Randomized Trial Evaluating the Impact of Ribavirin Mono-Therapy and Double Dosing on Viral Kinetics, Ribavirin Pharmacokinetics and Anemia in Hepatitis C Virus Genotype 1 Infection

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Waldenstrom , J , Westin , J , Nystrom , K , Christensen , P , Dalgard , O , Farkkila , M , Lindahl , K , Nilsson , S , Norkrans , G , Krarup , H , Norrgren , H , Buhl , M R , Stenmark , S & Lagging , M 2016 , ' Randomized Trial Evaluating the Impact of Ribavirin Mono-Therapy and Double Dosing on Viral Kinetics, Ribavirin Pharmacokinetics and Anemia in Hepatitis C Virus Genotype 1 Infection ' , PLoS One , vol. 11 , no. 5 , 0155142 . https://doi.org/10.1371/journal.pone.0155142

Title: Randomized Trial Evaluating the Impact of Ribavirin Mono-Therapy and Double Dosing on Viral Kinetics, Ribavirin Pharmacokinetics and Anemia in Hepatitis C Virus Genotype 1 Infection
Author: Waldenstrom, Jesper; Westin, Johan; Nystrom, Kristina; Christensen, Peer; Dalgard, Olav; Farkkila, Martti; Lindahl, Karin; Nilsson, Staffan; Norkrans, Gunnar; Krarup, Henrik; Norrgren, Hans; Buhl, Mads Rauning; Stenmark, Stephan; Lagging, Martin
Contributor: University of Helsinki, Clinicum
Date: 2016-05-11
Language: eng
Number of pages: 18
Belongs to series: PLoS One
ISSN: 1932-6203
URI: http://hdl.handle.net/10138/164632
Abstract: In this pilot study (RibaC), 58 hepatitis C virus (HCV) genotype 1 infected treatment-naive patients were randomized to (i) 2 weeks ribavirin double dosing concomitant with pegylated interferon-alpha (pegIFN-alpha), (ii) 4 weeks ribavirin mono-therapy prior to adding pegIFN-alpha, or (iii) standard-of-care (SOC) ribavirin dosing concurrent with pegIFN-alpha. Four weeks of ribavirin mono-therapy resulted in a mean 0.46 log(10) IU/mL HCV RNA reduction differentially regulated across IL28B genotypes (0.89 vs. 0.21 log(10) IU/mL for CC and CT/TT respectively; P = 0.006), increased likelihood of undetectable HCV RNA week 4 after initiating pegIFN-alpha and thus shortened treatment duration (P <0.05), and decreased median IP-10 concentration from 550 to 345 pg/mL (P <0.001). Both experimental strategies impacted on ribavirin concentrations, and high levels were achieved after one week of double dosing. However, by day 14, double dosing entailed a greater hemoglobin decline as compared to SOC (2.2 vs. 1.4 g/dL; P = 0.03). Conclusion: Ribavirin down-regulates IP-10, and may have an antiviral effect differently regulated across IL28B genotypes.
Subject: SUSTAINED VIROLOGICAL RESPONSE
RESISTANCE-ASSOCIATED VARIANTS
TREATMENT-NAIVE PATIENTS
INTERFERON-FREE THERAPY
SPONTANEOUS CLEARANCE
GENETIC-VARIATION
PLUS SOFOSBUVIR
IP-10 PREDICTS
HCV
COMBINATION
3121 Internal medicine
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