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New Fixed-Dose Combination Treatment Options for HIV Infection: How Do They Compare? An Expert Discussion

  • Authors: Presenters: Brian A. Boyle, MD, JD, and Calvin J. Cohen, MD; Moderator: Michael S. Saag, MD
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Target Audience and Goal Statement

This activity is intended for physicians, nurses, pharmacists, and other clinical personnel providing frontline care for persons with HIV/AIDS.

The goal of this activity is to provide clinicians involved in the care of patients with HIV/AIDS with an expert discussion of key data and issues concerning the labeling, selection, and use of 2 newly approved fixed-dose combination products for the treatment of HIV infection (tenofovir/emtricitabine and abacavir/lamivudine).

Upon completion of this activity, participants will be able to:

  1. Compare the advantages and disadvantages of once-daily antiretroviral therapy
  2. Review data concerning the safety and efficacy of 2 newly approved fixed-dose combination products for the treatment of HIV infection (tenofovir/emtricitabine and abacavir/lamivudine)
  3. Describe current guidelines, clinical data, and expert recommendations regarding the use of once-daily fixed-dose nucleoside/nucleotide backbones in antiretroviral-naive and -experienced patients


  • Brian A. Boyle, MD, JD

    Brian Boyle, MD, Associate Professor, Weill Medical College of Cornell University ; Attending Physician, New York Presbyterian Hospital -- Cornell Medical Center, New York, NY


    Disclosure: Brian A. Boyle, MD, JD, has disclosed that he has received grants for educational activities from and served as an advisor or consultant for Gilead Sciences, and has also served on the speaker's bureau and as a consultant for GlaxoSmithKline, Vertex, Abbott, MSD, Bristol-Myers Squibb, Roche, Johnson & Johnson, Tibotec, and Virco. Dr. Boyle does not discuss any investigational or unlabeled uses of commercial products in this activity.

  • Calvin J. Cohen, MD, MSc

    Clinical Instructor, Harvard Medical School, Cambridge, Massachusetts


    Disclosure: Calvin J. Cohen, MD, has disclosed that he has received grants for clinical research and grants for educational activities from, as well as served as an advisor or consultant for, Gilead, GlaxoSmithKline, Bristol-Myers Squibb, Abbott, and Boehringer Ingelheim. Dr. Cohen does not discuss any investigational or unlabeled uses of commercial products in this activity.

  • Michael S. Saag, MD

    Professor of Medicine; Director, AIDS Outpatient Clinic, University of Alabama at Birmingham


    Disclosure: Michael S. Saag, MD, has disclosed that he has received grants for clinical research and/or has served as an advisor or consultant for Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Pfizer/Agouron, Roche, Schering-Plough, Shire Pharmaceutical, Tanx, TherapyEdgem Tibotec/Virco, Trimeris, Vertex, and ViroLogic. Dr. Saag has served on the speaker's bureau for all of the above. Dr. Saag does not discuss any investigational or unlabeled uses of commercial products in this activity.

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  • Approved for 1.0 contact hour(s) of continuing education for RNs, LPNs, LVNs and NPs. This activity is cosponsored with Medical Education Collaborative, Inc. (MEC) and Medscape. MEC is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

    Provider approved by the California Board of Registered Nursing, Provider Number CEP 12990, for 1.0 contact hour(s).

    Approved by the Florida Board of Nursing, Provider Number FBN 2773.

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    For Pharmacists

  • 1.0 contact hour(s) (0.10 CEUs) of credit for pharmacists. Approval of this course for pharmacists is under a cosponsorship agreement between Medical Education Collaborative, Inc. (MEC) and Medscape. MEC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE # 815-999-04-046-C02

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New Fixed-Dose Combination Treatment Options for HIV Infection: How Do They Compare? An Expert Discussion: Moderator's Introduction and Overview


Moderator's Introduction and Overview

  • Craig Sterritt: Now I'd like to introduce our expert moderator, Dr. Michael Saag. Dr. Saag is Professor of Medicine and Director of the AIDS Outpatient Clinic at the University of Alabama at Birmingham. Good evening, Dr. Saag.

