Poster #822 Anlysis of Site Perf J. H. Jou, 1 M. S. Sulkowsk 1 Duke University Medicl Center nd Duke Clinicl Reserch Instit 5 Beth Isrel Liver Center,

Transcription

1 Poster #822 Anlysis of Site Performnce in Acdemic nd Community-Bsed Centers in the IDEAL Study J. H. Jou, 1 M. S. Sulkowski, 2 K. R. Reddy, 3 S. L. Flmm, 4 N. H. Afdhl, 5 J. M. Levin, 6 V. K. Rustgi, 7 R. S. Brown, 8 J. Long, 9 S. Noviello, 9 L. D. Pedicone, 9 J. K. Alrecht, 9 J. G. McHutchison 1 1 Duke University Medicl Center nd Duke Clinicl Reserch Institute, Durhm, NC, USA; 2 Johns Hopkins University School of Medicine, Bltimore, MD, USA; 3 University of Pennsylvni Helth System GI Reserch, Phildelphi, PA, USA; 4 Northwestern University, Evnston, IL, USA; 5 Beth Isrel Liver Center, Boston, MA, USA; 6 Den Clinic, Mdison, WI, USA; 7 Metropolitn Liver Diseses, Firfx, VA, USA; 8 Columi University Center for Liver Disese, New York, NY, USA; 9 Merck Reserch Lortories, Kenilworth, NJ, USA Astrct Bckground: 76 cdemic nd 42 community-sed US centers prticipted in the IDEAL study, providing n opportunity to evlute vrious metrics of qulity nd site performnce in this lrge multicenter study. Methods: 7 tretment-nive, HCV genotype 1 infected ptients received peg interferon (PEG) lf or 1 µg/kg/wk plus rivirin (RBV) 8- mg/d or PEG lf-2 18 µg/wk plus RBV -12 mg/d for up to 48 weeks. We retrospectively evluted rtes of screen filure, completion, nd discontinution of tretment nd follow-up, tretment dherence, nd virologic response y site type. Results: Of 4469 sujects screened, 63% nd 37% were in cdemic nd community centers, respectively. Screen filure rtes were similr (-3). Of the (6) nd (38%) ptients treted in cdemic nd community centers, respectively, seline chrcteristics were comprle, except more Africn Americns (2 vs 1) were treted t cdemic centers, nd more Hispnics were treted t community centers (% vs ) (Tle). End-of-tretment (EOT) response, relpse, nd sustined virologic response (SVR) rtes in cdemic nd community centers did not differ. 9% of ptients in cdemic nd 1 in community centers chieved rpid virologic response (undetectle HCV RNA t week 4); % nd 4 chieved complete erly virologic response (undetectle HCV RNA t week 12). Adherence to 8% of PEG nd RBV dosing for 8% ssigned durtion ws lso similr (46% in cdemic nd 47% in community centers). 54% of ptients in oth cdemic nd community centers completed tretment; there were similr discontinution rtes for tretment filure nd dverse events. Conclusions: No differences in dherence, incidence of dverse events, rtes of discontinution, on-tretment virologic response, nd SVR were found when compring cdemic nd community sites. This lrge tril further supports tht outcomes for ptients re lrgely similr when compring cdemic versus community sed tretment for chronic heptitis C. Screen filures 3 % Medin/men (SD) treted pts/site 18.5/25.7 (22.8) 21.5/27.7 (25.7) Men ge, yrs Cucsin//Hispnic 7/2/ 7/1/% METAVIR F3/4 % 1 Due to dverse events 1 1 Lost to follow-up 3% Week 24 follow-up phse Never entered 1 13% SVR/EOT/Relpse rte %/5/2 (248/996) %/%/27% (163/614) Bckground Ptients undergoing tretment for heptitis C t cdemic centers re thought to hve greter ccess to resources s compred with ptients treted t community-sed sites In the WIN-R study, tretment t predominntly community-sed centers ws ssocited with