The efficacy and safety of dual oral therapy with daclatasvir and asunaprevir for genotype 1b in Japanese real‐life settings

Sezaki, Hitomi; Suzuki, Fumitaka; Hosaka, Tetsuya; Akuta, Norio; Fujiyama, Shunichiro; Kawamura, Yusuke; Kobayashi, Masahiro; Suzuki, Yoshiyuki; Saitoh, Satoshi; Arase, Yasuji; Ikeda, Kenji; Kobayashi, Mariko; Kumada, Hiromitsu

doi:10.1111/liv.13384

Cited by 24 publications

(24 citation statements)

References 25 publications

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“…A new IFN‐free combination therapy using two direct acting anti‐viral agents (DAAs) that target different regions of the viral genome was recently introduced for the treatment of hepatitis C virus (HCV) genotype 1b. In Japan, the first IFN‐free dual oral therapy of dacratasvir (DCV; Daklinza ® , Bristol Myers Squibb) and asunaprevir (ASV; Sunvepra ® , Bristol Myers Squibb, New York, NY) was approved in September 2014 by the Government National Health Insurance scheme for patients with chronic HCV‐1b infection and has since its use shown promising results . However, there is little or no information on whether the DAA affects liver fibrosis or HCV‐associated hepatocarcinogenesis.…”

Section: Introductionmentioning

confidence: 99%

Serial changes in liver stiffness and controlled attenuation parameter following direct‐acting antiviral therapy against hepatitis C virus genotype 1b

Ogasawara

Kobayashi

Akuta

et al. 2017

Journal of Medical Virology

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Little information is available on the impact of direct-acting antiviral (DAA) therapy on changes in liver fibrosis and steatosis. Liver stiffness (LS) and controlled attenuation parameter (CAP) values were evaluated using transient elastography. The study subjects were 214 elderly patients infected with HCV genotype 1b who received 24-week daclatasvir and asunaprevir dual therapy. All patients of this retrospective study had no hepatocellular carcinoma before and during DAA therapy. LS and CAP were assessed before treatment (baseline), at end of treatment (EOT), and at 24, 48, 72 weeks (W) after EOT. The rate of sustained viral response (SVR) by daclatasvir and asunaprevir therapy was 91%. LS values for the entire group correlated with Fib-4 index at baseline (r = 0.565, P < 0.001). LS in both chronic hepatitis group (Fib-4 index <3.25) and cirrhosis group (Fib-4 index ≥3.25) decreased significantly at each time point compared with baseline (P < 0.001). Especially, a larger decrease in LS from baseline to EOT was seen in the cirrhosis group than chronic hepatitis group (P < 0.001). LS was also significantly lower in the SVR group at EOT, 24W, 48W, 72W compared with baseline (P < 0.001). Even in the non-SVR group, LS tended to be lower at EOT (P = 0.039), 24W (P = 0.009), 48W (P = 0.475), 72W (P = 0.033) compared with baseline. CAP increased significantly following the treatment from baseline to 48W post-EOT (P = 0.018). Our results showed significant improvement in LS in response to daclatasvir and asunaprevir dual therapy. In the other hand, there was a tendency that CAP increased from baseline.

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Section: Introductionmentioning

confidence: 99%

Serial changes in liver stiffness and controlled attenuation parameter following direct‐acting antiviral therapy against hepatitis C virus genotype 1b

Ogasawara

Kobayashi

Akuta

et al. 2017

Journal of Medical Virology

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“…The SVR rate in PP analysis (95.8%), which excluded those who discontinued the combination therapy due to nonmedical reasons, was higher in previously published studies . Notably, the treatment withdrawal rate in treatment‐experienced patients was very low (2/162, 1.2%), so that the SVR rate in those patients was not inferior to treatment‐naive patients.…”

Section: Discussionmentioning

confidence: 77%

“…This may be attributable to the Korean practice under Government insurance system requiring mandatory pretreatment testing for RAS. Because the SVR rate in RAS‐negative patients was consistently higher than those with RAS (usually <70%) in previous studies, recent post‐2016 real‐world studies from Korea did not include RAS‐positive patients, resulting in a more favorable treatment response rate compared with former studies …”

