Sustained virological response rates with direct‐acting antivirals in black subjects with HCV genotype 1 infection: systematic analysis of clinical trials

Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for black individuals non-black individuals. HCV trials submitted to the Food and Drug Administration (2013-2017) to support approval or to expa...

Celý popis

Uloženo v:
Podrobná bibliografie
Vydáno v:Journal of Virus Eradication Ročník 5; číslo 3; s. 138 - 144
Hlavní autoři: Struble, Kimberly, Chan-Tack, Kirk, Qi, Karen, Valappil, Thamban, Connelly, Sarah, Mishra, Poonam, Price, Dionne, Murray, Jeffrey, Birnkrant, Debra
Médium: Journal Article
Jazyk:angličtina
Vydáno: England Mediscript Ltd 18.09.2019
Elsevier
Témata:
ISSN:2055-6640, 2055-6659
On-line přístup:Získat plný text
Tagy: Přidat tag
Žádné tagy, Buďte první, kdo vytvoří štítek k tomuto záznamu!
Abstract Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for black individuals non-black individuals. HCV trials submitted to the Food and Drug Administration (2013-2017) to support approval or to expand an indication of 12-week interferon-free DAA regimens with or without ribavirin to treat HCV genotype 1 (GT1) infection were pooled to explore efficacy comparisons by ethnicity. Twenty-six trials were pooled and included 2869 individuals with HCV GT1 alone and 742 individuals with both HCV GT1 and HIV. Of the 2869 HCV GT1-mono-infected subjects, 408 (14.2%) were black. Sustained virological response assessed 12 weeks following cessation of treatment (SVR12) was 92%-100% in black individuals and 87.5%-100.0% in non-black individuals. In pooled analyses, SVR12 was numerically similar between black and non-black subjects (97.1% 97.3%). Baseline characteristics did not affect SVR12 for the two groups. Of the 742 subjects with both HCV GT1 and HIV, 243 (32.7%) were black: SVR12 was 89.5%-100% in black individuals and 94.4%-100% in non-black individuals. In pooled analyses for HCV GT1/HIV co-infection, black individuals had a 4% (95% confidence interval -7.7% to 0.3%) lower SVR12 than non-black individuals (93.4% 97.0%). This difference was driven by ION-4 in which study SVR12 was approximately 10% lower for black than for non-black individuals (89.5% 99.1%). Baseline characteristics did not affect SVR12 for the two groups. No notable SVR12 differences were seen in between black and non-black individuals with HCV GT1 alone. Although a numerical difference was observed between black and non-black individuals with both HCV GT1 and HIV, this finding was driven by results from a single trial and may be due to reasons other than ethnicity: 19 subgroup analyses showed baseline characteristics did not affect SVR12 for black and non-black individuals with both HCV GT1 and HIV.
AbstractList Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for black individuals vs non-black individuals. HCV trials submitted to the Food and Drug Administration (2013-2017) to support approval or to expand an indication of 12-week interferon-free DAA regimens with or without ribavirin to treat HCV genotype 1 (GT1) infection were pooled to explore efficacy comparisons by ethnicity.OBJECTIVESUnder representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for black individuals vs non-black individuals. HCV trials submitted to the Food and Drug Administration (2013-2017) to support approval or to expand an indication of 12-week interferon-free DAA regimens with or without ribavirin to treat HCV genotype 1 (GT1) infection were pooled to explore efficacy comparisons by ethnicity.Twenty-six trials were pooled and included 2869 individuals with HCV GT1 alone and 742 individuals with both HCV GT1 and HIV.METHODSTwenty-six trials were pooled and included 2869 individuals with HCV GT1 alone and 742 individuals with both HCV GT1 and HIV.Of the 2869 HCV GT1-mono-infected subjects, 408 (14.2%) were black. Sustained virological response assessed 12 weeks following cessation of treatment (SVR12) was 92%-100% in black individuals and 87.5%-100.0% in non-black individuals. In pooled analyses, SVR12 was numerically similar between black and non-black subjects (97.1% vs 97.3%). Baseline characteristics did not affect SVR12 for the two groups. Of the 742 subjects with both