low retention of ptients on tretment nd, consequently, higher rtes of drop-out 1 The extent tht differences etween community nd cdemic sites my influence tretment outcomes mong ptients receiving peginterferon (PEG-IFN) lf plus rivirin (RBV) for chronic heptitis C infection in clinicl trils is unknown nd should e systemticlly exmined Aim To evlute vrious metrics of qulity nd site performnce in cdemic nd community sites prticipting in the multicenter IDEAL study 2 Ptients nd Methods Study Design This evlution of study centers is retrospective nlysis sed on the IDEAL study dtse IDEAL ws phse 3, rndomized, prllel-rm tril conducted t 118 centers (76 cdemic nd 42 community-sed) in the United Sttes (Figure 1) PEG-IFN lf-2 dose ws doule-linded, nd PEG-IFN lf-2 nd RBV were dministered s open-lel tretments Ptients with detectle, <2-log decline in HCV-RNA t week 12, or with detectle HCV-RNA t week 24 were discontinued from tretment Figure 1. IDEAL study design Screening Weeks* *HCV-RNA ssessments t designted time periods. PEG-IFN = peginterferon; RBV = rivirin. 2 n = 19 PEG-IFN lf µg/kg/wk + RBV 8- mg/d 48 weeks n = 16 PEG-IFN lf-2 1. µg/kg/wk + RBV 8- mg/d 48 weeks n = 35 PEG-IFN lf-2 18 µg/wk + RBV -12 mg/d 48 weeks Ptient Popultion Tretment-nive with chronic heptitis C, genotype 1 infection 18 to 7 old Weight to 125 kg Compensted liver disese Outcomes Rtes of screen filure, completion nd discontinution of tretment nd follow-up, tretment dherence, nd virologic response y site type (cdemic versus community centers) were clculted Dt from the 3 tretment rms were comined for ll nlyses Virologic Response nd Adherence Definitions Rpid virologic response (RVR): undetectle HCV-RNA t week 4 Complete erly virologic response (cevr): undetectle HCV-RNA t week 12 End-of-tretment (EOT) response: undetectle HCV-RNA t the end of tretment Sustined virologic response (SVR): undetectle HCV-RNA t the end of the 24-week follow-up period Relpse: Detectle HCV-RNA during follow-up in ptients with n undetectle HCV-RNA t EOT 8:8:8 dherence: 8% of PEG nd RBV dosing for 8% ssigned durtion HCV-RNA levels mesured using the COBAS Tqmn ssy (Roche) with lower limit of quntittion of 27 IU/mL Acdemic nd Community Site Regions 3 Regions of the United Sttes were defined y the US Census Bureu regions nd divisions Acdemic nd community sites were locted in the following regions: Northest: Connecticut, Mine, Msschusetts, New Jersey, New York, Pennsylvni, Rhode Islnd, nd Vermont Midwest: Illinois, Indin, Iow, Knss, Michign, Minnesot, Missouri, Nersk, Ohio, nd Wisconsin South Atlntic: District of Columi, Florid, Georgi, Mrylnd, North Crolin, South Crolin, nd Virgini South (excluding South Atlntic): Alm, Kentucky, Louisin, Tennessee, nd Texs West: Arizon, Cliforni, Colordo, Oregon, Uth, nd Wshington Results Ptients Screened Ptients Of 4469 ptients screened in the IDEAL study, 2799 (63%) nd 167 (37%) ptients were enrolled in cdemic nd community centers, respectively (Tle 1) Screen filure rtes were similr (%-3) etween the center types Tle 1. Resons for Screen Filure t Community nd Overll screen filure rte Due to protocol ineligiility Due to ptient did not wish to continue Due to noncomplince with protocol Due to dverse events (n = 2799) 3 24%. (n = 167) % 23%. Treted Ptients Of 7 ptients treted in the IDEAL study, (6) nd (38%) ptients were