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      Efficacy and safety of daclatasvir plus asunaprevir for Korean patients with HCV genotype Ib infection: a retrospective multi-institutional study

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          Abstract

          Background/Aims

          The combination of daclatasvir (DCV) and asunaprevir (ASV) has demonstrated a high sustained virologic response at 12 weeks (SVR12) and a low rate of adverse events in previous clinical studies. The purpose of this study was to clarify the results of treatment and side effects in Korean patients with chronic hepatitis C virus (HCV) genotype Ib infection.

          Methods

          We retrospectively analyzed clinical data from chronic HCV genotype Ib patients treated with DCV+ASV from August 2015 to September 2016 at five hospitals in the Daejeon-Chungcheong area.

          Results

          A total of 152 patients were examined for resistance associated variants (RAVs). Among them, 15 (9.9%) were positive for Y93 and one (0.7%) was positive for L31. Of 126 patients treated with DCV+ASV, 83 patients completed treatment and 76 patients were included in safety and efficacy analysis. Five (6.6%) were positive for Y93 and 12 (15.8%) exhibited cirrhotic change. DCV+ASV was the first-line treatment for 58 (76.3%) patients. Eleven (14.5%) patients relapsed after previous treatment that included interferon and seven (9.2%) of these patients were found to be intolerant of interferon. Adverse events occurred in 10 (13.2%) patients and two patients stopped the medication because of severe itching and skin rash. SVR12 was 89.5% (68/76) in all patients and 91.5% (65/71) in RAV-negative patients.

          Conclusions

          DCV+ASV showed good efficacy in patients with HCV Ib infection in Korea. Close monitoring is needed for severe adverse events and treatment failure, which were uncommon.

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          EASL Recommendations on Treatment of Hepatitis C 2015.

          (2015)
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            Daclatasvir Plus Asunaprevir for Chronic HCV Genotype 1b Infection

            Hiromitsu Kumada, Yoshiyuki Suzuki, Kenji Ikeda … (2014)
            All-oral combinations of direct-acting antivirals may improve efficacy and safety outcomes for patients with hepatitis C virus (HCV) infection, particularly those who are poor candidates for current interferon/ribavirin-based regimens. In this open-label, phase 3 study, 135 interferon-ineligible/intolerant and 87 nonresponder patients with chronic HCV genotype 1b infection were enrolled at 24 centers in Japan. Patients received daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily for 24 weeks. The primary endpoint was sustained virologic response 24 weeks after treatment (SVR24). This study is registered with http://ClinicalTrials.gov (NCT01497834). SVR24 was achieved by 87.4% of interferon-ineligible/intolerant patients and 80.5% of nonresponder (null and partial) patients; rates were similar in cirrhosis (90.9%) and noncirrhosis (84.0%) patients, and in patients with IL28B CC (84.5%) or non-CC (84.8%) genotypes. Fourteen patients in each group (12.6%) discontinued dual therapy, mainly due to adverse events or lack of efficacy. Nine nonresponder patients received additional treatment with peginterferon/ribavirin per protocol-defined criteria. The rate of serious adverse events was low (5.9%) and varied among patients. The most common adverse events were nasopharyngitis, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST), headache, diarrhea, and pyrexia. Conclusion: Interferon-free, ribavirin-free all-oral therapy with daclatasvir and asunaprevir for 24 weeks is well tolerated and can achieve a high rate of SVR in patients with HCV genotype 1b who were ineligible, intolerant, or had not responded to prior interferon-based therapy. (Hepatology 2014;59:2083–2091)
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              Preliminary study of two antiviral agents for hepatitis C genotype 1.

              Anna Lok, David F. Gardiner, Eric Lawitz … (2012)
              Patients with chronic hepatitis C virus (HCV) infection who have not had a response to therapy with peginterferon and ribavirin may benefit from the addition of multiple direct-acting antiviral agents to their treatment regimen. This open-label, phase 2a study included an exploratory cohort of 21 patients with chronic HCV genotype 1 infection who had not had a response to previous therapy (i.e., had not had ≥2 log(10) decline in HCV RNA after ≥12 weeks of treatment with peginterferon and ribavirin). We randomly assigned patients to receive the NS5A replication complex inhibitor daclatasvir (60 mg once daily) and the NS3 protease inhibitor asunaprevir (600 mg twice daily) alone (group A, 11 patients) or in combination with peginterferon alfa-2a and ribavirin (group B, 10 patients) for 24 weeks. The primary end point was the percentage of patients with a sustained virologic response 12 weeks after the end of the treatment period. A total of 4 patients in group A (36%; 2 of 9 with HCV genotype 1a and 2 of 2 with genotype 1b) had a sustained virologic response at 12 weeks after treatment and also at 24 weeks after treatment.. Six patients (all with HCV genotype 1a) had viral breakthrough while receiving therapy, and resistance mutations to both antiviral agents were found in all cases; 1 patient had a viral response at the end of treatment but had a relapse after the treatment period. All 10 patients in group B had a sustained virologic response at 12 weeks after treatment, and 9 had a sustained virologic response at 24 weeks after treatment. Diarrhea was the most common adverse event in both groups. Six patients had transient elevations of alanine aminotransferase levels to more than 3 times the upper limit of the normal range. This preliminary study involving patients with HCV genotype 1 infection who had not had a response to prior therapy showed that a sustained virologic response can be achieved with two direct-acting antiviral agents only. In addition, a high rate of sustained virologic response was achieved when the two direct-acting antiviral agents were combined with peginterferon alfa-2a and ribavirin. (Funded by Bristol-Myers Squibb; ClinicalTrials.gov number, NCT01012895.).
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                Author and article information

                Journal
                Journal ID (nlm-ta): Clin Mol Hepatol
                Journal ID (iso-abbrev): Clin Mol Hepatol
                Journal ID (publisher-id): CMH
                Title: Clinical and Molecular Hepatology
                Publisher: The Korean Association for the Study of the Liver
                ISSN (Print): 2287-2728
                ISSN (Electronic): 2287-285X
                Publication date (Print): March 2017
                Publication date (Electronic): 16 March 2017
                Volume: 23
                Issue: 1
                Pages: 51-56
                Affiliations
                [1 ]Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea
                [2 ]Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea
                [3 ]Department of Internal Medicine, Konyang University College of Medicine, Daejeon, Korea
                [4 ]Department of Internal Medicine, Chungnam University College of Medicine, Daejeon, Korea
                [5 ]Department of Internal Medicine, Chungbuk University College of Medicine, Cheongju, Korea
                Author notes
                Corresponding author : Seok Bae Kim Department of Internal Medicine, Dankook University College of Medicine, 119 Dandae-ro, Dongnam-gu, Cheonan 31116, Korea Tel: +82-41-550-3910, Fax: +82-41-556-3256 E-mail: dryakson@ 123456hanmail.net
                Article
                Publisher ID: cmh-2016-0053
                DOI: 10.3350/cmh.2016.0053
                PMC ID: 5381834
                PubMed ID: 28297836
                SO-VID: cb69d016-3488-4be7-bba9-482f62e782ce
                Copyright © Copyright © 2017 by The Korean Association for the Study of the Liver
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 14 August 2016
                Date revision received : 6 December 2016
                Date accepted : 7 December 2016
                Categories
                Subject: Original Article

                ScienceOpen disciplines: Gastroenterology & Hepatology
                Keywords: daclatasvir,asunaprevir,hepatitis c, chronic,korea
                Data availability:
                ScienceOpen disciplines: Gastroenterology & Hepatology
                Keywords: daclatasvir, asunaprevir, hepatitis c, chronic, korea

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