HCV GT1 and HIV, 243 (32.7%) were black: SVR12 was 89.5%-100% in black individuals and 94.4%-100% in non-black individuals. In pooled analyses for HCV GT1/HIV co-infection, black individuals had a 4% (95% confidence interval -7.7% to 0.3%) lower SVR12 than non-black individuals (93.4% vs 97.0%). This difference was driven by ION-4 in which study SVR12 was approximately 10% lower for black than for non-black individuals (89.5% vs 99.1%). Baseline characteristics did not affect SVR12 for the two groups.RESULTSOf the 2869 HCV GT1-mono-infected subjects, 408 (14.2%) were black. Sustained virological response assessed 12 weeks following cessation of treatment (SVR12) was 92%-100% in black individuals and 87.5%-100.0% in non-black individuals. In pooled analyses, SVR12 was numerically similar between black and non-black subjects (97.1% vs 97.3%). Baseline characteristics did not affect SVR12 for the two groups. Of the 742 subjects with both HCV GT1 and HIV, 243 (32.7%) were black: SVR12 was 89.5%-100% in black individuals and 94.4%-100% in non-black individuals. In pooled analyses for HCV GT1/HIV co-infection, black individuals had a 4% (95% confidence interval -7.7% to 0.3%) lower SVR12 than non-black individuals (93.4% vs 97.0%). This difference was driven by ION-4 in which study SVR12 was approximately 10% lower for black than for non-black individuals (89.5% vs 99.1%). Baseline characteristics did not affect SVR12 for the two groups.No notable SVR12 differences were seen in between black and non-black individuals with HCV GT1 alone. Although a numerical difference was observed between black and non-black individuals with both HCV GT1 and HIV, this finding was driven by results from a single trial and may be due to reasons other than ethnicity: 19 subgroup analyses showed baseline characteristics did not affect SVR12 for black and non-black individuals with both HCV GT1 and HIV.CONCLUSIONNo notable SVR12 differences were seen in between black and non-black individuals with HCV GT1 alone. Although a numerical difference was observed between black and non-black individuals with both HCV GT1 and HIV, this finding was driven by results from a single trial and may be due to reasons other than ethnicity: 19 subgroup analyses showed baseline characteristics did not affect SVR12 for black and non-black individuals with both HCV GT1 and HIV.
Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for black individuals non-black individuals. HCV trials submitted to the Food and Drug Administration (2013-2017) to support approval or to expand an indication of 12-week interferon-free DAA regimens with or without ribavirin to treat HCV genotype 1 (GT1) infection were pooled to explore efficacy comparisons by ethnicity. Twenty-six trials were pooled and included 2869 individuals with HCV GT1 alone and 742 individuals with both HCV GT1 and HIV. Of the 2869 HCV GT1-mono-infected subjects, 408 (14.2%) were black. Sustained virological response assessed 12 weeks following cessation of treatment (SVR12) was 92%-100% in black individuals and 87.5%-100.0% in non-black individuals. In pooled analyses, SVR12 was numerically similar between black and non-black subjects (97.1% 97.3%). Baseline characteristics did not affect SVR12 for the two groups. Of the 742 subjects with both HCV GT1 and HIV, 243 (32.7%) were black: SVR12 was 89.5%-100% in black individuals and 94.4%-100% in non-black individuals. In pooled analyses for HCV GT1/HIV co-infection, black individuals had a 4% (95% confidence interval -7.7% to 0.3%) lower SVR12 than non-black individuals (93.4% 97.0%). This difference was driven by ION-4 in which study SVR12 was approximately 10% lower for black than for non-black individuals (89.5% 99.1%). Baseline characteristics did not affect SVR12 for the two groups. No notable SVR12 differences were seen in between black and non-black individuals with HCV GT1 alone. Although a numerical difference was observed between black and non-black individuals with both HCV GT1 and HIV, this finding was driven by results from a single trial and may be due to reasons other than ethnicity: 19 subgroup analyses showed baseline characteristics did not affect SVR12 for black and non-black individuals with both HCV GT1 and HIV.
