Safety and efficacy of daclatasvir and asunaprevir in hepatitis C virus‐infected patients with renal impairment

Suda, Goki; Nagasaka, Atsushi; Yamamoto, Yoshiya; Furuya, Ken; Kumagai, Kotaro; Kudo, Mineo; Terashita, Katsumi; Kobayashi, Tomoe; Tsunematsu, Izumi; Yoshida, Jun‐ichi; Meguro, Takeshi; Kimura, Megumi; Ito, Jun; Umemura, Machiko; Izumi, Takeshi; Tsunematsu, Seiji; Sato, Fumiyuki; Tsukuda, Yoko; Nakai, Masato; Sho, Takuya; Natsuizaka, Mitsuteru; Morikawa, Kenichi; Ogawa, Koji; Sakamoto, Naoya

doi:10.1111/hepr.12851

Cited by 34 publications

(47 citation statements)

References 34 publications

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“…Direct‐acting antiviral therapy is expected to produce a higher SVR rate. Direct‐acting antiviral therapy with ombitasvir, paritaprevir, and ritonavir, and daclatasvir plus asunaprevir can cure patients with chronic HCV genotype 1 undergoing dialysis . It is also important to follow up and treat patients with OCI.…”

Section: Discussionmentioning

confidence: 99%

Host genetic factors and clinical parameters influencing the occult hepatitis C virus infection in patients on chronic hemodialysis: Is it still a controversial infection?

Ayadi

Nafari

Sakhaee

et al. 2019

Hepatology Research

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Aim The presence of occult hepatitis C virus (HCV) infection (OCI) is still controversial, however, this infection cannot be ignored. Therefore, the current study aimed at assessing the OCI frequency in patients on chronic hemodialysis (CHD) and also evaluating the association between OCI incidence with clinical parameters and interferon lambda 3/4 (IFNL3/4) gene polymorphisms. Methods A total of 515 patients on CHD and HCV negative markers were selected. Plus‐ and minus‐stranded HCV‐RNA was tested in peripheral blood mononuclear cell samples by reverse transcription–polymerase chain reaction and then genotyped using the restriction fragment length polymorphism method. Results The frequency of OCI was 11.3% in patients on CHD. Among 58 patients with OCI, 25.8%, 62.1%, and 12.1% were infected with HCV‐1a, HCV‐1b, and HCV‐3a, respectively. The mean alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase levels were 31.9 ± 24.8, 32.3 ± 19.1, and 171.6 ± 88.9, respectively. None of the patients with OCI had a history of liver disease. Multivariate logistic regression analysis indicated that cholesterol, triglyceride, low‐density lipoprotein, 25‐hydroxyvitamin D, platelets, duration of hemodialysis, HCV subtypes, IFNL3 rs12979860 TT, IFNL3 rs8099917 GG, IFNL3 rs12980275 GG, and IFNL4 ss469415590 ΔG/ΔG genotypes were associated with OCI. Conclusion There was a moderate prevalence of OCI in Iranian patients on CHD. The current study findings indicated that this infection was associated with clinical parameters and unfavorable genotypes of IFNL3 single nucleotide polymorphisms and IFNL4 ss469415590. Further studies are required to determine the correlation between OCI incidence with clinical parameters and host genetic factors.

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Section: Discussionmentioning

confidence: 99%

Host genetic factors and clinical parameters influencing the occult hepatitis C virus infection in patients on chronic hemodialysis: Is it still a controversial infection?

Ayadi

Nafari

Sakhaee

et al. 2019

Hepatology Research

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“…This study was undertaken by the NORTE Study Group, which has been carrying out clinical liver disease studies . In this retrospective, multicenter study, between 2006 and 2018, a total of 567 HBV‐infected patients who were treated with ETV monotherapy were screened.…”

Section: Methodsmentioning

confidence: 99%

Entecavir treatment of hepatitis B virus‐infected patients with severe renal impairment and those on hemodialysis

