311 Longer treatment duration with peginterferon alfa-2A (40KD) (Pegasys®) and ribavirin (Copegus®) in naive patients with chronic hepatitis C and detectable HCV RNA by week 4 of therapy: Preliminary results of the teravic-4 study

Sánchez-Tapias, José-Marı́a; Diago, M.; Escartín, P; Enriquez, J.; Moreno, Rosa María Girón; Laprincesa, H; Romero-Gómez, María Pilar; Devalme, H; Bárcena, Rafael; Ycajal, H

doi:10.1016/s0270-9139(03)80354-3

Cited by 22 publications

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“…8 Our logistic regression model showed patients with subtype 1b infection responded particularly well to combination therapy if the HCV RNA level was below a threshold of 600,000 IU/mL. The corresponding threshold in patients infected with subtype 1a infection was lower (Յ200,000 IU/mL).…”

Section: Discussionmentioning

confidence: 76%

“…The results of this analysis and those from a recent randomized, multicenter trial 8 demonstrate that week 4 HCV RNA testing is useful in the routine management of patients with genotype 1 infection. In the TeraViC-4 study, patients with detectable HCV RNA at week 4 were randomized to either 48 or 72 weeks of treatment with peginterferon ␣-2a (40 kd) plus ribavirin 800 mg/d.…”

Section: Discussionmentioning

confidence: 81%

“…SVR rates in patients who did not achieve a RVR were significantly higher in the 72-week versus the 48-week treatment groups, primarily because of a reduced rate of virological relapse during follow-up. 8 Conversely, the overall SVR rate in genotype 1 patients with a baseline HCV RNA level of 800,000 IU/mL or less who had a RVR at week 4 was 76% after 24 or 48 weeks of treatment.…”

Section: Discussionmentioning

confidence: 97%

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Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon α-2a (40 kd)/ribavirin therapy

et al. 2006

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Approximately one third of hepatitis C virus (HCV) genotype 1 patients achieved a sustained virological response (SVR) after 24 weeks of treatment with peginterferon ␣-2a (40 kd) plus ribavirin in a randomized, multinational trial. We aimed to identify factors associated with a rapid virological response (RVR) at week 4 (HCV RNA <50 IU/mL) and a SVR (HCV RNA <50 IU/mL at the end of follow-up) in these patients. Stepwise multiple logistic regression analysis was used to explore the prognostic factors for a RVR and SVR in genotype 1 patients treated for 24 weeks. Fifty-one of 216 (24%) genotype 1 patients in the 24-week treatment groups had a RVR. SVR rates were considerably higher in patients with than without a RVR (89% vs. 19%, respectively). Patients with a baseline HCV RNA of less than 200,000 IU/mL (OR 9.7, 95% CI 4.2-22.5; P < .0001) or 200,000-600,000 IU/mL (OR 3.6, 95% CI 1.5-9.1; P ‫؍‬ .0057) were more likely to achieve a RVR than those with HCV RNA greater than 600,000 IU/mL. HCV subtype (1b vs. 1a) was also independently associated with RVR (OR 1.8, 95% CI 0.9-3.7; P ‫؍‬ .0954). RVR (OR 23.7 vs. no RVR, 95% CI 9.1-61.7) and baseline HCV RNA less than 200,000 IU/mL (OR 2.7 vs. >600,000 IU/mL, 95% CI 1.1-6.3; P < .026) were significant and independent predictors of SVR in patients treated for 24 weeks. T he treatment of choice for chronic hepatitis C is the combination of a pegylated interferon plus ribavirin. Overall sustained virological response (SVR) rates of up to 63% have been achieved with optimal regimens of peginterferon ␣-2a (40 kd) plus ribavirin in randomized phase III trials, 1,2 although SVR rates are heterogenous and vary significantly by hepatitis C virus (HCV) genotype. Current guidelines for the management of chronic hepatitis C recommend the combination of a pegylated interferon plus ribavirin 1,000 or 1,200 mg/d for 48 weeks as initial treatment for patients infected with HCV genotype 1. 3 Treatment for a shorter duration (24 weeks), with a lower dose of ribavirin (800 mg/d), or both, is associated with markedly reduced SVR rates in this frequently encountered but difficult-to-treat subpopulation. These recommendations are based on the results of a large, multinational, phase III trial in which patients were randomized to 1 of 4 combination regimens of peginterferon ␣-2a (40 kd) plus ribavirin. 2 The timing and magnitude of the virological response to antiviral therapy in patients infected with HCV genoAbbreviations: SVR, sustained virological response; HCV, hepatitis C virus; RVR, rapid virological response; LD, low dose; SD, standard dose. From the