Section: Discussionmentioning

confidence: 96%

“…In phase 3 global trial of DCV/ASV combination therapy (HALLMARK‐DUAL), the SVR rates for treatment‐naive patients, interferon nonresponders, and interferon‐ineligible/intolerable patients were 90%, 82%, and 82%, respectively . Moreover, Sezaki et al showed that the SVR rate in those who met the inclusion criteria for clinical trials (87%) was comparable to those who did not meet the criteria (86.7%) by the real‐life study. A meta‐analysis, including nine studies published before May 2016, had reported SVR rates of 89.9%, 84.7%, and 81.9% in treatment‐naive patients, interferon‐ineligible/intolerable patients, and nonresponders.…”

Section: Discussionmentioning

confidence: 99%

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Real‐life effectiveness and safety of the daclatasvir/asunaprevir combination therapy for genotype 1b chronic hepatitis C patients: An emphasis on the pretreatment NS5A resistance‐associated substitution test

Jang

Kim

et al. 2019

Journal of Medical Virology

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This study aimed to investigate the real‐life effectiveness and safety of daclatasvir (DCV) and asunaprevir (ASV) combination therapy in Korean patients. We consecutively enrolled patients with genotype 1b hepatitis C virus (HCV) infection treated with at least one dose of DCV/ASV combination therapy in seven tertiary hospitals of South Korea. The sustained virologic response (SVR) rates and safety according to intention‐to‐treat (ITT) and per‐protocol (PP) analyses were evaluated. Among the 526 enrolled patients, 91% showed negative (87%) or “undetermined” (4%) resistance‐associated substitution (RAS); 9% did not undergo RAS testing. The SVR rates for ITT and PP were 89.3% and 95.0% in treatment‐naive patients and 93.2% and 95.6% in treatment‐experienced patients, respectively. In PP analysis, negative RAS was associated with higher SVR (96.3%) than with “undetermined RAS” (85.7%) or “not tested for RAS” (84.4%). Adverse events were reported in 185 (35.4%) patients, and events leading to discontinuation were observed in 4.3% of the study population. Forty‐two (8.0%) patients developed transaminase elevation (≥2 × upper normal limit), resulting in treatment discontinuation in six (1.1%) patients. DCV/ASV combination therapy showed acceptable efficacy in genotype 1b compensated HCV‐infected patients with negative pretreatment RAS. Although most adverse events were tolerable to continue antiviral treatment, adequate monitoring for transaminase elevation is warranted.

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“…DCV/ASV kombinasyon tedavisinin değerlen-dirildiği, gerçek yaşam verilerini içeren çalışmalarda ALT yük-selmesi nedeniyle tedavinin %2.9 oranında sonlandırılması gerektiği bildirilmektedir (90).…”

Section: Asunaprevir Ve Daklatasvirunclassified

Management of Chronic Hepatitis C Virus Infection: A Consensus Report of the Study Group for Viral Hepatitis of the Turkish Society of Clinical Microbiology and Infectious Diseases-2017 Update

Aygen¹,

Demirtürk²,

Türker³

et al. 2017

Klimik Dergisi

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The efficacy and safety of dual oral therapy with daclatasvir and asunaprevir for genotype 1b in Japanese real‐life settings

Abstract: Dual oral therapy with DCV and ASV in real-life settings was well tolerated with a similar safety profile and achieved similar SVR12 rates as that of CTR.

Cited by 24 publications

References 25 publications

Serial changes in liver stiffness and controlled attenuation parameter following direct‐acting antiviral therapy against hepatitis C virus genotype 1b

Serial changes in liver stiffness and controlled attenuation parameter following direct‐acting antiviral therapy against hepatitis C virus genotype 1b

Real‐life effectiveness and safety of the daclatasvir/asunaprevir combination therapy for genotype 1b chronic hepatitis C patients: An emphasis on the pretreatment NS5A resistance‐associated substitution test

Management of Chronic Hepatitis C Virus Infection: A Consensus Report of the Study Group for Viral Hepatitis of the Turkish Society of Clinical Microbiology and Infectious Diseases-2017 Update

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