دورية أكاديمية
أعرض في EDS

Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1–6 without cirrhosis

التفاصيل البيبلوغرافية
العنوان: Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1–6 without cirrhosis
المؤلفون: Kwo, PY, Poordad, F, Asatryan, A, Wang, S, Wyles, DL, Hassanein, T, Felizarta, F, Sulkowski, MS, Gane, E, Maliakkal, B, Overcash, JS, Gordon, SC, Muir, AJ, Aguilar, H, Agarwal, K, Dore, GJ, Lin, CW, Liu, R, Lovell, SS, Ng, TI, Kort, J, Mensa, FJ
المصدر: urn:ISSN:0168-8278 ; urn:ISSN:1600-0641 ; Journal of Hepatology, 67, 2, 263-271
بيانات النشر: Elsevier
سنة النشر: 2017
المجموعة: UNSW Sydney (The University of New South Wales): UNSWorks
مصطلحات موضوعية: Liver Disease, Hepatitis - C, Emerging Infectious Diseases, Digestive Diseases, Infectious Diseases, Clinical Trials and Supportive Activities, HIV/AIDS, Hepatitis, Clinical Research, Genetics, Chronic Liver Disease and Cirrhosis, 6.1 Pharmaceuticals, 6 Evaluation of treatments and therapeutic interventions, Infection, 3 Good Health and Well Being, Adult, Aged, Aminoisobutyric Acids, Antiviral Agents, Benzimidazoles, Cyclopropanes, Drug Administration Schedule, Drug Resistance, Multiple, Viral, Drug Therapy, Combination, Female, Genotype, Hepacivirus
الوصف: Background & Aims Hepatitis C virus (HCV) therapy that is highly efficacious, pangenotypic, with a high barrier to resistance and short treatment duration is desirable. The efficacy and safety of 8- and 12-week treatments with glecaprevir (ABT-493; NS3/4 A protease inhibitor) and pibrentasvir (ABT-530; NS5A inhibitor) were evaluated in non-cirrhotic patients with chronic HCV genotype 1–6 infection. Methods SURVEYOR-I and SURVEYOR-II were phase II, open-label, multicenter, dose-ranging trials including patients with chronic HCV genotype 1–6 infection who were either previously untreated or treated with pegylated interferon plus ribavirin. Patients received once-daily glecaprevir plus pibrentasvir at varying doses with or without ribavirin for 8 or 12 weeks. The primary efficacy endpoint was the percentage of patients with a sustained virologic response at post-treatment week 12 (SVR12). Results Of the 449 patients who received varying doses of glecaprevir plus pibrentasvir, 25%, 29%, 39%, and 8% had HCV genotype 1, 2, 3, and 4–6 infection, respectively. Twelve-week treatment achieved SVR12 in 97–100%, 96–100%, 83–94%, and 100% in genotypes 1, 2, 3, and 4–6, respectively. Eight-week treatment with 300 mg glecaprevir plus 120 mg pibrentasvir in genotype 1-, 2-, or 3-infected patients yielded 97–98% SVR12 with no virologic failures. Three (0.7%) patients discontinued treatment due to adverse events; most events were mild (grade 1) in severity. No post-nadir alanine aminotransferase elevations were observed. Conclusions Glecaprevir plus pibrentasvir was well tolerated and achieved high sustained virologic response rates in HCV genotypes 1–6-infected patients without cirrhosis following 8- or 12-week treatment durations. Lay summary The combination of direct-acting antivirals glecaprevir and pibrentasvir comprise a once-daily, all-oral, pangenotypic treatment for HCV genotype 1–6 infection. This article describes results from two phase II trials investigating a range of doses at treatment durations of 8 or 12 ...
