Simplification of Care for Chronic Hepatitis C Virus Infection

Abstract

In 2016, the World Health Organization (WHO) set a target for eliminating viral hepatitis as a major public health threat by 2030. However, while today's highly effective and well-tolerated pangenotypic direct-acting antiviral regimens have maximized simplification of hepatitis C virus (HCV) treatment, there remain a plethora of barriers to HCV screening, diagnosis, and linkage to care. As of 2017, only 19% of the estimated 71 million individuals living with chronic HCV worldwide were diagnosed and in 2015 to 2016, only 21% of diagnosed individuals had accessed treatment. Simplification and decentralization of the HCV care cascade would bolster patient engagement and support the considerable scale-up needed to achieve WHO targets. Recent developments in HCV screening and diagnosis, together with reduced pretreatment assessment and on-treatment monitoring requirements, can further streamline the care continuum, ensuring patients are linked to care quickly and earlier in the disease course, and minimize clinic visits.

Keywords

hepatitis C virus - care cascade - screening - diagnosis - treatment

Publikationsverlauf

Artikel online veröffentlicht:
28. Juli 2020

• References

• 1 Cooke GS, Andrieux-Meyer I, Applegate TL. et al; Lancet Gastroenterology & Hepatology Commissioners. Accelerating the elimination of viral hepatitis: a Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol Hepatol 2019; 4 (02) 135-184
• 2 World Health Organization (WHO). Global health sector strategy on viral hepatitis, 2016–2021: towards ending viral hepatitis. Available at: https://apps.who.int/iris/bitstream/handle/10665/246177/WHO-HIV-2016.06-eng.pdf;jsessionid=3353B8BE60FB5081680122276F404913?sequence=1 . Accessed April 2020
• 3 World Health Organization (WHO). Hepatitis C: key facts. Available at: https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-c . Accessed April 2020
• 4 Lazarus JV, Pericàs JM, Picchio C. et al. We know DAAs work, so now what? Simplifying models of care to enhance the hepatitis C cascade. J Intern Med 2019; 286 (05) 503-525
• 5 American Association for the Study of Liver Diseases (AASLD) IDSA. HCV guidance: Recommendations for testing, managing, and treating hepatitis C. Available at: www.hcvguidelines.org . Accessed April 2020
• 6 European Association for the Study of the Liver. Electronic address: [e-mail]; European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C 2018. J Hepatol 2018; 69 (02) 461-511
• 7 World Health Organization (WHO). Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection. Available at: https://www.who.int/hepatitis/publications/hepatitis-c-guidelines-2018/en/ . Accessed April 2020
• 8 US Preventive Services Task Force. Hepatitis C virus infection in adolescents and adults: screening. Available at: https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/hepatitis-c-screening1 . Accessed April 2020
• 9 Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. Centers for Disease Control. CDC recommendations for hepatitis C screening among adults - United States, 2020. MMWR Recomm Rep 2020; 69 (02) 1-17
• 10 European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol 2011; 55 (02) 245-264
• 11 Mishra P, Murray J, Birnkrant D. Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: scientific and regulatory approaches to clinical trial designs. Hepatology 2015; 62 (04) 1298-1303
• 12 Mulligan K, Sullivan J, Yoon L, Chou J, Van Nuys K. Evaluating HCV screening, linkage to care, and treatment across insurers. Am J Manag Care 2018; 24 (08) e257-e264
• 13 Smith BD, Morgan RL, Beckett GA. et al; Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep 2012; 61 (RR-4): 1-32
• 14 Jemal A, Fedewa SA. Recent hepatitis C virus testing patterns among baby boomers. Am J Prev Med 2017; 53 (01) e31-e33
• 15 Konerman MA, Thomson M, Gray K. et al. Impact of an electronic health record alert in primary care on increasing hepatitis c screening and curative treatment for baby boomers. Hepatology 2017; 66 (06) 1805-1813
