scholarly journals Decentralized, Community-Based Hepatitis C Point-of-Care Testing and Direct-Acting Antiviral Treatment for People Who Inject Drugs and the General Population in Myanmar: Protocol for a Feasibility Study

10.2196/16863 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e16863
Author(s):  
Bridget Louise Draper ◽  
Alisa Pedrana ◽  
Jessica Howell ◽  
Win Lei Yee ◽  
Hla Htay ◽  
...  
Keyword(s):  
Hepatitis C ◽  
General Population ◽  
Feasibility Study ◽  
People Who Inject Drugs ◽  
Point Of Care ◽  
Community Based ◽  
Middle Income ◽  
Hepatitis C Rna ◽  
Direct Acting ◽  
Low And Middle Income

Background The advent of direct-acting antivirals (DAAs) and point-of-care (POC) testing platforms for hepatitis C allow for the decentralization of care to primary care settings. In many countries, access to DAAs is generally limited to tertiary hospitals, with limited published research documenting decentralized models of care in low-and middle-income settings. Objective This study aims to assess the feasibility, acceptability, effectiveness, and cost-effectiveness of decentralized community-based POC testing and DAA therapy for hepatitis C among people who inject drugs and the general population in Yangon, Myanmar. Methods Rapid diagnostic tests for anti-hepatitis C antibodies were carried out on-site and, if reactive, were followed by POC GeneXpert hepatitis C RNA polymerase chain reaction tests. External laboratory blood tests to exclude other major health issues were undertaken. Results were given to participants at their next appointment, with the participants commencing DAA therapy that day if a specialist review was not required. Standard clinical data were collected, and the participants completed behavioral questionnaires. The primary outcome measures are the proportion of participants receiving GeneXpert hepatitis C RNA test, the proportion of participants commencing DAA therapy, the proportion of participants completing DAA therapy, and the proportion of participants achieving sustained virological response 12 weeks after completing DAA therapy. Results Recruitment was completed on September 30, 2019. Monitoring visits and treatment outcome visits are scheduled to continue until June 2020. Conclusions This feasibility study in Myanmar contributes to the evidence gap for community-based hepatitis C care in low- and middle-income settings. Evidence from this study will inform the scale-up of hepatitis C treatment programs in Myanmar and globally.

scholarly journals Decentralized, Community-Based Hepatitis C Point-of-Care Testing and Direct-Acting Antiviral Treatment for People Who Inject Drugs and the General Population in Myanmar: Protocol for a Feasibility Study (Preprint)

2019 ◽  
Author(s):  
Bridget Louise Draper ◽  
Alisa Pedrana ◽  
Jessica Howell ◽  
Win Lei Yee ◽  
Hla Htay ◽  
...  
Keyword(s):  
Hepatitis C ◽  
General Population ◽  
Feasibility Study ◽  
People Who Inject Drugs ◽  
Point Of Care ◽  
Community Based ◽  
Middle Income ◽  
Hepatitis C Rna ◽  
Direct Acting ◽  
Low And Middle Income

BACKGROUND The advent of direct-acting antivirals (DAAs) and point-of-care (POC) testing platforms for hepatitis C allow for the decentralization of care to primary care settings. In many countries, access to DAAs is generally limited to tertiary hospitals, with limited published research documenting decentralized models of care in low-and middle-income settings. OBJECTIVE This study aims to assess the feasibility, acceptability, effectiveness, and cost-effectiveness of decentralized community-based POC testing and DAA therapy for hepatitis C among people who inject drugs and the general population in Yangon, Myanmar. METHODS Rapid diagnostic tests for anti-hepatitis C antibodies were carried out on-site and, if reactive, were followed by POC GeneXpert hepatitis C RNA polymerase chain reaction tests. External laboratory blood tests to exclude other major health issues were undertaken. Results were given to participants at their next appointment, with the participants commencing DAA therapy that day if a specialist review was not required. Standard clinical data were collected, and the participants completed behavioral questionnaires. The primary outcome measures are the proportion of participants receiving GeneXpert hepatitis C RNA test, the proportion of participants commencing DAA therapy, the proportion of participants completing DAA therapy, and the proportion of participants achieving sustained virological response 12 weeks after completing DAA therapy. RESULTS Recruitment was completed on September 30, 2019. Monitoring visits and treatment outcome visits are scheduled to continue until June 2020. CONCLUSIONS This feasibility study in Myanmar contributes to the evidence gap for community-based hepatitis C care in low- and middle-income settings. Evidence from this study will inform the scale-up of hepatitis C treatment programs in Myanmar and globally. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16863

Access to hepatitis C treatment for people who inject drugs in low and middle income settings: Evidence from 5 countries in Eastern Europe and Asia

2015 ◽  
Vol 26 (11) ◽  
pp. 1081-1087 ◽  
Author(s):  
Niklas Luhmann ◽  
Julie Champagnat ◽  
Sergey Golovin ◽  
Ludmila Maistat ◽  
Edo Agustian ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Eastern Europe ◽  
People Who Inject Drugs ◽  
Hepatitis C Treatment ◽  
Middle Income ◽  
Low And Middle Income

scholarly journals Towards HCV elimination among people who inject drugs in Hai Phong, Vietnam: study protocol for an effectiveness-implementation trial evaluating an integrated model of HCV care (DRIVE-C: DRug use & Infections in ViEtnam–hepatitis C)

