title: Combination Therapy with Ombitasvir/Paritaprevir/Ritonavir for Dialysis Patients Infected with Hepatitis C Virus: A Prospective Multi-Institutional Study.
abstract: Hepatitis C virus (HCV) infection is common in dialysis patients worldwide and nosocomial HCV spread within dialysis facilities continues to develop. Combination therapy with daclatasvir and asunaprevir (DCV/ASV) that has proven efficacy for dialysis patients infected with genotype 1b HCV (HCV/1b) has several concerns in Japan. The recently available combination therapy with ombitasvir, paritaprevir, and ritonavir (OBV/PTV/r) is not contraindicated in patients with chronic renal failure and has more safety profile and shorter treatment period than that with DCV/ASV. We evaluated the effects of combination therapy with OBV/PTV/r in four dialysis patients infected with HCV/1b, who were eligible for our study. On-treatment assessments included standard laboratory testing, serum HCV RNA and symptom-directed physical examinations. Three patients had a sustained virological response at 12 weeks after treatment, but one remaining patient had viral breakthrough. Notably, the patient with viral breakthrough had been coinfected with HCV/1b and HCV/2b; namely, HCV/2b with resistance-associated variations was not eradicated by the combination therapy. Among the three patients responsive to the combination therapy, one patient complained of appetite loss and itching, while in another patient the therapy was discontinued due to itching, exacerbation of wamble, and a falling tendency probably due to interaction with valsartan. These AEs were ameliorated or disappeared after the completion of the therapy. The significance of our study is persuasive virological evaluation associated to the combination therapy and reasonable interpretation of AEs. In conclusion, combination therapy with OBV/PTV/r may have promise as an efficacious therapy, but caution regarding AEs should be practiced.
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine.
authors.forename: Ken
authors.initials: K
authors.lastname: Sato
authors.forename: Kenichi
authors.initials: K
authors.lastname: Hosonuma
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Yamazaki
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Takakusagi
authors.forename: Norio
authors.initials: N
authors.lastname: Horiguchi
authors.forename: Satoru
authors.initials: S
authors.lastname: Kakizaki
authors.forename: Motoyasu
authors.initials: M
authors.lastname: Kusano
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ohnishi
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Okamoto
authors.forename: Masanobu
authors.initials: M
authors.lastname: Yamada
mesh_terms: D000368:Aged; D000813:Anilides / Q000494:pharmacology / Q000627:therapeutic use*; D002219:Carbamates / Q000494:pharmacology / Q000627:therapeutic use*; D003521:Cyclopropanes; D003710:Demography; D018450:Disease Progression; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics / Q000502:physiology*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011392:Proline / Q000031:analogs & derivatives; D006435:Renal Dialysis; D019438:Ritonavir / Q000494:pharmacology / Q000627:therapeutic use*; D013449:Sulfonamides; D014633:Valine
chemical_list: D000813:Anilides; D002219:Carbamates; D003521:Cyclopropanes; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds; D013449:Sulfonamides; C586094:ombitasvir; D011392:Proline; D014633:Valine; D019438:Ritonavir; C585405:paritaprevir