treted in cdemic nd community centers, respectively (Tle 2) Bseline chrcteristics were comprle More Africn Americns were treted t cdemic centers (2 vs 1) More Hispnics were treted t community centers (% vs ) Tle 2. Demogrphics nd Disese Chrcteristics of Treted Ptients (n = ) (n = ) Medin/men (SD) treted ptients/site 18.5/25.7 (22.8) 21.5/27.7 (25.7) Age, men (SD), y 47.6 (8.1) 47.4 (7.8) Weight, men (SD), kg 83.4 (16.3) 83.5 (16.3) Cucsin Hispnic % Asin HCV-RNA >6, IU/mL 8 8 Stetosis score Present 58% 6% Asent 36% 36% METAVIR firosis score F/1/2 84% 8 F3/4 % 1 Northest 2 7% South Atlntic 23% 33% South 26% 23% Midwest 2 16% West 9% 2 Dt missing for 147 ptients (4 in cdemic centers nd 43 in community-sed centers). 54% of ptients in oth cdemic nd community centers completed tretment ( Tle 3) There were similr discontinution rtes for tretment filure, dverse events, nd lost to follow-up t ech center type Tle 3. Study Prticiption (n = ) (n = ) Due to dverse events 1 1 Due to ptient did not wish to continue 3% 4% 3% Due to noncomplince with protocol Due to protocol ineligiility < < Week-24 follow-up phse Due to ptient did not wish to continue 3% 3% Due to noncomplince with protocol < < Due to dverse events < < Never entered 1 13% Tretment completion rtes were similr cross vrious demogrphic chrcteristics s well s regions in the United Sttes (Figure 2) Figure 2. Tretment completion rtes y demogrphic nd regionl chrcteristics Acdemic centers (n = ) (n = ) Tretment Completion, % pts Mle Femle Non > Northest South Atlntic South * Midwest 56 West Age * P >.5 for ll comprisons (nominl P vlues, undjusted for multiple comprisons). Virologic Response SVR, EOT response, nd relpse rtes were similr in ptients enrolled t cdemic nd community centers (Figure 3) Figure 3. Virologic response rtes t cdemic nd community centers Response Rte, % / Acdemic centers 455/ 55 49/ 66/ 248/ 996 SVR EOT Relpse EOT = end of tretment; SVR = sustined virologic response. Proportion of ptients with RVR, cevr, nd 8:8:8 dherence were lso similr t community nd cdemic sites (Figure 4) / 614 Figure 4. Proportion of ptients with RVR, cevr, nd dherence t community nd cdemic sites Proportion of Ptients, % / Acdemic centers 12 1/ 752/ / / 552/ RVR cevr 8:8:8 cevr = complete erly virologic response; RVR = rpid virologic response. There ws no significnt difference in SVR rtes etween community nd cdemic centers within most selected ptient sugroups (Tle 4) However, SVR rtes were significntly higher in ptients from the Western sttes when treted t cdemic centers compred with community centers (49% vs 38%, P =.4) Tle 4. SVR Rtes y Demogrphic nd Regionl Chrcteristics (n = ) (n = ) Mle 38% % Femle 43% 38% 2 2 Non- 4 4 Age old 54% 48% > old 37% 37% Northest 38% 43% South Atlntic % 38% South 37% % Midwest 4 % West 49% 38% P =.4; for ll other comprisons P >.5 (nominl P vlues, undjusted for multiple comprisons). SVR = sustined virologic response. Conclusions There were no differences in dherence, incidence of dverse events, rtes of discontinution, on-tretment virologic response, nd SVR when compring cdemic nd community sites SVR rtes were higher mong ptients from the western US sttes who were treted t cdemic centers compred with those treted t community centers These findings further support tht outcomes for ptients re lrgely similr when compring cdemic- versus