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e039234
Author(s):  
Delphine Rapoud ◽  
Catherine Quillet ◽  
Khue Pham Minh ◽  
Vinh Vu Hai ◽  
Binh Nguyen Thanh ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Drug Use ◽  
People Who Inject Drugs ◽  
Human Subjects ◽  
Linkage To Care ◽  
Population Level ◽  
Community Based ◽  
Resource Limited ◽  
Registration Number ◽  
Direct Acting

IntroductionIn Vietnam, people who inject drugs (PWID), who are the major population infected by hepatitis C virus (HCV), remain largely undiagnosed and unlinked to HCV prevention and care despite recommended universal hepatitis C treatment. The data on the outcomes of HCV treatment among PWID also remain limited in resource-limited settings. The DRug use & Infections in ViEtnam–hepatitis C (DRIVE-C) study examines the effectiveness of a model of hepatitis C screening and integrated care targeting PWID that largely uses community-based organisations (CBO) in Hai Phong, Vietnam. In a wider perspective, this model may have the potential to eliminate HCV among PWID in this city.Methods and analysisThe model of care comprises large community-based mass screening, simplified treatment with direct-acting antivirals (DAAs) and major involvement of CBO for PWID reaching out, linkage to care, treatment adherence and prevention of reinfection. The effectiveness of DAA care strategy among PWID, the potential obstacles to widespread implementation and its impact at population level will be assessed. A cost-effectiveness analysis is planned to further inform policy-makers. The enrolment target is 1050 PWID, recruited from the DRIVE study in Hai Phong. After initiation of pan-genotypic treatment consisting of sofosbuvir and daclatasvir administrated for 12 weeks, with ribavirin added in cases of cirrhosis, participants are followed-up for 48 weeks. The primary outcome is the proportion of patients with sustained virological response at week 48, that will be compared with a theoretical expected rate of 70%.Ethics and disseminationThe study was approved by Haiphong University of Medicine and Pharmacy's Ethics Review Board and the Vietnamese Ministry of Health. The sponsor and the investigators are committed to conducting this study in accordance with ethics principles contained in the World Medical Association's Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects). Informed consent is obtained before study enrolment. The data are anonymised and stored in a secure database. The study is ongoing. Results will be presented at international conferences and submitted to international peer-review journals.Trial registration numberNCT03537196.

scholarly journals Community‐based, point‐of‐care hepatitis C testing: perspectives and preferences of people who inject drugs

2019 ◽  
Vol 26 (7) ◽  
pp. 919-922 ◽  
Author(s):  
Ned H. Latham ◽  
Alisa Pedrana ◽  
Joseph S. Doyle ◽  
Jessica Howell ◽  
Bridget Williams ◽  
...  
Keyword(s):  
Hepatitis C ◽  
People Who Inject Drugs ◽  
Point Of Care ◽  
Community Based

scholarly journals Real-World Outcomes of Direct-Acting Antiviral Treatment and Retreatment in United Kingdom–Based Patients Infected With Hepatitis C Virus Genotypes/Subtypes Endemic in Africa

2021 ◽  
Author(s):  
Elihu Aranday-Cortes ◽  
C Patrick McClure ◽  
Christopher Davis ◽  
William L Irving ◽  
Kazeem Adeboyejo ◽  
...  
Keyword(s):  
United Kingdom ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Treatment Failure ◽  
Antiviral Treatment ◽  
Natural Resistance ◽  
Eastern Africa ◽  
Middle Income ◽  
Hcv Genotypes ◽  
Direct Acting

Abstract Background Chronic hepatitis C virus (HCV) infection affects 71 million individuals, mostly residing in low- and middle-income countries (LMICs). Direct-acting antivirals (DAAs) give high rates of sustained virological response (SVR) in high-income countries where a restricted range of HCV genotypes/subtypes circulate. Methods We studied United Kingdom–resident patients born in Africa to examine DAA effectiveness in LMICs where there is far greater breadth of HCV genotypes/subtypes. Viral genome sequences were determined from 233 patients. Results Full-length viral genomic sequences for 26 known subtypes and 5 previously unidentified isolates covering 5 HCV genotypes were determined. From 149 patients who received DAA treatment/retreatment, the overall SVR was 93%. Treatment failure was associated primarily with 2 subtypes, gt1l and gt4r, using sofosbuvir/ledipasvir. These subtypes contain natural resistance-associated variants that likely contribute to poor efficacy with this drug combination. Treatment failure was also significantly associated with hepatocellular carcinoma. Conclusions DAA combinations give high SVR rates despite the high HCV diversity across the African continent except for subtypes gt1l and gt4r, which respond poorly to sofosbuvir/ledipasvir. These subtypes are widely distributed across Western, Central, and Eastern Africa. Thus, in circumstances where accurate genotyping is absent, ledipasvir and its generic compounds should not be considered as a recommended treatment option.

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