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Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This activity is supported by an educational grant from:

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Page 1: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

Key HIV Research From ICAAC 2007: Complications of HIV/HAART Key HIV Research From ICAAC 2007: Complications of HIV/HAART

Chicago, Illinois | September 17-20, 2007

Faculty:

Cal Cohen, M.D., M.S.

Eric Daar, M.D.This activity is supported by an educational grant from:

Page 2: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Cal Cohen, M.D., M.S.

Eric Daar, M.D.

Dr. Daar is the chief of HIV medicine at Harbor-UCLA Medical Center in Los Angeles, Calif., and a professor of medicine at the University of California-Los Angeles' David Geffen School of Medicine. He has been an active HIV physician and researcher since the 1980s; during the past three decades, he has led dozens of studies on a vast range of HIV-related issues, with a particular focus on coinfections and other health complications associated

with HIV and HIV treatment, including hepatitis C, metabolic complications, cardiovascular disease and psychosocial issues such as depression.

Dr. Cohen is the research director of the Community Research Initiative of New England and teaches at Harvard Medical School in Boston, Mass. In addition, he works as a HIV clinical management consultant and internist at Harvard Pilgrim Health Care, Boston, Mass., and is affiliated with Harvard Vanguard Medical Associates. Dr. Cohen was co-chair of the Scientific Advisory Committee of amfAR community-based clinical trials network, and served as co-principal investigator of the Harvard/BCH AIDS Clinical Trials Unit, AIDS Clinical Trials Group. He holds appointments at Brigham and Women's Hospital and Beth Israel Hospital, both in Boston, Mass.

Faculty for This ActivityFaculty for This Activity

Page 3: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

ICAAC 2007: Key HIV ResearchICAAC 2007: Key HIV Research

About this slide presentation

• This presentation is one of three slide sets created to accompany The Body PRO's podcast summary of key research presented at ICAAC 2007, featuring interviews with Cal Cohen, M.D., M.S., and Eric Daar, M.D. To download the remaining slide sets or learn more about this, please visit us on the Web at:

TheBodyPRO.com/ICAAC2007

• 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 who granted permission for their slides to be adapted for this presentation.

DisclaimerKnowledge about HIV changes rapidly. Note the date of this presentation's publication, and before treating patients or employing any therapies described in these materials, verify all information independently. If you are a patient, please consult a doctor or other medical professional before acting on any of the information presented in this presentation.

Page 4: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

HIV Drug Resistance and the HIV Drug Resistance and the Complications of HIV/HAARTComplications of HIV/HAART

Page 5: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

TITAN: Development of Primary Protease Inhibitor Mutations and NRTI Resistance-Associated Mutations Upon Virologic Failure

TITAN: Development of Primary Protease Inhibitor Mutations and NRTI Resistance-Associated Mutations Upon Virologic Failure

Simon F. De Meyer et al. ICAAC 2007; abstract H-1020. Reprinted with permission.

Page 6: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

TITAN: Loss of Susceptibility to Antiretrovirals in Virologic Failures (VFs) upon VF

TITAN: Loss of Susceptibility to Antiretrovirals in Virologic Failures (VFs) upon VF

Simon F. De Meyer et al. ICAAC 2007; abstract H-1020. Reprinted with permission.

Page 7: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Genotypic Results and Virological Response After Interruption of NNRTI-Based Treatment

Genotypic Results and Virological Response After Interruption of NNRTI-Based Treatment

Study Design

Forty-three participants taking NNRTI-based antiretroviral therapy.

Dual NRTIs were continued for 7 or 10 days after participants stopped taking nevirapine and efavirenz, respectively.

Characteristics Upon Reinitiation of Antiretroviral

Therapy

Treatment was reinitiated a median of 5.6 (2.8-7.0) months after treatment interruption.

HIV-1 genotype testing in 21 patients (49%) showed that no mutations contributed to NRTI or NNRTI resistance.

Median CD4 cell count was 178 (152-214) cells/mm3 and median HIV RNA was 5.78 (4.86-5.88) log copies/mL.

Characteristics After Three and Six Months of Antiretroviral

Therapy

At three months, 24 (56%) patients achieved undetectable HIV RNA (<50 copies/mL) and the median CD4 cell count was 386 (224-492) cells/mm3.

