Boceprevir for Retreatment of HCV Genotype 1 Infection - RESPOND-2 Trial Results
Explore the results of the RESPOND-2 trial which investigated Boceprevir for the retreatment of HCV Genotype 1 infection in treatment-experienced patients. The study design, treatment regimens, and outcomes based on prior response and initial week 4 response are detailed, providing valuable insights into managing chronic HCV.
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Phase 3 Treatment Experienced Boceprevir in Treatment Experienced RESPOND-2 Bacon BR, et al. N Engl J Med. 2011;364:1207-17.
Boceprevir for Retreatment of HCV Genotype 1 Infection RESPOND-2 Trial: Study Design RESPOND-2: Study Features N = 403 HCV-monoinfected, treatment-experienced patients Randomized, double-blind, placebo-controlled, phase 3 study All with chronic HCV and genotype 1 Previously responded to treatment but did not obtain SVR Previous null responders excluded Mean Age = 53 88% with HCV RNA > 800,000 IU/mL Randomized to 3 arms (1:2:2) Drug Dosing Boceprevir = 800 mg three times daily Peginterferon alfa-2b = 1.5 g/kg once weekly Ribavirin = 600-1400 mg/day (based on weight) Source: Bacon BR, et al. N Engl J Med. 2011;364:1207-17.
Boceprevir for Retreatment of HCV Genotype 1 Infection RESPOND-2 Trial: Treatment Regimens 0 4 8 12 24 36 48 Week Lead In HCV RNA Placebo PR48 Peginterferon + Ribavirin Undetectable HCV RNA at week 8 &12 Stop Therapy Boceprevir B32 PR36-48 Peginterferon + Ribavirin Detectable HCV RNA at week 8, but Undetectable at week 12 Peginterferon + Ribavirin Boceprevir B44 PR48 Peginterferon + Ribavirin Source: Bacon BR, et al. N Engl J Med. 2011;364:1207-17.
Boceprevir for Retreatment of HCV Genotype 1 Infection RESPOND-2 Trial: Results RESPOND-2: SVR 24 by Prior Response and Regimen PR48 B24/PR28-48 B44/PR48 100 Patients with SVR (%) 75 80 69 66 59 60 52 40 40 29 21 20 7 17/80 95/162 107/161 15/51 72/105 77/103 23/57 30/58 2/29 0 All Prior Relapse *Prior Nonresponse *Prior Nonresponse = decrease in HCV RNA of at least 2 logs by week 12, but detectable HCV RNA level during therapy period SVR = Sustained Virologic Response; B = Boceprevir; PR = Peginterferon + Ribavirin Source: Bacon BR, et al. N Engl J Med. 2011;364:1207-17.
Boceprevir for Retreatment of HCV Genotype 1 Infection RESPOND-2 Trial: Results Based on Initial Week 4 Response RESPOND-2: SVR 24, by Initial Response and Regimen PR48 B24/PR28-48 B44/PR48 100 Patients with SVR (%) 79 80 73 60 40 34 33 25 20 0/12 15/46 15/44 17/67 80/110 90/114 0 0 *Poor Initial Response to PR ^Good Initial Response to PR *Poor Initial Response to PR = decrease in HCV RNA level < 1 log10 IU/ml after 4 week lead in ^Good Initial Response to PR = decrease in HCV RNA level > 1 log10 IU/ml after 4 week lead in SVR = Sustained Virologic Response; B = Boceprevir; PR = Peginterferon + Ribavirin Source: Bacon BR, et al. N Engl J Med. 2011;364:1207-17.
Boceprevir for Retreatment of HCV Genotype 1 Infection RESPOND-2 Trial: Conclusions Conclusions: The addition of boceprevir to peginterferon ribavirin resulted in significantly higher rates of sustained virologic response in previously treated patients with chronic HCV genotype 1 infection, as compared with peginterferon ribavirin alone. Source: Bacon BR, et al. N Engl J Med. 2011;364:1207-17.
