Hepatitis C Virus Diagnosis and the Holy Grail

Applegate, Tanya; Fajardo, Emmanuel; Sacks, Jilian A.

doi:10.1016/j.idc.2018.02.010

Cited by 58 publications

(75 citation statements)

References 91 publications

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“…Other sample collection methods and testing technologies, such as dried blood spot samples, rapid Point of Care tests or HCV core antigen testing, may be more cost‐effective and lead to further improvements in progression to RNA or genotype testing, linkage with care and treatment initiation. New pan‐genotypic DAA regimens may remove the need for HCV genotype testing prior to treatment initiation, particularly for people who are DAA treatment naive and do not have cirrhosis, which would further enhance progression through the care cascade and facilitate rapid treatment initiation strategies, especially where Point of Care HCV RNA tests are available. Removal of HCV genotype testing prior to treatment initiation has been suggested to be particularly beneficial for improving treatment initiation in resource‐limited settings where burden of disease is high.…”

Section: Discussionmentioning

confidence: 99%

The population level care cascade for hepatitis C in British Columbia, Canada as of 2018: Impact of direct acting antivirals

Bartlett

Chapinal

et al. 2019

Liver International

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Background: Population-level monitoring of hepatitis C virus (HCV) infected people across cascades of care identifies gaps in access and engagement in care and treatment. We characterized the population-level care cascade for HCV in British Columbia (BC), Canada before and after introduction of Direct Acting Antiviral (DAA) treatment. Methods: BC Hepatitis Testers Cohort (BC-HTC) includes 1.7 million individuals tested for HCV, HIV, reported cases of hepatitis B, and active tuberculosis in BC from 1990 to 2018 linked to medical visits, hospitalizations, cancers, prescription drugs and mortality data. We defined six HCV care cascade stages: (a) antibody diagnosed; (b) RNA tested; (c) RNA positive; (d) genotyped; (e) initiated treatment; and (f) achieved sustained virologic response (SVR). Results:We estimated 61 127 people were HCV antibody positive in BC in 2018 (undiagnosed: 7686, 13%; diagnosed: 53 441, 87%). Of those diagnosed, 83% (44 507) had HCV RNA testing, and of those RNA positive, 90% (28 716) were genotyped. Of those genotyped, 61% (17 441) received therapy, with 90% (15 672) reaching SVR.Individuals from older birth cohorts had lower progression to HCV RNA testing.While people who currently inject drugs had the highest proportional progression to RNA testing, this group had the lowest proportional treatment uptake. Conclusions: Although gaps in HCV RNA and genotype testing after antibody diagnosis exist, the largest gap in the care cascade is treatment initiation, despite introduction of DAA treatment and removal of treatment eligibility restrictions. Further interventions are required to ensure testing and treatment is equitably accessible in BC.

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Section: Discussionmentioning

confidence: 99%

The population level care cascade for hepatitis C in British Columbia, Canada as of 2018: Impact of direct acting antivirals

Bartlett

Chapinal

et al. 2019

Liver International

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“…Despite these recommendations, very limited real‐world validation of HCV RNA point‐of‐care exists in LIMCs and none in Africa have been published so far. The WHO has pre‐qualified the Xpert ® HCV VL assay, which not only ensures quality control but also is often a prerequisite for donor funded programmes . However, despite having a lower limit of detection significantly below recommendations (40 IU/mL) from a whole blood sample, the Xpert ® HCV VL Fingerstick assay is yet to receive WHO pre‐qualification.…”

Section: Discussionmentioning

confidence: 99%

“…29 quality control but also is often a prerequisite for donor funded programmes. 6 However, despite having a lower limit of detection significantly below recommendations (40 IU/mL) from a whole blood sample, the Xpert ® HCV VL Fingerstick assay is yet to receive WHO pre-qualification.…”

Section: Discussionmentioning

confidence: 99%

“…Ironically, in many resource-limited settings the cost of diagnosis exceeds the cost of treatment. 6 As HCV RNA confirmation is a pre-requisite for commencing treatment, it is not surprising that access to simple HCV diagnostics in such challenging settings has been underlined as a key priority in order to achieve HCV elimination.…”

