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

Publisher: Blackwell Science Country of Publication: Australia NLM ID: 9615568 Publication Model: Print Cited Medium: Internet ISSN: 1440-1797 (Electronic) Linking ISSN: 13205358 NLM ISO Abbreviation: Nephrology (Carlton) Subsets: MEDLINE

Original Publication: Carlton, Vic., Australia : Blackwell Science,

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

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.
(© 2017 Asian Pacific Society of Nephrology.)

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

0 (Anilides)
0 (Antiviral Agents)
0 (Carbamates)
0 (Cyclopropanes)
0 (Drug Combinations)
0 (Lactams, Macrocyclic)
0 (Macrocyclic Compounds)
0 (RNA, Viral)
0 (Sulfonamides)
2302768XJ8 (ombitasvir)
9DLQ4CIU6V (Proline)
HG18B9YRS7 (Valine)
O3J8G9O825 (Ritonavir)
OU2YM37K86 (paritaprevir)

Date Created: 20170617 Date Completed: 20180509 Latest Revision: 20211204

20221213

10.1111/nep.13011

28621007