82 Further reduction of ribavirin dose in HCV genotype 2/3 patients receiving peginterferon alpha-2a (40KD) (PEGASYS®) plus ribavirin (COPEGUS®): Interim results of a randomised controlled trial

Ferenci, Péter; Brünner, H.; Laferl, Hermann; Bergholz, U.; Rosenbeiger, M.; Stauber, R; Maieron, A; Fischer, Georg; Bischof, Martin; Steindl–Munda, Petra

doi:10.1016/s0168-8278(06)80083-8

Cited by 7 publications

(6 citation statements)

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“…A study by Ferenci et al. suggests that, in genotype 2 and 3 infected patients treated with a standard fixed dose of 800 mg, qd, RBV, SVR was greater in patients who were exposed to the highest mean dose of RBV based on body weight [59]. These findings are consistent with a retrospective analysis of data from the peginterferon alfa‐2b registration trial [2].…”

Section: Additional Factors To Considersupporting

confidence: 68%

“…However, for the minority of patients who do not achieve RVR, it is possible that increased RBV dose may improve treatment outcome, although sufficient data are not yet available to make a clear recommendation [ 11 ]. A study by Ferenci et al suggests that, in genotype 2 and 3 infected patients treated with a standard fixed dose of 800 mg, qd, RBV, SVR was greater in patients who were exposed to the highest mean dose of RBV based on body weight [ 59 ]. These findings are consistent with a retrospective analysis of data from the peginterferon alfa-2b registration trial [ 2 ].…”

Section: Additional Factors To Considermentioning

confidence: 99%

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Expert opinion on the treatment of patients with chronic hepatitis C

Zeuzem

Berg

Moeller

et al. 2009

Journal of Viral Hepatitis

227

143

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The current preferred treatment for patients with hepatitis C virus (HCV) is combination therapy consisting of pegylated interferon alfa and ribavirin (RBV) for 24–48 weeks. Although this approach appears to be highly effective for patients with HCV genotypes 2 or 3, who have a sustained virological response (SVR) of approximately 80%, the treatment algorithm is less effective for patients with HCV genotype 1, as these patients have SVR rates of just 40–50%. In order to improve treatment outcomes, this article explores potential approaches for the optimization of treatment for patients with HCV genotype 1: considering shorter treatment periods for patients with a rapid virological response (RVR), increasing treatment periods for slow responders, and increasing RBV dose are all suggestions. Results from clinical trials suggest that approximately 20% of the HCV genotype 1-infected population are slow responders, and around 15% of all HCV genotype-1 infected patients could benefit from a shorter treatment duration without compromising the SVR rate. Interest has also focused on whether treatment duration could be individualized in some patients with genotype 2 and 3 infection. Here all the findings from recent studies are translated into practical advice, to help practitioners make evidence-based treatment decisions in everyday clinical practice. Although there are areas where currently available data do not provide conclusive evidence to suggest amending treatment approaches, there is clearly potential for individualized treatment in all aspects of hepatitis treatment in the future.

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Section: Additional Factors To Considersupporting

confidence: 68%

Section: Additional Factors To Considermentioning

confidence: 99%

Expert opinion on the treatment of patients with chronic hepatitis C

Zeuzem

Berg

Moeller

et al. 2009

Journal of Viral Hepatitis

227

143

View full text Add to dashboard Cite

show abstract

“…High Rbv concentrations were associated with the occurrence of anemia but did not correlate with viral responses, in either the univariate or the multivariate analysis. Rbv dose and exposure have been associated with SVR for genotypes 1 and 4, 10 , 23 , 24 but this relationship has not been unanimously confirmed, with several studies suggesting that lower Rbv doses may be equally effective 25 , 26 , 27 , 28 . Although Rbv is indispensable in the current treatment for HCV, neither the susceptibilities of the different HCV genotypes to Rbv nor the relationship between plasma and intracellular (the true effect compartment) concentrations of Rbv are known.…”

