A Look Back at 2010 HIV/AIDS Research (Part 1)

Expert Commentary

A Clinical Context Report

Jointly Sponsored by:

and MedPage Today

A Look Back at 2010 HIV/AIDS Research (Part 1)

Supported in part by an educational grant from Bristol-Myers Squibb

A Look Back at 2010 HIV/AIDS Research (Part 1)

Clinical Context Series Target Audience

The goal of this program is to provide HIV/AIDS specialists, virologists, infectious disease specialists, experts in the care of patients with HIV/AIDS, physician assistants and nurse practitioners with up-to-date information and multiple perspectives on the pathogenesis, symptoms, risk factors, and complications of HIV/AIDS as well as current and emerging treatments and best practices in the management of HIV/AIDS.

Activity Learning Objectives

Upon successful completion of this educational program, participants should be able to: l  Review the relevance and significance of the

activity in the broader context of clinical care

CME Information: Physicians

l  Statement of Accreditation This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through joint sponsorship of Albert Einstein College of Medicine and MedPage Today. Albert Einstein College of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

CME Information

l  Credit Designation Albert Einstein College of Medicine designates this educational activity for a maximum of 0.5 AMA PRA Category 1 Credits.™ Physicians should only claim credit commensurate with the extent of their participation in the activity.

CE Information: Nurses

l  Statement of Accreditation –  Projects In Knowledge, Inc. (PIK) is accredited

as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

–  Projects In Knowledge is also an approved provider by the California Board of Registered Nursing, Provider Number CEP-15227.

–  This activity is approved for 0.50 nursing contact hours.

DISCLAIMER: Accreditation refers to educational content only and does not imply ANCC, CBRN, or PIK endorsement of any commercial product or service.

CE Information: Pharmacists

l  Projects In Knowledge® is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This program has been planned and implemented in accordance with the ACPE Criteria for Quality and Interpretive Guidelines. This activity is worth up to 0.5 contact hours (0.05 CEUs). The ACPE Universal Activity Number assigned to this knowledge-type activity is 0052-9999-11-861-H04-P.

Barry S. Zingman, MD Medical Director

AIDS Center Montefiore Medical Center

Professor of Clinical Medicine Albert Einstein College of Medicine

Bronx, NY

Discussant

Disclosure Information

Barry S. Zingman, MD, has disclosed that he has no relevant financial

relationships or conflicts of interest with commercial interests related directly or indirectly to this educational

activity.

Disclosure Information Dori F. Zaleznik, MD, Associate Clinical Professor of Medicine, Harvard Medical School, Boston; Michael Smith and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner, have disclosed that they have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity.

The staff of Albert Einstein College of Medicine, MedPage Today, and Projects In Knowledge have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity.

Disclaimer The moderators/authors have attempted to provide the most current and accurate clinical information according to accepted medical practice standards at the time of publication. The information should not be considered to be completely error-free or to include all relevant information; nor should it be used as an exclusive basis for decision-making. Neither Albert Einstein College of Medicine, Montefiore Medical Center, MedPage Today nor Bristol-Myers Squibb, the authors or any other party involved in the preparation of this work and the presentations contained herein warrant that the information is accurate or complete and are not responsible for any errors or omissions or for the results obtained from the use of such information. You are encouraged to consult other sources and confirm the information contained herein. Use of the information is strictly voluntary and at the user's sole risk. If misleading or otherwise inappropriate information is brought to our attention, a reasonable effort will be made to correct or delete it. Such concerns or any other questions or problems about the information should be sent to cme@montefiore.org.

The “Quad Pill”

•  Quad: elvitegravir, cobicistat, tenofovir, and emtricitabine versus Atripla: efavirenz, tenofovir, and emtricitabine

§  At 48 weeks, rate of undetectable HIV was 90% for the quad pill and 83% for Atripla

•  Quad: atazanavir/cobicistat, tenofovir, and emtricitabine versus Atazanavir/ritonavir, tenofovir, and emtricitabine

§  At 48 weeks, rate of undetectable HIV was 86% for atazanavir/cobicistat and 82% for atazanavir/ritonavir

Source: Elion R, et al. ICAAC 2010; Abstract H-938b.