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Section: Discussionmentioning

confidence: 76%

Section: Discussionmentioning

confidence: 81%

Section: Discussionmentioning

confidence: 97%

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Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon α-2a (40 kd)/ribavirin therapy

et al. 2006

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“…36,40,41 Important factors that may forecast response early in the course of treatment and in individualizing therapy in adults, such as early virologic response and 'duration of undetectability' have not been studied in children. [45][46][47] Adverse events are common in children during treatment with IFN products alone or in combination with ribavirin and include influenza-like symptoms, anorexia, weight loss, depression and hematological abnormalities.…”

Section: Hepatitis Cmentioning

confidence: 99%

Controversies in the management of pediatric liver disease: Hepatitis B, C and NAFLD: Summary of a single topic conference

2006

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. The conference was organized to juxtapose the current state-of-the-art in the management of pediatric liver disease with evidenced-based approaches that exist for the same problems in adults. The principal goal of the conference was to assess critically current management of hepatitis B and C, and NAFLD in children, since evidence-based approaches are generally lacking. The conference included formal didactic presentations by experts (Table 1A-C) and informal active discussions between faculty and conference participants. The informal discussions were very animated and educational including both question and answer sessions and case discussions. Herein, we synthesize some of the information presented during the proceedings. Our aim with this summary is to highlight salient issues that were discussed in the STC rather than present a comprehensive review of the topics or formulate consensus statements. Individual sections have been reviewed by the faculty for that particular section, although they are not co-authors per se. The success of the conference was due in large part to the active exchange of information that took place between faculty and the participants. Hepatitis BThe complex biology and natural history of hepatitis B virus (HBV) coupled with recent advances in therapeutic approaches makes clinical decision-making in this common infection very problematic. A relatively limited published dataset related to HBV in children has left the clinician without clear-cut clinical guidelines for nearly all aspects of the care of children with chronic HBV infection. The presentations (Table 1A), case discussions and question and answer sessions at the STC highlighted marked differences in approaches to HBV infection in children by clinicians who have longstanding expertise in the management of childhood liver disease. In addition, it was also notable that the application of adult HBV guidelines to children is problematic and potentially not appropriate, since children are typically in a different stage of HBV infection and are at lower near-term risk of developing significant morbidity and mortality. 1 Currently, there are National Institutes of Health (NIH)-funded multi-center studies of hepatitis C virus (HCV) and nonalcoholic fatty liver disease (NAFLD) in children and adults but there is a notable absence of similar investigations of HBV infection in children or adults.A careful and critical understanding of the natural history of HBV infection in children is essential in making informed decisions regarding monitoring and treatment. One needs to be cognizant of the effects of HBV genotype and potential environmental effects in different regions of the world when analyzing the natural history of HBV. Thus, longitudinal data from Southeast Asia may not necessarily be applicable to Western Europe or North America. It is useful to subdivide chronic HBV infection in children into perinatal versus other modes of transmission. Perinatal transmission of HBV is typically characterized by an immunotolerant state that ...

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“…This possibility may to a certain extent explain the low SVR rates observed in two trials of peginterferon and ribavirin in human immunodeficiency virus coinfected patients 12,13 and a recent Spanish Trial of 72 weeks versus 48 weeks of peginterferon plus ribavirin for patients who fail to achieve virological clearance at week four. 14 In summary, Lindahl et al's article is an important study whose results probably provoke more thought about ribavirin's mechanism of action than provide a practical therapeutic approach for patients with chronic hepatitis C. At present, this strategy should be reserved for the setting of controlled clinical trials and not become part of standard clinical practice.…”

mentioning

confidence: 99%

Pushing the treatment envelope for chronic hepatitis C?is more necessarily better?

Lutchman¹,

Ghany²

2005

Hepatology

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311 Longer treatment duration with peginterferon alfa-2A (40KD) (Pegasys®) and ribavirin (Copegus®) in naive patients with chronic hepatitis C and detectable HCV RNA by week 4 of therapy: Preliminary results of the teravic-4 study

Cited by 22 publications

References 0 publications

Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon α-2a (40 kd)/ribavirin therapy

Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon α-2a (40 kd)/ribavirin therapy

Controversies in the management of pediatric liver disease: Hepatitis B, C and NAFLD: Summary of a single topic conference

Pushing the treatment envelope for chronic hepatitis C?is more necessarily better?

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