نوع الوثيقة: article in journal/newspaper
اللغة: unknown
العلاقة: http://purl.org/au-research/grants/nhmrc/APP1118864Test; http://hdl.handle.net/1959.4/unsworks_44734Test; https://doi.org/10.1016/j.jhep.2017.03.039Test
DOI: 10.1016/j.jhep.2017.03.039
الإتاحة: https://doi.org/10.1016/j.jhep.2017.03.039Test
http://hdl.handle.net/1959.4/unsworks_44734Test
حقوق: metadata only access ; http://purl.org/coar/access_right/c_14cbTest ; CC-BY-NC-ND ; https://creativecommons.org/licenses/by-nc-nd/4.0Test/
رقم الانضمام: edsbas.9565DFD4
قاعدة البيانات: BASE
ResultId 1
Header edsbas
BASE
edsbas.9565DFD4
881
3
Academic Journal
academicJournal
880.555480957031
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&scope=site&db=edsbas&AN=edsbas.9565DFD4&custid=s6537998&authtype=sso
FullText Array ( [Availability] => 0 )
Array ( [0] => Array ( [Url] => https://doi.org/10.1016/j.jhep.2017.03.039# [Name] => EDS - BASE [Category] => fullText [Text] => View record in BASE [MouseOverText] => View record in BASE ) )
Items Array ( [Name] => Title [Label] => Title [Group] => Ti [Data] => Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1–6 without cirrhosis )
Array ( [Name] => Author [Label] => Authors [Group] => Au [Data] => <searchLink fieldCode="AR" term="%22Kwo%2C+PY%22">Kwo, PY</searchLink><br /><searchLink fieldCode="AR" term="%22Poordad%2C+F%22">Poordad, F</searchLink><br /><searchLink fieldCode="AR" term="%22Asatryan%2C+A%22">Asatryan, A</searchLink><br /><searchLink fieldCode="AR" term="%22Wang%2C+S%22">Wang, S</searchLink><br /><searchLink fieldCode="AR" term="%22Wyles%2C+DL%22">Wyles, DL</searchLink><br /><searchLink fieldCode="AR" term="%22Hassanein%2C+T%22">Hassanein, T</searchLink><br /><searchLink fieldCode="AR" term="%22Felizarta%2C+F%22">Felizarta, F</searchLink><br /><searchLink fieldCode="AR" term="%22Sulkowski%2C+MS%22">Sulkowski, MS</searchLink><br /><searchLink fieldCode="AR" term="%22Gane%2C+E%22">Gane, E</searchLink><br /><searchLink fieldCode="AR" term="%22Maliakkal%2C+B%22">Maliakkal, B</searchLink><br /><searchLink fieldCode="AR" term="%22Overcash%2C+JS%22">Overcash, JS</searchLink><br /><searchLink fieldCode="AR" term="%22Gordon%2C+SC%22">Gordon, SC</searchLink><br /><searchLink fieldCode="AR" term="%22Muir%2C+AJ%22">Muir, AJ</searchLink><br /><searchLink fieldCode="AR" term="%22Aguilar%2C+H%22">Aguilar, H</searchLink><br /><searchLink fieldCode="AR" term="%22Agarwal%2C+K%22">Agarwal, K</searchLink><br /><searchLink fieldCode="AR" term="%22Dore%2C+GJ%22">Dore, GJ</searchLink><br /><searchLink fieldCode="AR" term="%22Lin%2C+CW%22">Lin, CW</searchLink><br /><searchLink fieldCode="AR" term="%22Liu%2C+R%22">Liu, R</searchLink><br /><searchLink fieldCode="AR" term="%22Lovell%2C+SS%22">Lovell, SS</searchLink><br /><searchLink fieldCode="AR" term="%22Ng%2C+TI%22">Ng, TI</searchLink><br /><searchLink fieldCode="AR" term="%22Kort%2C+J%22">Kort, J</searchLink><br /><searchLink fieldCode="AR" term="%22Mensa%2C+FJ%22">Mensa, FJ</searchLink> )
Array ( [Name] => TitleSource [Label] => Source [Group] => Src [Data] => urn:ISSN:0168-8278 ; urn:ISSN:1600-0641 ; Journal of Hepatology, 67, 2, 263-271 )
Array ( [Name] => Publisher [Label] => Publisher Information [Group] => PubInfo [Data] => Elsevier )
Array ( [Name] => DatePubCY [Label] => Publication Year [Group] => Date [Data] => 2017 )
Array ( [Name] => Subset [Label] => Collection [Group] => HoldingsInfo [Data] => UNSW Sydney (The University of New South Wales): UNSWorks )
