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First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research First-Line HIV Therapy and Treatment Strategies The Body PRO Coverage.

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Presentation on theme: "First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research First-Line HIV Therapy and Treatment Strategies The Body PRO Coverage."— Presentation transcript:

1 First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research First-Line HIV Therapy and Treatment Strategies The Body PRO Coverage of the 15th Conference on Retroviruses and Opportunistic Infections (CROI 2008) February 3-6, 2008 Boston, Mass. Faculty: Kathryn Anastos, M.D. Cal Cohen, M.D., M.S. David Wohl, M.D.

2 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research Kathryn Anastos, M.D. Kathryn Anastos, M.D., is the Executive Co-Director for Clinical and Scientific Programs of WE-ACTx (Women's Equity in Access to Care and Treatment, a community-based organization committed to providing HIV primary care, including antiretroviral therapy, to female survivors of genocidal rape in Rwanda. She has also developed and serves as the Principal Investigator of the Rwandan Women's Cohort Study (RWISA), funded by the U.S. National Institutes of Health (NIH). She is currently Professor of Medicine, Epidemiology and Population Health at Albert Einstein College of Medicine, Bronx, N.Y. Additionally, since 1993, Dr. Anastos has served as the Principal Investigator for the New York City/Bronx Consortium of the Women's Interagency HIV Study (WIHS), also funded by NIH.Women's Equity in Access to Care and Treatment Cal Cohen, M.D., M.S. Dr. Cal Cohen is the research director of Harvard Vanguard Medical Associates and Community Research Initiative of New England in Boston, Mass. He is also a clinical instructor at Harvard Medical School. In addition, he works as an HIV clinical management consultant and internist at Harvard Pilgrim Health Care. Dr. Cohen holds appointments at Brigham and Women's Hospital and Beth Israel Hospital, both in Boston, Mass. In addition to caring for HIV-infected patients and directing clinical research at a large HIV community-based research site, Dr. Cohen is actively involved in evaluating new antiretroviral therapies, the durability and longevity of the benefits from such therapies and issues regarding compliance and adherence. Dr. Cohen has served as a consultant to or has received honoraria or research support from Abbott Laboratories, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline and Tibotec. David Wohl, M.D. Dr. Wohl is an associate professor of medicine at the University of North Carolina at Chapel Hill, and co-directs HIV services for the North Carolina Department of Corrections. Dr. Wohl is an investigator in the NIAID-sponsored AIDS Clinical Trials Group (ACTG) and a member of the ACTG Complications of HIV Disease Research Agenda Committee. His research focuses on metabolic and infectious complications of HIV and its therapies, as well as issues related to medication adherence and access to care—particularly among incarcerated inmates with HIV infection. Dr. Wohl has served as a consultant to or has received honoraria or research support from Abbott Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Merck & Co, Roche Laboratories and Tibotec. This activity is supported by an educational grant from Faculty

3 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research About This Slide Presentation This presentation was created to accompany The Body PRO's summary of key research presented at CROI 2008, featuring reports by Kathryn Anastos, M.D., Cal Cohen, M.D., M.S., and David Wohl, M.D. For more information about this program, please visit us on the Web at: TheBodyPRO.com/CROI2008TheBodyPRO.com/CROI2008 Please feel free to use this slide presentation for personal reference or for your own presentations; however, we ask that you not modify any aspects of the slides contained within this presentation, so proper attribution can be retained. If you would like to publish all or part of this presentation, or repost any of these slides online, permission must first be obtained from Body Health Resources Corporation. Our gratitude goes out to all the researchers who granted permission for their slides to be adapted for this presentation.

4 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research CASTLE: Primary Efficacy End Point ITT-Confirmed Virologic Response (NC = F) Jean-Michel Molina et al. CROI 2008; abstract 37. Reprinted with permission.

