Electrophysiological Adverse Effects of Direct-Acting Antivirals in Patients With Chronic Hepatitis C.

IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Journal of clinical pharmacology Pub Date : 2017-07-01 Epub Date: 2017-05-03 DOI:10.1002/jcph.905
Roberto Rossotti, Lucio Jesus Garcia-Fraile Fraile, Chiara Baiguera, Massimo Puoti
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Abstract

Dear Editor, We read with great interest the article by DuranteMangoni et al.1 Sofosbuvir (SOF) has recently been correlated with bradyarrhythmias, especially if coadministered with amiodarone. In this study, DuranteMangoni et al assessed several electrocardiographic (ECG) parameters in 26 subjects who were consecutively treated with various SOF-based regimens. They did not observe significant changes in ECG parameters except a transient increase of QTc duration during the first week that returned to baseline values afterward. In contrast to what was reported by Renet et al2 and Fontaine et al,3 the authors concluded that SOF-based regimens could be considered safe. HIV/HCV coinfected patients are often treated with methadone and antiretrovirals, such as atazanavir and rilpivirine, which have an effect on QTc duration. Thus, we performed a similar evaluation of ECG parameters in 58 coinfected individuals treated with different SOFbased regimens from January 2015 to July 2016. ECG parameters were prospectively collected at baseline, after 1 and 4 weeks, and at the end of therapy. Compared to the study by Durante-Mangoni and colleagues, our population is larger and has several differences, especially in terms of liver fibrosis severity (Table 1). In the overall analysis, QTc duration did not change significantly over treatment (P= .31). Patients receiving atazanavir or rilpivirine had stable QTc intervals during treatment. No difference was noted for any directacting antiviral combination. At baseline, F3 (defined by a stiffness between 10 and 14 kPa) and cirrhotic subjects had comparable QTc values (408 milliseconds vs 422 milliseconds for F4 [defined by a stiffness >14 kPa] overall, 421 milliseconds for Child-Pugh-Turcotte class [CPT] A and 425 for CPT B/C), but such difference was not significant (P = .16). At week 4, F3 individuals maintained the same QTc value (407 milliseconds), but F4 patients had a slight increase to 424 milliseconds (P = 0.01). If we consider F3, CPT A (423 milliseconds), and CPT B/C Table 1. Baseline Features of Study Population
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来源期刊
CiteScore
5.10
自引率
3.40%
发文量
176
审稿时长
2 months
期刊介绍: The Journal of Clinical Pharmacology (JCP) is a Human Pharmacology journal designed to provide physicians, pharmacists, research scientists, regulatory scientists, drug developers and academic colleagues a forum to present research in all aspects of Clinical Pharmacology. This includes original research in pharmacokinetics, pharmacogenetics/pharmacogenomics, pharmacometrics, physiologic based pharmacokinetic modeling, drug interactions, therapeutic drug monitoring, regulatory sciences (including unique methods of data analysis), special population studies, drug development, pharmacovigilance, womens’ health, pediatric pharmacology, and pharmacodynamics. Additionally, JCP publishes review articles, commentaries and educational manuscripts. The Journal also serves as an instrument to disseminate Public Policy statements from the American College of Clinical Pharmacology.
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