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

Abstract

IntroductionTo 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.MethodsThis 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.ResultsDuring 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).ConclusionsThis 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.

Assessing feasibility of a modified same-day test-and-treat model for hepatitis C among rural people who inject drugs

“…The modified same-day test-and-treat model was adapted from the existing practice in Malaysia (see Fig. 1 ) [ 19 ]. The implementation of this model in the current study was led by the Ministry of Health and did not receive any external funding.…”

“…Only individuals who met the following criteria were eligible for the current study: (i) were at least 18 years of age, (ii) had a history of intravenous drug use, (iii) tested positive for anti-HCV, and (iv) were naïve to DAA-based treatment. The required sample size for the study was 194, as estimated based on a pilot project of HCV care decentralization in Malaysia, which reported that 83.8% of anti-HCV-positive participants were HCV RNA positive [ 19 ]. The formula used for the sample size calculation was the single proportion estimation formula [ 25 ], with a fixed level of confidence of 90% and a precision of 5%.…”

“…In 2019, the decentralization of HCV care in Malaysia allowed for access to rapid anti-HCV testing and DAA-based treatment for key populations at risk of HCV in primary healthcare (PHC) centers operated by the Ministry of Health [ 19 ]. While hospitals continue to serve as referral centers for those with cirrhosis and offer laboratory support for HCV ribonucleic acid (RNA) testing, not all people who inject drugs (PWID) seek medical care despite the high incidence of HCV [ 20 , 21 ].…”

Diagnostic performance of two non-invasive biomarkers used individually and in sequential combination for cirrhosis associated with hepatitis C virus infection

“…The HEAD-Start study was a collaborative project between the Foundation for Innovative New Diagnostics (FIND), the Drugs for Neglected Diseases initiative (DND i ) and the Ministry of Health (MOH), aiming to decentralize hepatitis C screening and treatment through 25 PHC clinics across Malaysia. It targeted adults aged between 18 and 70 years who sought primary care or harm reduction services and were found to have a positive serological rapid diagnostic test (RDT) result for HCV between December 2018 and December 2019 9 . Participants with a positive RDT result were then referred to one of the five selected tertiary hospitals for confirmatory diagnosis of hepatitis C (based on HCV ribonucleic acid (RNA) test using the reverse transcription polymerase chain reaction technique), laboratory biochemical tests and liver stiffness assessment using transient elastography (TE).…”

“…However, it is often challenging to diagnose cirrhosis among potential treatment recipients in PHC settings due to the lack of facilities for imaging and biopsy 3 , 8 . Referring them to hospitals just for cirrhosis status assessment often results in loss to follow-up attributable to the stigma, logistical barriers and unaffordable transportation costs 9 , 10 .…”