메뉴 건너뛰기




Volumn 17, Issue , 2017, Pages

Optimising diagnosis of viraemic hepatitis C infection: The development of a target product profile

Author keywords

[No Author keywords available]

Indexed keywords

HEPATITIS C ANTIGEN; VIRUS ANTIGEN; VIRUS RNA;

EID: 85032748426     PISSN: None     EISSN: 14712334     Source Type: Journal    
DOI: 10.1186/s12879-017-2770-5     Document Type: Article
Times cited : (39)

References (37)
  • 1
    • 85019134828 scopus 로고    scopus 로고
    • Accessed June 2017.
    • Guidelines on hepatitis B and C testing. Geneva: World Health Organization; 2017. http://apps.who.int/iris/bitstream/10665/254621/1/9789241549981-eng.pdf?ua=1. Accessed June 2017.
    • (2017) Geneva: World Health Organization
  • 2
    • 84876149257 scopus 로고    scopus 로고
    • Global epidemiology of hepatitis C virus infection: New estimates of age-specific antibody to HCV seroprevalence
    • Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: New estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013;57:1333-42.
    • (2013) Hepatology , vol.57 , pp. 1333-1342
    • Mohd Hanafiah, K.1    Groeger, J.2    Flaxman, A.D.3    Wiersma, S.T.4
  • 3
    • 85019134828 scopus 로고    scopus 로고
    • Accessed June 2017.
    • Global Hepatitis Report 2017. Geneva: World Health Organization; 2017. http://apps.who.int/iris/bitstream/10665/255016/1/9789241565455-eng.pdf?ua=1. Accessed June 2017.
    • (2017) Geneva: World Health Organization
  • 4
    • 85006211254 scopus 로고    scopus 로고
    • Daclatasvir-sofosbuvir combination therapy with or without ribavirin for hepatitis C virus infection: from the clinical trials to real life
    • Pol S, Corouge M, Vallet-Pichard A. Daclatasvir-sofosbuvir combination therapy with or without ribavirin for hepatitis C virus infection: from the clinical trials to real life. Hepat Med. 2016;8:21-6.
    • (2016) Hepat Med , vol.8 , pp. 21-26
    • Pol, S.1    Corouge, M.2    Vallet-Pichard, A.3
  • 5
    • 84944252126 scopus 로고    scopus 로고
    • Affonso de Araujo E, Hamid S. Disparity in market prices for hepatitis C virus direct-acting drugs
    • Andrieux-Meyer I, Cohn J. Affonso de Araujo E, Hamid S. Disparity in market prices for hepatitis C virus direct-acting drugs. Lancet. 2015;3:e676-7.
    • (2015) Lancet , vol.3 , pp. e676-e677
    • Andrieux-Meyer, I.1    Cohn, J.2
  • 6
    • 85032721564 scopus 로고    scopus 로고
    • Chronic Hepatitis C Treatment Expansion Generic Manufacturing for Developing Countries
    • August. 2015 Accessed June
    • Gilead. Chronic Hepatitis C Treatment Expansion Generic Manufacturing for Developing Countries. August. 2015. p. 2. http://www.gilead.com/~/media/Files/pdfs/other/HCVGenericAgreementFactSheet.pdf. Accessed June 2017.
    • (2017) , pp. 2
  • 7
    • 85032748614 scopus 로고    scopus 로고
    • Available from 2016. Accessed June 2017.
    • The Medicines Patent Pool Signs First Sub-licences for Hepatitis C Medicine Daclatasvir. Available from https://medicinespatentpool.org/mpp-media-post/the-medicines-patent-pool-signs-licence-with-bristol-myers-squibb-to-increase-access-to-hepatitis-c-medicine-daclatasvir/. 2016. Accessed June 2017.
  • 8
    • 84987865013 scopus 로고    scopus 로고
    • Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C
    • Hill A, Bryony S, Dzintars G, Joseph F. Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C. J Virus Erad. 2016;2:28-31.
    • (2016) J Virus Erad , vol.2 , pp. 28-31
    • Hill, A.1    Bryony, S.2    Dzintars, G.3    Joseph, F.4
  • 9
    • 85032736924 scopus 로고    scopus 로고
    • Minimum costs for producing Hepatitis C Direct Acting Antivirals, for use in large-scale treatment access programs in developing countries
    • Hill A, Khoo S, Fortunak J, Simmons B, Ford N. Minimum costs for producing Hepatitis C Direct Acting Antivirals, for use in large-scale treatment access programs in developing countries. Clin Infect Dis. 2015;61:1174-82.
