Abstract
This prospective, multicenter, community-based and academic-based, open-label, investigator-initiated, U.S. study evaluated efficacy and safety of pegylated interferon (PEG-IFN) alfa-2b plus a flat or weight-based dose of ribavirin (RBV) in adults with chronic hepatitis C. Patients (n = 5027) were randomly assigned to receive PEG-IFN alfa-2b 1.5 μmg/kg/week plus flat-dose (800 mg/day) or weight-based (800-1400 mg/day) RBV for 48 weeks (patients with genotype 1, 4, 5, or 6) and for 24 or 48 weeks (genotype 2/3 patients). Primary end point was sustained virologic response (undetectable [< 125 IU/mL] serum hepatitis C virus RNA at 24-week follow-up). Sustained virologic response, but not end-of-treatment, rates were significantly higher with weight-based than with flat-dose RBV (44.2% versus 40.5%; P = 0.008). Sustained virologic response rates by intention-to-treat analysis were 34.0% and 28.9%, respectively, in genotype 1 patients (P = 0.005) and 31.2% and 26.7%, respectively, in genotype 1 patients with high baseline viral load (P = 0.056). In genotype 2/3 patients, rates were not significantly different (61.8% and 59.5%, respectively) regardless of treatment duration. Besides greater hemoglobin reductions with weight-based RBV, safety profiles were similar across RBV dosing groups, including the 1400-mg/day group. Conclusion: PEG-IFN alfa-2b plus weight-based RBV is more effective than flat-dose RBV, particularly in genotype 1 patients, providing equivalent efficacy across all weight groups. RBV 1400 mg/day is appropriate for patients 105 to 125 kg. For genotype 2/3 patients, 24 weeks of treatment with flat-dose RBV is adequate; no evidence of additional benefit of extending treatment to 48 weeks was demonstrated.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 971-981 |
| Number of pages | 11 |
| Journal | Hepatology |
| Volume | 46 |
| Issue number | 4 |
| DOIs | |
| State | Published - Oct 2007 |
ASJC Scopus subject areas
- Hepatology
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Peginterferon alfa-2b and Weight-Based or Flat-Dose Ribavirin in Chronic Hepatitis C Patients : A Randomized Trial. / Jacobson, Ira M.; Brown, Robert S.; Freilich, Bradley; Afdhal, Nezam; Kwo, Paul Y.; Santoro, John; Becker, Scott; Wakil, Adil E.; Pound, David; Godofsky, Eliot; Strauss, Robert; Bernstein, David; Flamm, Steven; Pauly, Mary Pat; Mukhopadhyay, Pabak; Griffel, Louis H.; Brass, Clifford A.; Black, Martin; Fried, Michael; Dies, David; Brodsky, Neil; Cerulli, Maurice; Esposito, Stephen; Rahmin, Michael; David, Jonathan; Lebovics, Edward; Kenny, Raymond; Levendoglu, Hulya; Ozick, Lisa; Gardner, Peter; Berman, David; Feldman, David; Tobias, Hillel; Klion, Frank; Min, Albert; Ehrlich, James; Spivack, Julie; Stein, David; Kwo, Paul; VanDrake, Vance; Behrle, Kevin; Serini, John; Monsour, Howard; Anand, B.; Galler, Greg; Stribling, Rise; Kelly, Stephen; Bala, Natarjan; McDonald, Thomas; Ghosh, Martha; Gordon, Fredric; Ades, Alain; Brand, Myron; Cooley, Jeffery; Epstein, Alan; Sepe, Thomas; Abraham, George; Agrawal, R.; Rabinovitz, Mordechai; Smith, Mark; Kilby, Fred; Nunes, David; Srour, James; Richter, Seth; Shick, Lawton; Varunok, Peter; Zucker, Geoffrey; Polito, Joseph; Lyons, Micheal; Maccini, David; Sahagun, Geronimo; Bedard, Charles; Wadland, Donald; Loura, Fredrich; Levin, Arnold; Box, Terry; Tsai, Naoky; Tolman, Keith; Baddoura, Walid; Bernstein, Micheal