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Sustained Virologic Response Rates with Telaprevir by Response After 4 Weeks of Lead-In Therapy in Patients with Prior Treatment Failureq

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Sustained Virologic Response Rates with Telaprevir by Response After 4 Weeks of Lead-In Therapy in Patients with Prior Treatment Failureq Research Article Sustained virologic response rates with telaprevir by response after 4 weeks of lead-in therapy in patients with prior treatment failureq ⇑ Graham R. Foster1, , Stefan Zeuzem2, Pietro Andreone3, Stanislas Pol4, Eric J. Lawitz5, Moises Diago6, Stuart Roberts7, Paul J. Pockros8, Zobair Younossi9, Isabelle Lonjon-Domanec10, Sandra De Meyer11, Don Luo12, Shelley George13, Maria Beumont11, Gaston Picchio12 1Queen Marys University of London, Institute of Cell and Molecular Science, London, UK; 2Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany; 3Università di Bologna, Bologna, Italy; 4Université Paris Descartes, INSERM Unité 1016, and Assistance Publique–Hôpitaux de Paris, Cochin Hospital, Paris, France; 5Alamo Medical Research, San Antonio, TX, USA; 6Hospital General de Valencia, Valencia, Spain; 7Department of Gastroenterology, Alfred Hospital, Melbourne, VIC, Australia; 8Scripps Clinic and The Scripps Research Institute, La Jolla, CA, USA; 9Center for Liver Diseases and Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA; 10Janssen Pharmaceuticals, Paris, France; 11Janssen Infectious Diseases BVBA, Beerse, Belgium; 12Janssen Therapeutics Inc., Titusville, NJ, USA; 13Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA Background & Aims: For hepatitis C virus (HCV)-infected Conclusions: In prior relapsers and partial responders there is no patients who have not responded to previous PegIFN/ribavirin apparent benefit of assessing response after a PegIFN/ribavirin treatment, it is unclear whether subsequent direct-acting antivi- lead-in with the aim of guiding telaprevir-based treatment. For ral therapy outcomes are better predicted by prior treatment patients known to be prior null responders, on-treatment response or by on-treatment response to a PegIFN/ribavirin response after a 4-week PegIFN/ribavirin lead-in may provide lead-in. clinically useful prognostic information. However, withhold- Methods: In REALIZE, treatment-experienced patients random- ing telaprevir-containing therapy in uncategorised treatment- ized to the lead-in telaprevir arm received 4 weeks of PegIFN- experienced patient populations (i.e., that could include prior a-2a (180 lg/week) and ribavirin (1000–1200 mg/day), then relapsers or partial responders), using response after a PegIFN/ 12 weeks of telaprevir (750 mg every 8 h) plus PegIFN-a-2a/riba- ribavirin lead-in could potentially exclude some patients with a virin, followed by 32 weeks of PegIFN-a-2a/ribavirin. This sub- high chance of SVR. analysis only included patients in the lead-in telaprevir arm Ó 2012 European Association for the Study of the Liver. Published with available week 4 on-treatment response data (n = 240). by Elsevier B.V. All rights reserved. Results: After 4 weeks of PegIFN/ribavirin, 90% of relapsers, 60% of partial responders, and 41% of null responders in the lead-in telaprevir arm had P1 log10 HCV RNA reduction. Sustained viro- logic response (SVR) rates for telaprevir-treated patients with P1 Introduction versus <1 log10 HCV RNA reduction after the PegIFN/ribavirin lead-in were 94% versus 62% in relapsers, 59% versus 56% in par- The importance of early on-treatment viral response in predict- tial responders and 54% versus 15% in null responders. ing treatment outcome in patients receiving peginterferon (Peg- IFN)-a plus ribavirin for hepatitis C virus (HCV) infection is well established. Notably, a decline in HCV RNA of <2 log10 at week 12 has the highest negative predictive value (98.4%) for sustained Keywords: Direct-acting antiviral; Hepatitis C virus; Response prediction; Null virologic response (SVR) [1]. A <1 log10 decrease in HCV RNA at responder; Telaprevir; REALIZE. week 4 is also a predictor of non-response to PegIFN-a/ribavirin Received 2 February 2012; received in revised form 6 November 2012; accepted 6 November 2012; available online 23 November 2012 therapy, as <5% of those patients achieved an SVR in the IDEAL q Financial support: The REALIZE trial was funded by Janssen Pharmaceuticals study [2]. and Vertex Pharmaceuticals. The authors acknowledge Emily de Looze and Ryan Recently, two direct-acting antivirals (DAAs), telaprevir and Woodrow (Gardiner-Caldwell Communications) for writing and editorial support, boceprevir, both HCV protease inhibitors, were approved (in which was funded by Janssen Pharmaceuticals. combination with PegIFN-a/ribavirin) for the treatment of ⇑ Corresponding author. Address: Queen Marys University of London, Blizard Institute of Cellular and Molecular Science, Barts and The London School of chronic HCV genotype 1 infection [3–6]. Significantly improved Medicine and Dentistry, 4 Newark Street, London E1 2AT, UK. Tel.: +44 (0) 207 SVR rates have been reported with DAA-based therapy versus 882 7242; fax: +44 (0) 207 882 2187. PegIFN-a/ribavirin alone in both treatment-naïve and treat- E-mail address: [email protected] (G.R. Foster). ment-experienced patients [7–11]. However, viral resistance Abbreviations: HCV, hepatitis C virus; SVR, sustained virologic response; DAA, has been reported in a proportion of patients failing to respond direct-acting antiviral; FDA, Food and Drug Administration; EMA, European Me- dicines Agency; SD, standard deviation; BMI, body mass index. to DAA-based regimens [12–17]. This may be particularly Journal of Hepatology 2013 vol. 58 j 488–494 JOURNAL OF HEPATOLOGY significant in prior null responders (defined as having <2 log10 The protocol was approved a priori by the relevant independent ethics com- decline in HCV RNA at week 12 of prior treatment) who are the mittees for all participating study centers and the trial was performed in accor- dance with the 1975 Declaration of Helsinki and Good Clinical Practice most difficult-to-cure patient population with the lowest guidelines. All patients provided written informed consent. REALIZE is registered reported SVR rates [7]. Although the long-term impact of resis- with ClinicalTrials.gov (NCT00703118). tance remains unclear, minimizing ineffective therapy through Patients were randomized 2:2:1 to receive telaprevir/PegIFN-a-2a/ribavirin early identification of patients unlikely to respond to treatment (T12PR48) with or without a PegIFN-a-2a/ribavirin lead-in phase, or PegIFN-a- (and therefore at risk of developing drug-resistance mutations) 2a/ribavirin only (PR48 control), as previously described [7]. Patients in the lead-in T12PR48 arm received 4 weeks of placebo plus PegIFN-a-2a (Pegasys, may be important in preserving future treatment options and 180 lg/week subcutaneously; Roche, Basel, Switzerland) and ribavirin (Copegus, reducing the costs and inconvenience of therapy that is likely 1000–1200 mg/day orally; Roche, Basel, Switzerland and Pantheon Inc., Toronto, to be futile. Canada), followed by 12 weeks of telaprevir (750 mg orally every 8 h; Tibotec, Given the importance of predicting response to DAA-based Beerse, Belgium) plus PegIFN-a-2a/ribavirin, then 32 weeks of PegIFN-a-2a/riba- virin alone. The T12PR48 arm without a PegIFN-a-2a/ribavirin lead-in and the therapy, baseline and on-treatment response data from phase PR48 (control) arm were not included in this subanalysis. 3 clinical trials of protease inhibitors have been examined in Patients were stratified for baseline HCV RNA < or P800,000 IU/ml and prior an effort to find determinants of treatment outcome. For response to PegIFN-a/ribavirin therapy. Patients were classified as prior relapsers patients with prior PegIFN-a/ribavirin experience, two strate- (having undetectable HCV RNA after P42 weeks of PegIFN-a/ribavirin therapy, gies have been used: one based on response to a previous but having detectable HCV RNA thereafter), prior partial responders (having P2 log10 HCV RNA reduction at week 12 of prior PegIFN-a/ribavirin therapy course of PegIFN-a/ribavirin therapy (i.e., relying on prior but never achieving undetectable HCV RNA), or prior null responders (having response classification of patients into prior relapsers, prior <2 log10 HCV RNA reduction at week 12 of prior PegIFN-a/ribavirin therapy). partial responders, or prior null responders) [7], and another based on the response to a 4-week PegIFN-a/ribavirin lead-in Assessments phase before adding a protease inhibitor to therapy. However, it is unclear whether these two approaches yield similar infor- Plasma HCV RNA levels were measured at screening, baseline, regularly during mation or whether combining them would provide additional treatment, at early discontinuation, follow-up visits 4, 12 and 24 weeks after benefit. the end of treatment, and at week 72 (including in patients who discontinued early) [7]. Allowed time windows were: ±1 day for visits before week 6; ±2 days The boceprevir phase 3 trial (RESPOND-2) used a 4-week Peg- from weeks 6–20; ±4 days from week 24 onward; ±1 week after the follow-up IFN-a/ribavirin lead-in phase before introducing the protease visit 4 weeks after last intake of study drug. Plasma HCV RNA was quantified inhibitor. It enrolled prior relapsers and prior partial responders using the COBAS TaqManÒ assay (Roche, Basel, Switzerland), version 2.0 (lower limit of quantification 25 IU/ml; lower limit of detection 10 IU/ml). SVR was (the latter defined as patients with P2 log10 HCV RNA reduction defined as undetectable (<10 IU/ml) HCV RNA 24 weeks after the last dose of at week 12 of prior therapy but never achieving undetectable study medication. HCV RNA), and excluded prior null responders. Patients with Virologic stopping rules for discontinuation of treatment have been described <1 log10 HCV RNA reduction during the lead-in achieved SVR elsewhere [7]. Briefly, telaprevir was discontinued if patients had HCV RNA rates of 33–34% with boceprevir-based therapy, whereas patients >100 IU/ml at 4, 6 or 8 weeks after starting telaprevir treatment, and all treat- ment was discontinued if patients had <2 log10 decline in HCV RNA 12 weeks with P1 log10 HCV RNA reduction achieved SVR rates of 73–79% after starting telaprevir or detectable (P10 IU/ml) HCV RNA at weeks 24 or 36. [8]. Patients who discontinued telaprevir due to stopping rules were considered viro- The telaprevir phase 3 REALIZE trial enrolled prior relapsers logic failures.
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