Evaluation of RIBAvirin Plasma COncentrations in Patients With Chronic Hepatitis C Infection Routinely Treated With Modern DAA Regimens
NCT ID: NCT02505243
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
252 participants
OBSERVATIONAL
2015-06-30
2016-06-30
Brief Summary
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Detailed Description
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Chronic HCV infection is treated with combination therapy, therefore manufacturers developed combination tablets such as Gilead's Harvoni (ledipasvir + sofosbuvir) and Abbvie's 3D combination (paritaprevir, ombitasvir, dasabuvir and ritonavir). Possibly, RBV will be added to these regimes in the future when the patient is a prior null responder or suffering from cirrhosis.
As RBV is a guanine analogue it is not specific for HCV and some severe adverse effects are known. The most important adverse effect is haemolytic anaemia,which usually occurs during the first weeks of treatment (\>10% of the treated patients, depending on co-medication). Other adverse reactions that were frequently reported were: neutropenia, anorexia, depression/insomnia, headache, dizziness, dyspnea, and cough 5.
In dual (PEG-IFN + RBV) HCV therapy RBV concentrations were associated with efficacy and toxicity. Also in former studies in HCV-infected patients treated with telaprevir (TVR) or boceprevir (BOC) in combination with PEG-IFN, the plasma concentration of RBV was associated with Sustained Virologic Response (SVR) and anaemia (defined as Hb\<8,5 g/dL). We have tried to determine an optimal therapeutic range for RBV when combined with these DAAs. The plasma concentration of RBV at week 8 should be 2.2-5.3 mg/L in combination with TVR. 48% of the HCV patients in the cohort had these plasma concentrations of which 81% achieved SVR and 5.2% reported anaemia. In combination with BOC the plasma concentration should be 2.2-3.6 mg/L, 50% of patients had these concentrations. In this group 69% of patients achieved SVR and 46% anaemia. So, for these therapies, therapeutic ranges for RBV could be defined for the optimal SVR rates and the lowest incidence of anaemia 6, 7.
As TVR and BOC have now been replaced by novel DAAs, we would like to investigate this described relationship between RBV concentrations, SVR and anaemia also with the newer DAAs that were licensed in the last year (simeprevir and sofosbuvir) and that are going to be available in 2015 in The Netherlands (daclatasvir, Harvoni, Abbvie 3D combo).
The aim of this study is to evaluate RBV plasma concentrations when used in combination with newly developed DAA combinations. If possible, its correlations with SVR rates and incidence of anaemia will be assessed in HCV-patients.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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HCV patients
HCV patients treated with direct acting antivirals and ribavirin
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient must be treated with ribavirin. The dosage of ribavirin may vary, as the different centers have different protocols for RBV dosing.
* Patient must be treated with one or more DAAs (simeprevir, sofosbuvir, daclatasvir, ledipasvir, paritaprevir, ombitasvir, or dasabuvir).
* At least 18 years of age at start of treatment.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
University Medical Center Groningen
OTHER
UMC Utrecht
OTHER
Maastricht University Medical Center
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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David Burder, PharmdD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands
Countries
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References
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van Tilborg M, Lieveld FI, Smolders EJ, van Erpecum KJ, de Kanter CTMM, Maan R, van der Valk M, Arends JE, Dofferhoff ASM, Blokzijl H, Bijmolen M, Drenth JPH, de Knegt RJ, Burger DM; HepNed Study Group. Ribavirin steady-state plasma level is a predictor of sustained virological response in hepatitis C-infected patients treated with direct-acting antivirals. Aliment Pharmacol Ther. 2017 Nov;46(9):864-872. doi: 10.1111/apt.14288. Epub 2017 Sep 7.
Other Identifiers
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UMCN-AKF-15.03
Identifier Type: -
Identifier Source: org_study_id