Efficacy and safety of ombitasvir/paritaprevir/ritonavir in dialysis patients with genotype 1b chronic hepatitis C

Atsukawa, Masanori; Tsubota, Akihito; Koushima, Yohei; Ikegami, Tadashi; Watanabe, Kouji; Shimada, Noritomo; Sato, Shinya; Kato, Kazúo; Abe, Hiroshi; Okubo, Tomomi; Arai, Taeang; Itokawa, Norio; Kondo, Chisa; Mikami, Shigeru; Asano, Toru; Chuganji, Yoshimichi; Matsuzaki, Yasushi; Iwakiri, Katsuhiko

doi:10.1111/hepr.12910

Cited by 42 publications

(44 citation statements)

References 46 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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“…Some IFN‐free DAA combination regimens, such as daclatasvir/asunaprevir and ombitasvir/paritaprevir/ritonavir, are effective and safe for patients with CKD, including those undergoing hemodialysis . However, these regimens involve the issue of drug–drug interaction, especially for patients with CKD who have commonly been administered multiple concomitant drugs for managing the complications associated with CKD.…”

Section: Discussionmentioning

confidence: 99%

“…Asunaprevir/daclatasvir is effective and safe for both non‐hemodialysis patients with CKD and those undergoing hemodialysis . In addition, ombitasvir/paritaprevir/ritonavir is highly effective and safe for both these patient groups . Moreover, combination of ombitasvir/paritaprevir/ritonavir and dasabuvir is highly effective and safe for patients with severe renal impairment, including those requiring hemodialysis .…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of elbasvir/grazoprevir for Japanese patients with genotype 1b chronic hepatitis C complicated by chronic kidney disease, including those undergoing hemodialysis: A post hoc analysis of a multicenter study

Atsukawa

Tsubota

Toyoda

et al. 2018

J of Gastro and Hepatol

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“…The enhanced selectivity of upadacitinib for JAK 1 may provide an improved benefit‐risk profile . Upadacitinib demonstrated favorable efficacy and acceptable safety profiles in 2 phase 2 studies and in 5 phase 3 studies in subjects with moderate to severe RA . In addition, upadacitinib recently demonstrated favorable efficacy in subjects with Crohn's disease, atopic dermatitis, and ulcerative colitis in phase 2 trials …”

mentioning

confidence: 99%

Characterization of the Effect of Hepatic Impairment on Upadacitinib Pharmacokinetics

Trueman

Mohamed

Tian

et al. 2019

The Journal of Clinical Pharma

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Upadacitinib is a selective Janus kinase 1 inhibitor being developed for the treatment of several inflammatory autoimmune diseases, including rheumatoid arthritis. Upadacitinib is a nonsensitive substrate for metabolism by cytochrome P450 3A enzymes. This open‐label, single‐dose, multicenter study assessed the pharmacokinetics of upadacitinib following oral administration of a single 15‐mg dose of the upadacitinib extended‐release formulation in subjects with mild (n = 6) and moderate (n = 6) hepatic impairment relative to demographically matched healthy subjects (n = 6). Subjects were assigned to 1 of the 3 groups according to the Child‐Pugh classification. Relative to subjects with normal hepatic function, the ratios (90% confidence intervals) of upadacitinib area under the plasma concentration‐versus‐time profile from time 0 to infinity (AUCinf) for subjects with mild and moderate hepatic impairment were 1.28 (0.91‐1.79) and 1.24 (0.87‐1.76), respectively. The central ratios of upadacitinib maximum observed concentration (Cmax) were 1.04 (0.77‐1.39) and 1.43 (1.05‐1.95) in subjects with mild and moderate hepatic impairment, respectively, compared with subjects with normal hepatic function. No clinically significant changes in vital signs or hematology measurements were observed, and no new safety events were identified in this study. These results indicate that mild and moderate hepatic impairment has no clinically relevant effect on upadacitinib pharmacokinetics.

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Efficacy and safety of ombitasvir/paritaprevir/ritonavir in dialysis patients with genotype 1b chronic hepatitis C

Abstract: The present study suggests that ombitasvir/paritaprevir/ritonavir combination therapy is effective and safe for genotype 1b chronic hepatitis C patients undergoing dialysis due to ESRD.

Cited by 42 publications

References 46 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?

Efficacy and safety of elbasvir/grazoprevir for Japanese patients with genotype 1b chronic hepatitis C complicated by chronic kidney disease, including those undergoing hemodialysis: A post hoc analysis of a multicenter study

Characterization of the Effect of Hepatic Impairment on Upadacitinib Pharmacokinetics

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