Array ( [Name] => Subject [Label] => Subject Terms [Group] => Su [Data] => <searchLink fieldCode="DE" term="%22Liver+Disease%22">Liver Disease</searchLink><br /><searchLink fieldCode="DE" term="%22Hepatitis+-+C%22">Hepatitis - C</searchLink><br /><searchLink fieldCode="DE" term="%22Emerging+Infectious+Diseases%22">Emerging Infectious Diseases</searchLink><br /><searchLink fieldCode="DE" term="%22Digestive+Diseases%22">Digestive Diseases</searchLink><br /><searchLink fieldCode="DE" term="%22Infectious+Diseases%22">Infectious Diseases</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+Trials+and+Supportive+Activities%22">Clinical Trials and Supportive Activities</searchLink><br /><searchLink fieldCode="DE" term="%22HIV%2FAIDS%22">HIV/AIDS</searchLink><br /><searchLink fieldCode="DE" term="%22Hepatitis%22">Hepatitis</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+Research%22">Clinical Research</searchLink><br /><searchLink fieldCode="DE" term="%22Genetics%22">Genetics</searchLink><br /><searchLink fieldCode="DE" term="%22Chronic+Liver+Disease+and+Cirrhosis%22">Chronic Liver Disease and Cirrhosis</searchLink><br /><searchLink fieldCode="DE" term="%226%2E1+Pharmaceuticals%22">6.1 Pharmaceuticals</searchLink><br /><searchLink fieldCode="DE" term="%226+Evaluation+of+treatments+and+therapeutic+interventions%22">6 Evaluation of treatments and therapeutic interventions</searchLink><br /><searchLink fieldCode="DE" term="%22Infection%22">Infection</searchLink><br /><searchLink fieldCode="DE" term="%223+Good+Health+and+Well+Being%22">3 Good Health and Well Being</searchLink><br /><searchLink fieldCode="DE" term="%22Adult%22">Adult</searchLink><br /><searchLink fieldCode="DE" term="%22Aged%22">Aged</searchLink><br /><searchLink fieldCode="DE" term="%22Aminoisobutyric+Acids%22">Aminoisobutyric Acids</searchLink><br /><searchLink fieldCode="DE" term="%22Antiviral+Agents%22">Antiviral Agents</searchLink><br /><searchLink fieldCode="DE" term="%22Benzimidazoles%22">Benzimidazoles</searchLink><br /><searchLink fieldCode="DE" term="%22Cyclopropanes%22">Cyclopropanes</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+Administration+Schedule%22">Drug Administration Schedule</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+Resistance%22">Drug Resistance</searchLink><br /><searchLink fieldCode="DE" term="%22Multiple%22">Multiple</searchLink><br /><searchLink fieldCode="DE" term="%22Viral%22">Viral</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+Therapy%22">Drug Therapy</searchLink><br /><searchLink fieldCode="DE" term="%22Combination%22">Combination</searchLink><br /><searchLink fieldCode="DE" term="%22Female%22">Female</searchLink><br /><searchLink fieldCode="DE" term="%22Genotype%22">Genotype</searchLink><br /><searchLink fieldCode="DE" term="%22Hepacivirus%22">Hepacivirus</searchLink> )
Array ( [Name] => Abstract [Label] => Description [Group] => Ab [Data] => Background & Aims Hepatitis C virus (HCV) therapy that is highly efficacious, pangenotypic, with a high barrier to resistance and short treatment duration is desirable. The efficacy and safety of 8- and 12-week treatments with glecaprevir (ABT-493; NS3/4 A protease inhibitor) and pibrentasvir (ABT-530; NS5A inhibitor) were evaluated in non-cirrhotic patients with chronic HCV genotype 1–6 infection. Methods SURVEYOR-I and SURVEYOR-II were phase II, open-label, multicenter, dose-ranging trials including patients with chronic HCV genotype 1–6 infection who were either previously untreated or treated with pegylated interferon