Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients

Jacobson, Ira M.; Brown, Robert S.; Freilich, Bradley; Afdhal, Nezam H.; Kwo, Paul Y.; Santoro, John J.; Becker, Scott; Wakil, Adil E.; Pound, David; Godofsky, Eliot; Strauss, Robert P.; Bernstein, David; Flamm, Steven L.; Pauly, Mary Pat; Mukhopadhyay, Pabak; Griffel, Louis; Brass, Clifford A.

doi:10.1002/hep.21932

Cited by 267 publications

(215 citation statements)

References 12 publications

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“…In addition, the rate of relapsers was low, and this may be related to the high doses of RBV administered to our patients, as suggested in one study with HCV-monoinfected patients. 32 SVR is usually associated with ALT normalization. 33,34 However, in co-infected patients, the coexistence of other factors that can contribute to liver inflammation, such as alcohol, drugs, or antiretroviral therapy, may explain the high rate of patients (18%) with SVR that failed to achieve sustained biochemical response in the current study.…”

Section: Discussionmentioning

confidence: 99%

Randomized trial comparing pegylated interferon α‐2b versus pegylated interferon α‐2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients†

et al. 2009

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. At baseline, both groups were well balanced: 73% male; 63% HCV genotype 1 through 4; 29% had fibrosis index of 3 or greater. The overall SVR was 44% (42% PEG 2b versus 46% PEG 2a, P ‫؍‬ 0.65). Among genotypes 1 through 4, SVRs were 28% versus 32% (P ‫؍‬ 0.67) and 62% versus 71% (P ‫؍‬ 0.6) in genotypes 2 through 3 for PEG 2b and PEG 2a, respectively. Early virological response (EVR; >2 log reduction from baseline or negative HCV-RNA at week 12) was 70% in the PEG 2b group and 80% in the PEG 2a group (P ‫؍‬ 0.13), reaching a positive predictive value of SVR of 64% and a negative predictive value of 100% in both arms. Side effects were present in 96% of patients but led to treatment discontinuation in 10% of patients (8% on PEG 2b and 13% on PEG 2a, P ‫؍‬ 0.47). Conclusion: In patients with HIV, HCV therapy with PEG 2b or PEG 2a plus RBV had no significant differences in efficacy and safety. (HEPATOLOGY 2009;49:22-310.)

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Section: Discussionmentioning

confidence: 99%

Randomized trial comparing pegylated interferon α‐2b versus pegylated interferon α‐2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients†

et al. 2009

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“…De los pacientes respondedores, sólo 13% de ellos tenía fi brosis F3 y F4 del score Metavir, y 87% restante correspondían a F0 y F1, siendo un importante predictor de respuesta la ausencia de fi brosis signifi cativa. Esta situación está ampliamente descrita en la literatura, en que el parámetro histológico es otro de los principales factores independientes predictivos de RVS, tanto en análisis univariado como multivariado 5,[12][13][14] .…”

Section: Discussionunclassified

Resultados del tratamiento con peginterferón alfa-2a y ribavirina en pacientes con hepatitis crónica C

et al. 2011

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“…[8][9][10][11] Previous multi-centre, open-label community trials in the United States and Canada had much lower outcomes across all genotypes, when compared to the drug registration trials. 26,27 These lower results have been suggested to be due to the large number of patients included in the analysis who were lost to follow-up. 21 Similarly, in the present study, loss of patients to follow-up occurred before treatment commenced, after treatment commenced and after the end of treatment (Figure 1).…”

Section: Side Effects and Treatment Cessationmentioning

confidence: 99%

Hepatitis C Virus Treatment in the ‘Real-World’: How Well Do ‘Real’ Patients Respond?

Friedman

Green

Weber

et al. 2014

Journal of Clinical and Experimental Hepatology

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Background: Published clinical trials of the treatment of HCV are largely multicentre prospective pharmaceutical trials. Patients in clinical trials tend to have more favorable outcomes than patients in the 'real-world', due to strict patient selection and differences in treatment conditions and available resources. Objectives: To assess the outcomes of Hepatitis C infected patients treated at the Barwon Health Liver Clinic with combination Pegylated interferon (PEG-IFN) and Ribavirin (RBV) therapy and to determine factors associated with a treatment response. Methods: Retrospective review of patients who received treatment for Hepatitis C at our institution's Liver Clinic from January 2001-September 2011. Patient demographics, comorbidities, treatment-related parameters and side effects were extracted from medical records and analyzed. Results: A total of 190 patients (120 male, 70 female) with a mean age of 42.8 years (range 20-68 years) commenced treatment. The most common genotype was genotype 3 (48.9%), followed by genotype 1 (42.6%). 150 of 190 patients (78.9%) completed treatment and had end of treatment data available. 107 of 182 patients, (58.8%) for whom sustained virologic response (SVR) rate data was available achieved an SVR. Overall response rates were; 46.9%, 68.8% and 62.4% in genotypes 1, 2 and 3 respectively. The response rate was significantly lower in 29 patients with documented cirrhosis (20.7%). Age, diabetes and alcohol abuse did not predict treatment response in our cohort. Side effects reported in 81.6% of patients included general malaise, hematological disturbance and psychiatric issues, and necessitated cessation of therapy in 16 patients (8.4%) and dose reduction in 26 patients (13.7%). Conclusions: Response rates to combination PEG-IFN and RBV therapy at our institution are comparable to other 'real-world' and pharmaceutical registration trials. Side effects of combination therapy were prominent but resulted in fewer discontinuations of therapy compared to pharmaceutical trials. ( J CLIN EXP HEPATOL 2014;4:214-220)

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Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients

Cited by 267 publications

References 12 publications

Randomized trial comparing pegylated interferon α‐2b versus pegylated interferon α‐2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients†

Randomized trial comparing pegylated interferon α‐2b versus pegylated interferon α‐2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients†

Resultados del tratamiento con peginterferón alfa-2a y ribavirina en pacientes con hepatitis crónica C

Hepatitis C Virus Treatment in the ‘Real-World’: How Well Do ‘Real’ Patients Respond?

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