Objectives: Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for black individuals vs non-black individuals. HCV trials submitted to the Food and Drug Administration (2013–2017) to support approval or to expand an indication of 12-week interferon-free DAA regimens with or without ribavirin to treat HCV genotype 1 (GT1) infection were pooled to explore efficacy comparisons by ethnicity. Methods: Twenty-six trials were pooled and included 2869 individuals with HCV GT1 alone and 742 individuals with both HCV GT1 and HIV. Results: Of the 2869 HCV GT1-mono-infected subjects, 408 (14.2%) were black. Sustained virological response assessed 12 weeks following cessation of treatment (SVR12) was 92%–100% in black individuals and 87.5%–100.0% in non-black individuals. In pooled analyses, SVR12 was numerically similar between black and non-black subjects (97.1% vs 97.3%). Baseline characteristics did not affect SVR12 for the two groups. Of the 742 subjects with both HCV GT1 and HIV, 243 (32.7%) were black: SVR12 was 89.5%–100% in black individuals and 94.4%–100% in non-black individuals. In pooled analyses for HCV GT1/HIV co-infection, black individuals had a 4% (95% confidence interval −7.7% to 0.3%) lower SVR12 than non-black individuals (93.4% vs 97.0%). This difference was driven by ION-4 in which study SVR12 was approximately 10% lower for black than for non-black individuals (89.5% vs 99.1%). Baseline characteristics did not affect SVR12 for the two groups. Conclusion: No notable SVR12 differences were seen in between black and non-black individuals with HCV GT1 alone. Although a numerical difference was observed between black and non-black individuals with both HCV GT1 and HIV, this finding was driven by results from a single trial and may be due to reasons other than ethnicity: 19 subgroup analyses showed baseline characteristics did not affect SVR12 for black and non-black individuals with both HCV GT1 and HIV.
Author Valappil, Thamban
Struble, Kimberly
Mishra, Poonam
Qi, Karen
Price, Dionne
Murray, Jeffrey
Chan-Tack, Kirk
Connelly, Sarah
Birnkrant, Debra
Author_xml – sequence: 1
  givenname: Kimberly
  surname: Struble
  fullname: Struble, Kimberly
– sequence: 2
  givenname: Kirk
  surname: Chan-Tack
  fullname: Chan-Tack, Kirk
– sequence: 3
  givenname: Karen
  surname: Qi
  fullname: Qi, Karen
– sequence: 4
  givenname: Thamban
  surname: Valappil
  fullname: Valappil, Thamban
– sequence: 5
  givenname: Sarah
  surname: Connelly
  fullname: Connelly, Sarah
– sequence: 6
  givenname: Poonam
  surname: Mishra
  fullname: Mishra, Poonam
– sequence: 7
  givenname: Dionne
  surname: Price
  fullname: Price, Dionne
– sequence: 8
  givenname: Jeffrey
  surname: Murray
  fullname: Murray, Jeffrey
– sequence: 9
  givenname: Debra
  surname: Birnkrant
  fullname: Birnkrant, Debra
BackLink https://www.ncbi.nlm.nih.gov/pubmed/31700657$$D View this record in MEDLINE/PubMed
BookMark eNqFkkluVDEQhp9QEBnIEUBehkVDeXgTSJFQK5BIkVgE2Fq2X7nj8NpubHdQ7zgCB-B0nAT3QIuwYVVW1V9flVz_cXXgg8eqekbhJQXavLphUNeTphFwxuAFBxB8Qh9VR7t03R_s3wIOq9OUnIYaWi4oo0-qQ05bgKZuj6qfN8uUlfM4kHsXwxhmzqiRREyL4BOSqDIm8s3lWzK4iCb_-v5Dmez8jCifXelRYyLOEz0q84Wkpb4rol3H5fQzmaEPebVAQovKlpoL_jVJq5RxrrIzBaPGVXKJBEvM6Pxmfo6ucJ9Wj20JeLqLJ9Wndxcfp5eT6w_vr6ZvrydGtG2eGIUKOqt7HHrDdDPojg-t7nRjWwuNAaa7WhhWc9BCU65AtHwQXCvK-KA0P6muttwhqDu5iG6u4koG5eQmEeJMqlh2HVGi6oxAGHqLVNBG98AsCAPUtj1jlhfW-Za1WOo5DgZ9Ll_0APqw4t2tnIV72XS0obQrgLMdIIavS0xZzl0yOI7KY1gmyTjlvO36mhbp879n7Yf8OW8R1FuBiSGliHYvoSDXTpIbJ8m1TSQDuXGSXIPf_NNnXFbr05WV3fif7t9nXtOc
CitedBy_id crossref_primary_10_1111_jvh_13901
crossref_primary_10_1093_ofid_ofaa044
crossref_primary_10_1002_hep_31742
Cites_doi 10.1056/NEJMoa1501315
10.1038/nature08309
10.1016/j.cgh.2011.03.004
10.1002/hep.29308
10.7326/M16-2575
10.1002/hep.29057
10.1002/hep.28334
10.7326/M13-1829
10.1093/cid/cix260
10.1002/hep.28625
10.1001/jama.2012.144878
10.1093/cid/cix111
10.1093/cid/cix117
10.1086/644771
10.1001/jama.2015.1328
10.1002/hep.29642
10.1002/hep.27978
10.1016/S1473-3099(15)00485-5
10.1093/ofid/ofx062
10.3851/IMP3117
10.1093/ofid/ofx264
10.1002/hep.28901
10.1056/NEJMoa1503153
10.1002/hep.510300319
10.7326/0003-4819-158-9-201305070-00604
ContentType Journal Article
Copyright 2019 The Authors. Journal of Virus Eradication published by Mediscript Ltd.