• 16 Grebely J, Larney S, Peacock A. et al. Global, regional, and country-level estimates of hepatitis C infection among people who have recently injected drugs. Addiction 2019; 114 (01) 150-166
• 17 Trickey A, Fraser H, Lim AG. et al. The contribution of injection drug use to hepatitis C virus transmission globally, regionally, and at country level: a modelling study. Lancet Gastroenterol Hepatol 2019; 4 (06) 435-444
• 18 Iversen J, Grebely J, Topp L, Wand H, Dore G, Maher L. Uptake of hepatitis C treatment among people who inject drugs attending Needle and Syringe Programs in Australia, 1999-2011. J Viral Hepat 2014; 21 (03) 198-207
• 19 Delile JM, de Ledinghen V, Jauffret-Roustide M. et al. Hepatitis C virus prevention and care for drug injectors: the French approach. Hepatol Med Policy 2018; 3: 7
• 20 Scherz N, Bruggmann P, Brunner N. Direct-acting antiviral therapy for hepatitis C infection among people receiving opioid agonist treatment or heroin assisted treatment. Int J Drug Policy 2018; 62: 74-77
• 21 Akiyama MJ, Norton BL, Arnsten JH, Agyemang L, Heo M, Litwin AH. Intensive models of hepatitis C care for people who inject drugs receiving opioid agonist therapy: a randomized controlled trial. Ann Intern Med 2019; 170 (09) 594-603
• 22 McLeod A, Weir A, Aitken C. et al. Rise in testing and diagnosis associated with Scotland's Action Plan on Hepatitis C and introduction of dried blood spot testing. J Epidemiol Community Health 2014; 68 (12) 1182-1188
• 23 Esmat G, El-Sayed MH, Hassany M, Doss W, Waked I. National Committee for the Control of Viral Hepatitis. One step closer to elimination of hepatitis C in Egypt. Lancet Gastroenterol Hepatol 2018; 3 (10) 665
• 24 Eckman MH, Ward JW, Sherman KE. Cost effectiveness of universal screening for hepatitis C virus infection in the era of direct-acting, pangenotypic treatment regimens. Clin Gastroenterol Hepatol 2019; 17 (05) 930-939.e9
• 25 Deuffic-Burban S, Huneau A, Verleene A. et al. Assessing the cost-effectiveness of hepatitis C screening strategies in France. J Hepatol 2018; 69 (04) 785-792
• 26 Koneru A, Nelson N, Hariri S. et al. Increased hepatitis C virus (HCV) detection in women of childbearing age and potential risk for vertical transmission—United States and Kentucky, 2011–2014. MMWR Morb Mortal Wkly Rep 2016; 65 (28) 705-710
• 27 Dibba P, Cholankeril R, Li AA. et al. Hepatitis C in pregnancy. Diseases 2018; 6 (02) 31
• 28 Indolfi G, Easterbrook P, Dusheiko G. et al. Hepatitis C virus infection in children and adolescents. Lancet Gastroenterol Hepatol 2019; 4 (06) 477-487
• 29 Saab S, Kullar R, Gounder P. The urgent need for hepatitis C screening in pregnant women: a call to action. Obstet Gynecol 2020; 135 (04) 773-777
• 30 Modin L, Arshad A, Wilkes B. et al. Epidemiology and natural history of hepatitis C virus infection among children and young people. J Hepatol 2019; 70 (03) 371-378
• 31 Andreone P, Di Marco V, Gaeta GB, Fagiuoli S, Vukotic R, Craxì A. Current and forthcoming perspectives in linkage to care of hepatitis C virus infection: assessment of an Italian focus group. Dig Liver Dis 2019; 51 (07) 915-921
• 32 Chevaliez S, Pawlotsky JM. New virological tools for screening, diagnosis and monitoring of hepatitis B and C in resource-limited settings. J Hepatol 2018; 69 (04) 916-926
• 33 World Health Organization (WHO). WHO prequalification of in vitro diagnostics public reports: hepatitis C assays. Available at: https://www.who.int/diagnostics_laboratory/evaluations/pq-list/hcv/public_report/en/ . Accessed April 2020
• 34 Tang W, Chen W, Amini A. et al. Diagnostic accuracy of tests to detect hepatitis C antibody: a meta-analysis and review of the literature. BMC Infect Dis 2017; 17 (Suppl. 01) 695
• 35 Bregenzer A, Conen A, Knuchel J. et al. Management of hepatitis C in decentralised versus centralised drug substitution programmes and minimally invasive point-of-care tests to close gaps in the HCV cascade. Swiss Med Wkly 2017; 147: w14544
