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Article ; Online: Advancing diagnosis of current HCV infection: A key to hepatitis C elimination in the United States.

Kamili, Saleem / Wester, Carolyn

2024

Abstract: Over 2 million adults have hepatitis C virus (HCV) infection in the United States, and new infections continue to increase. Without treatment, HCV infection can lead to advanced liver disease and death. Treatment is recommended for nearly everyone with ... ...

Abstract	Over 2 million adults have hepatitis C virus (HCV) infection in the United States, and new infections continue to increase. Without treatment, HCV infection can lead to advanced liver disease and death. Treatment is recommended for nearly everyone with hepatitis C, resulting in a cure in >95% of people treated and raising the possibility of hepatitis C elimination. Testing is the first step to accessing life-saving treatment. CDC recommends hepatitis C screening for all adults, all pregnant persons, and anyone with risk; yet about one-third of people with hepatitis C remain unaware of their infection. Testing begins with a hepatitis C antibody test followed, when reactive, by a nucleic acid test to detect HCV RNA. This antibody-first, two-step testing strategy misses early infections and can result in incomplete diagnoses. Advancements in hepatitis C diagnostics and the U.S. regulatory landscape have created an opportunity to include viral-first testing strategies and improve hepatitis C diagnosis. This journal supplement features eight articles detailing challenges and opportunities for improving hepatitis C diagnostics in support of advancing hepatitis C elimination in the United States.
Language	English
Publishing date	2024-03-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiae127
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Article ; Online: Updated Operational Guidance for Implementing CDC's Recommendations on Testing for Hepatitis C Virus Infection.

Cartwright, Emily J / Patel, Priti / Kamili, Saleem / Wester, Carolyn

MMWR. Morbidity and mortality weekly report

2023 Volume 72, Issue 28, Page(s) 766–768

Abstract: Current hepatitis C virus (HCV) testing guidance recommends a two-step testing sequence for diagnosis of HCV infection. Performing an HCV RNA test whenever an HCV antibody test is reactive (complete testing) is critical to achieve national HCV ... ...

Abstract	Current hepatitis C virus (HCV) testing guidance recommends a two-step testing sequence for diagnosis of HCV infection. Performing an HCV RNA test whenever an HCV antibody test is reactive (complete testing) is critical to achieve national HCV elimination goals. When an HCV antibody test is reactive and no HCV RNA test is performed, testing is considered incomplete. Historically, approximately one third of patients have incomplete testing. This update clarifies that all sites performing HCV screening should ensure single-visit sample collection. This approach allows for automatic HCV RNA testing when an HCV antibody test is reactive to avoid incomplete testing. Use of strategies that require multiple visits to collect HCV testing samples should be discontinued. Automatic HCV RNA testing on all HCV antibody reactive samples will increase the percentage of patients with current HCV infection who are linked to care and receive curative antiviral therapy.
MeSH term(s)	United States ; Humans ; Hepacivirus/genetics ; Hepatitis C/diagnosis ; Hepatitis C/prevention & control ; Centers for Disease Control and Prevention, U.S. ; Mass Screening ; RNA ; Hepatitis C Antibodies
Chemical Substances	RNA (63231-63-0) ; Hepatitis C Antibodies
Language	English
Publishing date	2023-07-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	412775-4
ISSN	1545-861X ; 0149-2195
ISSN (online)	1545-861X
ISSN	0149-2195
DOI	10.15585/mmwr.mm7228a2
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Article ; Online: Development of simple, rapid, and sensitive methods for detection of hepatitis C virus RNA from whole blood using reverse transcription loop-mediated isothermal amplification.

Pauly, Matthew D / Weis-Torres, Sabrina / Hayden, Tonya M / Ganova-Raeva, Lilia M / Kamili, Saleem

Journal of clinical microbiology

2023 Volume 61, Issue 11, Page(s) e0077123

Abstract: Hepatitis C virus (HCV) infection is an underdiagnosed global health problem. Diagnosis of current HCV infections typically requires testing for HCV RNA using high-complexity laboratory tests. Methods for the detection of HCV RNA that are simple, ... ...

