Peginterferon alfa-2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 2 receiving haemodialysis: a randomised trial

Liu, Chen–Hua; Liu, Chun‐Jen; Huang, Chung‐Feng; Lin, Jou‐Wei; Dai, Chia‐Yen; Liang, Cheng‐Chao; Huang, Jee‐Fu; Hung, Peir-Haur; Tsai, Hung-Bin; Tsai, Min Kuang; Lee, Chih-Yuan; Chen, Shih‐I; Yang, Sheng‐Shun; Su, Tung‐Hung; Yang, Hung‐Chih; Chen, Pei‐Jer; Chen, Ding‐Shinn; Chuang, Wan‐Long; Yu, Ming‐Lung; Kao, Jia‐Horng

doi:10.1136/gutjnl-2014-307080

Cited by 39 publications

(38 citation statements)

References 36 publications

(31 reference statements)

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“…The dose of EPO was increased in all study patients who had received erythropoietin at baseline. Markedly reduced doses of ribavirin (200 mg daily or 200 mg thrice weekly) could improve the tolerance of combination antiviral therapy for HCV in the dialysis population, as indicated in recent clinical trials [11][12][14][15], even if large doses of EPO and close monitoring of haemoglobin values are warranted. Espinosa…”

Section: Discussionmentioning

confidence: 99%

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Pegylated Interferon (Alone or With Ribavirin) for Chronic Hepatitis C in Haemodialysis Population

Espinosa

Hernández

Arenas

et al. 2015

Kidney Blood Press Res

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Background/Aims: Hepatitis C virus infection remains prevalent among patients undergoing long-term haemodialysis and has a detrimental impact on survival in this population. Antiviral therapy for chronic hepatitis C in haemodialysis patients is still a challenge to clinicians. The aim of the current study is to evaluate the efficacy and safety of therapy with pegylated interferon, alone or combined with ribavirin, for chronic hepatitis C among patients undergoing long-term hemodialysis. Methods: We conducted a retrospective, multicenter cohort trial with monotherapy (pegylated interferon) (n=21) or combined antiviral therapy (pegylated interferon plus ribavirin) (n=5) for chronic hepatitis C in patients undergoing long-term haemodialysis. Results: Sustained virological response was obtained in eleven (42%) patients. Seven (26.9%) patients interrupted prematurely the antiviral treatment due to serious side-effects, the most frequent cause of treatment withdrawal being hematological (n=3). HCV RNA load was lower in responder than non-responder patients, 5.44 (3.45; 6.36) vs. 5.86 (4.61; 6.46) log₁₀ copies/mL, even if the difference was not significant (P=0.099). Blood transfusion requirement was greater in patients on combined antiviral therapy than those on pegylated interferon alone, 100% (5/5) vs. 0% (0/21), P=0.0001. No difference in sustained viral response occurred between patients on combined antiviral therapy and those on pegylated interferon monotherapy [40% (2/5) vs. 42.8% (9/21), P=0.90]. Conclusions: Results from this study showed that pegylated interferon alone or with ribavirin is unsatisfactory in terms of efficacy and safety. Prospective trials based on interferon-free regimens (i.e., sofosbuvir plus ribavirin or sofosbuvir plus daclatasvir) are under way in patients with hepatitis C receiving long-term hemodialysis.

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Section: Discussionmentioning

confidence: 99%

“…Very little ribavirin is removed via dialysis so there is a propensity for the drug to accumulate, exacerbating haemolysis in the dialysis population already at risk for anaemia [10]. However, some recent studies support the combination of peg-IFN plus very low dose ribavirin to treat HCV positive haemodialysis patients [11][12].…”

Section: Introductionmentioning

confidence: 99%

Pegylated Interferon (Alone or With Ribavirin) for Chronic Hepatitis C in Haemodialysis Population

