دورية أكاديمية
Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1–6 without cirrhosis
| العنوان: | Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1–6 without cirrhosis |
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| 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 |
| DOI: | 10.1016/j.jhep.2017.03.039 |
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