Abstract	Hepatitis C virus (HCV) infection is an underdiagnosed global health problem. Diagnosis of current HCV infections typically requires testing for HCV RNA using high-complexity laboratory tests. Methods for the detection of HCV RNA that are simple, inexpensive, rapid, and compatible with use outside of a laboratory setting are very important in order to improve access to hepatitis C diagnostic testing and facilitate accelerated linkage to care. We developed and evaluated three simple workflows for extracting HCV RNA from small volumes of whole blood for use in a sensitive, pan-genotypic RT-LAMP assay. The water workflow uses osmotic stress to release HCV RNA and has a limit of detection of 4.3 log
MeSH term(s)	Humans ; Hepacivirus/genetics ; Reverse Transcription ; Sensitivity and Specificity ; RNA, Viral ; Hepatitis C/diagnosis ; Nucleic Acid Amplification Techniques/methods ; Water
Chemical Substances	RNA, Viral ; Water (059QF0KO0R)
Language	English
Publishing date	2023-11-07
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/jcm.00771-23
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Article ; Online: Hepatitis A virus survival on drug paraphernalia.

Medrzycki, Magdalena / Kamili, Saleem / Purdy, Michael A

Journal of viral hepatitis

2020 Volume 27, Issue 12, Page(s) 1484–1494

Abstract: The ongoing hepatitis A outbreaks in multiple states in the United States have concerned public health authorities since March 2017. The outbreaks have spread throughout 30 states and include primarily persons who use drugs, including persons who inject ... ...

Abstract	The ongoing hepatitis A outbreaks in multiple states in the United States have concerned public health authorities since March 2017. The outbreaks have spread throughout 30 states and include primarily persons who use drugs, including persons who inject drugs (PWID) and persons experiencing homelessness. Contaminated drug injection paraphernalia and sharing of these items could potentially aid in transmission of hepatitis A virus (HAV) among these populations. We examined HAV survival on drug paraphernalia frequently shared among PWIDs. The effect of low pH on HAV survival using citric acid, which is frequently used by PWIDs during dose preparation, was investigated. We compared the plaque assay results with those concurrently obtained by qRT-PCR to establish whether HAV RNA levels could be used as surrogates for plaque assay results. HAV suspended in minimal essential media at room temperature infected FRhK4 cells for more than 17 weeks. HAV remained viable in syringes/needles for up to 10 weeks depending on the gauge of the needles and the syringe dead volumes, and on cookers, tourniquets and cotton balls/filter surfaces for up to 4 weeks. HAV retained its infectivity for more than 10 weeks at pH as low as 2. In conclusion, our findings show that HAV survives and remains infective in or on injection drug use equipment for 1 to 10 weeks depending on the type of paraphernalia examined and environmental conditions. These findings suggest that contaminated drug paraphernalia can potentially facilitate the transmission of HAV within populations who share these items.
MeSH term(s)	Drug Users ; Hepatitis A ; Hepatitis A virus ; Humans ; Pharmaceutical Preparations ; Substance Abuse, Intravenous ; Syringes ; United States
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2020-09-14
Publishing country	England
Document type	Journal Article
ZDB-ID	1212497-7
ISSN	1365-2893 ; 1352-0504
ISSN (online)	1365-2893
ISSN	1352-0504
DOI	10.1111/jvh.13379
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Article ; Online: Toward the development of a hepatitis E vaccine.

Kamili, Saleem

Virus research

2011 Volume 161, Issue 1, Page(s) 93–100

Abstract: Hepatitis E virus (HEV) causes large epidemics of enterically transmitted acute hepatitis and accounts for a majority of sporadic acute hepatitis in endemic countries. Due to a very high mortality rate among infected pregnant women and substantial ... ...

