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

First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research

First-Line HIV Therapy andTreatment Strategies

The Body PRO Coverage of the 15th Conference on Retroviruses and Opportunistic Infections (CROI 2008)

February 3-6, 2008Boston, Mass.

Faculty:Kathryn Anastos, M.D.Cal Cohen, M.D., M.S.David Wohl, M.D.

David Wohl, M.D.

CROI 2008:Coverage From

The Body PRO


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.

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


The Body PRO


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/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.


The Body PRO


CASTLE: Primary Efficacy End Point ITT-Confirmed Virologic Response (NC = F)

Jean-Michel Molina et al. CROI 2008; abstract 37. Reprinted with permission.


The Body PRO


CASTLE: Response Rate by Baseline CD4+ Cell Count – Post Hoc Analysis



The Body PRO


CASTLE: Fasting Lipids Mean Percent Changes From Baseline (LOCF)



The Body PRO


HEAT: Median CD4+ Change From Baseline

Kimberly Smith et al. CROI 2008; abstract 774. Reprinted with permission.


The Body PRO


HEAT: Resistance Through 48 Weeks



The Body PRO


HEAT: Treatment-Related Adverse Events (AEs)



The Body PRO


MERIT: Week 48 Efficacy Results

Jayvant Heera et al. CROI 2008; abstract 40LB. Reprinted with permission.


The Body PRO


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.


The Body PRO


Cervicovaginal Fluid Exposure

Julie Dumond et al. CROI 2008; abstract 135LB. Reprinted with permission.


The Body PRO


Effect of Baseline Characteristics on Time to Virologic Failure

Risk FactorHazard Ratio 95% CI P

Age (Per 10-Year Increase) 0.81 0.69 – 0.94 0.005

CD4 (Per Higher Category (Table 1)) 0.88 0.79 – 0.99 0.03

Race (Non-Black vs. Black) 0.64 0.48 – 0.85 0.002

Sex (Male vs. Female) 0.73 0.53 – 0.99 0.046

Adapted from Sharon Riddler et al. CROI 2008; abstract 776.


The Body PRO


Sex Differences Between Regimens for Time to Virologic Failure and Time to Treatment Limiting Toxicity

Male Female

Regimen HR 95% CI P HR 95% CI P

Time to Virologic Failure

EFV vs. LPV 0.61 0.41 – 0.90 0.01 0.78 0.42 – 1.48 0.43

EFV vs. LPV/EFV 0.76 0.51 – 1.13 0.18 1.35 0.62 – 2.93 0.46

LPV vs. LPV/EFV 1.16 0.81 – 1.66 0.42 2.01 1.0 – 4.0 0.05

Time to Toxicity

EFV vs. LPV 1.0 0.62 – 1.62 0.99 1.31 0.52 – 3.22 0.56

EFV vs. LPV/EFV 0.83 0.53 – 1.31 0.43 3.48 0.93 – 13.1 0.07

LPV vs. LPV/EFV 0.85 0.54 – 1.36 0.50 3.86 1.04 – 14.4 0.04

Adapted from Sharon Riddler et al. CROI 2008; abstract 776.


The Body PRO


SMART: Re-initiation of ART in the CD4-Guided ART Interruption Group Lowers Risk of Opportunistic Disease or Death

Event Pre-January 2006 Post-January 2006 P 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

104 1.8 1.1 1.69(1.14 to

2.52)

75 1.1 0.9 1.24(0.79 to

1.96)

0.32

Death 85 1.5 0.8 1.85(1.19 to

2.88)

81 1.2 0.9 1.41(0.91 to

2.20)

0.40

Opportunistic Disease/Death

173 3.4 1.4 2.52(1.82 to

3.51)

127 1.9 1.4 1.37(0.96 to

1.94)

0.02

*per 100 person/years

Adapted from Wafaa El-Sadr et al. CROI 2008; abstract 36.


The Body PRO


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.

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

Documents

Transcript of First-Line HIV Therapy and Treatment Strategies: A Summary of Key CROI 2008 Research First-Line HIV...