What's New in HIV? Improving the Management of Treatment-Experienced Patients: Applying the Clinical Data to Practice.

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What's New in HIV? Improving the Management of Treatment-Experienced Patients: Applying the Clinical Data to Practice.

A CME newsletter based on a live CME dinner meeting

CME INFORMATION

Release date:January 1, 2008
Expiration date:January 1, 2009
Estimated time to complete: 1 hour

**This activity is sponsored by The Foundation for Better Health Care and is supported by an educational grant from Tibotec.**

Overview

You and your colleagues are encouraged to request a CME newsletter, designed to provide clinicians with the most current and up-to-date data regarding the management of HIV treatment-experienced patients. In addition, recent changes in treatment options for treatment-experienced patients have improved our potential for therapy. These issues that impact on constructing more durable therapy and long-term success will be highlighted.

Intended Audience

This educational activity is designed for physicians, physician assistants, nurse practitioners, and allied health professionals who treat patients with HIV.

Content Validation

The FBHC validates the content of its CME activities through a peer review process and by utilizing evidence-based medicine sources throughout the planning and implementation of its activities. Adopting the levels of evidence used by the American Academy of Family Physicians¹ and the principles of evidence-based medicine outlined by Straus et al,² the FBHC rates the level of evidence of the literature used to determine needs and learning objectives, as well as all data cited and presented.

All recommendations involving clinical medicine are based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. Further, all scientific research referred to, reported, or used in support or justification of a patient care recommendation conforms to the generally accepted standards of experimental design, data collection, and analysis.

Levels of Evidence¹

Level A (randomized controlled trial [RCT]/meta-analysis)
Level B (other evidence): A well-designed, nonrandomized clinical trial. A nonquantitative systematic review with appropriate search strategies and well-substantiated conclusions. Includes lower-quality RCTs, clinical cohort studies, and case-controlled studies with nonbiased selection of study participants and consistent findings. High-quality, historical, uncontrolled studies, or well-designed epidemiologic studies with compelling findings are also included
Level C (consensus/expert opinion)

Siwek J, Gourlay ML, Slawson DC, Shaughnessy AF. How to write an evidence-based clinical review article. Am Fam Physician. 2002;65:251-258.
Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-Based Medicine. 3rd ed. Edinburgh, Scotland: Churchill Livingstone; 2005.

NB: Because of ongoing research and continually emerging data that change daily in the areas of HIV/AIDS and oncology, the FBHC rates only the evidence-based support of Learning Objectives.

Learning Objectives

The learning objectives for this activity have been designed to address clinician competence, performance or patient outcomes. Upon completion of this activity, participants should be able to:

Cite HIV treatment guideline changes (competence) and integrate recent therapeutic recommendations for HIV-infected patients into your practice in order to optimize therapy (performance/patient outcomes)

Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/hiv/topics/surveillance/basic.htm#hivest. Accessed August 8, 2006. [Evidence Level C]
Panel on Clinical Practices for Treatment of HIV Infection. Update to the Guidelines for the Use of

Evaluate reasons for virologic failure (competence) and use this knowledge to employ the best possible therapy in order to achieve successful viral suppression (performance/patient outcomes)

Wegner SA, Wallace MR, Aronson NE, et al, and RV-125 Centers for Education and Research on Therapeutics Study Team. Long-term efficacy of routine access to antiretroviral-resistance testing in HIV type I infected patients: results of the clinical efficacy of resistance testing trial. Clin Inf Dis. 2004;38:723-730. [Evidence Level A]
Ananworanich J, Siangphoe U, Hill A, et al. Highly active antiretroviral therapy (HAART) retreatment in patients on CD4-guided therapy achieved similar virologic suppression compared with patients on continuous HAART: the HIV Netherlands Australia Thailand Research Collaboration 001.4 study. J Acquir Immune Defic Syndr. 2005;3:523-529. [Evidence Level B]
Trottier B, Walmsley S, Reynes J, et al. Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks. J Acquir Immune Defic Syndr. 2005;40:413-421. [Evidence Level A]
Nelson M, Arasteh K, Clotet B, et al. Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials. J Acquir Immune Defic Syndr. 2005;40:404-412. [Evidence Level A]
Hicks CB, Cahn P, Cooper DA, et al, for the RESIST investigator group. Durable efficacy of tipranavir-ritonavir in combination with an optimized background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006;368:466-475. [Evidence Level A]
Farthing C, Ward D, Hicks C, Johnson M, Cauda R, Cahn P. Tipranavir/r demonstrates superior and durable treatment response compared with comparator PI/r in highly treatment experienced (HTE) patients: week 96 RESIST 1 and 2 results. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy. September 27-30, 2006; San Francisco, CA. Abstract H-1385. [Evidence Level A]
Lazzarin A, Queiroz-Telles F, Frank I, et al. TMC114 provides durable viral load suppression in treatment-experienced patients: POWER 1 and 2 combined week 48 analysis. Presented at: 16th International AIDS Conference; August 13-18, 2006; Toronto, Canada. Abstract TUAB0104. [Evidence Level A]
Molina JM, Cohen C, Katlama C, et al. TMC114/r in treatment-experienced HIV patients in POWER 3: 24-week efficacy and safety analysis. Presented at: 16th International AIDS Conference; August 13-18, 2006; Toronto, Canada. Abstract TUPE0060. [Evidence Level A]
Katlama C, Campbell T, Clotet B, et al. DUET-2: 24 week results of a phase III randomised double-blind trial to evaluate the efficacy and safety of TMC125 versus placebo in 591 treatment-experienced HIV-1 infected patients. Presented at: 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention; July 22-25, 2007; Sydney, Australia. Abstract WESS204-2. [Evidence Level A]