At six months, 43 (100%) patients achieved undetectable HIV RNA (<50 copies/mL) and the median CD4 cell count was 419 (276-589) cells/mm3.

Adapted from Somnuek Sungkanuparph et al. ICAAC 2007; abstract H-368.

Page 8: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Change in cGFR: Abacavir (ABC) vs Tenofovir (TDF)Change in cGFR: Abacavir (ABC) vs Tenofovir (TDF)

Christopher Polk et al. ICAAC 2007; abstract H-383. Reprinted with permission.

Page 9: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Changes in Renal Function Among 10 Patients Categorized as Having “Current Renal Dysfunction” With Both Baseline and 12-Month Values, HIV Outpatient Study, November 2001 – September 2005

Changes in Renal Function Among 10 Patients Categorized as Having “Current Renal Dysfunction” With Both Baseline and 12-Month Values, HIV Outpatient Study, November 2001 – September 2005

Benjamin Young et al. ICAAC 2007; abstract H-382. Reprinted with permission.

Page 10: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

ACTG 5102: Lipid MetabolismACTG 5102: Lipid Metabolism

Pablo Tebas et al. ICAAC 2007; abstract H-378. Reprinted with permission.

Page 11: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

ACTG 5102: Changes in Immune ActivationACTG 5102: Changes in Immune Activation

Pablo Tebas et al. ICAAC 2007; abstract H-378. Reprinted with permission.

Page 12: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

CPCRA 060: Time to CD4 < 350 cells/µL, Therapy Initiation or Death

CPCRA 060: Time to CD4 < 350 cells/µL, Therapy Initiation or Death

Matthew B. Goetz et al. ICAAC 2007; abstract H-1027. Reprinted with permission.

Page 13: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Comparison of Luciferase Activity (RLUs) Between Standard and Enhanced Trofile Assays

Comparison of Luciferase Activity (RLUs) Between Standard and Enhanced Trofile Assays

Jacqueline D. Reeves et al. ICAAC 2007; abstract H-1026. Reprinted with permission.

Page 14: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Sensitivity to Detect Minor CXCR4-Using SubpopulationsSensitivity to Detect Minor CXCR4-Using Subpopulations

Jacqueline D. Reeves et al. ICAAC 2007; abstract H-1026. Reprinted with permission.

Page 15: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

V3 Loop Sequence-Based CRT Prediction ResultsV3 Loop Sequence-Based CRT Prediction Results

Eric W. Stawiski et al. ICAAC 2007; abstract H-1028. Reprinted with permission.

Page 16: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Description of the Most Frequent Non-AIDS, Non-HAART Related (NANHR) Severe Clinical Events

Description of the Most Frequent Non-AIDS, Non-HAART Related (NANHR) Severe Clinical Events

Tristan Ferry et al. ICAAC 2007; abstract H-1722. Reprinted with permission.

Page 17: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Factors Associated With the Occurrence of the 385 First NANHR Severe Clinical Events

Factors Associated With the Occurrence of the 385 First NANHR Severe Clinical Events

Tristan Ferry et al. ICAAC 2007; abstract H-1722. Reprinted with permission.

Page 18: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Incidence Rate Ratios (IRR) of Non-AIDS-Defining Malignancies (non-ADM) in HIV-Infected vs. Non-Infected Veterans in the HAART Era

Incidence Rate Ratios (IRR) of Non-AIDS-Defining Malignancies (non-ADM) in HIV-Infected vs. Non-Infected Veterans in the HAART Era

IRR in

HIV+ Veterans

Confidence

Interval (95%)

Overall 1.6 1.5-1.7

Anal Cancer 14.9 10.1-22.1

Hodgkin’s Lymphoma 4.6 3.6-6.6

Liver Cancer 2.8 2.2-3.5

Lung Cancer 2.0 1.7-2.2

Total of 33,420 HIV+ and 66,840 HIV- veterans followed.Incidence rates of non-ADM per 100,000 person-years were 1,260 and 841 respectively.

Adapted from Roger J. Bedimo et al. ICAAC 2007; abstract H-1721.

Page 19: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Re-treatment With Pegylated Interferon Plus Weight-Adjusted Ribavirin in HIV+ Patients With Chronic HCV Results

Re-treatment With Pegylated Interferon Plus Weight-Adjusted Ribavirin in HIV+ Patients With Chronic HCV Results

Eugenia Vispo et al. ICAAC 2007; abstract H-1734. Reprinted with permission.