    • (2015) Clin Infect Dis , vol.61 , pp. 1174-1182
    • Hill, A.1    Khoo, S.2    Fortunak, J.3    Simmons, B.4    Ford, N.5
  • 11
    • 84940447040 scopus 로고    scopus 로고
    • Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013
    • Vos T, Barber RM, Bell B, Bertozzi-Villa A, Biryukov SBI, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386:743-800.
    • (2015) Lancet , vol.386 , pp. 743-800
    • Vos, T.1    Barber, R.M.2    Bell, B.3    Bertozzi-Villa, A.4    Biryukov, S.B.I.5
  • 12
    • 85032739838 scopus 로고    scopus 로고
    • UNITAID Hepatitis C Diagnostics Technology Landscape 1st Edition
    • Geneva: 2015. Accessed June 2017.
    • Murtagh M. UNITAID Hepatitis C Diagnostics Technology Landscape 1st Edition. Geneva: 2015. http://unitaid.org/images/marketdynamics/publications/UNITAID-HCV_Diagnostic_Landscape-1st_edition.pdf. Accessed June 2017.
    • Murtagh, M.1
  • 13
    • 85032725812 scopus 로고    scopus 로고
    • Geneva: Médecins Sans Frontières (MSF)Accessed Nov 2016.
    • Putting HIV and HCV to the Test: A Product Guide for Point-of-Care CD4 and Laboratory-Based and Point-of-Care Virological HIV and HCV Tests. Geneva: Médecins Sans Frontières (MSF); 2015:1-100. http://www.msfaccess.org/sites/default/files/HIV_HCV_Report_Diagnostic_Guide_2015.pdf. Accessed Nov 2016.
    • (2015) , pp. 1-100
  • 14
    • 84964806345 scopus 로고    scopus 로고
    • Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges
    • Roberts T, Cohn J, Bonner K, Hargreaves S. Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges. Clin Infect Dis. 2016;62:1043-8.
    • (2016) Clin Infect Dis , vol.62 , pp. 1043-1048
    • Roberts, T.1    Cohn, J.2    Bonner, K.3    Hargreaves, S.4
  • 15
    • 0034065562 scopus 로고    scopus 로고
    • Detection of Hepatitis C Core Antigen in the Antibody Negative "Window" Phase of Hepatitis C Infection
    • Peterson J, Green G, Lida K, Lee S. Detection of Hepatitis C Core Antigen in the Antibody Negative "Window" Phase of Hepatitis C Infection. Vox Sang. 2000;78:80-5.
    • (2000) Vox Sang , vol.78 , pp. 80-85
    • Peterson, J.1    Green, G.2    Lida, K.3    Lee, S.4
  • 16
    • 85049575818 scopus 로고    scopus 로고
    • Clinical utility of Hepatitis C virus core antigen detection and quantification in the diagnosis and management of patients with chronic hepatitis C receiving an all-oral, interferon-free regimen
    • [Epub ahead of print]
    • Chevaliez S, Feld J, Cheng K, Wedemeyer H, Sarrazin C. Clinical utility of Hepatitis C virus core antigen detection and quantification in the diagnosis and management of patients with chronic hepatitis C receiving an all-oral, interferon-free regimen. Antivir Ther. 2016. doi: 10.3851/IMP3042. [Epub ahead of print]
    • (2016) Antivir Ther
    • Chevaliez, S.1    Feld, J.2    Cheng, K.3    Wedemeyer, H.4    Sarrazin, C.5
  • 17
    • 80055096809 scopus 로고    scopus 로고
    • Hepatitis C virus core antigen: Analytical performances, correlation with viremia and potential applications of a quantitative, automated immunoassay
    • Medici MC, Furlini G, Rodella A, Fuertes A, Monachetti A, Calderaro A, et al. Hepatitis C virus core antigen: Analytical performances, correlation with viremia and potential applications of a quantitative, automated immunoassay. J Clin Virol. 2011;51:264-9.
    • (2011) J Clin Virol , vol.51 , pp. 264-269
    • Medici, M.C.1    Furlini, G.2    Rodella, A.3    Fuertes, A.4    Monachetti, A.5    Calderaro, A.6
  • 18
    • 85032749108 scopus 로고    scopus 로고
    • Accessed Oct 2016.
    • Cepheid, Sunnyvale U. Cepheid brochure: Xpert HCV Viral load. http://www.cepheid.com/administrator/components/com_productcatalog/library-files/611eae732b51634d8a7e64878d8222a1-615085cee2245c0c5e547ebff5052119-Xpert-HCV-Viral-Load-Brochure-CEIVD-3043-02.pdf. Accessed Oct 2016.
