Prevalence of resistance associated substitutions and efficacy of baseline resistance-guided chronic hepatitis C treatment in Spain from the GEHEP-004 cohort

PLoS One. 2019 Aug 30;14(8):e0221231. doi: 10.1371/journal.pone.0221231. eCollection 2019.

Abstract

Treatment guidelines differ in their recommendation to determine baseline resistance associated substitutions (RAS) before starting a first-line treatment with direct-acting antivirals (DAAs). Here we analyze the efficacy of DAA treatment with baseline RAS information. We conducted a prospective study involving 23 centers collaborating in the GEHEP-004 DAA resistance cohort. Baseline NS5A and NS3 RASs were studied by Sanger sequencing. After issuing a comprehensive resistance report, the treating physician decided the therapy, duration and ribavirin use. Sustained virological response (SVR12) data are available in 275 patients. Baseline NS5A RAS prevalence was between 4.3% and 26.8% according to genotype, and NS3 RASs prevalence (GT1a) was 6.3%. Overall, SVR12 was 97.8%. Amongst HCV-GT1a patients, 75.0% had >800,000 IU/ml and most of those that started grazoprevir/elbasvir were treated for 12 weeks. In genotype 3, NS5A Y93H was detected in 9 patients. 42.8% of the HCV-GT3 patients that started sofosbuvir/velpatasvir included ribavirin, although only 14.7% carried Y93H. The efficacy of baseline resistance-guided treatment in our cohort has been high across the most prevalent HCV genotypes in Spain. The duration of the grazoprevir/elbasvir treatment adhered mostly to AASLD/IDSA recommendations. In cirrhotic patients infected with GT-3 there has been a high use of ribavirin.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amides
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use
  • Benzofurans / therapeutic use
  • Carbamates
  • Cyclopropanes
  • Drug Resistance, Viral / genetics
  • Female
  • Genotype
  • Hepacivirus / genetics*
  • Hepacivirus / pathogenicity
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / epidemiology
  • Hepatitis C, Chronic / genetics
  • Hepatitis C, Chronic / virology
  • Humans
  • Imidazoles / therapeutic use
  • Male
  • Middle Aged
  • Mutation
  • Quinoxalines / therapeutic use
  • Ribavirin / therapeutic use
  • Sofosbuvir / therapeutic use
  • Spain / epidemiology
  • Sulfonamides
  • Sustained Virologic Response
  • Viral Nonstructural Proteins / genetics*

Substances

  • Amides
  • Antiviral Agents
  • Benzofurans
  • Carbamates
  • Cyclopropanes
  • Imidazoles
  • NS3 protein, hepatitis C virus
  • Quinoxalines
  • Sulfonamides
  • Viral Nonstructural Proteins
  • Ribavirin
  • grazoprevir
  • elbasvir
  • NS-5 protein, hepatitis C virus
  • Sofosbuvir

Associated data

  • figshare/10.6084/m9.figshare.8796359.v1

Grants and funding

This work was supported in part by grants from Fondo de Investigacion Sanitaria (www.isciii.es) (PI15/00713), Plan Nacional de I+D+I and Fondo Europeo de Desarrollo Regional-FEDER (http://www.ciencia.gob.es/portal/site/MICINN/menuitem.dbc68b34d11ccbd5d52ffeb801432ea0/?vgnextoid=e331aa27bfba7610VgnVCM1000001d04140aRCRD) (RD16/0025/0040), Fundacion Progreso y salud, Junta de Andalucia (https://www.sspa.juntadeandalucia.es/fundacionprogresoysalud/gestionconvocatorias/ugc/login.sol.jsp?id=10) (PI-0411-2014), and GEHEP-SEIMC (GEHEP-004).