Effectiveness of a fixed combination formula of ombitasvir/paritaprevir/ritonavir for hepatitis C virus infection in patients on maintenance haemodialysis

Nephrology (Carlton). 2017 Jul;22(7):562-565. doi: 10.1111/nep.13011.

Abstract

A fixed-dose formula that combines Ombitasvir (OBV), Paritaprevir (PTV) and Ritonavir (RTV) has been launched into the field of anti-HCV therapy in Japan for patients infected with HCV genotypes 1 and 2 in 2015. However, little is yet known as to the efficacy and safety of this novel therapy in patients on maintenance haemodialysis (HD). The present report describes a preliminary experience in 10 patients (five males and five females) who underwent maintenance HD. All of them had HCV genotype 1b, without having the resistance-associated variants at Y93 or L31 in the nonstructural proteins 5A (NS5A) region. After the treatment, eight patients successfully achieved virus eradication and sustained a virological response at 12 weeks (SVR12). In addition, mac-2 binding protein glycosylation isomer (M2BPGi), a biomarker for liver fibrosis, was reduced after the therapy. Two patients withdrew from the therapy due to the development of erythema multiforme and a strong drowsiness, respectively. These results suggest that triple therapy combining OBV, PTV and RTV is effective in achieving SVR12 in most of the HCV-infected patients on HD. In addition, this combination therapy contributed to retard the progression of liver fibrosis. However, we suggest that further trial will be required to establish its clinical efficacy and safety.

Keywords: haemodialysis; hepatitis C virus; ombitasvir; paritaprevir; ritonavir.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anilides / adverse effects
  • Anilides / therapeutic use*
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Carbamates / adverse effects
  • Carbamates / therapeutic use*
  • Cyclopropanes
  • Disease Progression
  • Drug Combinations
  • Drug Compounding
  • Female
  • Genotype
  • Hepacivirus / drug effects*
  • Hepacivirus / genetics
  • Hepatitis C / complications
  • Hepatitis C / diagnosis
  • Hepatitis C / drug therapy*
  • Hepatitis C / virology
  • Humans
  • Japan
  • Lactams, Macrocyclic
  • Liver Cirrhosis / diagnosis
  • Liver Cirrhosis / drug therapy
  • Liver Cirrhosis / virology
  • Macrocyclic Compounds / adverse effects
  • Macrocyclic Compounds / therapeutic use*
  • Male
  • Middle Aged
  • Proline / analogs & derivatives
  • RNA, Viral / genetics
  • Renal Dialysis* / adverse effects
  • Renal Insufficiency, Chronic / complications
  • Renal Insufficiency, Chronic / diagnosis
  • Renal Insufficiency, Chronic / therapy*
  • Ritonavir / adverse effects
  • Ritonavir / therapeutic use*
  • Sulfonamides
  • Sustained Virologic Response
  • Time Factors
  • Treatment Outcome
  • Valine
  • Viral Load

Substances

  • Anilides
  • Antiviral Agents
  • Carbamates
  • Cyclopropanes
  • Drug Combinations
  • Lactams, Macrocyclic
  • Macrocyclic Compounds
  • RNA, Viral
  • Sulfonamides
  • ombitasvir
  • Proline
  • Valine
  • Ritonavir
  • paritaprevir