community-sed tretment for chronic heptitis C Acknowledgments The uthors thnk the other IDEAL study investigtors: A. Al-Osimi, B. Bcon, L. Blrt, M. Bennett, D. Bernstein, E. Bini, M., J. Bloomer, H. Bonill, T. Box, T. Boyer, N. Bru, K. Brown, C. Bruno, W. Cssidy, R. Chung, D. Clin, J. Crippin, D. Dlke, M. Dvis, C. Dvis, G. Dvis, F. Felizrt, R. Firpi-Morell, J. Frnco, B. Freilich, J. Glti, G. Gller, R. Ghli, A. Gis, E. Godofsky, F. Gordon, J. Gross, S. Hrrison, J. Herrer, S. Herrine, R. Herring, K.-Q. Hu, J. Isrel, I. Jcoson, S. Joshi, M. Khlili, A. Kily, J. King, P. King, A. Koch, E. Krwitt, M. Kugelms, P. Kwo, L. Lmise, E. Lwitz, E. Leovics, W. Lee, R. Levine, S. Lidofsky, M. Lucey, M. Millird, L. Mrsno, P. Mrtin, J. McCone, T. McGrrity, D. Mikolich, T. Morgn, A. Muir, K. Mullen, S. Munoz, D. Nelson, F. Nunes, A. Nyerg, L. Nyerg, S. Oh, P. Pndy, M. P. Puly, C. Peine, R. Perrillo, G. Poleynrd, F. Poordd, A. Post, J. Poulos, D. Pound, M. Rinovitz, N. Rvendhrn, J. Redy, R. Reindollr, A. Reuen, L. Rossro, L. Rothmn, R. Ruin, M. Ryn, E. Schiff, W. Schmidt, W. Semon, T. Sepe, K. Shermn, M. Shiffmn, M. Sjogren, R. Sjogren, C. Smith, L. Stein, R. Struss, M. Swim, G. Szo, J. Thurn, M. Tong, J. Vierling, G. Wu, R. Ypp, Z. Younes, A. Zmn References 1. Jcoson IM, et l. Heptology. 27;46(4): McHutchison JG, et l. N Engl J Med. 29;361(6): US Census Bureu. Disclosures J. H. Jou hs nothing to disclose. M. S. Sulkowski serves s dvisor for Roche, Schering-Plough, Merck, Humn Genome Sciences, BIPI, Giled, Vertex, Tiotec, Bristol-Myers Squi, nd Pfizer nd receives grnt/reserch support from Mederx, Peregrine, Deiophrm, nd Aott. K. R. Reddy hs served s dvisor to Byer, Genentech/Roche, Giled, Merck, Slix, Tiotec, nd Vertex nd s investigtor for Bristol-Myers Squi, Genentech/Roche, Giled, Merck, Tiotec, nd Vertex. S. L. Flmm serves s speker for Giled nd Merck, consultnt for Giled, Merck, nd Vertex, nd receives reserch support from Aott, Giled, Merck, Pfizer, nd Vertex. N. H. Afdhl hs nothing to disclose. J. M. Levin serves s dvisor to Giled, Merck, Roche, nd Schering-Plough Corportion, now Merck & Co., Inc., nd s speker for Cuist, Giled, Merck, nd Schering-Plough Corportion, now Merck & Co., Inc. V. K. Rustgi hs served s speker for Bristol-Myers Squi, Giled, Roche, nd Schering-Plough Corportion, now Merck & Co., Inc., nd hs received reserch funding from Bristol-Myers Squi, Giled Sciences, Roche, Schering-Plough Corportion, now Merck & Co., Inc., nd Vertex Phrmceuticls. R. S. Brown hs served s speker for Schering-Plough Corportion, now Merck & Co., Inc., nd received reserch funding from Schering-Plough Corportion, now Merck & Co., Inc. S. Noviello is former employee nd now consultnt of Schering-Plough Reserch Institute, now Merck & Co., Inc. J. Long, L. D. Pedicone, nd J. K. Alrecht re employees of Schering-Plough Reserch Institute, now Merck & Co., Inc., nd S. Noviello, L. D. Pedicone, nd J. K. Alrecht re stockholders of Schering-Plough Corportion, now Merck & Co., Inc. J. G. McHutchison hs received reserch support from nd served s dvisor to Schering-Plough Corportion, now Merck & Co., Inc. Presented t the 61st Annul Meeting of the Americn Assocition for the Study of Liver Diseses, Octoer 29 Novemer 2, 2, Boston, MA. Supported y Schering-Plough Corportion, now Merck & Co., Inc., Whitehouse Sttion, NJ, USA.

