Research finds community-based non-specialist providers are effective in the absence of Hepatitis C experts and a growing patient population
Baltimore, MD, April 13, 2016: The Institute of Human Virology (IHV) at the University of Maryland School of Medicine released data today at The International Liver CongressTM 2016 in Barcelona, Spain demonstrating that treatment for hepatitis C virus (HCV) can be provided safely and effectively within a community-based and non-specialist setting. The study, sponsored by the National Institutes of Health (NIH), alleviates growing pressure on overburdened HCV specialists by showing that alternative, trained providers are effective.;
“With such a large patient cohort, ensuring that patients can access safe, effective and appropriate treatment is essential,” said Sarah Kattakuzhy, MD, Associate Professor of Medicine, Institute of Human Virology, University of Maryland School of Medicine and lead author of the study. “Currently, the limited availability of experienced specialists restricts rapid expansion of Hepatitis C treatment, compromising the goal of global eradication. As such, care models which bypass this therapeutic bottleneck must be explored.”
The multi-center, open label, Phase 4 clinical trial assessed chronic HCV-infected patients at community health centers in the United States. Patients received non-randomized treatment from a specialist provider, primary care physician or nurse practitioner. According to study protocols, providers underwent uniform three hour training on the Infectious Disease Society of America (IDSA) – American Association for the Study of Liver Disease (AASLD) guidelines for HCV.
To ensure continuity, patients received the same standardized treatments with direct-acting antivirals (ledipasvir and sofosbuvir), with outcomes assessed via unquantifiable HCV RNA viral load 12 weeks after the completion of treatment (SVR12) and by a composite score of attendance.* Patients participating in the study were inclusive of challenging subpopulations; predominantly they were black (96%) and genotype 1a (72%), 24% were co-infected with HIV and HCV, 18% were treatment experienced and 20% had cirrhosis, or scarring of the liver.
"Availability of new drugs makes treatment for hepatitis C very effective and simple,” said Shyamasundaran Kottilil, MBBS, PhD, Professor of Medicine, Co-Director, Clinical Research Unit, Associate Director for Clinical Research, Institute of Human Virology, University of Maryland School of Medicine. “However, we need to train new providers other than hematologist and infectious disease physicians to expand care of hepatitis C. This study is the first step toward development of a training paradigm that is tested and proven. We hope this model of care can be adapted to other communities and countries with high prevalence of hepatitis C."
The study found that of the 304 patients, 285 achieved SVR12 (93.8% per protocol; 88.2%
intention-to-treat including patients who discontinued medication early), with no significant difference identified between providers for achieving this outcome. SVR12 was achieved by 92.1% of patients receiving care from specialists, 96.7% of patients receiving care from primary care physicians and 94.9% of patients receiving care from nurse practitioners.
“The data presented here is extremely welcome and shows great potential to escalate treatment options and protocols for Hepatitis C. We have the therapies, we now need to make sure we can effectively roll them out to patients,” said Professor Tom Hemming Karlsen, EASL Vice-Secretary. “We know we have too few experienced specialists treating HCV and this is severely hampering our ability to eradicate this disease once and for all. This research has the potential to be a genuine game changer in the way we look at HCV treatment across the board, and could provide the opportunity to increase access to care and treatment to many regions of the world.”
*Statistical analysis included chi-squared or Fisher’s exact test and logistic regression using SAS, version 9.3.
1 World Health Organization. Hepatitis C Fact Sheet N°164. Available from: http://www.who.int/mediacentre/factsheets/fs164/en/. Last accessed: March 2016.
2 World Health Organization. Global Alert and Response – Hepatitis C. Available from: http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index3.html. Last accessed: March 2016.
About the Institute of Human Virology
Formed in 1996 as a partnership between the State of Maryland, the City of Baltimore, the University System of Maryland and the University of Maryland Medical System, IHV is an institute of the University of Maryland School of Medicine and is home to some of the most globally-recognized and world-renowned experts in all of virology. The IHV combines the disciplines of basic research, epidemiology and clinical research in a concerted effort to speed the discovery of diagnostics and therapeutics for a wide variety of chronic and deadly viral and immune disorders - most notably, HIV the virus that causes AIDS. For more information, visit www.ihv.org and follow us on Twitter @IHVmaryland.
About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ takes place from April 13 – 17, 2016, at the Fira Barcelona Gran Via, Barcelona, Spain.
About EASL (www.easl.eu)
Since EASL’s foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.
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