Abstract	Hepatitis E virus (HEV) causes large epidemics of enterically transmitted acute hepatitis and accounts for a majority of sporadic acute hepatitis in endemic countries. Due to a very high mortality rate among infected pregnant women and substantial morbidity, disability and costs associated with hepatitis E, concerted efforts are being made to develop an efficacious vaccine. Experimental vaccines, based on recombinant proteins derived from the capsid gene of HEV, have been shown efficacious in pre-clinical trials in macaques conferring cross-protection against various genotypes. Two vaccine candidates, the rHEV vaccine expressed in baculovirus and the HEV 239 vaccine, expressed in Escherichia coli, were successfully evaluated in Phase II/III trials. However, at this time no approved vaccine against hepatitis E is commercially available.
MeSH term(s)	Animals ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Hepatitis E/immunology ; Hepatitis E/prevention & control ; Hepatitis E/virology ; Hepatitis E virus/genetics ; Hepatitis E virus/immunology ; Humans ; Viral Hepatitis Vaccines/genetics ; Viral Hepatitis Vaccines/immunology ; Viral Proteins/genetics ; Viral Proteins/immunology
Chemical Substances	Viral Hepatitis Vaccines ; Viral Proteins
Language	English
Publishing date	2011-10
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	605780-9
ISSN	1872-7492 ; 0168-1702
ISSN (online)	1872-7492
ISSN	0168-1702
DOI	10.1016/j.virusres.2011.05.008
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Article ; Online: Dried blood spot is the feasible matrix for detection of some but not all hepatitis B virus markers of infection.

Kikuchi, Minami / Lindstrom, Patrick / Tejada-Strop, Alexandra / Mixson-Hayden, Tonya / Kamili, Saleem / Sawabe, Motoji

BMC research notes

2022 Volume 15, Issue 1, Page(s) 287

Abstract: Objective: Use of dried blood spots (DBS) for detection of hepatitis B virus (HBV) markers of infection has the potential to facilitate diagnosis of HBV infection especially in resource-limited countries. The aim of this study was to evaluate the ... ...

Abstract	Objective: Use of dried blood spots (DBS) for detection of hepatitis B virus (HBV) markers of infection has the potential to facilitate diagnosis of HBV infection especially in resource-limited countries. The aim of this study was to evaluate the feasibility of DBS for detection of various markers of HBV infections. Results: Fifty-four DBS samples were engineered from well-characterized plasma samples. All DBS samples were tested for HBsAg, total anti-HBc and HBV DNA, 20 of 54 samples were also tested for HBeAg using commercially available assays. HBsAg was detected in 24 of 25 (96%), HBV DNA in 22 of 25 (88%), total anti-HBc in all 9 (100%), and HBeAg in all 7 (100%) DBS samples. The average difference in HBV DNA levels between DBS eluates and corresponding plasma samples was 2.7 log
MeSH term(s)	DNA, Viral/genetics ; Hepatitis A ; Hepatitis B ; Hepatitis B Antibodies ; Hepatitis B Surface Antigens ; Hepatitis B virus/genetics ; Humans
Chemical Substances	DNA, Viral ; Hepatitis B Antibodies ; Hepatitis B Surface Antigens
Language	English
Publishing date	2022-09-05
Publishing country	England
Document type	Journal Article
ZDB-ID	2413336-X
ISSN	1756-0500 ; 1756-0500
ISSN (online)	1756-0500
ISSN	1756-0500
DOI	10.1186/s13104-022-06178-x
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Article ; Online: Hepatitis D-associated hospitalizations in the United States: 2010-2018.

Wasuwanich, Paul / Striley, Catherine W / Kamili, Saleem / Teshale, Eyasu H / Seaberg, Eric C / Karnsakul, Wikrom

Journal of viral hepatitis

2022 Volume 29, Issue 3, Page(s) 218–226

Abstract: In the United States, hepatitis D is not a reportable condition, leading to gaps in epidemiological and clinical knowledge. We aim to estimate the incidence of hepatitis D-associated hospitalizations in the United States and describe the clinical, ... ...