Section: Backg Rou N Dmentioning

confidence: 99%

“…Recent times have seen the WHO prequalification of DAAs to ensure the quality control, and fierce competition from generic manufacturers has resulted in a sharp reduction in cost of treatment. Ironically, in many resource‐limited settings the cost of diagnosis exceeds the cost of treatment . As HCV RNA confirmation is a pre‐requisite for commencing treatment, it is not surprising that access to simple HCV diagnostics in such challenging settings has been underlined as a key priority in order to achieve HCV elimination.…”

Section: Introductionmentioning

confidence: 99%

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In‐field evaluation of Xpert® HCV viral load Fingerstick assay in people who inject drugs in Tanzania

Mohamed

Mbwambo

Rwegasha

et al. 2019

Liver International

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Background Although novel hepatitis C virus (HCV) RNA point‐of‐care technology has the potential to enhance the diagnosis in resource‐limited settings, very little real‐world validation of their utility exists. We evaluate the performance of HCV RNA quantification using the Xpert® HCV viral load Fingerstick assay (Xpert® HCV VL Fingerstick assay) as compared to the World Health Organisation pre‐qualified plasma Xpert® HCV VL assay among people who inject drugs (PWID) attending an opioid agonist therapy (OAT) clinic in Dar‐es‐Salaam, Tanzania. Methods Between December 2018 and February 2019, consecutive HCV seropositive PWID attending the OAT clinic provided paired venous and Fingerstick samples for HCV RNA quantification. These were processed onsite using the GeneXpert® platform located at the Central tuberculosis reference laboratory. Results A total of 208 out of 220 anti‐HCV‐positive participants recruited (94.5%) had a valid Xpert® HCV VL result available; 126 (61%; 95% CI 53.8‐67.0) had detectable and quantifiable HCV RNA. About 188 (85%) participants had paired plasma and Fingerstick whole blood samples; the sensitivity and specificity for the quantification of HCV RNA levels were 99.1% and 98.7% respectively. There was an excellent correlation (R2 = .95) and concordance (mean difference 0.13 IU/mL, (95% CI −0.9 to 0.16 IU/mL) in HCV RNA levels between plasma samples and Fingerstick samples. Conclusion This study found excellent performance of the Xpert® HCV VL Fingerstick assay for HCV RNA detection and quantification in an African‐field setting. Its clinical utility represents an important watershed in overcoming existing challenges to HCV diagnosis, which should play a crucial role in HCV elimination in Africa.

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The implications of cell‐free DNAs derived from tumor viruses as biomarkers of associated cancers

Wang

Liang

et al. 2022

Journal of Medical Virology

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Cancer is still ranked as a leading cause of death according to estimates from the World Health Organization (WHO) and the strong link between tumor viruses and human cancers have been proved for almost six decades. Cell‐free DNA (cfDNA) has drawn enormous attention for its dynamic, instant, and noninvasive advantages as one popular type of cancer biomarker. cfDNAs are mainly released from apoptotic cells and exosomes released from cancer cells, including those infected with viruses. Although cfDNAs are present at low concentrations in peripheral blood, they can reflect tumor load with high sensitivity. Considering the relevance of the tumor viruses to the associated cancers, cfDNAs derived from viruses may serve as good biomarkers for the early screening, diagnosis, and treatment monitoring. In this review, we summarize the methods and newly developed analytic techniques for the detection of cfDNAs from different body fluids, and discuss the implications of cfDNAs derived from different tumor viruses in the detection and treatment monitoring of virus‐associated cancers. A better understanding of cfDNAs derived from tumor viruses may help formulate novel antitumoral strategies to decrease the burden of cancers that attributed to viruses.

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Hepatitis C Virus Diagnosis and the Holy Grail

Cited by 58 publications

References 91 publications

The population level care cascade for hepatitis C in British Columbia, Canada as of 2018: Impact of direct acting antivirals

The population level care cascade for hepatitis C in British Columbia, Canada as of 2018: Impact of direct acting antivirals

In‐field evaluation of Xpert® HCV viral load Fingerstick assay in people who inject drugs in Tanzania

The implications of cell‐free DNAs derived from tumor viruses as biomarkers of associated cancers

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