Eliminating hepatitis C in a rural Appalachian county: protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C
| Autor: | Peter Vickerman, Jennifer R. Havens, Michele Staton, Michelle R. Lofwall, Ardis D. Hoven, Takako Schaninger, Sharon L. Walsh, April M. Young, Hannah Fraser |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Genotype Sofosbuvir Hepatitis C virus Kentucky Gastroenterology and Hepatology Hepacivirus medicine.disease_cause Antiviral Agents Heterocyclic Compounds 4 or More Rings Sofosbuvir/velpatasvir 03 medical and health sciences 0302 clinical medicine Pregnancy Internal medicine Humans Medicine 030212 general & internal medicine business.industry public health General Medicine Hepatitis C Hepatitis C Chronic medicine.disease Institutional review board Clinical trial Treatment Outcome hepatology epidemiology Drug Therapy Combination Female 030211 gastroenterology & hepatology Carbamates business Viral hepatitis Viral load medicine.drug |
| Zdroj: | BMJ Open, Vol 11, Iss 7 (2021) BMJ Open |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2020-041490 |
| Popis: | ObjectivesThe overall goal of the Kentucky Viral Hepatitis Treatment Study (KeY Treat) is to eliminate hepatitis C transmission from a county in Appalachian Kentucky by removing the barriers to accessing hepatitis C virus (HCV) treatment.Methods/analysisKeY Treat is a phase IV, open-label, single-arm clinical trial of sofosbuvir/velpatasvir (SOF/VEL) for the treatment of viraemic HCV infections. Those eligible for KeY Treat are at least 18 years of age, viraemic and are residents of the target county. Pregnant women are not eligible. Rapid HCV RNA screening is used to determine eligibility, and those with a quantifiable viral load (VL) consenting to participate initiate SOF/VEL on the same day. All pharmacologic treatment and related medical care is provided free of charge using a non-specialist provider model. Follow-up visits occur at 2, 6 and 12 weeks during treatment to assess medication adherence (measured via VL and self-report), side effects and engagement in risk behaviours. Post-treatment visits occur at 12 weeks (sustained virologic response (SVR12) visit), 6 months and 12 months post-treatment completion to assess re-infection. A control county has also been identified, and prevalence and incidence of chronic HCV infections will be compared with the target community longitudinally. The primary outcome to assess elimination is SVR12. However, several outcomes will be measured to assess the effectiveness of removing the barriers to HCV treatment, including treatment entry, completion and re-infection. Analyses will be conducted via a generalised linear model framework that can incorporate flexible covariate adjustment and multiple outcome types with a compatible link function. Mathematical modelling will be completed assessing the impact and cost-effectiveness of the intervention.Ethics and disseminationKeY Treat has been approved by the Institutional Review Board at the University of Kentucky. Results from KeY Treat will be presented at conferences and published in peer-reviewed journals.Trial registration numberNCT03949764. |
| Databáze: | OpenAIRE |
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