Abstract	In the United States, hepatitis D is not a reportable condition, leading to gaps in epidemiological and clinical knowledge. We aim to estimate the incidence of hepatitis D-associated hospitalizations in the United States and describe the clinical, demographic and geographic characteristics of those hospitalizations. We utilized hospitalization data from the 2010-2018 National Inpatient Sample from the Healthcare Cost and Utilization Project. Hepatitis D and hepatitis B only (HBV only) hospitalizations were identified by International Classification of Diseases, Ninth Revision (ICD-9) and International Classification of Diseases, Tenth Revision (ICD-10) codes. We identified 3825 hepatitis D-associated hospitalizations. The hospitalization rate of hepatitis D was between 6.9 and 20.7 per 10,000,000 but did not change significantly over time. Compared to HBV only, the hepatitis D cohort had a greater proportion of males, Hispanics, hospitalizations in the Northeast region. The hepatitis D-associated hospitalizations also had significantly greater frequencies of liver failure, non-alcoholic cirrhosis, portal hypertension, ascites and thrombocytopenia. While mortality in hepatitis D was similar to that of HBV only, age >65 years (odds ratio [OR] = 3.79; p = .020) and having a diagnosis of alcoholic cirrhosis (OR = 3.37; p = .044) increased the odds of mortality within the hepatitis D cohort. Although the hepatitis D-associated hospitalizations were relatively uncommon, they were associated with severe complications.
MeSH term(s)	Aged ; Health Care Costs ; Hepatitis ; Hepatitis D ; Hospitalization ; Humans ; Inpatients ; Liver Cirrhosis/epidemiology ; Male ; United States/epidemiology
Language	English
Publishing date	2022-02-02
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1212497-7
ISSN	1365-2893 ; 1352-0504
ISSN (online)	1365-2893
ISSN	1352-0504
DOI	10.1111/jvh.13645
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Article ; Online: Infectivity and vaccination efficacy studies in animal models of HBV S and pol gene mutants.

Kamili, Saleem

Antiviral therapy

2010 Volume 15, Issue 3 Pt B, Page(s) 477–485

Abstract: Infectious HBV wild-type and mutant clones were produced in vitro with three mutations in pol (rtV173L plus rtL180M plus rtM204V) or with a single mutation in the S gene (sG145R) and inoculated in treatment-naive chimpanzees. Intravenous inoculation of ... ...

Abstract	Infectious HBV wild-type and mutant clones were produced in vitro with three mutations in pol (rtV173L plus rtL180M plus rtM204V) or with a single mutation in the S gene (sG145R) and inoculated in treatment-naive chimpanzees. Intravenous inoculation of these mutants in chimpanzees resulted in HBV infection; the pol mutations remained stable, whereas the sG145R mutation reverted to wild type during viraemia. Additional hepatitis B vaccine efficacy studies conducted in chimpanzees showed lack of sterilizing immunity against the pol mutant. Whether such mutants can transmit to and infect vaccinated humans requires further investigation.
MeSH term(s)	Animals ; Disease Models, Animal ; Genes, pol/genetics ; Genes, pol/immunology ; Hepatitis B/immunology ; Hepatitis B/prevention & control ; Hepatitis B/virology ; Hepatitis B Surface Antigens/genetics ; Hepatitis B Surface Antigens/immunology ; Hepatitis B Vaccines/administration & dosage ; Hepatitis B Vaccines/genetics ; Hepatitis B Vaccines/therapeutic use ; Hepatitis B virus/genetics ; Hepatitis B virus/immunology ; Hepatitis B virus/pathogenicity ; Humans ; Mice ; Mutation ; Pan troglodytes ; Treatment Outcome ; Vaccination
Chemical Substances	Hepatitis B Surface Antigens ; Hepatitis B Vaccines
Language	English
Publishing date	2010
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1339842-8
ISSN	2040-2058 ; 1359-6535
ISSN (online)	2040-2058
ISSN	1359-6535
DOI	10.3851/IMP1520
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Article ; Online: Impact of nucleic acid extraction platforms on hepatitis virus genome detection.