• 36 Anderson ES, Galbraith JW, Deering LJ. et al. Continuum of care for hepatitis C virus among patients diagnosed in the emergency department setting. Clin Infect Dis 2017; 64 (11) 1540-1546
• 37 Parisi MR, Tecco S, Gastaldi G. et al. Point-of-care testing for hepatitis C virus infection at alternative and high-risk sites: an Italian pilot study in a dental clinic. New Microbiol 2017; 40 (04) 242-245
• 38 Chiong F, Post J. Opportunistic assessment and treatment of people with hepatitis C virus infection admitted to hospital for other reasons: a prospective cohort study. Int J Drug Policy 2019; 65: 50-55
• 39 Hughes BL, Page CM, Kuller JA. Society for Maternal-Fetal Medicine (SMFM). Electronic address: [e-mail]. Hepatitis C in pregnancy: screening, treatment, and management. Am J Obstet Gynecol 2017; 217 (05) B2-B12
• 40 Morano JP, Zelenev A, Lombard A, Marcus R, Gibson BA, Altice FL. Strategies for hepatitis C testing and linkage to care for vulnerable populations: point-of-care and standard HCV testing in a mobile medical clinic. J Community Health 2014; 39 (05) 922-934
• 41 Calderon Y, Cowan E, Schramm C. et al. HCV and HBV testing acceptability and knowledge among urban emergency department patients and pharmacy clients. Prev Med 2014; 61: 29-33
• 42 Lazarus JV, Picchio C, Dillon JF, Rockstroh JK, Weis N, Buti M. Too many people with viral hepatitis are diagnosed late—with dire consequences. Nat Rev Gastroenterol Hepatol 2019; 16 (08) 451-452
• 43 Vázquez-Morón S, Ardizone Jiménez B, Jiménez-Sousa MA, Bellón JM, Ryan P, Resino S. Evaluation of the diagnostic accuracy of laboratory-based screening for hepatitis C in dried blood spot samples: a systematic review and meta-analysis. Sci Rep 2019; 9 (01) 7316
• 44 Rege S, Sanchez Y, Marx S. et al. PS-066-Patient flow across physician specialties over the course of the hepatitis C care cascade: a real-world analysis from the United States. J Hepatol 2019; 70: e40
• 45 Centre for Disease Analysis. Web Annex C. Estimates of the coverage of diagnosis and treatment for hepatitis B and C virus infection, by WHO region and income group, 2015. In: Global Hepatitis Report 2017. Geneva: World Health Organization; 2018 (WHO/CDS/HIV/18.47). Available at: https://apps.who.int/iris/bitstream/handle/10665/277006/WHO-CDS-HIV-18.47-eng.pdf . Accessed April 2020
• 46 European Union HCV Collaborators. Hepatitis C virus prevalence and level of intervention required to achieve the WHO targets for elimination in the European Union by 2030: a modelling study. Lancet Gastroenterol Hepatol 2017; 2 (05) 325-336
• 47 Hajarizadeh B, Grebely J, McManus H. et al. Chronic hepatitis C burden and care cascade in Australia in the era of interferon-based treatment. J Gastroenterol Hepatol 2017; 32 (01) 229-236
• 48 Veterans Health Administration. Review of hepatitis C virus care within the Veterans Health Administration. Available at: https://www.va.gov/oig/pubs/VAOIG-17-05297-85.pdf . Accessed April 2020
• 49 Falade-Nwulia O, McAdams-Mahmoud A, Irvin R. et al. Primary care providers knowledge, attitude and practices related to hepatitis C screening and treatment in the oral direct acting antiviral agents era. J Community Med Health Educ 2016; 6 (05) 6
• 50 American Association for the Study of Liver Diseases (AASLD) IDSA. Simplified HCV treatment algorithm for treatment-naive adults without cirrhosis. Available at: https://www.hcvguidelines.org/sites/default/files/full-guidance-pdf/AASLD-IDSA_HCV-Guidance_TxN-Simplified-Tx-No-Cirr_c.pdf . Accessed April 2020
• 51 American Association for the Study of Liver Diseases (AASLD) IDSA. Simplified HCV treatment algorithm for treatment-naive adults with compensated cirrhosis. Available at: https://www.hcvguidelines.org/sites/default/files/full-guidance-pdf/AASLD-IDSA_HCV-Guidance_TxN-Simplified-Tx-Comp-Cirr_c.pdf . Accessed April 2020
• 52 Wade AJ, Doyle JS, Gane E. et al. Outcomes of treatment for hepatitis C in primary care, compared to hospital-based care: a randomized, controlled trial in people who inject drugs. Clin Infect Dis 2020; 70 (09) 1900-1906