2019 The Authors.   published by Mediscript Ltd
Copyright_xml – notice: 2019 The Authors. Journal of Virus Eradication published by Mediscript Ltd.
– notice: 2019 The Authors.   published by Mediscript Ltd
DBID AAYXX
CITATION
NPM
7X8
5PM
DOA
DOI 10.1016/S2055-6640(20)30043-1
DatabaseName CrossRef
PubMed
MEDLINE - Academic
PubMed Central (Full Participant titles)
DOAJ Directory of Open Access Journals
DatabaseTitle CrossRef
PubMed
MEDLINE - Academic
DatabaseTitleList MEDLINE - Academic
PubMed

Database_xml – sequence: 1
  dbid: DOA
  name: DOAJ Directory of Open Access Journals
  url: https://www.doaj.org/
  sourceTypes: Open Website
– sequence: 2
  dbid: NPM
  name: PubMed
  url: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed
  sourceTypes: Index Database
– sequence: 3
  dbid: 7X8
  name: MEDLINE - Academic
  url: https://search.proquest.com/medline
  sourceTypes: Aggregation Database
DeliveryMethod fulltext_linktorsrc
EISSN 2055-6659
EndPage 144
ExternalDocumentID oai_doaj_org_article_ea8c4e0d9fe1416b902f04c01f7922f3
PMC6816118
31700657
10_1016_S2055_6640_20_30043_1
Genre Editorial
Commentary
GroupedDBID AAYXX
ALMA_UNASSIGNED_HOLDINGS
CITATION
M~E
NPM
7X8
0R~
5PM
AAEDW
AALRI
AAXUO
AAYWO
ACVFH
ADBBV
ADCNI
ADVLN
AEUPX
AFJKZ
AFPUW
AIGII
AITUG
AKBMS
AKRWK
AKYEP
AMRAJ
AOIJS
EBS
FDB
GROUPED_DOAJ
HYE
OK1
RPM
W2D
ID FETCH-LOGICAL-c477t-caea08fb9ed9c2b6db83d7b8b6f7f06c02b854c2530b4b13a0473d43ba123dab3
IEDL.DBID DOA
ISICitedReferencesCount 4
ISICitedReferencesURI http://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=Summon&SrcAuth=ProQuest&DestLinkType=CitingArticles&DestApp=WOS_CPL&KeyUT=000494965700002&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D
ISSN 2055-6640
IngestDate Fri Oct 03 12:28:43 EDT 2025
Thu Aug 21 14:12:48 EDT 2025
Wed Oct 01 14:06:36 EDT 2025
Wed Jun 21 02:32:03 EDT 2023
Tue Nov 18 22:21:28 EST 2025
Wed Nov 05 20:51:51 EST 2025
IsDoiOpenAccess true
IsOpenAccess true
IsPeerReviewed true
IsScholarly true
Issue 3
Keywords clinical trial
hepatitis C
Food and Drug Administration
Language English
License 2019 The Authors. Journal of Virus Eradication published by Mediscript Ltd.
This is an open access article published under the terms of a Creative Commons License.
LinkModel DirectLink
MergedId FETCHMERGED-LOGICAL-c477t-caea08fb9ed9c2b6db83d7b8b6f7f06c02b854c2530b4b13a0473d43ba123dab3
Notes SourceType-Scholarly Journals-1
content type line 23
ObjectType-Editorial-2
ObjectType-Commentary-1
Shared first authorship.
