 12 was associated with a short time interval between treatment start and HCV PCR negativity (P = 0.005) or HCV-core-Ag negativity (P = 0.003, Mann-Whitney test). No severe side effects were observed.

Conclusions: DAA treatment is safe and well tolerated in OLT. The time points of HCV-core-Ag loss and PCR negativity were predictors of SVR 12.

Keywords: DAA; HCV; PCR; core antigen.

MeSH terms

  • Adult
  • Aged
  • Antiviral Agents / therapeutic use*
  • Cohort Studies
  • Female
  • Hepacivirus / genetics
  • Hepacivirus / isolation & purification*
  • Hepatitis C / drug therapy*
  • Hepatitis C / virology
  • Humans
  • Liver Transplantation / adverse effects*
  • Male
  • Middle Aged
  • RNA, Viral / blood
  • Ribavirin / therapeutic use
  • Sofosbuvir / therapeutic use*
  • Viral Core Proteins / blood
  • Viral Load

Substances

  • Antiviral Agents
  • RNA, Viral
  • Viral Core Proteins
  • Ribavirin
  • Sofosbuvir