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

Trickey, Adam; Fajardo, Emmanuel; Alemu, Daniel; Artenie, Andreea Adelina; Easterbrook, Philippa

doi:10.1016/s2468-1253(22)00346-6

Cited by 39 publications

(28 citation statements)

References 40 publications

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“…This finding highlights the critical need for a commercially available point-of-care HCV RNA test. Although we cannot know whether these individuals would have opted for same-day DAA treatment, other studies suggest that point-of-care HCV RNA testing embedded in a simplified care model improves DAA uptake. Finally, 18 individuals with anti-HCV Ab positivity were unable to get HCV RNA confirmatory testing, and 3 participants could not receive end-of-treatment HCV RNA testing because of blood draw challenges.…”

Section: Discussionmentioning

confidence: 90%

Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations

Morris,

McDonell,

Luetkemeyer

et al. 2023

JAMA Netw Open

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ImportanceDisparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors.ObjectiveTo determine the feasibility, acceptability, and safety of HCV treatment at the point of HCV infection diagnosis disclosure in a nonclinical community setting.Design, Setting, and ParticipantsIn this single-arm nonrandomized controlled trial conducted between July 1, 2020, and October 31, 2021, street-outreach recruitment targeted people experiencing homelessness and injecting drugs in an urban US community who were eligible for simplified HCV treatment.InterventionsStudy procedures were designed to reflect the community environment and services needed to provide HCV testing, disclosure, and treatment in a nonclinical site. The test-and-treat No One Waits (NOW) model of care provided a 2-week starter pack of 400 mg of sofosbuvir and 100 mg of velpatasvir at time of HCV RNA results disclosure. Participants were transitioned to insurance-provided sofosbuvir-velpatasvir when feasible to complete a 12-week treatment course.Main Outcomes and MeasuresThe primary end point was sustained virologic response at posttreatment week 12 or later (SVR12). Acceptability end points were treatment initiation and completion. Safety end points were treatment discontinuation because of a late exclusion criterion and adverse events.ResultsOf the 492 people (median [IQR] age, 48 [37-58] years; 62 [71%] male) who underwent anti-HCV testing, 246 (50%) tested anti-HCV positive, and 111 (23%) tested HCV RNA positive and were eligible for simplified HCV treatment. Eighty-nine of the 111 eligible participants (80%) returned for confirmatory RNA results, and 87 (98%) accepted and initiated HCV treatment. Seventy (80%) were currently injecting drugs, 83 (97%) had an income below the poverty line, and 53 (61%) were currently unsheltered. Most had HCV genotype 1a (45 [52%]) or 3 (20 [23%]). Sixty-nine (79%) completed 12 weeks of sofosbuvir-velpatasvir treatment, 2 stopped treatment because of low adherence, and 16 were lost to follow-up. Of the 66 participants who completed treatment and had a successful blood draw, 61 (92%) had undetectable HCV RNA at treatment completion. Of the 87 treated patients, 58 achieved SVR12, leading to a treatment response of 67% (95% CI, 56%-76%) among the intention-to-treat group and 84% (95% CI, 73%-92%) among the per-protocol group. There were no adverse events, late exclusions, or deaths.Conclusions and RelevanceIn this nonrandomized controlled trial of HCV treatment at the point of diagnosis, the NOW model of care reduced steps between HCV testing and treatment initiation and resulted in high levels of treatment initiation, completion, and cure. The NOW model of care can expand the current HCV test-and-treat toolkit by reaching a broader population of marginalized communities and expediting curative therapy.Trial RegistrationClinicalTrials.gov Identifier: NCT03987503

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Section: Discussionmentioning

confidence: 90%

Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations

Morris,

McDonell,

Luetkemeyer

et al. 2023

JAMA Netw Open

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“…To address this, we plan to introduce a point of care HCV‐RNA test at reception for individuals known to be HCV‐Ab positive, to speed up the time to diagnosis of HCV viraemia, which will hopefully translate into higher rates of treatment initiation. This method has been shown to increase antiviral treatment uptake and reduce time to treatment initiation 27,28 …”

Section: Discussionmentioning

confidence: 99%

Impact of 5 years of hepatitis C testing and treatment in the North East of England prisons

