Abstract
Background:
Point of care (POC) hepatitis C virus (HCV) viral load (VL) assays are being used increasingly as an alternate to laboratory-based high-throughput standard-of-care (SoC) VL assays to reduce loss to follow-up. We undertook a systematic review and meta-analysis to evaluate the impact of using POC HCV VL compared to laboratory-based SoC approaches on uptake of VL testing and treatment, and turnaround times.
Methods:
We searched PubMed, Embase, Web of Science, and conference abstracts for studies published from 01/2016-09/2020 that used POC HCV VL assays and had data on cascade of care outcomes and/or turnaround times. We categorised study arms according to whether the POC VL was based onsite at the clinic (Arm 1), in a mobile unit (Arm 2), or in a laboratory (Arm 3), versus a lab-based SoC VL assay (Arm 4). For turnaround times we calculated the weighted median of medians. We analysed VL testing and treatment uptake using random-effects meta-analysis. The quality of evidence was rated using the GRADE framework. PROSPERO registration: CRD42020218239.
Findings:
We included 45 studies with 64 within-study arms: 28 studies among people who inject drugs/homeless populations, 4 among prisoners, 9 among general population, and 4 among persons with HIV. All were observational studies. The pooled median turnaround times between HCV antibody test and treatment initiation was shorter with onsite POC VL (18.5 days [95%CI: 14–53]) than with either lab-based POC VL (64 [64–64]), or lab-based SoC VL (67 [50–67]). Treatment uptake was higher with onsite POC VL (Arm 1) 77% (72%–83%), or 81% (60%–97%) with mobile POC VL (Arm 2) versus 53% (31%–75%) with lab-based SoC VL (Arm 4): Arms 1/2 versus 4 p-value=0.03. Four studies had direct within-study POC versus lab-based comparison for VL testing uptake and 10 studies on treatment uptake. The pooled relative risk for VL uptake was 1.11 (0.89–1.38) for POC versus lab-based arms and 1.32 (1.06–1.64) for treatment uptake. Overall, the quality of evidence was rated as low (observational studies only).
Interpretation:
The use of POC HCV VL was associated with reduced time to from antibody test to treatment initiation and increased treatment uptake. The impact of POC VL is greatest when positioned within a simplified care where testing and treatment are ideally conducted at the same site, and, where possible, the same day. POC HCV VL testing is now recommended by WHO guidelines as an alternative strategy to lab-based VL testing.
Point of care (POC) hepatitis C virus (HCV) viral load (VL) assays are being used increasingly as an alternate to laboratory-based high-throughput standard-of-care (SoC) VL assays to reduce loss to follow-up. We undertook a systematic review and meta-analysis to evaluate the impact of using POC HCV VL compared to laboratory-based SoC approaches on uptake of VL testing and treatment, and turnaround times.
Methods:
We searched PubMed, Embase, Web of Science, and conference abstracts for studies published from 01/2016-09/2020 that used POC HCV VL assays and had data on cascade of care outcomes and/or turnaround times. We categorised study arms according to whether the POC VL was based onsite at the clinic (Arm 1), in a mobile unit (Arm 2), or in a laboratory (Arm 3), versus a lab-based SoC VL assay (Arm 4). For turnaround times we calculated the weighted median of medians. We analysed VL testing and treatment uptake using random-effects meta-analysis. The quality of evidence was rated using the GRADE framework. PROSPERO registration: CRD42020218239.
Findings:
We included 45 studies with 64 within-study arms: 28 studies among people who inject drugs/homeless populations, 4 among prisoners, 9 among general population, and 4 among persons with HIV. All were observational studies. The pooled median turnaround times between HCV antibody test and treatment initiation was shorter with onsite POC VL (18.5 days [95%CI: 14–53]) than with either lab-based POC VL (64 [64–64]), or lab-based SoC VL (67 [50–67]). Treatment uptake was higher with onsite POC VL (Arm 1) 77% (72%–83%), or 81% (60%–97%) with mobile POC VL (Arm 2) versus 53% (31%–75%) with lab-based SoC VL (Arm 4): Arms 1/2 versus 4 p-value=0.03. Four studies had direct within-study POC versus lab-based comparison for VL testing uptake and 10 studies on treatment uptake. The pooled relative risk for VL uptake was 1.11 (0.89–1.38) for POC versus lab-based arms and 1.32 (1.06–1.64) for treatment uptake. Overall, the quality of evidence was rated as low (observational studies only).
Interpretation:
The use of POC HCV VL was associated with reduced time to from antibody test to treatment initiation and increased treatment uptake. The impact of POC VL is greatest when positioned within a simplified care where testing and treatment are ideally conducted at the same site, and, where possible, the same day. POC HCV VL testing is now recommended by WHO guidelines as an alternative strategy to lab-based VL testing.
| Original language | English |
|---|---|
| Pages (from-to) | 253-270 |
| Number of pages | 18 |
| Journal | Lancet Gastroenterology and Hepatology |
| Volume | 8 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 24 Jan 2023 |
Bibliographical note
Funding Information:This work was supported through a grant from Unitaid to WHO. We thank all authors of the included studies, particularly Elena Ivanova and Sonjelle Shilton (Foundation for Innovative Diagnostics) for sharing updated data from Unitaid funded studies; Jason Grebely, Saeed Hamid, Suna Balkan, Yvonne Flammer, and Martin Colla for their assistance in identifying relevant unpublished literature; and Roger Chou for guidance on the grading of evidence and Grading of Recommendations, Assessment, Development and Evaluations tables.
Publisher Copyright:
© 2023 World Health Organization
Research Groups and Themes
- GEM-B
