Evaluation of the Xpert HCV Viral Load Fingerstick assay in the harm reduction setting in Catalonia, Spain

Author: Saludes V, Antuori A, Folch C, González-Gómez S, González N, Ibáñez N, Colom J, Lazarus JV, L. Matas, Casabona J, Martró E

Theme: Models of Care Year: 2019

Background: In Catalonia, approximately 6,000 people who inject drugs (PWID) attend the network
of harm reduction services, where a hepatitis C virus (HCV) antibody point-of-care test (Ab-PoCT) is
offered and seropositive individuals are referred to care. The HepCdetectII study showed a 79.8%
seroprevalence and 58.5% prevalence of viremic infection in this setting, and that linkage to care
and antiviral therapy was suboptimal (33.1%).
Description of model of care/intervention: A one-step, HCV-RNA point-of-care (RNA-PoCT) testing
strategy (RUO version of the Xpert® HCV Viral Load Fingerstick, Cepheid) was evaluated in
comparison to plasma (Xpert® HCV Viral Load, Cepheid) in a sample of current PWID (N=100)
recruited at a drug consumption room (DCR) in Barcelona. HCV was genotyped by Sanger
sequencing, and HIV infection was assessed by serology. Preferences on delivery of RNA-PoCT
results, results delivery and referral to care were recorded.
Effectiveness: The fingerstick RNA-PoCT detected HCV viremia in 62 out of 63 participants positive in
plasma (98.4% sensitivity and 100% specificity), including HCV genotypes 1a, 1b, 3a, 4a and 4d, AbPoCT negative cases (3.2%), and HIV co-infection cases (25.8%). RNA-PoCT results were delivered in
all cases; 34 viremic participants (54.8%) became aware of their status, and 96.8% of them were
referred to care. Same-day delivery of results was achieved in 80.0% of cases and preferred by 50.0%
of participants (76% of those unaware and 24% of those aware of their status, p=0.041).
Conclusion and next steps: This RNA-PoCT diagnosis strategy increased PWID awareness on HCV
status and allowed for the timely and reliable identification of treatment candidates. Local costeffectiveness studies are required to establish whether this RNA-PoCT could either substitute the
Ab-PoCT (one-step strategy) or complement it (reflex two-step strategy) in this setting. This study
has contributed to a decentralized “test and treat” pilot intervention in this DCR.
Disclosure of Interest Statement: EM has received a research grant from Cepheid. EM is also a
Gilead advisory board member and has received research grants, travel sponsorship and speaker
fees from Gilead and Abbott GmbH & Co. KG. VS has received travel sponsorship from Gilead. JVL
has received speaker fees from Cepheid, and research grants and speaker fees from Gilead. This
study was partly funded by the competitive Fellowship Program from Gilead Spain (grant number
GLD16-00135) and by Cepheid, but neither Cepheid nor Gilead had a role in study design, data
collection and analysis, decision to publish, or preparation of the abstract. This study was also
funded by public grant number PI15/000284 (Instituto de Salud Carlos III/FEDER, European Union).

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