    • Cepheid brochure: Xpert HCV Viral load
    • Cepheid, S.U.1
  • 19
    • 0035015948 scopus 로고    scopus 로고
    • Point-of-care testing. Impact on medical outcomes
    • Price CP. Point-of-care testing. Impact on medical outcomes. Clin Lab Med. 2001;21:285-303.
    • (2001) Clin Lab Med , vol.21 , pp. 285-303
    • Price, C.P.1
  • 20
    • 84940762731 scopus 로고    scopus 로고
    • Accessed June 2017.
    • Target product profiles and priority digital health products for TB. Geneva: World Health Organization; 2015. http://www.who.int/tb/areas-of-work/digital-health/target-product-profiles/en/. Accessed June 2017.
    • (2015) Geneva: World Health Organization
  • 21
    • 84946216666 scopus 로고    scopus 로고
    • Accessed June 2017.
    • High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. Geneva: World Health Organization; 2014. http://apps.who.int/iris/bitstream/10665/135617/1/WHO_HTM_TB_2014.18_eng.pdf?ua=1&ua=1. Accessed June 2017.
    • (2014) Geneva: World Health Organization
  • 22
    • 85032733741 scopus 로고    scopus 로고
    • Guidance for Industry and Review Staff: Target Product Profile
    • Rockville MD. 2007. Available from June 2017.
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry and Review Staff: Target Product Profile - A Strategic Development Process Tool. Rockville MD. 2007. Available from http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080593.pdf. Accessed June 2017.
    • A Strategic Development Process Tool
  • 23
    • 85032730045 scopus 로고    scopus 로고
    • May 6-8, Annecy, France. Accessed June 2017.
    • STI POCT Meeting report: Point of Care Tests --Target Product Profiles and Research Questions, May 6-8, Annecy, France. http://who.int/reproductivehealth/POTC-TPPs-2016.pdf?ua=1. Accessed June 2017.
    • Target Product Profiles and Research Questions
  • 24
    • 84930007214 scopus 로고    scopus 로고
    • Target product profile of a molecular drug-susceptibility test for use in microscopy centers
    • Denkinger CM, Dolinger D, Schito M, Wells W, Cobelens F, Pai M, et al. Target product profile of a molecular drug-susceptibility test for use in microscopy centers. J Infect Dis. 2015;211:S39-49.
    • (2015) J Infect Dis , vol.211 , pp. S39-S49
    • Denkinger, C.M.1    Dolinger, D.2    Schito, M.3    Wells, W.4    Cobelens, F.5    Pai, M.6
  • 26
    • 0036237357 scopus 로고    scopus 로고
    • Medical and Economic Outcomes of Point-of-Care Testing
    • Price CP. Medical and Economic Outcomes of Point-of-Care Testing. Clin Chem Lab Med. 2002;40:246-51.
    • (2002) Clin Chem Lab Med , vol.40 , pp. 246-251
    • Price, C.P.1
  • 27
    • 84907959202 scopus 로고    scopus 로고
    • The Clinical and Economic Impact of Point-of-Care CD4 Testing in Mozambique and Other Resource-Limited Settings: A Cost-Effectiveness Analysis
    • Hyle EP, Jani I V., Lehe J, Su AE, Wood R, Quevedo J, et al. The Clinical and Economic Impact of Point-of-Care CD4 Testing in Mozambique and Other Resource-Limited Settings: A Cost-Effectiveness Analysis. Sansom SL, editor. PLoS Med Public Libr Sci; 2014;11:e1001725.
    • (2014) Sansom SL, editor. PLoS Med Public Libr Sci , vol.11
    • Hyle, E.P.1    Jani, I.V.2    Lehe, J.3    Su, A.E.4    Wood, R.5    Quevedo, J.6
  • 28
    • 0000895370 scopus 로고    scopus 로고
    • The Delphi technique as a forecasting tool: issues and analysis
    • Rowe G, Wright G. The Delphi technique as a forecasting tool: issues and analysis. Int J Forecast. 1999;15:353-75.
    • (1999) Int J Forecast , vol.15 , pp. 353-375
    • Rowe, G.1    Wright, G.2
  • 30
    • 34447503644 scopus 로고    scopus 로고
    • Frequency of very low HCV viremia detected by a highly sensitive HCV-RNA assay