2 Poster #822 Anlysis of Site Perf J. H. Jou, 1 M. S. Sulkowsk 1 Duke University Medicl Center nd Duke Clinicl Reserch Instit 5 Beth Isrel Liver Center, Boston, MA, USA; 6 D Astrct Bckground: 76 cdemic nd 42 community-sed US centers prticipted in the IDEAL study, providing n opportunity to evlute vrious metrics of qulity nd site performnce in this lrge multicenter study. Methods: 7 tretment-nive, HCV genotype 1 infected ptients received peg interferon (PEG) lf or 1 µg/kg/wk plus rivirin (RBV) 8- mg/d or PEG lf-2 18 µg/wk plus RBV -12 mg/d for up to 48 weeks. We retrospectively evluted rtes of screen filure, completion, nd discontinution of tretment nd follow-up, tretment dherence, nd virologic response y site type. Results: Of 4469 sujects screened, 63% nd 37% were in cdemic nd community centers, respectively. Screen filure rtes were similr (-3). Of the (6) nd (38%) ptients treted in cdemic nd community centers, respectively, seline chrcteristics were comprle, except more Africn Americns (2 vs 1) were treted t cdemic centers, nd more Hispnics were treted t community centers (% vs ) (Tle). End-of-tretment (EOT) response, relpse, nd sustined virologic response (SVR) rtes in cdemic nd community centers did not differ. 9% of ptients in cdemic nd 1 in community centers chieved rpid virologic response (undetectle HCV RNA t week 4); % nd 4 chieved complete erly virologic response (undetectle HCV RNA t week 12). Adherence to 8% of PEG nd RBV dosing for 8% ssigned durtion ws lso similr (46% in cdemic nd 47% in community centers). 54% of ptients in oth cdemic nd community centers completed tretment; there were similr discontinution rtes for tretment filure nd dverse events. Conclusions: No differences in dherence, incidence of dverse events, rtes of discontinution, on-tretment virologic response, nd SVR were found when compring cdemic nd community sites. This lrge tril further supports tht outcomes for ptients re lrgely similr when compring cdemic versus community sed tretment for chronic heptitis C. Screen filures 3 % Medin/men (SD) treted pts/site 18.5/25.7 (22.8) 21.5/27.7 (25.7) Men ge, yrs Cucsin//Hispnic 7/2/ 7/1/% METAVIR F3/4 % 1 Due to dverse events 1 1 Lost to follow-up 3% Week 24 follow-up phse Never entered 1 13% SVR/EOT/Relpse rte %/5/2 (248/996) %/%/27% (163/614) Bckground Ptients undergoing tretment for heptitis C t cdemic centers re thought to hve greter ccess to resources s compred with ptients treted t community-sed sites In the WIN-R study, tretment t predominntly community-sed centers ws ssocited with low retention of ptients on tretment nd, consequently, higher rtes of drop-out 1 The extent tht differences etween community nd cdemic sites my influence tretment outcomes mong ptients receiving peginterferon (PEG-IFN) lf plus rivirin (RBV) for chronic heptitis C infection in clinicl trils is unknown nd should e systemticlly exmined Aim To evlute vrious metrics of qulity nd site performnce in cdemic nd community sites prticipting in the multicenter IDEAL study 2 Ptients nd Methods Study Design This evlution of study centers is retrospective nlysis sed on the IDEAL study dtse IDEAL ws phse 3, rndomized, prllel-rm tril conducted t 118 centers (76 cdemic nd 42 community-sed) in the United Sttes (Figure 1) PEG-IFN lf-2 dose ws doule-linded, nd PEG-IFN lf-2 nd RBV were dministered s open-lel tretments Ptients with detectle, <2-log decline in HCV-RNA t week 12, or with detectle HCV-RNA t week 24 were discontinued from tretment Figure 1. IDEAL study design Screening n = 19 PEG-IFN lf µg/kg/wk + RBV 8- mg/d 48 weeks n = 16 PEG-IFN lf-2 1. µg/kg/wk + RBV 8- mg/d 48 weeks n = 35 PEG-IFN lf-2 18 µg/wk + RBV -12 mg/d 48 weeks Weeks* *HCV-RNA ssessments t designted time periods. PEG-IFN = peginterferon; RBV = rivirin Presented t the 61st Annul Meeting of the Americn Assocition for the Study of Liver Diseses, Oc

