BACKGROUND: Despite the availability of safe and effective direct-acting antiviral drugs (DAAs), the vast majority of patients with chronic hepatitis C (HCV) in the USA remain untreated, in part due to lack of access to specialist providers. AIMS: To determine the effectiveness of DAA-based treatment in medically underserved areas in California, in a healthcare model dependent on task-shifting--wherein a visiting hepatologist assesses patients for treatment eligibility, but subsequent routine follow-up evaluation of patients prescribed treatment is devolved to a part-time licensed vocational nurse under remote supervision of the hepatologist. METHODS: We retrospectively determined rates of sustained virologic response 12 weeks after treatment completion (SVR-12), adverse events, and treatment discontinuations in patients who received sofosbuvir-based DAA regimens between December 2013 and November 2014. RESULTS: Despite limited specialist provider involvement in medically underserved areas, all but two of 58 patients completed treatment, and 88 % of patients achieved the curative endpoint of undetectable HCV RNA 12 weeks after completing treatment (sustained virologic response, SVR-12). Almost 80 % of patients with cirrhosis and 85 % of patients with prior treatment experience achieved SVR-12. CONCLUSIONS: Treatment effectiveness with sofosbuvir-based regimens in medically underserved areas utilizing task-shifting from a specialist to a mid-level provider is comparable to those achieved in pivotal clinical trials for these regimens, and to “real-world” experiences of tertiary care centers in the USA.
BACKGROUND: Despite the availability of safe and effective direct-acting antiviral drugs (DAAs), the vast majority of patients with chronic hepatitis C (HCV) in the USA remain untreated, in part due to lack of access to specialist providers. AIMS: To determine the effectiveness of DAA-based treatment in medically underserved areas in California, in a healthcare model dependent on task-shifting--wherein a visiting hepatologist assesses patients for treatment eligibility, but subsequent routine follow-up evaluation of patients prescribed treatment is devolved to a part-time licensed vocational nurse under remote supervision of the hepatologist. METHODS: We retrospectively determined rates of sustained virologic response 12 weeks after treatment completion (SVR-12), adverse events, and treatment discontinuations in patients who received sofosbuvir-based DAA regimens between December 2013 and November 2014. RESULTS: Despite limited specialist provider involvement in medically underserved areas, all but two of 58 patients completed treatment, and 88 % of patients achieved the curative endpoint of undetectable HCV RNA 12 weeks after completing treatment (sustained virologic response, SVR-12). Almost 80 % of patients with cirrhosis and 85 % of patients with prior treatment experience achieved SVR-12. CONCLUSIONS: Treatment effectiveness with sofosbuvir-based regimens in medically underserved areas utilizing task-shifting from a specialist to a mid-level provider is comparable to those achieved in pivotal clinical trials for these regimens, and to “real-world” experiences of tertiary care centers in the USA.
Authors: Stefan Zeuzem; Geoffrey M Dusheiko; Riina Salupere; Alessandra Mangia; Robert Flisiak; Robert H Hyland; Ari Illeperuma; Evguenia Svarovskaia; Diana M Brainard; William T Symonds; G Mani Subramanian; John G McHutchison; Ola Weiland; Hendrik W Reesink; Peter Ferenci; Christophe Hézode; Rafael Esteban Journal: N Engl J Med Date: 2014-05-04 Impact factor: 91.245
Authors: Mehdi Najafzadeh; Karin Andersson; William H Shrank; Alexis A Krumme; Olga S Matlin; Troyen Brennan; Jerry Avorn; Niteesh K Choudhry Journal: Ann Intern Med Date: 2015-03-17 Impact factor: 25.391
Authors: Eric Lawitz; Alessandra Mangia; David Wyles; Maribel Rodriguez-Torres; Tarek Hassanein; Stuart C Gordon; Michael Schultz; Mitchell N Davis; Zeid Kayali; K Rajender Reddy; Ira M Jacobson; Kris V Kowdley; Lisa Nyberg; G Mani Subramanian; Robert H Hyland; Sarah Arterburn; Deyuan Jiang; John McNally; Diana Brainard; William T Symonds; John G McHutchison; Aasim M Sheikh; Zobair Younossi; Edward J Gane Journal: N Engl J Med Date: 2013-04-23 Impact factor: 91.245
Authors: Maxine M Denniston; Ruth B Jiles; Jan Drobeniuc; R Monina Klevens; John W Ward; Geraldine M McQuillan; Scott D Holmberg Journal: Ann Intern Med Date: 2014-03-04 Impact factor: 25.391
Authors: Eric Lawitz; Mark S Sulkowski; Reem Ghalib; Maribel Rodriguez-Torres; Zobair M Younossi; Ana Corregidor; Edwin DeJesus; Brian Pearlman; Mordechai Rabinovitz; Norman Gitlin; Joseph K Lim; Paul J Pockros; John D Scott; Bart Fevery; Tom Lambrecht; Sivi Ouwerkerk-Mahadevan; Katleen Callewaert; William T Symonds; Gaston Picchio; Karen L Lindsay; Maria Beumont; Ira M Jacobson Journal: Lancet Date: 2014-07-28 Impact factor: 79.321
Authors: Channa R Jayasekera; Rachel Beckerman; Nathaniel Smith; Ryan B Perumpail; Robert J Wong; Zobair M Younossi; Aijaz Ahmed Journal: J Clin Transl Hepatol Date: 2017-02-02
Authors: Yuely A Capileno; Rafael Van den Bergh; Dmytro Donchunk; Sven Gudmund Hinderaker; Saeed Hamid; Rosa Auat; Gul Ghuttai Khalid; Razia Fatima; Aashifa Yaqoob; Catherine Van Overloop Journal: PLoS One Date: 2017-04-27 Impact factor: 3.240
Authors: Sarah A Rojas; Job G Godino; Adam Northrup; Maureen Khasira; Aaron Tam; Lisa Asmus; Catherine Frenette; Christian B Ramers Journal: Hepatol Commun Date: 2020-12-21