The “Quad Pill” – Adverse Events

•  Adverse event rate similar but slightly lower for quad pill versus Atripla – 46% compared with 57%

•  In the booster study, adverse events were noninferior between the two arms, at 36% and 48%

Source: Elion R, et al. ICAAC 2010; Abstract H-938b.

TMC278

•  Two trials, THRIVE and ECHO, with 1,368 treatment-naive patients

•  TMC278 versus efavirenz •  Pooled 48-week data: 84.3% of TMC278 patients had

undetectable HIV, compared with 82.3% of efavirenz patients

•  TMC278 better when viral load <100,000 copies •  Fewer adverse events with TMC278: 16% versus

31% (P<0.0001) •  Fewer dropouts because of toxicity for TMC278: 3%

versus 8% (P=0.0005) Rimsky L, et al. ICAAC 2010; Abstract H-1810.

Darunavir

•  590 treatment-experienced patients •  800 mg/day versus 600 mg BID •  Each dose boosted with 100 mg ritonavir •  48 weeks: 72.1% on daily dose and 70.9% on

twice-daily dose had fully suppressed HIV •  One patient with virologic failure developed

resistance

Lathouwers E, et al. ICAAC 2010; Abstract H-1811.

Vicriviroc

•  218 treatment-naive patients •  Vicriviroc versus tenofovir/emtricitabine •  48 weeks: vicriviroc response rate 76%, compared

with 83% for tenofovir/emtricitabine •  Statistically noninferior

Dunkle LM, et al. ICAAC 2010; Abstract H-938a.

Veteran Testing

•  In 2006, the CDC recommended expanded routine testing for HIV in people up to age 64

•  The Veterans Administration was able to eliminate written informed consent

•  Subsequent national survey of veterans receiving care in VA health centers §  HIV testing very low

§  5.7 million outpatients treated in 2009

§  2.5% tested for HIV in 2009

§  Only 9.2% have ever been tested

Welch M, et al. IDSA 2010; Abstract 1063.

Rapid HIV Testing in Jails

•  Washington, DC: 14% of inmates tested before program introduced, 79% in 2009

•  Philadelphia: 10% tested before program, 69% in 2009 •  Baltimore: 0.4% tested before program, 22% from May

2008 through April 2009

•  Similar prior success in Rhode Island: 15% of all new HIV cases identified during the same time period

Beckwith C, et al. IDSA 2010; Abstract 1068.

Treatment Initiation Lags

•  Retrospective analysis of records •  In 2008, one-third of patients with HIV not treated •  Half had indication for therapy under guidelines

(CD4 count under 350) •  75% would be eligible under current guidelines

(CD4 count under 500)

Dombrowski J, et al. IDSA 2010; Abstract 809.

Treatment Initiation Lags

•  In 2008, cohort included 4,765 patients, 77% of whom had been on antiretroviral therapy and 23% antiretroviral-naïve

•  Of naïve patients, 439 had CD4 counts below 350 cells/microliter, 336 were between 351 and 500, and 331 had counts greater than 500 cells/microliter

•  Depending upon the institution, the percentage of HIV patients currently on antiretroviral therapy ranged from 60% to 78%

Dombrowski J, et al. IDSA 2010; Abstract 809.

Experience Improves Outcomes

•  Retrospective analysis of more than 12,000 patients •  Chance of undetectable HIV 44% higher if physician

practice included more than 100 patients •  Overall, 81.1% of patients controlled virus

Horberg M, et al. IDSA 2010; Abstract 1131.

Summary

l  details of new drugs presented at ICAAC, including the “quad” pill with cobicistat and TMC278

l  once-daily dosing of darunavir in treatment-experienced patients

l  why vicriviroc is no longer under development

At the end of this activity, participants should understand:

l  HIV testing remains low in the VA system l  rapid testing and the jail system l  lags in treatment initiation l  the effect of provider experience on patient

adherence

Summary

At the end of this activity, participants should understand:

Thank you for your participation.

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A Look Back at 2010 HIV/AIDS Research (Part 1)