David; DePasquale, Joseph; Bermanski, Paul; Gabbazaideh, David; Lake-Bakaar, Gerond; Cowan, Jay; Hagendom, Curt; Fixelle, Alan; Rubin, Raymond; Albert, Clive; Hudes, Brian; Murphy, Mark; Cochran, J. Lynn; Herrera, Jorge; Gitlin, Norman; Reindollar, Robert; Fenyves, Jeffrey; Dye, Kevin; Noble, Thomas; Weprin, Larry; Epstein, Michael; Finkel, Robert; Ravendhran, Natarajan; Cox, Michael; Rai, Rudra; Gelrud, Lou; Lobis, Ira; Ryan, Michael; Rustgi, Vinod; Shiffman, Mitchell; Lewis, James; McCone, Jonathan; Kaplan, William; Hurwich, David; Goldman, Donna; Yapp, Rockford; Te, Helen; Perez, Rodger; Weston, Allan; Regenstein, Fredric; Rinker, Ronald; Dragutsky, Michael; Migicovsky, Barry; Herring, Robert; Ross, William; Lyles, William; Nelson, Andrew; Cofrancesco, Simon; King, John; Allen, Thomas; Bhandari, Raj; Gordon, Stuart; Siddiqui, Firdous; Peine, Craig; Gross, John; Lake, John; Kichner, John; Franco, Jose; Nelson, James; Levin, James; Ho, Samuel; Smith, Coleman; Levin, Douglas; Henry, Michael; Dalke, Douglas; Jensen, Jonathon; Kim, Lawrence; Levine, Robert; Goff, John; Brouillette, Douglas; Lanspa, Stephen; Manning, Robert; Harrison, Stephen; Diamond, Kenneth; Davis, Mitchell; Nguyen, Thuan; Vemuru, Rvikumar; Cox, James; Ganeshappa, K.; Matossian, Harry; Galen, Edward; Nader, Pierre; Reddy, K. Rajender; Matusow, Gary; Carlson, Steve; Szpakowski, Jean Luc; Esrason, Karl; Pham, Thai Van; Lee, Alexander; Jenkins, Timothy; Ready, Joanna; Kam, Nathan; Shlager, Lyle; Pimstone, Neville; Cheung, Ramsey; Wong, Helen; Hargrave, Thomas; Sylvestre, Diana; Devault, Kenneth; Aggarwal, Avanish; Schwertner, Darrell; Cavacini, Timothy; Reisman, Terence; Lambiase, Louis; Ricci, Donate; Eisner, Mark; Rothman, S. Lawrence; Bloom, Michael; Berman, Arthur; Yudelman, Paul; Wiesen, Scott; Shankar, Murali; Rosenfield, Thomas; Vierling, John; Schulman, David; Han, Steven Huy; Lyche, Kip; Felizarta, Franco; Deguzman, Lino; Hillebrand, Donald; Bock, Bonnie; Tuan, Trong Nguyen; Demicco, Michael; Woolf, Graham; Araya, Victor; Shaw, Ellen; Stein, Lawrence; Digregorio, K.; D'Angelo, Carl; Thornton, James; Chen, Steve; Jolley, John; Terrault, Norah; Gish, Robert; Wasserman, Ronald; Layden, Thomas; Van Thiel, David; Jensen, Donald; Levstik, Mark; Pruitt, Ronald; Siciliano, Gerald; Cecil, Bennett; Marsano, Luis; Jonas, Mark; Knapple, Whit; Balan, Vijay; Meline, Daniel; Palley, Steven; Rigberg, Leon; Winston, David; Hassanein, Tarek.
In: Hepatology, Vol. 46, No. 4, 10.2007, p. 971-981.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Peginterferon alfa-2b and Weight-Based or Flat-Dose Ribavirin in Chronic Hepatitis C Patients
T2 - A Randomized Trial
AU - Jacobson, Ira M.
AU - Brown, Robert S.
AU - Freilich, Bradley
AU - Afdhal, Nezam
AU - Kwo, Paul Y.
AU - Santoro, John
AU - Becker, Scott
AU - Wakil, Adil E.
AU - Pound, David
AU - Godofsky, Eliot
AU - Strauss, Robert
AU - Bernstein, David
AU - Flamm, Steven
AU - Pauly, Mary Pat
AU - Mukhopadhyay, Pabak
AU - Griffel, Louis H.
AU - Brass, Clifford A.
AU - Black, Martin
AU - Fried, Michael
AU - Dies, David
AU - Brodsky, Neil
AU - Cerulli, Maurice
AU - Esposito, Stephen
AU - Rahmin, Michael
AU - David, Jonathan
AU - Lebovics, Edward
AU - Kenny, Raymond
AU - Levendoglu, Hulya
AU - Ozick, Lisa
AU - Gardner, Peter
AU - Berman, David
AU - Feldman, David
AU - Tobias, Hillel
AU - Klion, Frank
AU - Min, Albert
AU - Ehrlich, James
AU - Spivack, Julie
AU - Stein, David
AU - Kwo, Paul
AU - VanDrake, Vance
AU - Behrle, Kevin
AU - Serini, John
AU - Monsour, Howard
AU - Anand, B.
AU - Galler, Greg
AU - Stribling, Rise
AU - Kelly, Stephen
AU - Bala, Natarjan
AU - McDonald, Thomas
AU - Ghosh, Martha
AU - Gordon, Fredric
AU - Ades, Alain
AU - Brand, Myron
AU - Cooley, Jeffery
AU - Epstein, Alan
AU - Sepe, Thomas
AU - Abraham, George
AU - Agrawal, R.