OpenAccessLink https://doaj.org/article/ea8c4e0d9fe1416b902f04c01f7922f3
PMID 31700657
PQID 2313378951
PQPubID 23479
PageCount 7
ParticipantIDs doaj_primary_oai_doaj_org_article_ea8c4e0d9fe1416b902f04c01f7922f3
pubmedcentral_primary_oai_pubmedcentral_nih_gov_6816118
proquest_miscellaneous_2313378951
pubmed_primary_31700657
crossref_primary_10_1016_S2055_6640_20_30043_1
crossref_citationtrail_10_1016_S2055_6640_20_30043_1
PublicationCentury 2000
PublicationDate 20190918
PublicationDateYYYYMMDD 2019-09-18
PublicationDate_xml – month: 9
  year: 2019
  text: 20190918
  day: 18
PublicationDecade 2010
PublicationPlace England
PublicationPlace_xml – name: England
PublicationTitle Journal of Virus Eradication
PublicationTitleAlternate J Virus Erad
PublicationYear 2019
Publisher Mediscript Ltd
Elsevier
Publisher_xml – name: Mediscript Ltd
– name: Elsevier
References Kirk (10.1016/S2055-6640(20)30043-1_bb0195) 2013; 158
Collins (10.1016/S2055-6640(20)30043-1_bb0205) 2018; 5
van der Meer (10.1016/S2055-6640(20)30043-1_bb0035) 2012; 308
Zepatier (package insert) (10.1016/S2055-6640(20)30043-1_bb0145) 2017
Harvoni (package insert) (10.1016/S2055-6640(20)30043-1_bb0150) 2017
Reddy (10.1016/S2055-6640(20)30043-1_bb0045) 1999; 30
Bhattacharya (10.1016/S2055-6640(20)30043-1_bb0115) 2017; 64
Chen (10.1016/S2055-6640(20)30043-1_bb0200) 2009; 49
Backus (10.1016/S2055-6640(20)30043-1_bb0030) 2011; 9
O’Brien (10.1016/S2055-6640(20)30043-1_bb0070) 2017; 65
Patel (10.1016/S2055-6640(20)30043-1_bb0130) 2017; 4
Centers for Disease Control and Prevention (10.1016/S2055-6640(20)30043-1_bb0015) 2018
Daklinza (package insert) (10.1016/S2055-6640(20)30043-1_bb0140) 2017
Wilder (10.1016/S2055-6640(20)30043-1_bb0040) 2016; 108
Wyles (10.1016/S2055-6640(20)30043-1_bb0110) 2017; 65
Falade-Nwulia (10.1016/S2055-6640(20)30043-1_bb0090) 2017; 166
Platt (10.1016/S2055-6640(20)30043-1_bb0025) 2016; 16
Backus (10.1016/S2055-6640(20)30043-1_bb0075) 2016; 64
Victrelis® (package insert) (10.1016/S2055-6640(20)30043-1_bb0055) 2017
Wilder (10.1016/S2055-6640(20)30043-1_bb0085) 2016; 63
Wyles (10.1016/S2055-6640(20)30043-1_bb0105) 2015; 373
Sikavi (10.1016/S2055-6640(20)30043-1_bb0135) 2018; 67
Vosevi (package insert) (10.1016/S2055-6640(20)30043-1_bb0175) 2017
Edlin (10.1016/S2055-6640(20)30043-1_bb0020) 2015; 62
Incivek® (package insert) (10.1016/S2055-6640(20)30043-1_bb0060) 2013
Mavyret (package insert) (10.1016/S2055-6640(20)30043-1_bb0155) 2017
Burton (10.1016/S2055-6640(20)30043-1_bb0120) 2017; 64
Epclusa (package insert) (10.1016/S2055-6640(20)30043-1_bb0170) 2017
Struble (10.1016/S2055-6640(20)30043-1_bb0180) 2017
Su (10.1016/S2055-6640(20)30043-1_bb0065) 2017; 65
World Health Organization (WHO) (10.1016/S2055-6640(20)30043-1_bb0010) 2017
Viekira Pak (package insert) (10.1016/S2055-6640(20)30043-1_bb0160) 2017
Ge (10.1016/S2055-6640(20)30043-1_bb0050) 2009; 461
Chung (10.1016/S2055-6640(20)30043-1_bb0185) 2018
Lo Re (10.1016/S2055-6640(20)30043-1_bb0190) 2014; 160
Sulkowski (10.1016/S2055-6640(20)30043-1_bb0100) 2015; 313
Falade-Nwulia (10.1016/S2055-6640(20)30043-1_bb0125) 2017; 66
Backus (10.1016/S2055-6640(20)30043-1_bb0080) 2017; 22
Naggie (10.1016/S2055-6640(20)30043-1_bb0095) 2015; 373
Olysio (package insert) (10.1016/S2055-6640(20)30043-1_bb0165) 2017
References_xml – year: 2013
  ident: 10.1016/S2055-6640(20)30043-1_bb0060
– volume: 373
  start-page: 705
  year: 2015
  ident: 10.1016/S2055-6640(20)30043-1_bb0095
  article-title: Ledipasvir and sofosbuvir for HCV in patients coinfected with HIV-1
  publication-title: N Engl J Med
  doi: 10.1056/NEJMoa1501315
– volume: 461
  start-page: 399
  year: 2009
  ident: 10.1016/S2055-6640(20)30043-1_bb0050
  article-title: Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance
  publication-title: Nature
  doi: 10.1038/nature08309
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0140
– volume: 9
