Safety, Tolerability, and Pharmacokinetics of Ribavirin in Hepatitis C Virus-Infected Patients with Various Degrees of Renal Impairment

Brennan, Barbara J.; Wang, K.; Blotner, Steve; Magnusson, Martin H.; Wilkins, Justin; Martin, Paul; Solsky, Jonathan; Nieforth, Keith; Wat, Cynthia; Grippo, Joseph F.

doi:10.1128/aac.00608-13

Cited by 25 publications

(26 citation statements)

References 23 publications

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“…Jin and colleagues (27) did not assess CrCL because 85% of the participants had normal renal function, and decrements were generally mild in those outside the reference range. Our finding of an influence of CrCL is not unexpected, given the known effect of renal impairment on the pharmacokinetics of ribavirin, a renally cleared compound (28)(29)(30).…”

Section: Discussionsupporting

confidence: 55%

Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies

Mensing

Polepally

König

et al. 2015

AAPS J

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Abstract. Direct-acting antiviral agents (DAAs) are established as the standard of care for chronic hepatitis C virus (HCV) infection. One of the newest additions to the HCV arsenal is an oral three-DAA combination therapy (i.e., the 3D regimen) that does not require concomitant use of pegylated interferon. The clinical development program for the 3D regimen has yielded a robust dataset that is inclusive of various dosing schemes and a diverse patient population. Using data from nine phase 1b/2a/ 2b studies that enrolled patients with HCV genotype 1 infection, population pharmacokinetic models were developed for each component of the 3D regimen (ombitasvir, paritaprevir, ritonavir, and dasabuvir) and for ribavirin, an adjunctive therapy used to enhance therapeutic efficacy in some populations. Formulation effects, accumulation, relative bioavailability, and interactions between DAAs were assessed during model development, and demographic and clinical covariates were identified and evaluated for their effects on drug exposures. Proposed models were assessed via goodness-of-fit plots, visual predictive checks, and bootstrap evaluations. Population pharmacokinetic models adequately described their respective plasma concentration-time data with precise and reliable model parameter estimates and with good predictive performance. Covariates, including age, sex, body weight, cytochrome P450 2C8 inhibitor use, non-Hispanic ethnicity, and creatinine clearance, were associated with apparent clearance and/or apparent volume parameters; however, the magnitude of effect on drug exposure was modest and not considered to be clinically significant. No patient-related or clinical parameters were identified that would necessitate dose adjustment of the 3D regimen in patients with HCV genotype 1 infection.

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Section: Discussionsupporting

confidence: 55%

Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies

Mensing

Polepally

König

et al. 2015

AAPS J

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“…Additionally, certain populations are at increased risk of both diseases, including those with human immunodeficiency virus (HIV) and those who engage in intravenous drug use [17] . The presence of both HCV and CKD can make treatment difficult [11,18,19] due to tolerance and exacerbations associated with certain treatments [20,21] .…”

mentioning

confidence: 99%

Impact of Renal Disease on Patients with Hepatitis C: A Retrospective Analysis of Disease Burden, Clinical Outcomes, and Health Care Utilization and Cost

Solid

Peter

Natwick

et al. 2017

Nephron

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Background/Aims: Few studies explore the magnitude of the disease burden and health care utilization imposed by renal disease among patients with hepatitis C virus (HCV). We aimed to describe the characteristics, outcomes, and health care utilization and costs of patients with HCV with and without renal impairment. Methods: This retrospective analysis used 2 administrative claims databases: the US commercially insured population in Truven Health MarketScan® data (aged 20-64 years), and the US Medicare fee-for-service population in the Medicare 20% sample (aged ≥65 years). Baseline characteristics and comorbid conditions were identified from claims during 2011; patients were followed for up to 1 year (beginning January 1, 2012) to identify health outcomes of interest and health care utilization and costs. Results: In the MarketScan and Medicare databases, 35,965 and 10,608 patients with HCV were identified, 8.5 and 26.5% with evidence of renal disease (chronic kidney disease [CKD] or end-stage renal disease [ESRD]). Most comorbid conditions and unadjusted outcome rates increased across groups from patients with no evidence of renal disease to non-ESRD CKD to ESRD. Health care utilization followed a similar pattern, as did the costs. Conclusions: Our findings suggest that HCV patients with concurrent renal disease have significantly more comorbidity, a higher likelihood of negative health outcomes, and higher health care utilization and costs.