3 ormnce in Acdemic nd i, 2 K. R. Reddy, 3 S. L. Flmm, 4 N. H. Afdh L. D. Pedicone, 9 J. K. Alr ute, Durhm, NC, USA; 2 Johns Hopkins University School of Medicine, Bltim en Clinic, Mdison, WI, USA; 7 Metropolitn Liver Diseses, Firfx, VA, USA Ptient Popultion Tretment-nive with chronic heptitis C, genotype 1 infection 18 to 7 old Weight to 125 kg Compensted liver disese Outcomes Rtes of screen filure, completion nd discontinution of tretment nd follow-up, tretment dherence, nd virologic response y site type (cdemic versus community centers) were clculted Dt from the 3 tretment rms were comined for ll nlyses Virologic Response nd Adherence Definitions Rpid virologic response (RVR): undetectle HCV-RNA t week 4 Complete erly virologic response (cevr): undetectle HCV-RNA t week 12 End-of-tretment (EOT) response: undetectle HCV-RNA t the end of tretment Sustined virologic response (SVR): undetectle HCV-RNA t the end of the 24-week follow-up period Relpse: Detectle HCV-RNA during follow-up in ptients with n undetectle HCV-RNA t EOT 8:8:8 dherence: 8% of PEG nd RBV dosing for 8% ssigned durtion HCV-RNA levels mesured using the COBAS Tqmn ssy (Roche) with lower limit of quntittion of 27 IU/mL Acdemic nd Community Site Regions 3 Regions of the United Sttes were defined y the US Census Bureu regions nd divisions Acdemic nd community sites were locted in the following regions: Northest: Connecticut, Mine, Msschusetts, New Jersey, New York, Pennsylvni, Rhode Islnd, nd Vermont Midwest: Illinois, Indin, Iow, Knss, Michign, Minnesot, Missouri, Nersk, Ohio, nd Wisconsin South Atlntic: District of Columi, Florid, Georgi, Mrylnd, North Crolin, South Crolin, nd Virgini South (excluding South Atlntic): Alm, Kentucky, Louisin, Tennessee, nd Texs West: Arizon, Cliforni, Colordo, Oregon, Uth, nd Wshington Results Ptients Screened Ptients Of 4469 ptients screened in the IDEAL study, 2799 (63%) nd 167 (37%) ptients were enrolled in cdemic nd community centers, respectively (Tle 1) Screen filure rtes were similr (%-3) etween the center types Tle 1. Resons for Screen Filure t Community nd Overll screen filure rte Due to protocol ineligiility Due to ptient did not wish to continue Due to noncomplince with protocol Due to dverse events (n = 2799) 3 24%. (n = 167) % 23%. Treted Ptients Of 7 ptients treted in the IDEAL study, (6) nd (38%) ptients were treted in cdemic nd community centers, respectively (Tle 2) Bseline chrcteristics were comprle More Africn Americns were treted t cdemic centers (2 vs 1) More Hispnics were treted t community centers (% vs ) Tle 2. Demogrphics nd Disese Chrcteristics of Treted Ptients (n = ) (n = ) Medin/men (SD) treted ptients/site 18.5/25.7 (22.8) 21.5/27.7 (25.7) Age, men (SD), y 47.6 (8.1) 47.4 (7.8) Weight, men (SD), kg 83.4 (16.3) 83.5 (16.3) Cucsin Hispnic % Asin HCV-RNA >6, IU/mL 8 8 Stetosis score Present 58% 6% Asent 36% 36% METAVIR firosis score F/1/2 84% 8 F3/4 % 1 Northest 2 7% South Atlntic 23% 33% South 26% 23% Midwest 2 16% West 9% 2 Dt missing for 147 ptients (4 in cdemic centers nd 43 in community-sed centers). 54% of ptients in oth cdemic nd community centers completed tretment ( Tle 3) There were similr discontinution rtes for tretment filure, dverse events, nd lost to follow-up t ech center type toer 29 Novemer 2, 2, Boston, MA.

