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Assessing the impact of simplified HCV care on linkage to care amongst high-risk patients at primary healthcare clinics in Malaysia: a prospective observational study

Markby J 1 , Shilton S 2 , Sem X 1 , Chan HK 3 , Md Said R 4 , Siva S 5 Show all authors , Zainuddin Z 6 , Abu Bakar N 7 , Omar H 8 , Ruiz RJI 1 , Gaeddert M 9 , Tyshkovskiy A 10 , Adee M 11 , Chhatwal J 11 , Kumar S 12 , Piedagnel JM 5 , Mohd Zain R 13 , Menétrey C 5 , Yuswan F 14 , Hairizan Nasir N 15 , Andrieux-Meyer I 5 , Ismail F 15 , Zakaria R 15 , Hasim R 15 , Murad S 5 , Easterbrook P 16 , Hassan MRA 3

Affiliations 

  • 1 FIND, Geneva, Switzerland
  • 2 FIND, Geneva, Switzerland [email protected]
  • 3 Clinical Research Centre, Hospital Sultanah Bahiyah, Alor Setar, Malaysia
  • 4 Hospital Ampang, Ampang Jaya, Malaysia
  • 5 Drugs for Neglected Diseases initiative, Geneva, Switzerland
  • 6 Hospital Sultanah Bahiyah, Alor Setar, Malaysia
  • 7 Hospital Raja Perempuan Zainab II, Kota Bharu, Malaysia
  • 8 Hospital Selayang, Batu Caves, Malaysia
  • 9 Division of Clinical Tropical Medicine, Center of Infectious Diseases, University Hospital Heidelberg, Heidelberg, Germany
  • 10 Division of Genetics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
  • 11 Institute for Technology Assessment, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
  • 12 Hospital Sungai Buloh, Sungai Buloh, Malaysia
  • 13 Institute for Medical Research, Kuala Lumpur, Malaysia
  • 14 Disease Control Division, Ministry of Health, Putrajaya, Malaysia
  • 15 Family Health Development Division, Ministry of Health, Putrajaya, Malaysia
  • 16 Global HIV, Hepatitis & STI Programmes, World Health Organization, Geneva, Switzerland
BMJ Open, 2021 Dec 24;11(12):e055142.
PMID: 34952885 DOI: 10.1136/bmjopen-2021-055142

Abstract

INTRODUCTION: To achieve the elimination of hepatitis C virus (HCV), substantial scale-up in access to testing and treatment is needed. This will require innovation and simplification of the care pathway, through decentralisation of testing and treatment to primary care settings and task-shifting to non-specialists. The objective of this study was to evaluate the feasibility and effectiveness of decentralisation of HCV testing and treatment using rapid diagnostic tests (RDTs) in primary healthcare clinics (PHCs) among high-risk populations, with referral of seropositive patients for confirmatory viral load testing and treatment.

METHODS: This observational study was conducted between December 2018 and October 2019 at 25 PHCs in three regions in Malaysia. Each PHC was linked to one or more hospitals, for referral of seropositive participants for confirmatory testing and pretreatment evaluation. Treatment was provided in PHCs for non-cirrhotic patients and at hospitals for cirrhotic patients.

RESULTS: During the study period, a total of 15 366 adults were screened at the 25 PHCs, using RDTs for HCV antibodies. Of the 2020 (13.2%) HCV antibody-positive participants, 1481/2020 (73.3%) had a confirmatory viral load test, 1241/1481 (83.8%) were HCV RNA-positive, 991/1241 (79.9%) completed pretreatment assessment, 632/991 (63.8%) initiated treatment, 518/632 (82.0%) completed treatment, 352/518 (68.0%) were eligible for a sustained virological response (SVR) cure assessment, 209/352 (59.4%) had an SVR cure assessment, and SVR was achieved in 202/209 (96.7%) patients. A significantly higher proportion of patients referred to PHCs initiated treatment compared with those who had treatment initiated at hospitals (71.0% vs 48.8%, p<0.001).

CONCLUSIONS: This study demonstrated the effectiveness and feasibility of a simplified decentralised HCV testing and treatment model in primary healthcare settings, targeting high-risk groups in Malaysia. There were good outcomes across most steps of the cascade of care when treatment was provided at PHCs compared with hospitals.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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