• 53 Beste LA, Glorioso TJ, Ho PM. et al. Telemedicine specialty support promotes hepatitis C treatment by primary care providers in the Department of Veterans Affairs. Am J Med 2017; 130 (04) 432.e3-438.e3
• 54 Arora S, Thornton K, Murata G. et al. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med 2011; 364 (23) 2199-2207
• 55 Kattakuzhy S, Gross C, Emmanuel B. et al; and the ASCEND Providers. Expansion of treatment for hepatitis C virus infection by task shifting to community-based nonspecialist providers: a nonrandomized clinical trial. Ann Intern Med 2017; 167 (05) 311-318
• 56 Lee A, Hanson J, Fox P, Spice G, Russell D, Boyd P. A decentralised, multidisciplinary model of care facilitates treatment of hepatitis C in regional Australia. J Virus Erad 2018; 4 (03) 160-164
• 57 Nasir IA, Yakubu S, Mustapha JO. Epidemiology and synergistic hepatopathology of malaria and hepatitis C virus coinfection. Virology (Auckl) 2017; 8: X17724411
• 58 Popping S, Bade D, Boucher C. et al. The global campaign to eliminate HBV and HCV infection: International Viral Hepatitis Elimination Meeting and core indicators for development towards the 2030 elimination goals. J Virus Erad 2019; 5 (01) 60-66
• 59 Rhea S, Seña AC, Hilton A, Hurt CB, Wohl D, Fleischauer A. Integrated hepatitis C testing and linkage to care at a local health department sexually transmitted disease clinic: determining essential resources and evaluating outcomes. Sex Transm Dis 2018; 45 (04) 229-232
• 60 Cachay ER, Hill L, Ballard C. et al. Increasing hepatitis C treatment uptake among HIV-infected patients using an HIV primary care model. AIDS Res Ther 2013; 10 (01) 9
• 61 Bischoff J, Boesecke C, Ingiliz P. et al; GECCO study group. Has increased rollout of direct acting antiviral therapy decreased the burden of late presentation and advanced liver disease in patients starting hepatitis C virus therapy in Germany?. J Clin Gastroenterol 2020; 54 (02) 192-199
• 62 Chirikov VV, Marx SE, Manthena SR, Strezewski JP, Saab S. Development of a comprehensive dataset of hepatitis C patients and examination of disease epidemiology in the United States, 2013–2016. Adv Ther 2018; 35 (07) 1087-1102
• 63 Trivedi HD, Patwardhan VR, Malik R. Chronic hepatitis C infection—noninvasive assessment of liver fibrosis in the era of direct acting antivirals. Dig Liver Dis 2019; 51 (02) 183-189
• 64 Norton BL, Akiyama MJ, Zamor PJ, Litwin AH. Treatment of chronic hepatitis C in patients receiving opioid agonist therapy: a review of best practice. Infect Dis Clin North Am 2018; 32 (02) 347-370
• 65 Bruggmann P, Litwin AH. Models of care for the management of hepatitis C virus among people who inject drugs: one size does not fit all. Clin Infect Dis 2013; 57 (Suppl. 02) S56-S61
• 66 Fontana RJ, Lens S, McPherson S. et al. Efficacy and safety of 8 weeks of glecaprevir/pibrentasvir in treatment-naïve adults with HCV genotype 1–6 and aspartate aminotransferase to platelet ratio index (APRI) ≤1. Hepatology 2018; 68: 388A-389A
• 67 Gupta N, Kateera F, Desalegn H, Ocama P, Njouom R, Lacombe K. Is resistance to direct-acting antivirals in sub-Saharan Africa a threat to HCV elimination? Recommendations for action. J Hepatol 2020; 72 (03) 583-584
• 68 World Health Organization W. Progress report on access to hepatitis C treatment: Focus on overcoming barriers in low- and middle-income countries. Available at: https://www.who.int/hepatitis/publications/hep-c-access-report-2018/en/ . Accessed April 2020
• 69 Marshall AD, Pawlotsky JM, Lazarus JV, Aghemo A, Dore GJ, Grebely J. The removal of DAA restrictions in Europe—One step closer to eliminating HCV as a major public health threat. J Hepatol 2018; 69 (05) 1188-1196
• 70 National Viral Hepatitis Roundtable. Hepatitis C: the state of Medicaid access: 2017 National Summary Report, October 23, 2017. Available at: https://stateofhepc.org/wp-content/uploads/2017/10/State-of-HepC_2017_FINAL.pdf . Accessed April 2020
