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Article: Deferred treatment with a fixed‐dose combination of sofosbuvir‐velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection

TitleDeferred treatment with a fixed‐dose combination of sofosbuvir‐velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection
Authors
KeywordsDirect-acting antivirals
NS5A inhibitor
NS5B inhibitor
Pangenotypic activity
Issue Date2019
PublisherWiley-Blackwell Publishing Ltd. The Journal's web site is located at http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1365-2893
Citation
Journal of Viral Hepatitis, 2019, v. 26 n. 10, p. 1229-1232 How to Cite?
AbstractSofosbuvir‐velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection. In this single‐arm, open‐label, phase 3, deferred treatment study, we investigated the efficacy and safety of sofosbuvir‐velpatasvir among patients randomized to the placebo group in the ASTRAL‐1 study. Patients received sofosbuvir‐velpatasvir (400/100 mg) once daily for 12 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response 12 weeks after the end of therapy (SVR12). The primary safety endpoint was any adverse events (AEs) leading to the permanent discontinuation of study drug. Overall, 108/111 (97%, 95% confidence interval [CI], 92%‐99%) achieved SVR12, and only one patient had virological failure. SVR12 was achieved by 61/63 (97%, 95%CI, 89%‐100%) genotype 1 patients, 20/20 (100%; 95%CI, 83%‐100%) with genotype 2, 19/19 (100%; 95%CI, 82%‐100%) with genotype 4 and 8/9 (89%; 95% CI, 52%‐100%) with genotype 6. All (19/19; 95%CI, 82‐100) patients with cirrhosis and all (31/31, 95%CI, 89‐100) with prior treatment experience achieved SVR12. The safety profile during treatment was similar to that observed in patients receiving placebo treatment. The most common AEs were headache, fatigue and nausea. One patient (1%) discontinued treatment due to an AE of gallbladder carcinoma, which was not considered related to treatment. Of five reported serious AEs, none were considered related to study drug. Sofosbuvir‐velpatasvir for 12 weeks was effective and well tolerated among untreated and previously treated patients with HCV genotype 1, 2, 4 or 6 infection, including those with compensated cirrhosis (ClinicalTrials.gov NCT02346721).
Persistent Identifierhttp://hdl.handle.net/10722/275104
ISSN
2020 Impact Factor: 3.728
2015 SCImago Journal Rankings: 1.815
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorAsselah, T-
dc.contributor.authorShafran, SD-
dc.contributor.authorBourgeois, S-
dc.contributor.authorLai, CL-
dc.contributor.authorMathurin, P-
dc.contributor.authorWillems, B-
dc.contributor.authorNguyen, MH-
dc.contributor.authorDavis, MN-
dc.contributor.authorHuang, KC-
dc.contributor.authorSvarovskaia, E-
dc.contributor.authorOsinusi, A-
dc.contributor.authorMcNally, J-
dc.contributor.authorBrainard, DM-
dc.contributor.authorShaikh, OS-
dc.contributor.authorTran, TT-
dc.date.accessioned2019-09-10T02:35:33Z-
dc.date.available2019-09-10T02:35:33Z-
dc.date.issued2019-
dc.identifier.citationJournal of Viral Hepatitis, 2019, v. 26 n. 10, p. 1229-1232-
dc.identifier.issn1352-0504-
dc.identifier.urihttp://hdl.handle.net/10722/275104-
dc.description.abstractSofosbuvir‐velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection. In this single‐arm, open‐label, phase 3, deferred treatment study, we investigated the efficacy and safety of sofosbuvir‐velpatasvir among patients randomized to the placebo group in the ASTRAL‐1 study. Patients received sofosbuvir‐velpatasvir (400/100 mg) once daily for 12 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response 12 weeks after the end of therapy (SVR12). The primary safety endpoint was any adverse events (AEs) leading to the permanent discontinuation of study drug. Overall, 108/111 (97%, 95% confidence interval [CI], 92%‐99%) achieved SVR12, and only one patient had virological failure. SVR12 was achieved by 61/63 (97%, 95%CI, 89%‐100%) genotype 1 patients, 20/20 (100%; 95%CI, 83%‐100%) with genotype 2, 19/19 (100%; 95%CI, 82%‐100%) with genotype 4 and 8/9 (89%; 95% CI, 52%‐100%) with genotype 6. All (19/19; 95%CI, 82‐100) patients with cirrhosis and all (31/31, 95%CI, 89‐100) with prior treatment experience achieved SVR12. The safety profile during treatment was similar to that observed in patients receiving placebo treatment. The most common AEs were headache, fatigue and nausea. One patient (1%) discontinued treatment due to an AE of gallbladder carcinoma, which was not considered related to treatment. Of five reported serious AEs, none were considered related to study drug. Sofosbuvir‐velpatasvir for 12 weeks was effective and well tolerated among untreated and previously treated patients with HCV genotype 1, 2, 4 or 6 infection, including those with compensated cirrhosis (ClinicalTrials.gov NCT02346721).-
dc.languageeng-
dc.publisherWiley-Blackwell Publishing Ltd. The Journal's web site is located at http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1365-2893-
dc.relation.ispartofJournal of Viral Hepatitis-
dc.rightsThis is the peer reviewed version of the following article: Journal of Viral Hepatitis, 2019, v. 26 n. 10, p. 1229-1232, which has been published in final form at https://doi.org/10.1111/jvh.13159. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions.-
dc.subjectDirect-acting antivirals-
dc.subjectNS5A inhibitor-
dc.subjectNS5B inhibitor-
dc.subjectPangenotypic activity-
dc.titleDeferred treatment with a fixed‐dose combination of sofosbuvir‐velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection-
dc.typeArticle-
dc.identifier.emailLai, CL: hrmelcl@hkucc.hku.hk-
dc.identifier.authorityLai, CL=rp00314-
dc.description.naturepostprint-
dc.identifier.doi10.1111/jvh.13159-
dc.identifier.pmid31216086-
dc.identifier.scopuseid_2-s2.0-85070491277-
dc.identifier.hkuros304349-
dc.identifier.volume26-
dc.identifier.issue10-
dc.identifier.spage1229-
dc.identifier.epage1232-
dc.identifier.isiWOS:000478826600001-
dc.publisher.placeUnited Kingdom-
dc.identifier.issnl1352-0504-

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