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“…Impaired renal clearance increases the potential risk of ribavirin-induced hemolytic anemia [22] . Because of the distribution of RBV occurs mainly outside the plasma [primarily intracellular], since a very small amount of the drug in the body is available to be eliminated by dialysis [23] . Safety and efficacy of the RBV-free regimen ombitasvir/ paritaprevir/ ritonavir ± dasabuvir in patients with ESRD [on hemodialysis] with HCV genotype 1a or 4 studied in RUBY-II clinical trial, which enrolled 18 treatment-naïve and non-cirrhotic adults patients.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Ombitasvir/Paritaprevir/Ritonavir plus Ribavirin in Treatment of Chronic Hepatitis C Patients with End Stage Renal Disease on Regular Hemodialysis

Elgendy

El-Raey

Nassib

et al. 2020

International Journal of Medical Arts

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Background: Hepatitis C virus [HCV] infection is associated with more significant morbidity and mortality among dialysis patients than in healthy populations. The fixed-dose tablet [ombitasvir/ paritaprevir/ritonavir] in combination with ribavirin was effective and generally well tolerated in treatment of chronic HCV infected patients with end stage renal disease [ESRD] on hemodialysis. However, limited published data are known about the usefulness of this regimen for treatment of HCV patients with ESRD on hemodialysis. Aim of the work: The aim of this study was to evaluate the safety and efficacy of treatment regimen of ombitasvir [OBV] 25 mg /paritaprevir [PTV] 150 mg /ritonavir [RTV] 100 mg plus generic ribavirin [RBV] 200 mg in Egyptian HCV-infected naive patients with ESRD on regular hemodialysis. Patients and methods: A prospective cohort study involved 40 chronic HCV on regular hemodialysis patients, who were eligible for treatment with combined oral antiviral therapy. Results: The results showed that thirty-five patients [35/40[87.5%]] completed 12 weeks of HCV therapy; they had a virological response at end of therapy and sustained virological response. Anemia was the main observed side effect which lead to discontinuation of the treatment in five patients [12.2%]. As these patients were not responding to anemia correction measures [blood transfusion, erythropoietin-stimulating agents, and modification of RBV dose]. Conclusion: OBV/PTV/RTV plus Ribavirin can be used in treatment of chronic HCV patients with ESRD on regular hemodialysis. This is an open access article under the Creative Commons license [CC BY] [https://creativecommons.org/licenses/by/2.0/] Please cite this article as El-Gendy NA, EL-Raey FM, Nassibi SA, Elsadany N. Efficacy of Ombitasvir/Paritaprevir/Ritonavir plus Ribavirin in Treatment of Chronic Hepatitis C Patients with End Stage Renal Disease on Regular Hemodialysis. IJMA 2020; 2[1]: 313-319.

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Safety, Tolerability, and Pharmacokinetics of Ribavirin in Hepatitis C Virus-Infected Patients with Various Degrees of Renal Impairment

Cited by 25 publications

References 23 publications

Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies

Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies

Impact of Renal Disease on Patients with Hepatitis C: A Retrospective Analysis of Disease Burden, Clinical Outcomes, and Health Care Utilization and Cost

Efficacy of Ombitasvir/Paritaprevir/Ritonavir plus Ribavirin in Treatment of Chronic Hepatitis C Patients with End Stage Renal Disease on Regular Hemodialysis

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