    Michael Saag: Good evening. Thanks, Craig, and welcome, everyone.

    I'm going to briefly go over the issues in choice of initial antiretroviral regimens and sort of set the stage for the value and the role of fixed-dose combinations, predominantly in primary or initial therapy, but also these agents could be used in a fixed-dose combination form later in the course of disease, as well. We're already used to fixed-dose combinations in the sense that we already know about Kaletra, which is lopinavir/ritonavir. We also know about Combivir, AZT/3TC [zidovudine/lamivudine]. And so now there are 2 new ones that we're going to really focus on for the most part this evening.

  • Slide 3 -- Moderator's Introduction and Overview

    Slide 3

    (Enlarge Slide)
  • The issues to consider when initiating a new regimen are listed on this next slide, where we talk about potency, tolerability, convenience, coburden, long-term toxicities, and then future potential therapeutic options. And I think we all are very comfortable balancing out these different issues.

    I would add to that, these are the issues that I think play a large role in how patients accept new therapies, especially for the tolerability and convenience and pill burden. And the physicians are thinking about potency, long-term toxicities, and options.

    The other thing that I think is new on the horizon that a lot of us are facing in practice is the issue of copayments for patients; when you have fixed-dose combinations, sometimes it's easier for patients who have third-party payers in terms of just having 1 copay for 2 drugs, as opposed to separate copays. And then finally, some of the issue of convenience in terms of how much time does it take for the provider to go over the instructions, which is becoming more and more of an issue as we're faced with pressures from our administrators to see as many patients and in the most efficient way possible.

    Getting back to the issue of potency, my opinion is that a lot of the success of first regimens is really about not so much potency, but really the tolerability.

  • Slide 4 -- Issues to Consider...

    Slide 4

    (Enlarge Slide)
  • In this survey of 24 weeks of response rates to initial antiretroviral regimens, you can see that there is an improvement over time. This listing starts with a meta-analysis that John Bartlett and Ralph DeMasi did back in the late '90s, early 2000 range, where only about 54% of patients achieved viral loads < 50 copies/mL. Then we have a smattering of additional studies that have come on the heels of that, such that by intent-to-treat analysis, we can see response rates as high as 82% to 83% or so with some of the newer regimens.

    My position would be that this trend doesn't reflect, for example, that an efavirenz-based regimen is inherently more potent than, say, a lopinavir/ritonavir-based regimen, but rather that the tolerability, and to some degree the convenience, of drug regimens is playing a role here. In my opinion it's really mostly an issue of tolerability. Thus it's important when selecting a regimen to concentrate not only on what's convenient, but what the patients will be able to tolerate over the short-to-intermediate term.

  • Slide 5 -- Survey of 24-Week Virologic Response Rates...

    Slide 5

    (Enlarge Slide)
  • Here, I simply point out some of the advantages and disadvantages of fixed-dose combinations. I think the advantages are pretty straightforward; I'm not going to read through them, but just point out that in the case of these 2 new fixed-dose combination formulations, they are thymidine-sparing.

    The disadvantages are that if they miss a dose as a 48-hour gap, then we have to think about the forgiveness of a missed dose. I would like to add, however, that every dose of medicine -- whether we give it q12 or q24 -- is really based on an exposure that would allow that type of dosing. So I'm not sure that missing a dose of a q24 drug is inherently worse than a missing a dose of a q12-hour drug, but it is a potential issue. Also, with respect to disadvantages, we have with FDC [fixed-dose combination] agents a lack of flexibility in dosing. You can't necessarily just cut the pill in half and use it that way.

    Finally, because these are relatively new agents, there may be some unanticipated interactions or long-term toxicity that we haven't really noted as yet, but could emerge over time. Obviously, we've been surprised throughout the years at how certain drug combinations, that we could have sworn we [understood] and didn't anticipate problems with, turned out later to have longer-term problems. This is just a caution.

  • Slide 6 -- Common Features of Fixed-Dose Combination (FDC)...

    Slide 6

    (Enlarge Slide)