• 71 Cunningham EB, Amin J, Feld JJ. et al; SIMPLIFY study group. Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use: The SIMPLIFY study. Int J Drug Policy 2018; 62: 14-23
• 72 Kattakuzhy S, Mathur P, Gross C. et al. High SVR in PWID with HCV despite imperfect medication adherence: data from the Anchor study. Hepatology 2018; 68: 12A (abstract18)
• 73 The National Academies of Sciences, Engineering, and Medicine. A national strategy for the elimination of hepatitis B and C: phase two report, Available at: http://www.nationalacademies.org/hmd/reports/2017/national-strategy-for-the-elimination-of-hepatitis-b-and-c.aspx . Accessed April 2020
• 74 AbbVie. Mavyret (glecaprevir/pibrentasvir) US prescribing information (September 2019). Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209394s002lbl.pdf . Accessed April 2020
• 75 Gilead. Epclusa (sofosbuvir/velpatasvir) US prescribing information. Available at: https://www.gilead.com/-/media/files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf . Accessed April 2020
• 76 Republic of Rwanda Ministry of Health. Rwanda's fight in the elimination of hepatitis C virus. Available at: http://moh.gov.rw/index.php?id=19&tx_news_pi1%5Bnews%5D=76&tx_news_pi1%5Bday%5D=1&tx_news_pi1%5Bmonth%5D=8&tx_news_pi1%5Byear%5D=2019&cHash=5bd9a53465e639666f11d1b7aa0ea60a . Accessed April 2020
• 77 Iyengar S, Tay-Teo K, Vogler S. et al. Prices, costs, and affordability of new medicines for hepatitis C in 30 countries: an economic analysis. PLoS Med 2016; 13 (05) e1002032-e1002032
• 78 Perazzo H, Castro R, Luz PM. et al. Effectiveness of generic direct-acting agents for the treatment of hepatitis C: systematic review and meta-analysis. Bull World Health Organ 2020; 98 (03) 188-197K
• 79 VanOpdorp JR, Ferrentino N, Strader DB, Lidofsky SD. Utility of laboratory monitoring during hepatitis C treatment with ribavirin-free direct-acting antiviral regimens. J Viral Hepat 2019; 26 (06) 778-781
• 80 D'Ambrosio R, Pasulo L, Puoti M. et al; NAVIGATORE-Lombardia Study Group. Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C. J Hepatol 2019; 70 (03) 379-387
• 81 Maasoumy B, Buggisch P, Mauss S. et al. Clinical significance of detectable and quantifiable HCV RNA at the end of treatment with ledipasvir/sofosbuvir in GT1 patients. Liver Int 2018; 38 (11) 1906-1910
• 82 Cuadrado A, Llerena S, Cobo C. et al. Microenvironment eradication of hepatitis C: a novel treatment paradigm. Am J Gastroenterol 2018; 113 (11) 1639-1648
• 83 Dore G, Feld J, Thompson A. et al. PS-178-Simplified monitoring for hepatitis C virus treatment with glecaprevir plus pibrentasvir: the SMART-C study. J Hepatol 2019; 70: e110
• 84 Mutasa-Apollo T, Ford N, Wiens M. et al. Effect of frequency of clinic visits and medication pick-up on antiretroviral treatment outcomes: a systematic literature review and meta-analysis. J Int AIDS Soc 2017; 20 (Suppl. 04) 21647
• 85 Welzel TM, Yang M, Sajeev G. et al. Assessing patient preferences for treatment decisions for new direct acting antiviral (DAA) therapies for chronic hepatitis C virus infections. Adv Ther 2019; 36 (09) 2475-2486
• 86 Aspinall EJ, Corson S, Doyle JS. et al. Treatment of hepatitis C virus infection among people who are actively injecting drugs: a systematic review and meta-analysis. Clin Infect Dis 2013; 57 (Suppl. 02) S80-S89
• 87 Heffernan A, Cooke GS, Nayagam S, Thursz M, Hallett TB. Scaling up prevention and treatment towards the elimination of hepatitis C: a global mathematical model. Lancet 2019; 393 (10178): 1319-1329
• 88 Loustaud-Ratti V, Debette-Gratien M, Carrier P. European Association for the Study of the Liver and French hepatitis C recent guidelines: the paradigm shift. World J Hepatol 2018; 10 (10) 639-644
• 89 Hepatitis C Virus Infection Consensus Statement Working Group. Australian recommendations for the management of hepatitis C infection: a consensus statement. Available at: https://www.asid.net.au/documents/item/1208 . Accessed April 2020