Individualized treatment duration for hepatitis C genotype 1 patients: A randomized controlled trial

Mangia, Alessandra; Minerva, Nicola; Bacca, D.; Cozzolongo, Raffaele; Ricci, Giovanni; Carretta, Vito; Vinelli, F.; Scotto, Gaetano; Montalto, Giuseppe; Romano, Mario R.; Cristofaro, Giuseppe; Mottola, Leonardo; Spirito, F.; Andriulli, Angelo

doi:10.1002/hep.22061

Cited by 230 publications

(351 citation statements)

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“…4,5 Several studies adopting this approach have shown that extending therapy to 72 weeks may increase SVR rates in selected G1 patients. [6][7][8][9][10][11] However, the on-treatment virologic criteria used to select patients for extended therapy vary across studies.…”

mentioning

confidence: 99%

Randomized Trial of Peginterferon alfa-2b and Ribavirin for 48 or 72 Weeks in Patients with Hepatitis C Virus Genotype 1 and Slow Virologic Response

Buti

Lurie

Zakharova³

et al. 2010

Hepatology

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The benefit of extending treatment duration with peginterferon (PEG-IFN) and ribavirin (RBV) from 48 weeks to 72 weeks for patients with chronic hepatitis C genotype 1 infection has not been well established. In this prospective, international, open-label, randomized, multicenter study, 1,428 treatment-naïve patients from 133 centers were treated with PEG-IFN alfa-2b (1.5 lg/kg/week) plus RBV (800-1,400 mg/day). Patients with detectable hepatitis C virus (HCV) RNA and a !2-log 10 drop in HCV RNA levels at week 12 (slow responders) were randomized 1:1 to receive 48 weeks (n 5 86) or 72 weeks (n 5 73) of treatment. Sustained virologic response (SVR) rates were 43% in slow responders treated for 48 weeks and 48% in slow responders treated for 72 weeks (P 5 0.644). Relapse rates were similar in slow responders treated for 48 or 72 weeks (47% versus 33%, P 5 0.169). The safety profile was similar in both treatment arms; serious adverse events leading to discontinuation of treatment were observed in 3.5% of slow responders treated for 48 weeks and 8.2% of those treated for 72 weeks. Among slow responders with a <2-log drop in HCV RNA at week 8, SVR was 39% in the 72-week arm and 19% in the 48-week arm. Conclusion: These data suggest that 48 weeks of therapy with PEG-IFN alfa-2b plus RBV (800-1,400 mg/day) should remain a standard-of-care treatment for treatment-naïve G1 slow responders. (HEPATOLOGY 2010;52:1201-1207

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mentioning

confidence: 99%

Randomized Trial of Peginterferon alfa-2b and Ribavirin for 48 or 72 Weeks in Patients with Hepatitis C Virus Genotype 1 and Slow Virologic Response

Buti

Lurie

Zakharova³

et al. 2010

Hepatology

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“…Le gain est d'environ 10 % [8][9][10]. Cependant, ce traitement paraît désuet à l'heure de la trithérapie (ajout d'une antiprotéase) devenant le traitement de référence chez ces patients de génotype 1, toujours virémiques après 4 semaines de bithérapie ; -Enfin, si la virémie est toujours détectable à S24, on dispose de peu d'arguments pour poursuivre le traitement (sauf peut-être en présence d'une réponse biochimique, c'est-à-dire une normalisation des transaminases, chez des patients présentant une atteinte hépatique évoluée) mais cette proposition n'est pas consensuelle et reste un sujet non résolu ; -En présence d'un génotype 2, l'annulation de la virémie à S4 permet d'interrompre le traitement à 16 voire 12 semaines : il est vrai que, par habitude, peu de praticiens choisissent cette stratégie mais chez certains patients qui supportent mal la bithérapie, il peut s'agir d'une stratégie intéressante ; -En présence de génotype 3, la situation est intermédiaire et finalement s'apparente plus au génotype 1 qu'au génotype 2 ; il est préférable de prolonger le traitement à 48 semaines de bithérapie pégylée chez des patients en surpoids, présentant au moins un facteur de comorbidité comme l'alcool, le surpoids, ou simplement l'âge avancé (au-delà de 65 ans) ; -Le génotype 4 s'assimile au génotype 1 dans sa stratégie thérapeutique.…”

Section: La Bithérapie Traditionnelleunclassified

Le traitement de l’hépatite C : la révolution des nouvelles molécules pour quels patients ?