Espinosa

Hernández

Arenas

et al. 2015

Kidney Blood Press Res

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“…134, 135 Liu et al further evaluated PEG-IFN α-2a at a dose of 135 µg per week plus RBV at a dose of 200 mg per day for 48 and 24 weeks in treatment-naïve and -experienced East Asian HCV-1 and HCV-2 patients on hemodialysis. 130,131,136 The SVR rates for treatment-naïve HCV-1 and HCV-2 patients were 64% and 74%, respectively; those for treatment-experienced HCV-1 and HCV-2 patients were 52% and 80%, respectively. Furthermore, Tseng et al evaluated PEG-IFN α-2b at a dose of 1.0 µg per kg of body weight per week plus RBV at a dose of 200 mg three times per week for 48 and 24 weeks in treatment-naïve East Asian HCV-1 and non-HCV-1 patients on hemodialysis, and the overall SVR rate was 62%.…”

mentioning

confidence: 99%

“…[129][130][131] Two recent pilot studies used TVR in combination with PEG-IFN α plus low-dose RBV to treat Western HCV-1 patients on hemodialysis, and the SVR rates were superior to those using PEG-IFN α plus low-dose RBV. 137,138 Whether triple therapy or all oral DAA regimen could benefit Asian patients on hemodialysis deserves further investigation.…”

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confidence: 99%

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Nanomedicines in the treatment of hepatitis C virus infection in Asian patients: optimizing use of peginterferon alfa

Liu¹,

Kao

2014

IJN

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Asia is endemic for hepatitis C virus (HCV) infection, which is the leading cause of cirrhosis, hepatic decompensation, hepatocellular carcinoma, and liver transplantation worldwide. HCV has six major genotypes and each HCV genotype has its specific geographic distribution. HCV genotypes 1, 2, 3, and 6 are common in Asia. The aim of HCV treatment is to eradicate the virus by effective therapeutic agents; viral clearance is durable after long-term post-treatment follow-up. In most Asian countries, peginterferon alfa (PEG-IFN α) in combination with ribavirin remains the standard of care, and the overall sustained viral response (SVR) rate in Asian HCV patients is higher than that in Western patients. The differences are most significant in patients with HCV genotype 1 (HCV-1) infection, which is attributed to the higher frequency of IFN-responsive or favorable interleukin-28B (IL-28B) genotype in Asian populations than in other ethnic populations. In addition, the introduction of response-guided therapy, where the optimized treatment duration is based on the early viral kinetics during the first 12 weeks of treatment, increases the SVR rate. Recently, telaprevir or boceprevir-based triple therapy was found to further improve the SVR rate in treated and untreated HCV-1 patients and has become the new standard of care in Western and some Asian countries. Many novel direct-acting antiviral agents, either in combination with PEG-IFN α plus ribavirin or used as IFN-free regimens are under active investigation. At the time of this writing, simeprevir and sofosbuvir have been approved in the US. Because the SVR rates in Asian HCV patients receiving PEG-IFN α plus ribavirin therapy are high, health care providers should judiciously determine the clinical usefulness of these novel agents on the basis of treatment duration, anticipated viral responses, patient tolerance, financial burdens, and drug accessibility.

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Interventions for dialysis patients with hepatitis C virus (HCV) infection

Attur

Nair

Pai

et al. 2015

Cochrane Database of Systematic Reviews

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Our review demonstrated that in CKD patients on haemodialysis with HCV infection treatment with standard interferon brings about an end of treatment but not a sustained virological response and is relatively well tolerated. PEG interferon is more effective than standard interferon for end of treatment response but not for sustained response; both were equally tolerated. Increasing doses of PEG interferon did not improve responses but high and low doses are equally tolerated. Addition of ribavirin results in more treatment discontinuation.

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Peginterferon alfa-2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 2 receiving haemodialysis: a randomised trial

Abstract: ClinicalTrial.gov number, NCT00491244.

Cited by 39 publications

References 36 publications

Pegylated Interferon (Alone or With Ribavirin) for Chronic Hepatitis C in Haemodialysis Population

Pegylated Interferon (Alone or With Ribavirin) for Chronic Hepatitis C in Haemodialysis Population

Nanomedicines in the treatment of hepatitis C virus infection in Asian patients: optimizing use of peginterferon alfa

Interventions for dialysis patients with hepatitis C virus (HCV) infection

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