Section: Discussionmentioning

confidence: 99%

“…For pegIFN‐α‐2a, higher plasma levels were found at day 29 of treatment in responders when compared with nonresponders (30,768 vs. 15,525 pg/ml), although these differences were not statistically significant because of the small size of the sample 21 . Regarding Rbv, adverse events are associated with higher plasma levels, 22 , 23 but there are contradictory reports about the influence of Rbv exposure on viral response 24 , 25 , 26 , 27 . To date, most studies have considered the effects of either pegIFN‐α or Rbv levels, but none has simultaneously evaluated the levels of the two drugs.…”

mentioning

confidence: 97%

Role of Pegylated Interferon-α-2a and Ribavirin Concentrations in Sustained Viral Response in HCV/HIV-Coinfected Patients

López‐Cortés

Valera-Bestard

Gutiérrez‐Valencia

et al. 2008

Clin Pharmacol Ther

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The effect of simultaneous plasma concentrations of pegylated interferon-alpha-2a (pegIFN-alpha-2a) and ribavirin (Rbv) on viral response has not been addressed to date. Hepatitis C virus (HCV)/human immunodeficiency virus (HIV)-coinfected patients received pegIFN-alpha-2a and Rbv under routine clinical care conditions. Plasma concentrations of the two drugs were measured using enzyme-linked immunosorbent assay and high-performance liquid chromatography after 2, 4, 8, and 12 weeks and at the end of the treatment period (24-48 weeks, according to HCV genotype and treatment duration). Large interindividual variability was observed in the plasma levels of both drugs. After multivariate analysis, only HCV genotype 3, low HCV-RNA levels, and pegIFN-alpha-2a exposure remained as independent factors associated with sustained viral response (SVR). The probability of attaining an SVR in HCV genotypes 1 and 4 was more than three to four times higher in patients with pegIFN-alpha-2a levels above the selected cutoff point. Early therapeutic drug monitoring of pegIFN-alpha-2a levels could be beneficial in improving current treatment outcomes.

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“…Interim analysis of a randomized study of peginterferon alfa plus ribavirin for 24 weeks at doses of either 400 or 800 mg suggests no decrease in SVR rates in the lowerdose group [45]. Lower doses of ribavirin may also be appropriate in certain patient groups who could not otherwise tolerate ribavirin therapy, such as those with renal impairment.…”

Section: Selecting the Appropriate Starting Dosementioning

confidence: 99%

Ribavirin: Current role in the optimal clinical management of chronic hepatitis C

Reddy

Nelson

Zeuzem

2009

Journal of Hepatology

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Ribavirin in combination with peginterferon alfa shows strong clinical efficacy against chronic hepatitis C, and is now established as the standard of care. However, the precise role of ribavirin is still being defined, suggesting that optimal ribavirin dose should be maintained over the whole treatment period. Ribavirin dosage varies by bodyweight for genotype 1 disease (1000mg/day in patients 75kg), whereas 800mg/day is sufficient to ensure optimal response in all genotype 2/3 patients. Similarly, genotype 1 patients benefit from 48 weeks of therapy, while 24 weeks is sufficient for genotype 2/3 disease. Recent data suggest treatment success is dependent on cumulative ribavirin exposure, as patients who receive <60% of the planned dose have lower response rates, regardless of whether reductions are from temporary interruptions or premature cessation of therapy. All patients should be monitored for hemolytic anemia, as early diagnosis allows management through small dose reductions and stepwise return to the target dose, maximizing cumulative exposure. Despite these recent advances in our knowledge, many questions remain, such as whether the role of ribavirin will change or even be eliminated as new therapies are developed.

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82 Further reduction of ribavirin dose in HCV genotype 2/3 patients receiving peginterferon alpha-2a (40KD) (PEGASYS®) plus ribavirin (COPEGUS®): Interim results of a randomised controlled trial

Cited by 7 publications

References 0 publications

Expert opinion on the treatment of patients with chronic hepatitis C

Expert opinion on the treatment of patients with chronic hepatitis C

Role of Pegylated Interferon-α-2a and Ribavirin Concentrations in Sustained Viral Response in HCV/HIV-Coinfected Patients

Ribavirin: Current role in the optimal clinical management of chronic hepatitis C

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