Vienne 2010 - PROGRESS - 48 semaines
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Lopinavir/ritonavir (LPV/r) Combined with Raltegravir (RAL) Demonstrated Similar Antiviral Efficacy and Safety as LPV/r Combined with Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) in Treatment-Naïve HIV-1-Infected Subjects:
![Background ,[object Object],[object Object],[object Object],[object Object],[object Object],PROGRESS 48 week results – XVIII IAC 19-Jul-10 1. Hogg, RS et al . , Lancet , 1997; 349:1294; 2. Lewis, W et al . , Nat. Rev. Drug Discov ., 2003;2:812-22; 3. Shikuma, CM et al., AIDS , 2001;15:1801-9; 4. Nolan, D et al . , Sex Health , 2005;2:153-63; 5. Riddler, SA et al . , N. Engl. J. Med ., 2008;358:2095-106; 6. Gathe JR et al., JAIDS , 2009;50:474-481; 7. Zajdenverg, R., et al., JAIDS , 2010;54:143-51; 8 Kaletra US prescribing Information, 2010; 9. Lennox, J et al., Lancet , 2009; 374:796-806. 10. Isentress US prescribing Information, 2009.](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
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Vienne 2010 - PROGRESS - 48 semaines
- 1. Jacques Reynes 1 , Adebayo Lawal 2 , Federico Pulido 3 , Ruth Soto-Malave 4 , Joseph Gathe 5 , Min Tian 2 , Linda Fredrick 2 , Todd Correll 2 , Thomas Podsadecki 2 , Angela Nilius 2 XVIII International AIDS Conference ● Vienna, Austria ●18-23 July 2010 1. Department of Infectious and Tropical Diseases, Montpellier University Hospital, Montpellier, France 2. Abbott, Abbott Park, Illinois 3. Unidad VIH. Hospital Universitario 12 de Octubre, Universidad Complutense de Madrid, Madrid Spain 4. University of Puerto Rico, School of Medicine, Infectious Diseases Section, San Juan, Puerto Rico and Innovative Care PSC, Bayamon, Puerto Rico 5. Therapeutic Concepts, Houston, Texas MOAB0101 Lopinavir/ritonavir (LPV/r) Combined with Raltegravir (RAL) Demonstrated Similar Antiviral Efficacy and Safety as LPV/r Combined with Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) in Treatment-Naïve HIV-1-Infected Subjects: PROGRESS 48 week results
- 4. Baseline Demographics and HIV Disease Characteristics* PROGRESS 48 week results – XVIII IAC 19-Jul-10 * Excludes randomized but not dosed, n=3 † Plasma HIV-1 viral loads determined using automated, quantitative RT-PCR assay Variable LPV/r + RAL (N=101) LPV/ + TDF/FTC (N=105) Total (N=206) Males, n (%) 88 (87.1) 86 (81.9) 174 (84.5) White, n (%) 74 (73.3) 81 (77.1) 155 (75.2) Black, n (%) Other, n (%) 22 (21.8) 5 (4.9) 22 (21.0) 2 (1.9) 44 (21.4) 7 (3.4) Mean age ± SD, years 39.8 ± 9.9 39.4 ± 11.2 39.6 ± 10.6 Mean BL HIV-1 RNA, log 10 copies/mL (range) † 4.24 (2.0-6.0) 4.25 (2.7 – 6.0) 4.25 (2.0 – 6.0) Mean BL CD4, cells/ μ L (range) 289.3 (5 – 668) 297.6 (5 – 743) 293.5 (5 – 743)
- 5. Subject Disposition at Week 48 PROGRESS 48 week results – XVIII IAC 19-Jul-10 *P >0.100 for LPV/r + RAL vs . LPV/r + TDF/FTC comparison for each reason † 4 subjects discontinued prior to week 48 and 4 subjects discontinued after week 48 visit ** 9 subjects discontinued prior to week 48 and 2 subjects discontinued after week 48 visit ║ 1 LPV/r + RAL subject discontinued due to two reasons: Noncompliance and Other Reasons for Discontinuations LPV/r + RAL (N=101) n, (%) LPV/ + TDF/FTC (N=105) n, (%) Total (N=206) n, (%) All Reasons* 8 (7.9) † 11 (10.5) ** 19 (9.2) AE/HIV-related Event 2 (2.0) 2 (1.9) 4 (1.9) Withdrew Consent 1 (1.0) 3 (2.9) 4 (1.9) Lost to Follow-Up 3 (3.0) 3 (2.9) 6 (2.9) Noncompliance ║ 1 (1.0) 0 (0) 1 (0.5) Virologic Failure 1 (1.0) 2 (1.9) 3 (1.5) Other ║ 1 (1.0) 1 (1.0) 2 (1.0) On treatment beyond week 48 93 (92.1) 94 (89.5) 187 (90.8)
- 6. PROGRESS 48 week results – XVIII IAC 19-Jul-10 Primary Efficacy Endpoint at Week 48: Proportion of Subjects Responding (FDA ITT TLOVR) LPV/r + RAL was non-inferior to LPV/r + TDF/FTC in treatment-naïve subjects at 48 weeks
- 7. Mean CD4+ T-cell Count Change from Baseline to Week 48 (cells/mm 3 ) PROGRESS 48 week results – XVIII IAC 19-Jul-10
- 9. Percentages of Subjects with Moderate or Severe Drug-related Adverse Events* PROGRESS 48 week results – XVIII IAC 19-Jul-10 *Occurring in ≥2.0% in either treatment group P >0.100 for LPV/r + RAL vs . LPV/r + TDF/FTC comparison for each adverse event LPV/r + RAL (N=101) n (%) LPV/r + TDF/FTC (N=105) n (%) Any Adverse Event 28 (27.7) 29 (27.6) Diarrhea Hypercholesterolemia 8 (7.9) 8 (7.9) 14 (13.3) 5 (4.8) Hypertriglyceridemia 6 (5.9) 2 (1.9) Hyperlipidemia 3 (3.0) 1 (1.0) Blood triglycerides increased Alanine aminotransferase increased 3 (3.0) 2 (2.0) 1 (1.0) 1 (1.0)
- 10. Number and % of Subjects with Grade 3+ Laboratory Values* PROGRESS 48 week results – XVIII IAC 19-Jul-10 *Occurring in ≥2.0% in either treatment group † P =0.023 for LPV/r + RAL vs . LPV/r + TDF/FTC comparison LPV/r + RAL (N=101) n (%) LPV/r + TDF/FTC (N=105) n (%) SGPT/ALT >5X ULN, n (%) SGOT/AST >5X ULN Creatine phosphokinase >4X ULN † Calcium <1.75 mmol/L Cholesterol >7.77 mmol/L Triglycerides >8.475 mmol/L Calculated creatinine clearance <50 mL/min Lipase >2X ULN 3 (3.0) 5 (5.0) 13 (12.9) 2 (2.0) 16 (15.8) 10 (9.9) 1 (1.0) 4 (4.0) 1 (1.0) 1 (1.0) 4 (3.8) 0 14 (13.5) 5 (4.8) 4 (3.8) 7 (6.7)
- 11. PROGRESS 48 week results – XVIII IAC 19-Jul-10 Lipid Changes From Baseline to Week 48 # P-values based on one-way ANOVA Variable LPV/r + RAL N=97 LPV/r + TDF/FTC N=97 P-value #