Suzuki

Suda

Yamamoto

et al. 2019

Hepatology Research

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Aim Entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF) are first‐line nucleos(t)ide analogues for hepatitis B virus (HBV)‐infected patients. However, consecutive TDF treatment causes renal dysfunction, and the safety and efficacy of TAF have not been established in severe renal dysfunction patients, including hemodialysis patients. The efficacy and safety of ETV in these populations has not been clarified. The study aimed to clarify this. Methods In this retrospective multicenter study, between 2006 and 2018, a total of 567 HBV‐infected patients treated with ETV monotherapy were screened. Patients were included if >20 years old, treated with ETV monotherapy for >1 year, and had proper clinical information. The efficacy of ETV and changes in renal function were evaluated according to renal function. Results A total of 273 patients were included: 9.2% (25/273), 1.8% (5/273), and 3.7% (10/273) had chronic kidney disease (CKD) stage G3, CKD stage G4/5, and were on hemodialysis, respectively. Overall, 84.2%, 94.0%, and 96.2% of patients experienced serum HBV‐DNA disappearance at 1, 2, and 3 years, respectively, after treatment initiation. In patients with CKD stage G3–5, estimated glomerular filtration rate tended to restore with time, which was in contrast to patients without renal dysfunction. The rate of disappearance in serum HBV‐DNA, alanine transaminase normalization, and virological breakthrough was similar between patients with or without renal dysfunction. ETV showed high efficacy for all 10 hemodialysis patients without virological breakthrough. Conclusions Entecavir for HBV‐infected patients with severe renal dysfunction, including hemodialysis patients, is highly effective and does not affect renal function.

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“…The combination of HCV NS3/4A protease inhibitor asunaprevir (200 mg daily) and HCV NS5A inhibitor daclatasvir (60 mg daily) for 24 weeks resulted in 100% (16/16) and 100% (8/8) SVR rates in stages 3b, 4 and 5 CKD and HCV GT1b-patients, respectively [22]. This treatment combination also reportedly led to 96% (20/21) and 100% (28/28) SVR rates [23, 24].…”

Section: Selection Of Daas In Hcv-infected Patients With Severe Renalmentioning

confidence: 99%

APASL clinical practice recommendation: how to treat HCV-infected patients with renal impairment?

et al. 2018

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Chronic hepatitis C virus (HCV) infection is common among patients with chronic kidney disease (CKD) and those on hemodialysis due to nosocomial infections and past blood transfusions. While a majority of HCV-infected patients with end-stage renal disease are asymptomatic, some may ultimately experience decompensated liver diseases and hepatocellular carcinoma. Administration of a combination of elbasvir/grazoprevir for 12 weeks leads to high sustained virologic response (SVR) rates in patients with HCV genotypes (GTs) 1a, 1b or 4 and stage 4 or 5 CKD. Furthermore, a combination of glecaprevir/pibrentasvir for 8–16 weeks also results in high SVR rates in patients with all HCV GTs and stage 4 or 5 CKD. However, these regimens are contraindicated in the presence of advanced decompensated cirrhosis. Although sofosbuvir and/or ribavirin are not generally recommended for HCV-infected patients with severe renal impairment, sofosbuvir-based regimens may be appropriate for those with mild renal impairment. To eliminate HCV worldwide, HCV-infected patients with renal impairment should be treated with interferon-free therapies.Electronic supplementary materialThe online version of this article (10.1007/s12072-018-9915-5) contains supplementary material, which is available to authorized users.

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Safety and efficacy of daclatasvir and asunaprevir in hepatitis C virus‐infected patients with renal impairment

Abstract: Daclatasvir and asunaprevir combination therapy for patients with renal dysfunction was highly effective and safe.

Cited by 34 publications

References 34 publications

Host genetic factors and clinical parameters influencing the occult hepatitis C virus infection in patients on chronic hemodialysis: Is it still a controversial infection?

Host genetic factors and clinical parameters influencing the occult hepatitis C virus infection in patients on chronic hemodialysis: Is it still a controversial infection?

Entecavir treatment of hepatitis B virus‐infected patients with severe renal impairment and those on hemodialysis

APASL clinical practice recommendation: how to treat HCV-infected patients with renal impairment?

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