4 Community-Bsed Centers hl, 5 J. M. Levin, 6 V. K. Rustgi, 7 R. S. Brow recht, 9 J. G. McHutchison 1 imore, MD, USA; 3 University of Pennsylvni Helth System GI Reserch, Phi SA; 8 Columi University Center for Liver Disese, New York, NY, USA; 9 Merc Tle 3. Study Prticiption (n = ) (n = ) Due to dverse events 1 1 Due to ptient did not wish to continue 3% 4% 3% Due to noncomplince with protocol Due to protocol ineligiility < < Week-24 follow-up phse Due to ptient did not wish to continue 3% 3% Due to noncomplince with protocol < < Due to dverse events < < Never entered 1 13% Tretment completion rtes were similr cross vrious demogrphic chrcteristics s well s regions in the United Sttes (Figure 2) Figure 2. Tretment completion rtes y demogrphic nd regionl chrcteristics Tretment Completion, % pts Acdemic centers (n = ) Mle Femle Non- (n = ) > Northest South Atlntic South * Midwest 56 West Age * P >.5 for ll comprisons (nominl P vlues, undjusted for multiple comprisons). Virologic Response SVR, EOT response, nd relpse rtes were similr in ptients enrolled t cdemic nd community centers (Figure 3) Figure 3. Virologic response rtes t cdemic nd community centers 8 Acdemic centers 7 Response Rte, % / 455/ 49/ 66/ 248/ 996 SVR EOT Relpse 163/ 614 EOT = end of tretment; SVR = sustined virologic response. Proportion of ptients with RVR, cevr, nd 8:8:8 dherence were lso similr t community nd cdemic sites (Figure 4)

5 s in the IDEAL Study wn, 8 J. Long, 9 S. Noviello, 9 Phildelphi, PA, USA; 4 Northwestern University, Evnston, IL, USA; erck Reserch Lortories, Kenilworth, NJ, USA Figure 4. Proportion of ptients with RVR, cevr, nd dherence t community nd cdemic sites Proportion of Ptients, % / Acdemic centers 12 1/ 752/ / / 552/ RVR cevr 8:8:8 cevr = complete erly virologic response; RVR = rpid virologic response. There ws no significnt difference in SVR rtes etween community nd cdemic centers within most selected ptient sugroups (Tle 4) However, SVR rtes were significntly higher in ptients from the Western sttes when treted t cdemic centers compred with community centers (49% vs 38%, P =.4) Tle 4. SVR Rtes y Demogrphic nd Regionl Chrcteristics (n = ) (n = ) Mle 38% % Femle 43% 38% 2 2 Non- 4 4 Age old 54% 48% > old 37% 37% Northest 38% 43% South Atlntic % 38% South 37% % Midwest 4 % West 49% 38% P =.4; for ll other comprisons P >.5 (nominl P vlues, undjusted for multiple comprisons). SVR = sustined virologic response. Conclusions There were no differences in dherence, incidence of dverse events, rtes of discontinution, on-tretment virologic response, nd SVR when compring cdemic nd community sites SVR rtes were higher mong ptients from the western US sttes who were treted t cdemic centers compred with those treted t community centers These findings further support tht outcomes for ptients re lrgely similr when compring cdemic- versus community-sed tretment for chronic heptitis C Acknowledgments The uthors thnk the other IDEAL study investigtors: A. Al-Osimi, B. Bcon, L. Blrt, M. Bennett, D. Bernstein, E. Bini, M., J. Bloomer, H. Bonill, T. Box, T. Boyer, N. Bru, K. Brown, C. Bruno, W. Cssidy, R. Chung, D. Clin, J. Crippin, D. Dlke, M. Dvis, C. Dvis, G. Dvis, F. Felizrt, R. Firpi-Morell, J. Frnco, B. Freilich, J. Glti, G. Gller, R. Ghli, A. Gis, E. Godofsky, F. Gordon, J. Gross, S. Hrrison, J. Herrer, S. Herrine, R. Herring, K.