  start-page: 509
  year: 2011
  ident: 10.1016/S2055-6640(20)30043-1_bb0030
  article-title: A sustained virologic response reduces risk of all-cause mortality in patients with hepatitis C
  publication-title: Clin Gastroenterol Hepatol
  doi: 10.1016/j.cgh.2011.03.004
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0150
– volume: 66
  start-page: 1402
  year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0125
  article-title: High hepatitis C cure rates among black and non-blacks human immunodeficiency virus-infected adults in an urban center
  publication-title: Hepatology
  doi: 10.1002/hep.29308
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0010
  publication-title: Global hepatitis report, 2017
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0175
– volume: 166
  start-page: 637
  year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0090
  article-title: Oral direct-acting agent therapy for hepatitis C virus infection: a systematic review
  publication-title: Ann Intern Med
  doi: 10.7326/M16-2575
– volume: 65
  start-page: 2124
  year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0070
  article-title: Race or genetic makeup for hepatitis C virus treatment decisions?
  publication-title: Hepatology
  doi: 10.1002/hep.29057
– volume: 63
  start-page: 437
  year: 2016
  ident: 10.1016/S2055-6640(20)30043-1_bb0085
  article-title: Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: a retrospective analysis of phase 3 data
  publication-title: Hepatology
  doi: 10.1002/hep.28334
– volume: 160
  start-page: 369
  year: 2014
  ident: 10.1016/S2055-6640(20)30043-1_bb0190
  article-title: Hepatic decompensation in antiretroviral-treated patients co-infected with HIV and hepatitis C virus compared with hepatitis C virus-mono-infected patients: a cohort study
  publication-title: Ann Intern Med
  doi: 10.7326/M13-1829
– volume: 108
  start-page: 24
  year: 2016
  ident: 10.1016/S2055-6640(20)30043-1_bb0040
  article-title: A systematic review of race and ethnicity in hepatitis C clinical trial enrollment
  publication-title: J Natl Med Assoc
– volume: 65
  start-page: 6
  year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0110
  article-title: Sofosbuvir and velpatasvir for the treatment of HCV in patients coinfected with HIV-1: an open-label, phase 3 study
  publication-title: Clin Infect Dis
  doi: 10.1093/cid/cix260
– volume: 64
  start-page: 405
  year: 2016
  ident: 10.1016/S2055-6640(20)30043-1_bb0075
  article-title: Real-world effectiveness of ledipasvir/sofosbuvir in 4,365 treatment-naive, genotype 1 hepatitis C-infected patients
  publication-title: Hepatology
  doi: 10.1002/hep.28625
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0165
– volume: 308
  start-page: 2584
  year: 2012
  ident: 10.1016/S2055-6640(20)30043-1_bb0035
  article-title: Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis
  publication-title: JAMA
  doi: 10.1001/jama.2012.144878
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0155
– volume: 64
  start-page: 1711
  year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0115
  article-title: Effectiveness of all-oral antiviral regimens in 996 human immunodeficiency virus/hepatitis C virus genotype 1-coinfected patients treated in routine practice
  publication-title: Clin Infect Dis
  doi: 10.1093/cid/cix111
– volume: 64
  start-page: 1721
  year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0120
  article-title: Real-world effectiveness of DAA therapies in human immunodeficiency virus/hepatitis C virus coinfection: 996 veterans can't be wrong
  publication-title: Clin Infect Dis
  doi: 10.1093/cid/cix117
– volume: 49
  start-page: 1605
  year: 2009
  ident: 10.1016/S2055-6640(20)30043-1_bb0200
  article-title: Meta-analysis: increased mortality associated with hepatitis C in HIV-infected persons is unrelated to HIV disease progression
