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New WHO study: Making diagnosis of hepatitis C more accessible and closer to the community using point-of-care HCV viral load assays
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Download the PDF here
Jan 23 2023
Today, Lancet Gastroenterology and Hepatology published a key new WHO-led study in collaboration with the University of Bristol showing the benefit of using a quick clinic-based diagnostic test for hepatitis C virus (HCV) infection over a standard laboratory-based test.
The findings from this study led to recent WHO recommendations for adoption of POC HCV viral load testing as an alternative approach to laboratory-based platforms for diagnosing HCV infection and speeding up starting curative treatment.
WHO is encouraging affected countries to consider including use of POC assays in their national policies on hepatitis C.
The COVID-19 pandemic prompted a major expansion of these POC diagnostic assays in many LMICs, which provides an opportunity to share their use for HCV VL testing and therefore reduce costs. Many countries including Australia, Cambodia, Malaysia and Myanmar have adopted use of these POC assays in their national programmes. WHO is now undertaking a similar evaluation of POC viral load assays for hepatitis B in its planned 2023 updated guidance.
The optimal populations and settings for POC assays are hard to reach or marginalized populations at high risk of loss to follow-up, such as persons who inject drugs or persons experiencing homelessness. The POC assay can be placed in harm-reduction clinics, primary care clinics, prisons, in mobile units or even in community clinics, and offers the possibility of a one-stop, same-day diagnosis and treatment of HCV infection.
https://www.who.int/news/item/24-01-2023-new-who-study-making-diagnosis-of-hcv-more-accessible-and-closer-to-the-community-using-poc-hcv-viral-load-assays
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HCV POC (Point of Care) Viral Load Testing is Quick and Results in Immediate linkage or Treatment - So why is it taking so long for the FDA to approve the Cepheid Test - new study reports
There were several key findings. First, compared with SOC viral load testing, the pooled median turnaround times between HCV antibody testing and treatment initiation was reduced with onsite POC assays (19 days) versus laboratory-based POC assays (64 days) or laboratory-based SOC assays (67 days), mainly due to reduced time from viral load testing to treatment initiation.
Second, there was an overall increase in treatment uptake with onsite (77%) or mobile POC assays (81%) compared with SOC assays (53%).
Third, increased HCV viral load testing and treatment uptake with POC viral load assays was greatest among people who inject drugs, were homeless, or both for viral load testing uptake, and among people incarcerated in prison for treatment uptake. Fourth, direct within-study comparisons of groups receiving POC and SOC testing confirmed the shorter turnaround times in the POC groups in seven studies and improved treatment uptake in ten studies (relative risk 1⋅32 [95% CI 1⋅06-1⋅64]) and some evidence to suggest increased viral load testing uptake among those receiving POC testing (1⋅11 [0⋅89-1⋅38]) in four studies. Finally, the impact of POC viral load was greatest when positioned in a simplified care model in which testing and treatment were done at the same site, and, where possible, on the same day.
Time between HCV antibody testing and treatment initiation was shorter for the ten onsite POC arms (weighted median of medians 19 days [95% CI 14-53]) than for the one laboratory-based POC assay arm (64 days [64-64]) and the two arms that used SOC assays (67 days [50-67]; table 5). The one small study (n=44) that used a POC assay in a mobile unit reported a median of 0 days (95% CI 0-0) between HCV antibody testing and treatment initiation (table 5).
The pooled median turnaround times between HCV antibody test and treatment initiation was shorter with onsite POC assays (19 days [95% CI 14-53], ten arms) than with either laboratory-based POC assays (64 days [64-64], one arm) or laboratory-based SOC assays (67 days [50-67], two arms). Treatment uptake was higher with onsite POC assays (77% [95% CI 72-83], 34 arms) or mobile POC assays (81% [60-97], five arms) than with SOC assays (53% [31-75], 12 arms);
The main intervention group was use of a POC HCV RNA assay (POC group), and the comparator group was use of a centralised, laboratory-based, high-throughput SOC HCV RNA assay (SOC group).
All of the POC viral load assays were GeneXpert (Cepheid, Sunnyvale, CA, USA), except one study that used Genedrive (Epistem, Manchester, UK) 52 Overall, the POC RNA viral load test was done onsite in 39 study arms, in a mobile unit in six arms, and in a laboratory in six arms. 12 studies (13 arms) had a SOC assay comparator, including one study (HEAD-start Georgia) with two SOC arms. Most comparator arms were based on historical data, and one was based on concurrent data. 44 Of the 51 POC arms and 13 SOC arms, 32 (63%) and seven (54%), respectively, comprised people who inject drugs, were homeless, or both (p=0⋅30), and 24 (47%) and eight (62%), respectively, were in high-income countries (p=0⋅35).
Impact of hepatitis C virus point-of-care RNA viral load testing compared with laboratory-based testing on uptake of RNA testing and treatment, and turnaround times: a systematic review and meta-analysis
Findings
We included 45 studies with 64 within-study arms: 28 studies were in people who inject drugs, were homeless, or both; four were in people incarcerated in prison; nine were in the general or mixed (ie, includes high-risk groups) populations; and four were in people living with HIV. All were observational studies. The pooled median turnaround times between HCV antibody test and treatment initiation was shorter with onsite POC assays (19 days [95% CI 14-53], ten arms) than with either laboratory-based POC assays (64 days [64-64], one arm) or laboratory-based SOC assays (67 days [50-67], two arms). Treatment uptake was higher with onsite POC assays (77% [95% CI 72-83], 34 arms) or mobile POC assays (81% [60-97], five arms) than with SOC assays (53% [31-75], 12 arms); onsite and mobile POC assay vs SOC assay p=0⋅029). For POC and SOC arms, higher RNA viral load testing uptake was seen with the same-site models for testing and treatment than with different-site models (all within-category p≤0⋅0001). For onsite and mobile POC arms, there was higher treatment uptake for same-site than different-site models (within-category p<0⋅0001). Four studies had direct within-study POC versus SOC comparisons for RNA viral load testing uptake (pooled relative risk 1⋅11 [95% CI 0⋅89-1⋅38]), and there were ten studies on treatment uptake (1⋅32 [1⋅06-1⋅64]). Overall, the quality of evidence was rated as low.
Interpretation
Compared with use of laboratory-based SOC HCV viral load testing, the use of POC assays was associated with reduced time from antibody test to treatment initiation and increased treatment uptake. The effect of POC viral load testing is greatest when positioned within a simplified care model in which testing and treatment are provided at the same site, and, where possible, on the same day. POC HCV RNA viral load testing is now recommended in WHO guidelines as an alternative strategy to laboratory-based viral load testing.
Funding
Unitaid.
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