5 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research CASTLE: Response Rate by Baseline CD4+ Cell Count – Post Hoc Analysis Jean-Michel Molina et al. CROI 2008; abstract 37. Reprinted with permission.

6 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research CASTLE: Fasting Lipids Mean Percent Changes From Baseline (LOCF) Jean-Michel Molina et al. CROI 2008; abstract 37. Reprinted with permission.

7 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research HEAT: Median CD4+ Change From Baseline Kimberly Smith et al. CROI 2008; abstract 774. Reprinted with permission.

8 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research HEAT: Resistance Through 48 Weeks Kimberly Smith et al. CROI 2008; abstract 774. Reprinted with permission.

9 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research HEAT: Treatment-Related Adverse Events (AEs) Kimberly Smith et al. CROI 2008; abstract 774. Reprinted with permission.

10 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research MERIT: Week 48 Efficacy Results Jayvant Heera et al. CROI 2008; abstract 40LB. Reprinted with permission.

11 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research MERIT: Percentage of Patients With HIV-1 RNA < 50 Copies/mL at Week 48 by Tropism Result at Baseline Jayvant Heera et al. CROI 2008; abstract 40LB. Reprinted with permission.

12 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research Cervicovaginal Fluid Exposure Julie Dumond et al. CROI 2008; abstract 135LB. Reprinted with permission.

13 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research Effect of Baseline Characteristics on Time to Virologic Failure Risk Factor Hazard Ratio95% CIP Age (Per 10-Year Increase)0.810.69 – 0.940.005 CD4 (Per Higher Category (Table 1))0.880.79 – 0.990.03 Race (Non-Black vs. Black)0.640.48 – 0.850.002 Sex (Male vs. Female)0.730.53 – 0.990.046 Adapted from Sharon Riddler et al. CROI 2008; abstract 776.

14 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research Sex Differences Between Regimens for Time to Virologic Failure and Time to Treatment Limiting Toxicity MaleFemale Regimen HR95% CIPHR95% CIP Time to Virologic Failure EFV vs. LPV 0.610.41 – 0.900.010.780.42 – 1.480.43 EFV vs. LPV/EFV 0.760.51 – 1.130.181.350.62 – 2.930.46 LPV vs. LPV/EFV 1.160.81 – 1.660.422.011.0 – 4.00.05 Time to Toxicity EFV vs. LPV 1.00.62 – 1.620.991.310.52 – 3.220.56 EFV vs. LPV/EFV 0.830.53 – 1.310.433.480.93 – 13.10.07 LPV vs. LPV/EFV 0.850.54 – 1.360.503.861.04 – 14.40.04 Adapted from Sharon Riddler et al. CROI 2008; abstract 776.

15 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research SMART: Re-initiation of ART in the CD4- Guided ART Interruption Group Lowers Risk of Opportunistic Disease or Death EventPre-January 2006Post-January 2006P Value Comparing Hazard Ratios # of Patients Rate* of Drug Conversion (DC) Rate* of Viral Suppression (VS) Hazard Ratio (DC/VS) (95% CI) # of Patients Rate* of Drug Conversion (DC) Rate* of Viral Suppression (VS) Hazard Ratio (DC/VS) (95% CI) Cardiovascular Disease/Renal/ Hepatic 1041.81.11.69 (1.14 to 2.52) 751.10.91.24 (0.79 to 1.96) 0.32 Death851.50.81.85 (1.19 to 2.88) 811.20.91.41 (0.91 to 2.20) 0.40 Opportunistic Disease/Death 1733.41.42.52 (1.82 to 3.51) 1271.91.41.37 (0.96 to 1.94) 0.02 *per 100 person/years Adapted from Wafaa El-Sadr et al. CROI 2008; abstract 36.

16 CROI 2008: Coverage From The Body PRO First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research Primary and Major Secondary End Points in the SMART Study* Adapted from Wafaa El-Sadr et al. N Engl J Med. 2006;355(22):2283-2296.


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