Elbasvir/grazoprevir in women with hepatitis C virus infection taking oral contraceptives or hormone replacement therapy
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F19%3A00078737" target="_blank" >RIV/00023001:_____/19:00078737 - isvavai.cz</a>
Result on the web
<a href="https://www.dovepress.com/elbasvirgrazoprevir-in-women-with-hepatitis-c-virus-infection-taking-o-peer-reviewed-fulltext-article-IJWH" target="_blank" >https://www.dovepress.com/elbasvirgrazoprevir-in-women-with-hepatitis-c-virus-infection-taking-o-peer-reviewed-fulltext-article-IJWH</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.2147/IJWH.S203022" target="_blank" >10.2147/IJWH.S203022</a>
Alternative languages
Result language
angličtina
Original language name
Elbasvir/grazoprevir in women with hepatitis C virus infection taking oral contraceptives or hormone replacement therapy
Original language description
Introduction: Some direct-acting antiviral regimens for hepatitis C virus (HCV) infection pose safety or efficacy concerns if coadministered with drugs containing ethinyl estradiol. The present analysis was conducted to examine the impact of concomitant oral contraceptive pills (OCP) or hormone replacement therapy (HRT) during treatment with elbasvir (EBR)/grazo-previr (GZR) in women with HCV genotype (GT)1 or GT4 infection. Methods: This is a post hoc, integrated retrospective analysis of female participants with HCV GT1 or GT4 infection who received EBR 50 mg/GZR 100 mg once daily for 12 weeks in phase 2/3 clinical trials. The primary end point was sustained virologic response at 12 weeks after therapy completion (SVR12). For this analysis, participants were stratified according to whether they received OCP or HRT during the original treatment study. Results: A total of 1,022 women with HCV GT1 or GT4 infection were included (receiving OCP/HRT, n=81; not receiving OCP/HRT, n=941). Most participants receiving OCP/HRT were treatment-naive (79%), noncirrhotic (91.4%), and aged >35 years (71.6%). SVR12 rates were similar in women receiving OCP/HRT and those not receiving OCP/HRT (95.1% vs 96.3%). SVR12 rates remained high across all subgroups within the population receiving OCP/HRT: SVR12 rates were 94.6%, 100%, and 100% in participants with GT1a, GT1b, and GT4 infection, and all women aged 18–35 years achieved SVR (21/21). Treatment-related adverse events occurred in 40.7% (33/81) and 30.1% (283/941) of women receiving and those not receiving OCP/HRT, respectively. Conclusion: The efficacy and safety of EBR/GZR administered for 12 weeks was similar in women receiving OCP/HRT and those not on OCP/HRT. These data indicate that EBR/GZR can be safely used for the treatment of HCV GT1 or GT4 infection in women receiving concomitant OCP/HRT. © 2019 Hézode et al.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30214 - Obstetrics and gynaecology
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
International journal of women's health
ISSN
1179-1411
e-ISSN
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Volume of the periodical
11
Issue of the periodical within the volume
20 November
Country of publishing house
NZ - NEW ZEALAND
Number of pages
12
Pages from-to
617-628
UT code for WoS article
000503965000001
EID of the result in the Scopus database
2-s2.0-85075287330