Universal Sustained Viral Response to the Combination of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with/without Ribavirin in Patients on Hemodialysis Infected with Hepatitis C Virus Genotypes 1 and 4

Abstract

Background: Hepatitis C virus (HCV) infection is highly prevalent among patients on hemodialysis (HD) and is associated with poor prognosis. Treatment with interferon and ribavirin is poorly tolerated, and few data are available on the impact of new direct-acting antivirals (DAAs). This study was intended to analyze the efficacy and safety of treatment with a combination of ombitasvir/paritaprevir/ritonavir and dasabuvir with/without ribavirin in HCV-infected patients on HD from 3 hospitals. Methods: This is a multicentric study. We analyze the clinical course of all patients on HD with HCV infection who had been treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir in 3 hospitals in Madrid, Spain. All patients under treatment had undergone Transient elastography (FibroScan®) and HCV RNA (PCR) and HCV genotype were determined simultaneously. Results: Thirty-five patients aged 53.3 ± 8.9 years (68.6% males) and with genotypes 1 and 4 were treated with the DAA regimen, and 17 were also given ribavirin. The most common etiology was glomerular disease. Sustained viral response was achieved in 100% of patients. Adverse effects were negligible, and no patient had to discontinue treatment. The most significant side effect was anemia, which led to a significant increase in the dose of erythropoiesis-stimulating agents. Anemia was more marked in patients receiving ribavirin. No patients required transfusions. Conclusion: A combination of ombitasvir/paritaprevir/ritonavir and dasabuvir with/without ribavirin for the treatment of HCV in patients on HD is highly effective and causes minimal side effects. This regimen represents a major advance in disease management. A considerable improvement in prognosis seems likely.

Paritaprevir/ritonavir, ombitasvir plus dasabuvir for East Asian non‐cirrhotic hepatitis C virus genotype 1b patients receiving hemodialysis

“…Our study showed that the SVR 12 rate of PrOD for 12 weeks was excellent (100%) for East Asian HCV GT1b non-cirrhotic patients receiving hemodialysis and was comparable with the response rates in clinical trials and real-world studies. 14,[17][18][19][20] The SVR 12 rate in our study was 36% higher than the response rate of 64% by pegylated IFN/RBV therapy. Based on the excellent efficacy, applying PrOD would be a preferred choice for treating East Asian HCV GT1b non-cirrhotic patients receiving hemodialysis.…”

“…Following the clinical trials that demonstrated the excellent efficacy and safety profiles, the real-world effectiveness of PrOD in HCV GT1 patients receiving hemodialysis from Spain, Czech Republic, and Saudi Arabia showed that the SVR 12 rates ranged from 96% to 100%. [17][18][19][20] However, data regarding the efficacy and safety of PrOD for HCV GT1b patients receiving hemodialysis are lacking in East Asia, where HCV GT1b infection is prevalent. We aimed to conduct a clinical trial to assess the performance of PrOD for 12 weeks in HCV GT1b non-cirrhotic patients receiving hemodialysis in Taiwan.…”

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

“…Similar SVR rates (excellent or absolute) were described in two real-life cohorts of haemodialysed patients: the SVR rate in the study by Muñoz-Gómez et al [15] was 95.7%, where 2 out of 46 patients discontinued treatment for non-virological reasons, but the analysis evaluated patients infected with genotypes 1 and 4 together. Abad et al [14] achieved an absolute SVR rate in a group of 35 haemodialysed patients infected with genotypes 1 and 4. The explanation for the 100% SVR rate in our group of patients may be due to our patients being predominantly infected with HCV subtype 1b (20 of 23, 87%).…”

“…Anaemia was the most common AE in the RUBY-I study, and RBV was interrupted in 9 out of 13 HCV subtype 1a patients to whom RBV was administered [13]. In the study by Muñoz-Gómez et al [15], 16 out of 27 patients receiving ESA (10 of them treated with RBV), and in the study by Abad et al [14], 15 out of 28 patients receiving ESA needed an increase of the ESA dose. We assume that the reduced RBV dose was the reason for different AEs profile in our cohort of patients.…”

“…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].…”