Pauly, Matthew D / Kamili, Saleem / Hayden, Tonya M

Journal of virological methods

2019 Volume 273, Page(s) 113715

Abstract: Detection and quantification of viral nucleic acids are important for diagnosing current viral infections and monitoring response to antiviral therapy. Automated nucleic acid extraction and purification platforms are routinely used during the first step ... ...

Abstract	Detection and quantification of viral nucleic acids are important for diagnosing current viral infections and monitoring response to antiviral therapy. Automated nucleic acid extraction and purification platforms are routinely used during the first step in these processes in clinical and research laboratories. Here, we compare the extraction efficiencies of four MagNA Pure magnetic bead-based nucleic acid extraction platforms and associated kits using samples positive for nucleic acids from HAV, HBV, HCV, HDV, and HEV. These five hepatitis viruses are diverse in their virion structures and type of nucleic acid that compose their genomes. We found that the most efficient nucleic acid extraction platform and corresponding kit, when averaged across all tested viruses, was the MagNA Pure 96, which yielded twice as much detectable nucleic acid as the other platforms. However, the relative efficiencies of the different platforms varied by virus type, suggesting that an extraction platform that is more efficient for one virus type will not necessarily function better with a different virus type. Our results show that the choice of a nucleic acid extraction platform influences the sensitivity of the methodology and has the potential to generate false-negative results especially in samples with low levels of viral nucleic acids.
MeSH term(s)	DNA, Viral/isolation & purification ; Genome, Viral ; Hepatitis Viruses/isolation & purification ; Hepatitis, Viral, Human ; Humans ; Nucleic Acids/blood ; Nucleic Acids/isolation & purification ; RNA, Viral/isolation & purification ; Reagent Kits, Diagnostic/standards ; Sensitivity and Specificity
Chemical Substances	DNA, Viral ; Nucleic Acids ; RNA, Viral ; Reagent Kits, Diagnostic
Language	English
Publishing date	2019-08-13
Publishing country	Netherlands
Document type	Comparative Study ; Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	8013-5
ISSN	1879-0984 ; 0166-0934
ISSN (online)	1879-0984
ISSN	0166-0934
DOI	10.1016/j.jviromet.2019.113715
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Article ; Online: CDC's New Hepatitis C Virus Testing Recommendations for Perinatally Exposed Infants and Children: A Step Towards Hepatitis C Elimination.

Panagiotakopoulos, Lakshmi / Miele, Kathryn / Cartwright, Emily J / Kamili, Saleem / Furukawa, Nathan / Woodworth, Kate / Tong, Van T / Kim, Shin Y / Wester, Carolyn / Sandul, Amy L

Journal of women's health (2002)

2024

Abstract: New U.S. Centers for Disease Control and Prevention (CDC) guidelines for hepatitis C virus (HCV) testing of perinatally exposed infants and children released in 2023 recommend a nucleic acid test (NAT) for detection of HCV ribonucleic acid ( ...

Abstract	New U.S. Centers for Disease Control and Prevention (CDC) guidelines for hepatitis C virus (HCV) testing of perinatally exposed infants and children released in 2023 recommend a nucleic acid test (NAT) for detection of HCV ribonucleic acid (
Language	English
Publishing date	2024-03-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	1139774-3
ISSN	1931-843X ; 1059-7115 ; 1540-9996
ISSN (online)	1931-843X
ISSN	1059-7115 ; 1540-9996
DOI	10.1089/jwh.2023.1114
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