plus ribavirin. Patients received once-daily glecaprevir plus pibrentasvir at varying doses with or without ribavirin for 8 or 12 weeks. The primary efficacy endpoint was the percentage of patients with a sustained virologic response at post-treatment week 12 (SVR12). Results Of the 449 patients who received varying doses of glecaprevir plus pibrentasvir, 25%, 29%, 39%, and 8% had HCV genotype 1, 2, 3, and 4–6 infection, respectively. Twelve-week treatment achieved SVR12 in 97–100%, 96–100%, 83–94%, and 100% in genotypes 1, 2, 3, and 4–6, respectively. Eight-week treatment with 300 mg glecaprevir plus 120 mg pibrentasvir in genotype 1-, 2-, or 3-infected patients yielded 97–98% SVR12 with no virologic failures. Three (0.7%) patients discontinued treatment due to adverse events; most events were mild (grade 1) in severity. No post-nadir alanine aminotransferase elevations were observed. Conclusions Glecaprevir plus pibrentasvir was well tolerated and achieved high sustained virologic response rates in HCV genotypes 1–6-infected patients without cirrhosis following 8- or 12-week treatment durations. Lay summary The combination of direct-acting antivirals glecaprevir and pibrentasvir comprise a once-daily, all-oral, pangenotypic treatment for HCV genotype 1–6 infection. This article describes results from two phase II trials investigating a range of doses at treatment durations of 8 or 12 ... )
Array ( [Name] => TypeDocument [Label] => Document Type [Group] => TypDoc [Data] => article in journal/newspaper )
Array ( [Name] => Language [Label] => Language [Group] => Lang [Data] => unknown )
Array ( [Name] => NoteTitleSource [Label] => Relation [Group] => SrcInfo [Data] => http://purl.org/au-research/grants/nhmrc/APP1118864; http://hdl.handle.net/1959.4/unsworks_44734; https://doi.org/10.1016/j.jhep.2017.03.039 )
Array ( [Name] => DOI [Label] => DOI [Group] => ID [Data] => 10.1016/j.jhep.2017.03.039 )
Array ( [Name] => URL [Label] => Availability [Group] => URL [Data] => https://doi.org/10.1016/j.jhep.2017.03.039<br />http://hdl.handle.net/1959.4/unsworks_44734 )
Array ( [Name] => Copyright [Label] => Rights [Group] => Cpyrght [Data] => metadata only access ; http://purl.org/coar/access_right/c_14cb ; CC-BY-NC-ND ; https://creativecommons.org/licenses/by-nc-nd/4.0/ )
Array ( [Name] => AN [Label] => Accession Number [Group] => ID [Data] => edsbas.9565DFD4 )
RecordInfo Array ( [BibEntity] => Array ( [Identifiers] => Array ( [0] => Array ( [Type] => doi [Value] => 10.1016/j.jhep.2017.03.039 ) ) [Languages] => Array ( [0] => Array ( [Text] => unknown ) ) [Subjects] => Array ( [0] => Array ( [SubjectFull] => Liver Disease [Type] => general ) [1] => Array ( [SubjectFull] => Hepatitis - C [Type] => general ) [2] => Array ( [SubjectFull] => Emerging Infectious Diseases [Type] => general ) [3] => Array ( [SubjectFull] => Digestive Diseases [Type] => general ) [4] => Array ( [SubjectFull] => Infectious Diseases [Type] => general ) [5] => Array ( [SubjectFull] => Clinical Trials and Supportive Activities [Type] => general ) [6] => Array ( [SubjectFull] => HIV/AIDS [Type] => general ) [7] => Array ( [SubjectFull] => Hepatitis [Type] => general ) [8] => Array ( [SubjectFull] => Clinical Research [Type] => general ) [9] => Array ( [SubjectFull] => Genetics [Type] => general ) [10] => Array ( [SubjectFull] => Chronic Liver Disease and Cirrhosis [Type] => general ) [11] => Array ( [SubjectFull] => 6.1 Pharmaceuticals [Type] => general ) [12] => Array ( [SubjectFull] => 