  publication-title: Clin Infect Dis
  doi: 10.1086/644771
– volume: 313
  start-page: 1223
  year: 2015
  ident: 10.1016/S2055-6640(20)30043-1_bb0100
  article-title: Ombitasvir, paritaprevir co-dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: a randomized trial
  publication-title: JAMA
  doi: 10.1001/jama.2015.1328
– volume: 67
  start-page: 847
  year: 2018
  ident: 10.1016/S2055-6640(20)30043-1_bb0135
  article-title: Hepatitis C and human immunodeficiency virus co-infection in the era of direct-acting antiviral agents: no longer a difficult to treat population
  publication-title: Hepatology
  doi: 10.1002/hep.29642
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0170
– volume: 62
  start-page: 1353
  year: 2015
  ident: 10.1016/S2055-6640(20)30043-1_bb0020
  article-title: Toward a more accurate estimate of the prevalence of hepatitis C in the United States
  publication-title: Hepatology
  doi: 10.1002/hep.27978
– volume: 16
  start-page: 797
  year: 2016
  ident: 10.1016/S2055-6640(20)30043-1_bb0025
  article-title: Prevalence and burden of HCV co-infection in people living with HIV: a global systematic review and meta-analysis
  publication-title: Lancet Infect Dis
  doi: 10.1016/S1473-3099(15)00485-5
– volume: 4
  year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0130
  article-title: Highly successful hepatitis C virus (HCV) treatment outcomes in human immunodeficiency virus/HCV-coinfected patients at a large, urban, Ryan White clinic
  publication-title: Open Forum Infect Dis
  doi: 10.1093/ofid/ofx062
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0055
– volume: 22
  start-page: 481
  year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0080
  article-title: Real-world effectiveness and predictors of sustained virological response with all-oral therapy in 21,242 hepatitis C genotype-1 patients
  publication-title: Antivir Ther
  doi: 10.3851/IMP3117
– volume: 5
  year: 2018
  ident: 10.1016/S2055-6640(20)30043-1_bb0205
  article-title: Direct-acting antivirals improve access to care and cure for patients with HIV and chronic HCV infection
  publication-title: Open Forum Infect Dis
  doi: 10.1093/ofid/ofx264
– volume: 65
  start-page: 426
  year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0065
  article-title: The association between race/ethnicity and the effectiveness of direct antiviral agents for hepatitis C virus infection
  publication-title: Hepatology
  doi: 10.1002/hep.28901
– year: 2018
  ident: 10.1016/S2055-6640(20)30043-1_bb0185
  publication-title: Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C
– year: 2018
  ident: 10.1016/S2055-6640(20)30043-1_bb0015
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0145
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0180
  publication-title: Guidance for industry chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment guidance for industry
– volume: 373
  start-page: 714
  year: 2015
  ident: 10.1016/S2055-6640(20)30043-1_bb0105
  article-title: Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1
  publication-title: N Engl J Med
  doi: 10.1056/NEJMoa1503153
– volume: 30
  start-page: 787
  year: 1999
  ident: 10.1016/S2055-6640(20)30043-1_bb0045
  article-title: Racial differences in responses to therapy with interferon in chronic hepatitis C. Consensus Interferon Study Group
  publication-title: Hepatology
  doi: 10.1002/hep.510300319
– year: 2017
  ident: 10.1016/S2055-6640(20)30043-1_bb0160
– volume: 158
  start-page: 658
  year: 2013
  ident: 10.1016/S2055-6640(20)30043-1_bb0195
  article-title: HIV, age, and the severity of hepatitis C virus-related liver disease: a cohort study
  publication-title: Ann Intern Med
  doi: 10.7326/0003-4819-158-9-201305070-00604
SSID ssib050734121
ssj0001634228
Score 2.1094933
Snippet Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for...
