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      Clinical utility of ledipasvir/sofosbuvir in the treatment of adolescents and children with hepatitis C

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          Abstract

          Chronic infection with hepatitis C virus (HCV) affects an estimated 0.1%–2% of the pediatric population in the United States. While the clinical course in young children is indolent, adolescents who contract HCV have a disease course similar to adults, with a 26-fold increased risk of chronic liver disease-associated mortality, hepatocellular carcinoma, and need for curative liver transplantation. Furthermore, adolescent patients are entering childbearing age and carry a risk of passing HCV to their offspring via vertical transmission. Pegylated-interferon (PEG-IFN) with ribavirin was previously the only treatment option for pediatric patients with chronic hepatitis C (CHC), but the high likelihood of adverse reactions and subcutaneous route of administration limited its use and efficacy. Recently, the direct-acting antivirals (DAAs) ledipasvir (LDV) and sofosbuvir (SOF) were approved for adolescents with CHC. This review discusses the natural history of CHC in pediatric patients, data supporting LDV/SOF in adolescents, and ongoing studies evaluating DAAs in pediatric patients.

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          Diagnosis, management, and treatment of hepatitis C: an update.

          Marc G Ghany, Doris B Strader, David Thomas … (2009)
          Article 0 comments Cited 609 times – based on 0 reviews     Review now
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            The prevalence of hepatitis C virus infection in the United States, 1999 through 2002.

            Gregory Armstrong, Annemarie Wasley, Edgar Simard … (2006)
            Defining the primary characteristics of persons infected with hepatitis C virus (HCV) enables physicians to more easily identify persons who are most likely to benefit from testing for the disease. To describe the HCV-infected population in the United States. Nationally representative household survey. U.S. civilian, noninstitutionalized population. 15,079 participants in the National Health and Nutrition Examination Survey between 1999 and 2002. All participants provided medical histories, and those who were 20 to 59 years of age provided histories of drug use and sexual practices. Participants were tested for antibodies to HCV (anti-HCV) and HCV RNA, and their serum alanine aminotransferase (ALT) levels were measured. The prevalence of anti-HCV in the United States was 1.6% (95% CI, 1.3% to 1.9%), equating to an estimated 4.1 million (CI, 3.4 million to 4.9 million) anti-HCV-positive persons nationwide; 1.3% or 3.2 million (CI, 2.7 million to 3.9 million) persons had chronic HCV infection. Peak prevalence of anti-HCV (4.3%) was observed among persons 40 to 49 years of age. A total of 48.4% of anti-HCV-positive persons between 20 and 59 years of age reported a history of injection drug use, the strongest risk factor for HCV infection. Of all persons reporting such a history, 83.3% had not used injection drugs for at least 1 year before the survey. Other significant risk factors included 20 or more lifetime sex partners and blood transfusion before 1992. Abnormal serum ALT levels were found in 58.7% of HCV RNA-positive persons. Three characteristics (abnormal serum ALT level, any history of injection drug use, and history of blood transfusion before 1992) identified 85.1% of HCV RNA-positive participants between 20 and 59 years of age. Incarcerated and homeless persons were not included in the survey. Many Americans are infected with HCV. Most were born between 1945 and 1964 and can be identified with current screening criteria. History of injection drug use is the strongest risk factor for infection.
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              Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial.

              Masashi Mizokami, Osamu Yokosuka, Tetsuo Takehara … (2015)
              Compared with other countries, patients with chronic hepatitis C infection in Japan tend to be older, have more advanced liver disease, and are more likely to have been previously treated for hepatitis C. We aimed to assess the efficacy and safety of an all-oral, fixed-dose combination of the hepatitis C virus NS5A inhibitor ledipasvir and the NS5B nucleotide polymerase inhibitor sofosbuvir with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with chronic genotype 1 hepatitis C virus infection.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Adolesc Health Med Ther
                Journal ID (iso-abbrev): Adolesc Health Med Ther
                Journal ID (publisher-id): Adolescent Health, Medicine and Therapeutics
                Title: Adolescent Health, Medicine and Therapeutics
                Publisher: Dove Medical Press
                ISSN (Electronic): 1179-318X
                Publication date Collection: 2018
                Publication date (Electronic): 30 July 2018
                Volume: 9
                Pages: 103-110
                Affiliations
                [1 ]Division of Pediatric Gastroenterology, Stanford University School of Medicine, Stanford, CA, USA
                [2 ]Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA, USA, aijazahmed@ 123456stanford.edu
                Author notes
                Correspondence: Aijaz Ahmed, Division of Gastroenterology and Hepatology, Stanford University School of Medicine, 750 Welch Road, Suite #210, Stanford, CA 94304, USA, Tel +1 650 498 6091, Fax +1 650 498 5692, Email aijazahmed@ 123456stanford.edu
                Article
                Publisher ID: ahmt-9-103
                DOI: 10.2147/AHMT.S147896
                PMC ID: 6071628
                SO-VID: 33e6d507-1a7b-4284-b872-1675e0ac3ce2
                Copyright © © 2018 Yang et al. This work is published and licensed by Dove Medical Press Limited
                License:

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
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                Subject: Review

                Keywords: hepatitis c virus,chronic hepatitis c,adolescent,pediatric,direct-acting antivirals
                Data availability:
                Keywords: hepatitis c virus, chronic hepatitis c, adolescent, pediatric, direct-acting antivirals

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