-Q. Hu, J. Isrel, I. Jcoson, S. Joshi, M. Khlili, A. Kily, J. King, P. King, A. Koch, E. Krwitt, M. Kugelms, P. Kwo, L. Lmise, E. Lwitz, E. Leovics, W. Lee, R. Levine, S. Lidofsky, M. Lucey, M. Millird, L. Mrsno, P. Mrtin, J. McCone, T. McGrrity, D. Mikolich, T. Morgn, A. Muir, K. Mullen, S. Munoz, D. Nelson, F. Nunes, A. Nyerg, L. Nyerg, S. Oh, P. Pndy, M. P. Puly, C. Peine, R. Perrillo, G. Poleynrd, F. Poordd, A. Post, J. Poulos, D. Pound, M. Rinovitz, N. Rvendhrn, J. Redy, R. Reindollr, A. Reuen, L. Rossro, L. Rothmn, R. Ruin, M. Ryn, E. Schiff, W. Schmidt, W. Semon, T. Sepe, K. Shermn, M. Shiffmn, M. Sjogren, R. Sjogren, C. Smith, L. Stein, R. Struss, M. Swim, G. Szo, J. Thurn, M. Tong, J. Vierling, G. Wu, R. Ypp, Z. Younes, A. Zmn References 1. Jcoson IM, et l. Heptology. 27;46(4): McHutchison JG, et l. N Engl J Med. 29;361(6): US Census Bureu. Disclosures J. H. Jou hs nothing to disclose. M. S. Sulkowski serves s dvisor for Roche, Schering-Plough, Merck, Humn Genome Sciences, BIPI, Giled, Vertex, Tiotec, Bristol-Myers Squi, nd Pfizer nd receives grnt/reserch support from Mederx, Peregrine, Deiophrm, nd Aott. K. R. Reddy hs served s dvisor to Byer, Genentech/Roche, Giled, Merck, Slix, Tiotec, nd Vertex nd s investigtor for Bristol-Myers Squi, Genentech/Roche, Giled, Merck, Tiotec, nd Vertex. S. L. Flmm serves s speker for Giled nd Merck, consultnt for Giled, Merck, nd Vertex, nd receives reserch support from Aott, Giled, Merck, Pfizer, nd Vertex. N. H. Afdhl hs nothing to disclose. J. M. Levin serves s dvisor to Giled, Merck, Roche, nd Schering-Plough Corportion, now Merck & Co., Inc., nd s speker for Cuist, Giled, Merck, nd Schering-Plough Corportion, now Merck & Co., Inc. V. K. Rustgi hs served s speker for Bristol-Myers Squi, Giled, Roche, nd Schering-Plough Corportion, now Merck & Co., Inc., nd hs received reserch funding from Bristol-Myers Squi, Giled Sciences, Roche, Schering-Plough Corportion, now Merck & Co., Inc., nd Vertex Phrmceuticls. R. S. Brown hs served s speker for Schering-Plough Corportion, now Merck & Co., Inc., nd received reserch funding from Schering-Plough Corportion, now Merck & Co., Inc. S. Noviello is former employee nd now consultnt of Schering-Plough Reserch Institute, now Merck & Co., Inc. J. Long, L. D. Pedicone, nd J. K. Alrecht re employees of Schering-Plough Reserch Institute, now Merck & Co., Inc., nd S. Noviello, L. D. Pedicone, nd J. K. Alrecht re stockholders of Schering-Plough Corportion, now Merck & Co., Inc. J. G. McHutchison hs received reserch support from nd served s dvisor to Schering-Plough Corportion, now Merck & Co., Inc. Supported y Schering-Plough Corportion, now Merck & Co., Inc., Whitehouse Sttion, NJ, USA.