Objectives: Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential...
SourceID doaj
pubmedcentral
proquest
pubmed
crossref
SourceType Open Website
Open Access Repository
Aggregation Database
Index Database
Enrichment Source
StartPage 138
SubjectTerms clinical trial
Food and Drug Administration
hepatitis C
Original Research
Title Sustained virological response rates with direct‐acting antivirals in black subjects with HCV genotype 1 infection: systematic analysis of clinical trials
URI https://www.ncbi.nlm.nih.gov/pubmed/31700657
https://www.proquest.com/docview/2313378951
https://pubmed.ncbi.nlm.nih.gov/PMC6816118
https://doaj.org/article/ea8c4e0d9fe1416b902f04c01f7922f3
Volume 5
WOSCitedRecordID wos000494965700002&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D
hasFullText 1
inHoldings 1
isFullTextHit
isPrint
journalDatabaseRights – providerCode: PRVAON
  databaseName: DOAJ Directory of Open Access Journals
  customDbUrl:
  eissn: 2055-6659
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssj0001634228
  issn: 2055-6640
  databaseCode: DOA
  dateStart: 20150101
  isFulltext: true
  titleUrlDefault: https://www.doaj.org/
  providerName: Directory of Open Access Journals
– providerCode: PRVHPJ
  databaseName: ROAD: Directory of Open Access Scholarly Resources
  customDbUrl:
  eissn: 2055-6659
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssib050734121
  issn: 2055-6640
  databaseCode: M~E
  dateStart: 20150101
  isFulltext: true
  titleUrlDefault: https://road.issn.org
  providerName: ISSN International Centre
link http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwrV1Lb9QwELag4sAFgXgFSmUkDnAI9SuxzY1WrXqhQiqgvVnxC1aqstVmlyM_hF_bsZ1NdyukXrgkkmMnlj32fBnPfIPQOyp9pFHrmnopaxG8rW3wvAbN4GJjnfBNSTYhz8_VbKa_bqX6Sj5hhR64DNxh6JQTgXgdAwXwYDVhkQhHaJSasZh5PgH1bP1MgSQByIHdOQddMdI0ddsKchO-c3gxFb5n5APPJ9B0RzFl_v5_gc7bvpNbyuj0MXo0okj8ufT-CboX-qfo70UJhgoep-C1cVPDy-IFG3AihRhwMrziosjqFNTQ_8QwuPPk63s54HmPbTLp4WFtk4VmrH92_AMnNtdksMUUbzy4-k_4hgkaXlP4TfAi4k3AJc5ZQYZn6Pvpybfjs3pMvVA7IeWqdl3oiIpWB68ds623intplW2jjKR1hFnVCMcaTqywlHdESO4Ftx1oQt9Z_hzt9Ys-vERYe9CHVnhPUxCr5DZECZiNtbHt4K4qJDbjbtzIS57SY1yayQEtTZdJ02UYMXm6DK3Qx6nZVSHmuKvBUZrUqXLi1c4FIG1mlDZzl7RV6O1GJAysw3S40vVhsR4M4GTOpQLAWqEXRUSmT_FEgtg2skJyR3h2-rL7pJ__ylzfrQJITtWr_9H51-ghwL3sIUfVPtpbLdfhDXrgfq_mw_IA3ZczdZCXEVy__Dm5Bp2hIjI
linkProvider Directory of Open Access Journals
openUrl ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Sustained+virological+response+rates+with+direct-acting+antivirals+in+black+subjects+with+HCV+genotype+1+infection%3A+systematic+analysis+of+clinical+trials&rft.jtitle=Journal+of+virus+eradication&rft.au=Struble%2C+Kimberly&rft.au=Chan-Tack%2C+Kirk&rft.au=Qi%2C+Karen&rft.au=Valappil%2C+Thamban&rft.date=2019-09-18&rft.issn=2055-6640&rft.volume=5&rft.issue=3&rft.spage=138&rft_id=info:doi/10.1016%2FS2055-6640%2820%2930043-1&rft_id=info%3Apmid%2F31700657&rft.externalDocID=31700657
thumbnail_l http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=2055-6640&client=summon
thumbnail_m http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=2055-6640&client=summon
thumbnail_s http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=2055-6640&client=summon