    • Fytili P, Tiemann C, Wang C, Schulz S, Schaffer S, Manns MP, et al. Frequency of very low HCV viremia detected by a highly sensitive HCV-RNA assay. J Clin Virol. 2007;39:308-11.
    • (2007) J Clin Virol , vol.39 , pp. 308-311
    • Fytili, P.1    Tiemann, C.2    Wang, C.3    Schulz, S.4    Schaffer, S.5    Manns, M.P.6
  • 31
    • 84938578428 scopus 로고    scopus 로고
    • Utility of Hepatitis C Viral Load Monitoring on Direct-Acting Antiviral Therapy
    • Sidharthan S, Kohli A, Sims Z, Nelson A, Osinusi A, Masur H, et al. Utility of Hepatitis C Viral Load Monitoring on Direct-Acting Antiviral Therapy. Clin Infect Dis. 2015;60:1743-51.
    • (2015) Clin Infect Dis , vol.60 , pp. 1743-1751
    • Sidharthan, S.1    Kohli, A.2    Sims, Z.3    Nelson, A.4    Osinusi, A.5    Masur, H.6
  • 32
    • 84882636387 scopus 로고    scopus 로고
    • Are peripheral microscopy centres ready for next generation molecular tuberculosis diagnostics?
    • Denkinger C, Nicolau I, Ramsay A, Chedore P, Pai M. Are peripheral microscopy centres ready for next generation molecular tuberculosis diagnostics? Eur Respir J. 2013;42:544-7.
    • (2013) Eur Respir J , vol.42 , pp. 544-547
    • Denkinger, C.1    Nicolau, I.2    Ramsay, A.3    Chedore, P.4    Pai, M.5
  • 33
    • 67649908265 scopus 로고    scopus 로고
    • Time delays in diagnosis of pulmonary tuberculosis: a systematic review of literature
    • Sreeramareddy CT, Kishore PV, Menten J, Van den Ende J. Time delays in diagnosis of pulmonary tuberculosis: a systematic review of literature. BMC Infect Dis. 2009;9:91.
    • (2009) BMC Infect Dis , vol.9 , pp. 91
    • Sreeramareddy, C.T.1    Kishore, P.V.2    Menten, J.3    Van den Ende, J.4
  • 34
    • 77950919250 scopus 로고    scopus 로고
    • Patient needs and point-of-care requirements for HIV load testing in resource-limited settings
    • Usdin M, Guillerm M, Calmy A. Patient needs and point-of-care requirements for HIV load testing in resource-limited settings. J Infect Dis. 2010;201:S73-7.
    • (2010) J Infect Dis , vol.201 , pp. S73-S77
    • Usdin, M.1    Guillerm, M.2    Calmy, A.3
  • 35
    • 85032725170 scopus 로고    scopus 로고
    • Values, preferences and current hepatitis B and C testing practices in low- and middle-income countries: results of a survey of end users and implementers
    • Ivanova E, Trianni A, Krakower D, Ongarello S, Roberts T, Easterbrook P and Denkinger C. Values, preferences and current hepatitis B and C testing practices in low- and middle-income countries: results of a survey of end users and implementers. BMC Infect Dis. 2017;17:(Suppl 1). doi: 10.1186/s12879-017-2769-y.
    • (2017) BMC Infect Dis , vol.17
    • Ivanova, E.1    Trianni, A.2    Krakower, D.3    Ongarello, S.4    Roberts, T.5    Easterbrook, P.6    Denkinger, C.7
  • 36
    • 84875971562 scopus 로고    scopus 로고
    • Is HCV core antigen a reliable marker of viral load? An evaluation of HCV core antigen automated immunoassay
    • Hadziyannis E, Minopetrou M, Georgiou A, Spanou F, Koskinas J. Is HCV core antigen a reliable marker of viral load? An evaluation of HCV core antigen automated immunoassay. Ann Gastroenterol. 2013;26:146-9.
    • (2013) Ann Gastroenterol , vol.26 , pp. 146-149
    • Hadziyannis, E.1    Minopetrou, M.2    Georgiou, A.3    Spanou, F.4    Koskinas, J.5
  • 37
    • 84942912048 scopus 로고    scopus 로고
    • Simplified diagnostic monitoring for Hepatitis C, in the era of Direct Acting Antiviral treatment
    • Cohn J, Roberts T, Amorosa V, Lemoine M, Hill A. Simplified diagnostic monitoring for Hepatitis C, in the era of Direct Acting Antiviral treatment. Curr Opin HIV AIDS. 2015;10:369-73.
    • (2015) Curr Opin HIV AIDS , vol.10 , pp. 369-373
    • Cohn, J.1    Roberts, T.2    Amorosa, V.3    Lemoine, M.4    Hill, A.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.