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.

Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir Regimen in Haemodialysis Patients With Hepatitis C Virus Infection

“…None of the patients discontinued treatment prematurely. The SVR rate in our group of patients is consistent with the results reported by other authors [18][19][20] . In the RUBY-I study, the achieved overall SVR rate was 90% (intentto-treat 95%) in CKD4 and CKD5, genotype 1 infected patients.…”

Safety and efficacy of direct-acting antivirals for chronic hepatitis C in patients with chronic kidney disease

“…The development of DAAs has enlarged therapeutic options in patients with severe CKD and replacement of kidney function. Several studies have reported the safety and efficacy of paritaprevir/ ombitasvir/ ritonavir and dasabuvir for genotype 1b chronic hepatitis C patients undergoing dialysis due to ESRD [41][42][43][44]. In our study, all patients with hemodialysis completed the antiviral therapy, achieving SVR, with no severe reactions noted.…”

Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir Regimen in the Treatment of Genotype 1 Chronic Hepatitis C Infection in Patients with Severe Renal Impairment and End-Stage Renal Disease: a Real-Life Cohort

“…The high antiviral efficacy and favourable safety profile of PrOD was also demonstrated in patients with severe renal impairment as well as in patients on maintenance haemodialysis infected with HCV genotype 1 (95% SVR rate) in a prospective registration trial [13]. Recently published real-world cohort studies showed similar data on PrOD efficacy, safety, and tolerability in haemodialysed patients [14-17]. A substantial number of drug-drug interactions represents the only limitation of PrOD regimen [18].…”