6 Evaluation of treatments and therapeutic interventions [Type] => general ) [13] => Array ( [SubjectFull] => Infection [Type] => general ) [14] => Array ( [SubjectFull] => 3 Good Health and Well Being [Type] => general ) [15] => Array ( [SubjectFull] => Adult [Type] => general ) [16] => Array ( [SubjectFull] => Aged [Type] => general ) [17] => Array ( [SubjectFull] => Aminoisobutyric Acids [Type] => general ) [18] => Array ( [SubjectFull] => Antiviral Agents [Type] => general ) [19] => Array ( [SubjectFull] => Benzimidazoles [Type] => general ) [20] => Array ( [SubjectFull] => Cyclopropanes [Type] => general ) [21] => Array ( [SubjectFull] => Drug Administration Schedule [Type] => general ) [22] => Array ( [SubjectFull] => Drug Resistance [Type] => general ) [23] => Array ( [SubjectFull] => Multiple [Type] => general ) [24] => Array ( [SubjectFull] => Viral [Type] => general ) [25] => Array ( [SubjectFull] => Drug Therapy [Type] => general ) [26] => Array ( [SubjectFull] => Combination [Type] => general ) [27] => Array ( [SubjectFull] => Female [Type] => general ) [28] => Array ( [SubjectFull] => Genotype [Type] => general ) [29] => Array ( [SubjectFull] => Hepacivirus [Type] => general ) ) [Titles] => Array ( [0] => Array ( [TitleFull] => Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1–6 without cirrhosis [Type] => main ) ) ) [BibRelationships] => Array ( [HasContributorRelationships] => Array ( [0] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Kwo, PY ) ) ) [1] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Poordad, F ) ) ) [2] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Asatryan, A ) ) ) [3] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Wang, S ) ) ) [4] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Wyles, DL ) ) ) [5] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Hassanein, T ) ) ) [6] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Felizarta, F ) ) ) [7] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Sulkowski, MS ) ) ) [8] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Gane, E ) ) ) [9] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Maliakkal, B ) ) ) [10] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Overcash, JS ) ) ) [11] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Gordon, SC ) ) ) [12] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Muir, AJ ) ) ) [13] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Aguilar, H ) ) ) [14] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Agarwal, K ) ) ) [15] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Dore, GJ ) ) ) [16] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Lin, CW ) ) ) [17] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Liu, R ) ) ) [18] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Lovell, SS ) ) ) [19] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Ng, TI ) ) ) [20] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Kort, J ) ) ) [21] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Mensa, FJ ) ) ) ) [IsPartOfRelationships] => Array ( [0] => Array ( [BibEntity] => Array ( [Dates] => Array ( [0] => Array ( [D] => 01 [M] => 01 [Type] => published [Y] => 2017 ) ) [Identifiers] => Array ( [0] => Array ( [Type] => issn-locals [Value] => edsbas ) [1] => Array ( [Type] => issn-locals [Value] => edsbas.oa ) ) [Titles] => Array ( [0] => Array ( [TitleFull] => urn:ISSN:0168-8278 ; urn:ISSN:1600-0641 ; Journal of Hepatology, 67, 2, 263-271 [Type] => main ) ) ) ) ) ) )
IllustrationInfo