AU - Rabinovitz, Mordechai
AU - Smith, Mark
AU - Kilby, Fred
AU - Nunes, David
AU - Srour, James
AU - Richter, Seth
AU - Shick, Lawton
AU - Varunok, Peter
AU - Zucker, Geoffrey
AU - Polito, Joseph
AU - Lyons, Micheal
AU - Maccini, David
AU - Sahagun, Geronimo
AU - Bedard, Charles
AU - Wadland, Donald
AU - Loura, Fredrich
AU - Levin, Arnold
AU - Box, Terry
AU - Tsai, Naoky
AU - Tolman, Keith
AU - Baddoura, Walid
AU - Bernstein, Micheal David
AU - DePasquale, Joseph
AU - Bermanski, Paul
AU - Gabbazaideh, David
AU - Lake-Bakaar, Gerond
AU - Cowan, Jay
AU - Hagendom, Curt
AU - Fixelle, Alan
AU - Rubin, Raymond
AU - Albert, Clive
AU - Hudes, Brian
AU - Murphy, Mark
AU - Cochran, J. Lynn
AU - Herrera, Jorge
AU - Gitlin, Norman
AU - Reindollar, Robert
AU - Fenyves, Jeffrey
AU - Dye, Kevin
AU - Noble, Thomas
AU - Weprin, Larry
AU - Epstein, Michael
AU - Finkel, Robert
AU - Ravendhran, Natarajan
AU - Cox, Michael
AU - Rai, Rudra
AU - Gelrud, Lou
AU - Lobis, Ira
AU - Ryan, Michael
AU - Rustgi, Vinod
AU - Shiffman, Mitchell
AU - Lewis, James
AU - McCone, Jonathan
AU - Kaplan, William
AU - Hurwich, David
AU - Goldman, Donna
AU - Yapp, Rockford
AU - Te, Helen
AU - Perez, Rodger
AU - Weston, Allan
AU - Regenstein, Fredric
AU - Rinker, Ronald
AU - Dragutsky, Michael
AU - Migicovsky, Barry
AU - Herring, Robert
AU - Ross, William
AU - Lyles, William
AU - Nelson, Andrew
AU - Cofrancesco, Simon
AU - King, John
AU - Allen, Thomas
AU - Bhandari, Raj
AU - Gordon, Stuart
AU - Siddiqui, Firdous
AU - Peine, Craig
AU - Gross, John
AU - Lake, John
AU - Kichner, John
AU - Franco, Jose
AU - Nelson, James
AU - Levin, James
AU - Ho, Samuel
AU - Smith, Coleman
AU - Levin, Douglas
AU - Henry, Michael
AU - Dalke, Douglas
AU - Jensen, Jonathon
AU - Kim, Lawrence
AU - Levine, Robert
AU - Goff, John
AU - Brouillette, Douglas
AU - Lanspa, Stephen
AU - Manning, Robert
AU - Harrison, Stephen
AU - Diamond, Kenneth
AU - Davis, Mitchell
AU - Nguyen, Thuan
AU - Vemuru, Rvikumar
AU - Cox, James
AU - Ganeshappa, K.
AU - Matossian, Harry
AU - Galen, Edward
AU - Nader, Pierre
AU - Reddy, K. Rajender
AU - Matusow, Gary
AU - Carlson, Steve
AU - Szpakowski, Jean Luc
AU - Esrason, Karl
AU - Pham, Thai Van
AU - Lee, Alexander
AU - Jenkins, Timothy
AU - Ready, Joanna
AU - Kam, Nathan
AU - Shlager, Lyle
AU - Pimstone, Neville
AU - Cheung, Ramsey
AU - Wong, Helen
AU - Hargrave, Thomas
AU - Sylvestre, Diana
AU - Devault, Kenneth
AU - Aggarwal, Avanish
AU - Schwertner, Darrell
AU - Cavacini, Timothy
AU - Reisman, Terence
AU - Lambiase, Louis
AU - Ricci, Donate
AU - Eisner, Mark
AU - Rothman, S. Lawrence
AU - Bloom, Michael
AU - Berman, Arthur
AU - Yudelman, Paul
AU - Wiesen, Scott
AU - Shankar, Murali
AU - Rosenfield, Thomas
AU - Vierling, John
AU - Schulman, David
AU - Han, Steven Huy
AU - Lyche, Kip
AU - Felizarta, Franco
AU - Deguzman, Lino
AU - Hillebrand, Donald
AU - Bock, Bonnie
AU - Tuan, Trong Nguyen
AU - Demicco, Michael
AU - Woolf, Graham
AU - Araya, Victor
AU - Shaw, Ellen
AU - Stein, Lawrence
AU - Digregorio, K.