Fontanges¹

2011

Hegel

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RésuméL'avènement des antiprotéases est une réelle avancée dans le traitement de l'hépatite C permettant de guérir 3 patients sur 4 de génotype 1, génotype prédominant dans notre pays de sorte que la bithérapie pégylée devient désuète. Nos patients en échec de bithérapie peuvent bénéficier également de ces trithérapies, et ainsi, éviter de renouveler des traitements aux résultats décevants. Ces trithérapies nécessitent une surveillance clinique, biochimique et virologique stricte du fait des interactions médicamenteuses et des évènements indésirables nouveaux. En ce qui concerne les autres génotypes, la bithérapie reste à l'honneur et doit être utilisée en l'optimisant (prise en compte des facteurs de réponse pré-thérapeutiques, intérêt d'un dosage précoce de ribavirine). Mots-clésTrithérapie ; Antiprotéases ; Télaprévir ; Bocéprévir ; Genotype 1 ; Hépatite chronique ; VHC ; Bithérapie pégylée ; génotype non 1 Abstract DAA therapy is a real progress in the management of patients infected by HCV genotype 1; indeed, 75% of new patients can be cured by this new therapy. In case of failure after classical bitherapy, DAA is also the best way to eradicate RNA if compared to the disappointing results obtained with biotherapy retreatment. Nevertheless, due to side effects and drug interactions, DAA requires a careful follow-up of patients. The duration of treatment is strongly correlated with the virological kinetics during the first months and should be rigorous.

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“…[Mangia et al 2008;Pearlman et al 2007;Berg et al 2006]. Extension of therapy in that setting has been associated with improved SVR.…”

Section: Relapsementioning

confidence: 99%

Review: Rapid virological response to peginterferon alfa and ribavirin treatment of chronic hepatitis C predicts sustained virological response and relapse in genotype 1 patients

Poordad

Landaverde

2009

Therap Adv Gastroenterol

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The treatment of chronic hepatitis C is a rapidly changing arena with new medications, new guidelines, and an evolving understanding of the virus, host factors and natural history. With the explosion of new information, the educational infrastructure to update clinicians has been outpaced; many feel uncertain if the tools they are using to care for patients are meeting the standard of practice. This review focuses on the most common genotype of the hepatitis C virus and the rules of engagement when treating with pegylated interferon and ribavirin. Viral assessment guideposts are evaluated and put into context for a clinical audience. The expected arrival of newer antiviral therapies is still years away, and maximizing the current treatment regimens is of utmost importance to eradicate virus when feasible, while minimizing toxicity.

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Individualized treatment duration for hepatitis C genotype 1 patients: A randomized controlled trial

Abstract: Variable treatment duration ensures SVR rates similar to those of standard treatment duration, sparing unnecessary side effects and costs.

Cited by 230 publications

References 104 publications

Randomized Trial of Peginterferon alfa-2b and Ribavirin for 48 or 72 Weeks in Patients with Hepatitis C Virus Genotype 1 and Slow Virologic Response

Randomized Trial of Peginterferon alfa-2b and Ribavirin for 48 or 72 Weeks in Patients with Hepatitis C Virus Genotype 1 and Slow Virologic Response

Le traitement de l’hépatite C : la révolution des nouvelles molécules pour quels patients ?

Review: Rapid virological response to peginterferon alfa and ribavirin treatment of chronic hepatitis C predicts sustained virological response and relapse in genotype 1 patients

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