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P-6 SOFOSBUVIR CONTAINING REGIMENS ARE SAFE AND EFFECTIVE IN ADOLESCENTS WITH CHRONIC HEPATITIS C INFECTION
Stefan Wirth1, Regino Gonzalez-Peralta2, Philip Rosenthal3, Winita Hardikar4, Jessica Wen5, Maureen M. Jonas6, Naveen Mittal7, Mary Whitworth8, Ronen Arnon9, Chuan-Hao Lin10, Yury Lobzin11, Rene Romero12, Vladimir Chulanov13, Girish Subbarao14, Jeffrey Teckman15, Vyacheslav Morozov16, Eric Bassetti17,*, Kathryn Kersey17, Benedetta Massetto17, Yanni Zhu17..., Polina German17, Diana M. Brainard17, Sanjay Bansal18, Karen F. Murray19, Kathleen Schwarz20, William Balistreri21Ver más
1 Helios Medical Center, Witten/Herdecke University, Wuppertal, Germany
2 Gonzalez Peralta Regino, University of Florida, Gainesville, FL, USA
3 Rosenthal Philip, University of California San Francisco, San Francisco, CA, USA
4 The Royal Children's Hospital Melbourne, VIC, Australia
5 The Children's Hospital of Philadelphia, Philadelphia, PA, USA
6 Boston Children's Hospital, Boston, MA, USA
7 UTHSCSA, SA, Texas, USA
8 Cook Children's Health Care System, Fort Worth, TX, USA
9 Mount Sinai Medical Center, New York, USA
10 Children's Hospital Los Angeles, Los Angeles, CA, USA
11 Research Institute of Children's Infections, Federal Biomedical Agency of Russia, Saint Petersburg, Russia
12 Children's Healthcare of Atlanta and Emory University, Atlanta, USA
13 Central Scientific-Research Institute of Epidemiology, Moscow, Russia
14 Riley Hospital for Children at IU Health, Indianapolis, USA
15 Saint Louis University, Cardinal Glennon Children's Medical Center, St Louis, MO, USA
16 Medical State University, Samara, Russia
17 Gilead Sciences, Foster City, CA, USA
18 Kings College Hospital, London, UK
19 Seattle Children's Hospital, Seattle, WA, USA
20 Johns Hopkins University School of Medicine, Baltimore, MD, US
21 Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
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        "resumen" => "<span id="abss0001_100366_6" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0001_100366_6">Background</span><p id="spara001_100366_6" class="elsevierStyleSimplePara elsevierViewall">HCV-specific DAAs have transformed treatment of chronic HCV&#44; but few studies have evaluated these therapies in children&#46;</p></span> <span id="abss0002_100366_6" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0002_100366_6">Methods</span><p id="spara002_100366_6" class="elsevierStyleSimplePara elsevierViewall">Patients aged 12&#8211;17 years old with chronic GT1 HCV were enrolled into an open-label study to receive 12 weeks of LDV&#47;SOF 90 mg&#47;400 mg once daily&#44; and those with HCV GT2 or GT3 to receive SOF &#40;400 mg once daily&#41;&#8239;&#43;&#8239;RBV &#40;15 mg&#47;kg&#47;day&#41; for 12 &#40;GT2&#41; or 24 weeks &#40;GT3&#41;&#44; respectively&#46; Primary efficacy endpoint was SVR12&#46; Safety was assessed by adverse events and clinical&#47;laboratory data&#46; Pharmacokinetic &#40;PK&#41; sampling was conducted to confirm the appropriateness of the doses&#46;</p></span> <span id="abss0003_100366_6" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0003_100366_6">Results</span><p id="spara003_100366_6" class="elsevierStyleSimplePara elsevierViewall">150 adolescents &#40;100 GT1&#44; 13 GT2 and 37 GT3&#41; were enrolled and treated&#46; The majority were female &#40;56&#37;&#41;&#44; white &#40;90&#37;&#41;&#44; treatment naive &#40;81&#37;&#41;&#44; and vertically infected &#40;80&#37;&#41;&#46; The mean age was 15 years &#40;range 12&#8211;17&#41;&#46; LDV&#44; SOF and GS-331007 &#40;primary metabolite&#41; exposures were within the range of adult exposures observed in the SOF and LDV&#47;SOF phase 2&#47;3 studies&#46; The SVR12 rate was 98&#37; in GT1&#44; 100&#37; in GT2 and 97&#37; in GT3&#59; all 3 patients who were considered not to have achieved SVR12 were lost to follow-up&#46; No adverse event &#40;AE&#41; leading to study drug discontinuation or serious AEs have been reported&#46;</p></span> <span id="abss0004_100366_6" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0004_100366_6">Conclusion</span><p id="spara004_100366_6" class="elsevierStyleSimplePara elsevierViewall">In adolescents&#44; LDV&#47;SOF for 12 weeks and SOF&#8239;&#43;&#8239;RBV for 12 or 24 weeks&#44; resulted in a SVR12 rate of 97&#8211;100&#37; with no virologic failures&#46; These regimens were well tolerated&#44; demonstrating their potential as an important treatment option for children with HCV infection&#46;</p></span>"
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Article information
ISSN: 16652681
Original language: English
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