Discuss new clinical trial data on emerging therapeutic options for treatment-experienced patients and recognize the patients who may benefit from these newer therapies (competence)

Grinsztejn B, Nguyen B, Katlama C, et al. Potent efficacy of MK-0518, a novel HIV-1 integrase inhibitor, in patients with triple-class resistant virus: 24-week data. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; September 27-30, 2006; San Francisco, CA. Abstract H-1670b. [Evidence Level A]
Cohen C, Steinhart C, Ward D, et al. Efficacy and safety results at 48 weeks with the novel NNRTI, TMC125, and impact of baseline resistance on the virologic response in study TMC125-C223. Presented at: 16th International AIDS Conference; August 13-18. 2006; Toronto, Canada. Abstract TUPE0061. [Evidence Level B]
Saag M, Ive P, Heera J, et al. A multicenter, randomized, double-blind, comparative trial of a novel CCR5 antagonist, maraviroc versus efavirenz, both in combination with Combivir (zidovudine [ZDV]/lamivudine [3TC]), for the treatment of antiretroviral naïve patients infected with R5 HIV 1: Week 48 results of the MERIT study. Presented at: 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention; July 22-25, 2007; Sydney, Australia. Abstract WESS104. [Evidence Level A]

Needs Assessment

The FBHC has incorporated into this CME activity the relevant educational needs concerning knowledge, competence, or performance that underlie the professional practice gaps of our participants.

Accreditation

The FBHC is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The FBHC takes responsibility for the content, quality, and scientific integrity of this CME activity.

Credit Designation

The FBHC designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)^TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Identifying and Resolving Conflicts of Interest

The FBHC requires all planning committee members, faculty, teachers, authors, and staff of a CME activity to identify all relevant financial relationships that benefit the individual and his or her spouse or partner in any financial amount within the past 12 months. Such relationships may affect the content of CME regarding the products or services of the commercial interest.

The FBHC has created the FBHC Committee to Identify and Resolve Conflicts of Interest, which reviews Faculty and Staff Disclosure Statements, identifies and resolves conflicts of interest, and determines the level of participation of planning committee members, faculty members, teachers, and authors.

FBHC Faculty and Staff Disclosure Policy Statement

The FBHC will disclose to participants the existence of any relevant financial relationships between faculty members, FBHC staff members, and the staffs of Joint Sponsor and/or Educational Partner (when applicable), who planned, authored, contributed, and/or reviewed the content of this activity, and any commercial interest discussed in this educational activity. Disclosure will occur prior to the presentation(s), either through oral communication to the audience by the moderator or chair, or written communication in the syllabus or handout material.

FBHC Disclosure Statement

The FBHC is an independent professional organization that does not endorse specific products of any pharmaceutical concern. This FBHC CME activity has been independently planned by the FBHC.

Independent CME Reviewer

Charles Hicks, MD
Associate Professor of Medicine
Duke University Medical Center
Durham, NC

Independent CME Reviewer Disclosures

It is the policy of the FBHC to ensure balance, independence, objectivity, and scientific rigor in all its sponsored educational activities. All faculty are expected to disclose to the activity audience any real or apparent conflict(s) of interest related to the content of their presentation(s). The following relationships have been disclosed:

Charles Hicks, MD

Grant: Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals; Bristol-Myers Squibb Co; Monogram Biosciences; Merck & Co, Inc; Pfizer Inc; Tibotec
Research Support: Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals; Bristol-Myers Squibb Co; Koronis Pharmaceuticals; Monogram Biosciences; Merck & Co, Inc; Pfizer Inc; Tibotec
Advisory Board: Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals; Bristol-Myers Squibb Co; Monogram Biosciences; Merck & Co, Inc; Pfizer Inc; Tibotec

FBHC Staff Disclosures

The FBHC, in keeping with the ACCME's Essential Areas and their Elements and Standards for Commercial Support, has asked each FBHC staff member who has developed and/or reviewed content for this activity, to disclose to learners all financial relationships, including those of their spouse or partner, with the manufacturer(s) of any pharmaceutical product(s), device(s), or providers of commercial services in any financial amount within the past 12 months. The FBHC staff members have disclosed the following:

LaTanya Brown, Project Director
Nothing to disclose

Michelle Dien, Project Director
Nothing to disclose

Annika Dronge, MD, Medical Director
Nothing to disclose

Susan Duff, Managing Editor
Nothing to disclose

Michael Hite, CEO
Nothing to disclose

Nancy Larsen, Consultant
Nothing to disclose

Andrew McCrea, PhD, Executive Director
Nothing to disclose

Natacha Menar, Sr. Editor/Writer
Nothing to disclose

Sejal Patel, Account Manager
Nothing to disclose

Lauren Janay, Content Coordinator
Nothing to disclose

Judy Seraphine, Consultant
Nothing to disclose

Simone Stromer, MD, Medical Director
Nothing to disclose

Diane Zuckerman, RPh, Consultant
Nothing to disclose

Disclaimer

The views expressed are those of the authors. It should not be assumed that this activity expresses the views of Tibotec or any manufacturer of pharmaceuticals. This FBHC CME activity has been independently planned by the FBHC.

All rights reserved, including translation into other languages. No part of these CME activities may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or storage in information storage and retrieval systems, without permission in writing from The Foundation for Better Health Care, 33 East 33rd Street, 8th Floor, New York, NY 10016.

Contact Us

For questions regarding the content of this activity, contact info@FBHC.org. For technical assistance, contact webmaster@FBHC.org.