AU - D'Angelo, Carl
AU - Thornton, James
AU - Chen, Steve
AU - Jolley, John
AU - Terrault, Norah
AU - Gish, Robert
AU - Wasserman, Ronald
AU - Layden, Thomas
AU - Van Thiel, David
AU - Jensen, Donald
AU - Levstik, Mark
AU - Pruitt, Ronald
AU - Siciliano, Gerald
AU - Cecil, Bennett
AU - Marsano, Luis
AU - Jonas, Mark
AU - Knapple, Whit
AU - Balan, Vijay
AU - Meline, Daniel
AU - Palley, Steven
AU - Rigberg, Leon
AU - Winston, David
AU - Hassanein, Tarek
PY - 2007/10
Y1 - 2007/10
N2 - This prospective, multicenter, community-based and academic-based, open-label, investigator-initiated, U.S. study evaluated efficacy and safety of pegylated interferon (PEG-IFN) alfa-2b plus a flat or weight-based dose of ribavirin (RBV) in adults with chronic hepatitis C. Patients (n = 5027) were randomly assigned to receive PEG-IFN alfa-2b 1.5 μmg/kg/week plus flat-dose (800 mg/day) or weight-based (800-1400 mg/day) RBV for 48 weeks (patients with genotype 1, 4, 5, or 6) and for 24 or 48 weeks (genotype 2/3 patients). Primary end point was sustained virologic response (undetectable [< 125 IU/mL] serum hepatitis C virus RNA at 24-week follow-up). Sustained virologic response, but not end-of-treatment, rates were significantly higher with weight-based than with flat-dose RBV (44.2% versus 40.5%; P = 0.008). Sustained virologic response rates by intention-to-treat analysis were 34.0% and 28.9%, respectively, in genotype 1 patients (P = 0.005) and 31.2% and 26.7%, respectively, in genotype 1 patients with high baseline viral load (P = 0.056). In genotype 2/3 patients, rates were not significantly different (61.8% and 59.5%, respectively) regardless of treatment duration. Besides greater hemoglobin reductions with weight-based RBV, safety profiles were similar across RBV dosing groups, including the 1400-mg/day group. Conclusion: PEG-IFN alfa-2b plus weight-based RBV is more effective than flat-dose RBV, particularly in genotype 1 patients, providing equivalent efficacy across all weight groups. RBV 1400 mg/day is appropriate for patients 105 to 125 kg. For genotype 2/3 patients, 24 weeks of treatment with flat-dose RBV is adequate; no evidence of additional benefit of extending treatment to 48 weeks was demonstrated.
AB - This prospective, multicenter, community-based and academic-based, open-label, investigator-initiated, U.S. study evaluated efficacy and safety of pegylated interferon (PEG-IFN) alfa-2b plus a flat or weight-based dose of ribavirin (RBV) in adults with chronic hepatitis C. Patients (n = 5027) were randomly assigned to receive PEG-IFN alfa-2b 1.5 μmg/kg/week plus flat-dose (800 mg/day) or weight-based (800-1400 mg/day) RBV for 48 weeks (patients with genotype 1, 4, 5, or 6) and for 24 or 48 weeks (genotype 2/3 patients). Primary end point was sustained virologic response (undetectable [< 125 IU/mL] serum hepatitis C virus RNA at 24-week follow-up). Sustained virologic response, but not end-of-treatment, rates were significantly higher with weight-based than with flat-dose RBV (44.2% versus 40.5%; P = 0.008). Sustained virologic response rates by intention-to-treat analysis were 34.0% and 28.9%, respectively, in genotype 1 patients (P = 0.005) and 31.2% and 26.7%, respectively, in genotype 1 patients with high baseline viral load (P = 0.056). In genotype 2/3 patients, rates were not significantly different (61.8% and 59.5%, respectively) regardless of treatment duration. Besides greater hemoglobin reductions with weight-based RBV, safety profiles were similar across RBV dosing groups, including the 1400-mg/day group. Conclusion: PEG-IFN alfa-2b plus weight-based RBV is more effective than flat-dose RBV, particularly in genotype 1 patients, providing equivalent efficacy across all weight groups. RBV 1400 mg/day is appropriate for patients 105 to 125 kg. For genotype 2/3 patients, 24 weeks of treatment with flat-dose RBV is adequate; no evidence of additional benefit of extending treatment to 48 weeks was demonstrated.
UR - http://www.scopus.com/inward/record.url?scp=36348981708&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=36348981708&partnerID=8YFLogxK
U2 - 10.1002/hep.21932
DO - 10.1002/hep.21932
M3 - Article
C2 - 17894303
AN - SCOPUS:36348981708
VL - 46
SP - 971
EP - 981
JO - Hepatology
JF - Hepatology
SN - 0270-9139
IS - 4
ER -