Johnson,

Shearer,

Thompson

et al. 2023

Journal of Viral Hepatitis

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Hepatitis C virus infection (HCV) is prevalent in prisons. Therefore, effective prison HCV services are critical for HCV elimination programmes. We aimed to evaluate the efficacy of a regional HCV prison testing and treatment programme. Between July 2017 and June 2022, data were collected prospectively on HCV test offer and uptake rates, HCV Antibody (HCV‐Ab) and HCV‐RNA positivity, treatment starts and outcomes for new inmates incarcerated in three prisons. Rates of HCV‐Ab and RNA positivity at reception, incidence of new HCV infections and reinfection following treatment were determined. From a total of 39,652 receptions, 33,028 (83.3%) were offered HCV testing and 20,394 (61.7%) completed testing. Including all receptions, 24.5% of tests (n = 4995) were HCV‐Ab positive and 8.4% of tests (n = 1713) were HCV‐RNA positive. When considering the first test for each individual (median age 34 years; 88.1% male), 14.8% (n = 1869) and 7.2% (n = 905) were HCV‐Ab and HCV‐RNA positive, respectively. The incidence of new HCV‐Ab and RNA positivity was 5.1 and 3.3 per 100 person‐years, respectively. Of 1145 HCV viraemic individuals, 18 died within 6 months and 150 were rapidly transferred out of area, leaving 977 individuals with outcomes. Of these, 835 (85.5%) received antivirals and 47 spontaneously cleared the infection, leaving 95 (9.7%) untreated. 607 (72.7%) achieved SVR. 95 patients had reinfection post‐treatment (rate 10.1 cases per 100 person‐years). Testing for HCV has increased in our prisons and the majority with viraemia are initiated on antiviral treatment. Reassuringly, a significant fall in frequency of HCV‐RNA positivity at prison reception was observed suggesting progress towards HCV elimination.

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“…Although 10 million hepatitis C patients had received DAA until 2020, only 20% of those infected worldwide had been diagnosed and 13% treated. To address this gap, POC viral load assays have recently been recommended by the WHO for hepatitis C 84 . These tests for diagnosis and treatment monitoring have already shown their benefit on tuberculosis and HIV.…”

Section: Rapid Testsmentioning

confidence: 99%

“…These tests for diagnosis and treatment monitoring have already shown their benefit on tuberculosis and HIV. The use of POC HCV viral load assays is especially relevant for promoting linkage to care for hard to reach or marginalized populations at high risk of loss to follow-up, and at decentralized HCV testing and treatment sites that might include opioid harm reduction services, primary clinics, prisons as well as STI and HIV clinics 84 .…”

Section: Rapid Testsmentioning

confidence: 99%

Viral hepatitis in persons living with HIV in the post-COVID era

Soriano¹,

Moreno-Torres²,

Mendoza³

et al. 2024

AIDSRev

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Coinfection with hepatitis viruses A to E is frequent in persons living with HIV (PLWH) and causes significant morbidity and mortality. Oro-fecal transmissible hepatitis A and E mostly produce acute self-limited episodes in poor income regions and in non-vaccinated travelers. In high-income countries, outbreaks of hepatitis A occur in men having sex with men (MSM) and chronic hepatitis E is occasionally reported among PLWH with severe immunodeficiency. Chronic hepatitis B, C, and D are frequent in PLWH in highly endemic regions and globally in persons who inject drugs (PWID) and MSM. Progression to liver cirrhosis and development of hepatocellular carcinoma (HCC) is major clinical complications in coinfected patients. Current estimates for PLWH are of 38 million worldwide. Roughly 12% have chronic viral hepatitis (5 million). Coinfection figures are of 5-10% for HBV (2-4 million), 4% for HCV (1.5 million), and 15% of HBsAg+ for HDV (0.5 million). Oral direct-acting antivirals (DAA) cure almost all treated patients with hepatitis C. However, given that there is no protective HCV immunity, PLWH with high-risk behaviors may experience HCV reinfection episodes. Tenofovir is the drug of choice in PLWH with chronic hepatitis B, given its dual effect on HIV and HBV. Lifelong oral tenofovir suppresses HBV replication and ameliorate liver damage. However, the risk of HCC persists even in the absence of cirrhosis. Finally, HDV causes the worst of viral hepatitis with faster progression to cirrhosis and HCC. An entry inhibitor, bulevirtide, has recently been approved and another drug, lonafarnib, is completing Phase 3 trials. Combination antiviral therapy for hepatitis D could improve dramatically the poor prognosis of HIV-HDV coinfected patients. The resumption of good medical practices in PLWH after the big disruption caused by COVID-19 will reduce the burden of viral hepatitis coinfections. Renewed efforts on HAV and HBV vaccination of susceptible individuals and earlier and wider prescription of antiviral therapy for HBV, HCV, and/or HDV coinfection should be prioritized in PLWH. The benefits of innovative strategies for viral hepatitis, including pre-exposure prophylaxis or use of long-acting antivirals, warrant further consideration in PLWH.

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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

Cited by 39 publications

References 40 publications

Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations

Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations

Impact of 5 years of hepatitis C testing and treatment in the North East of England prisons

Viral hepatitis in persons living with HIV in the post-COVID era

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