Page 20: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

Three-Year Survival Data of Liver Transplant Recipients in Spain

Three-Year Survival Data of Liver Transplant Recipients in Spain

Hepatitis C Monoinfected

Patients*

HIV/Hepatitis C CoinfectedPatients*

Years After Transplant

1 2

81%(78%-83%)

74%(70%-76%)

69%(65%-72%)

88%(74%-94%)

75%(58%-86%)

64%(43%-79%)

3

Twelve (24%) HIV/hepatitis C coinfected and 273 (23%) hepatitis C monoinfected patients died during a median follow-up of 1.3 (0.5-2.4) years.

*95% confidence intervals

Adapted from José M. Miró et al. ICAAC 2007; abstract H-1732.

Page 21: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

PROVE1: Study DesignPROVE1: Study Design

Adapted from Mark Sulkowski et al. ICAAC 2007; abstract V-1383.

Group 1

20 patients

Telaprevir (TVR, VX-950) 750 mg q8h

Peginterferon alfa-2A 180 µg/week

Ribavirin (RBV) 1,000-1,200 mg/day

Group 2

80 patients

Telaprevir 750 mg q8h

Peginterferon alfa-2A 180 µg/week

Ribavirin 1,000-1,200 mg/day

Group 3

82 patients

Telaprevir 750 mg q8h

Peginterferon alfa-2A 180 µg/week

Ribavirin 1,000-1,200 mg/day

Group 4 (control)

81 patients

Peginterferon alfa-2A/Ribavirin

Weeks 1-12

0 Weeks

Peginterferon alfa-2Awith Ribavirin

12 Weeks

Peginterferon alfa-2Awith Ribavirin

36 Weeks

Peginterferon alfa-2Awith Ribavirin

36 Weeks

Peginterferon alfa-2Awith Ribavirin

Additional Weeks and Doses

Analysis performed when all patients

completed 12 weeks.

Samples were collected for

sequencing at baseline and

at each HCV RNA

assessment.

Page 22: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

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ICAAC 2007: Complications of HIV/HAART

PROVE1 Study Results: Undetectable HCV RNAPROVE1 Study Results: Undetectable HCV RNA

Adapted from Mark Sulkowski et al. ICAAC 2007; abstract V-1383.

Week 4

Groups 1-3*Undetectable HCV RNA

(LOD 10 IU/mL) 79%

Group 4 (Control)Undetectable HCV RNA

(LOD 10 IU/mL)11%

Week 12

Groups 1-3*Undetectable HCV RNA

(LOD 10 IU/mL)70%

Group 4 (Control)Undetectable HCV RNA

(LOD 10 IU/mL)39%

All Group Results, Weeks 4 and 12

Note: Of those in groups 1-3* receiving 12 weeks of treatment, six of nine

subjects with rapid virological response had undetectable HCV RNA

20 weeks after termination of treatment.

* Groups 1-3 were taking telaprevir (TVR, VX-950) with peginterferon alfa-2A and ribavirin (RBV).

Page 23: Key HIV Research From ICAAC 2007: Complications of HIV/HAART Chicago, Illinois | September 17-20, 2007 Faculty: Cal Cohen, M.D., M.S. Eric Daar, M.D. This

The Body PRO

ICAAC 2007: Complications of HIV/HAART

ICAAC 2007: Key HIV ResearchICAAC 2007: Key HIV Research

• Visit The Body PRO for Comprehensive Coverage of ICAAC 2007.This presentation is one of three slide sets created to accompany The Body PRO's CME/CE podcast summary of key research presented at ICAAC 2007, featuring interviews with Cal Cohen, M.D., M.S., and Eric Daar, M.D. To download the remaining slide sets or learn more about this CME/CE program, please visit us on the Web at: TheBodyPRO.com/ICAAC2007

• In addition, be sure to browse through The Body PRO’s extensive coverage of ICAAC 2007, which includes:– Downloadable MP3s and full transcripts– Expert discussion of key research– Slides and in-depth data analyses

• Visit TheBodyPRO.com/ICAAC2007 today for a full listing of our conference materials!