New York Course 2007: ART Controversies-- Expert Interview with Dr. Hirsch
New York Course 2007: ART Controversies-- Expert Interview with Dr. Hirsch
Editor's Note:
Speaking at HIV Management 2007: The New York Course, Martin S. Hirsch, MD, reviewed the data that inform decisions and guidelines in 3 controversial areas of HIV management. First, should primary HIV infection be treated, and if so, for how long? Next, as guidelines on initiating HIV therapy have evolved, where do we stand today on recommending antiretroviral therapy in the course of chronic HIV disease -- and how are these recommendations supported by the literature? Finally, should measurements of plasma HIV RNA guide therapy, and if so, how? Mary Anderson, PhD, Clinical Editor of Medscape HIV/AIDS, spoke with Dr. Hirsch, who is Professor of Medicine, Harvard Medical School, and Physician, Massachusetts General Hospital, Boston, Massachusetts, about decisions to treat HIV based on CD4+ cell counts, and how the thresholds for treatment recommendations have changed over time
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Transcript
Medscape: I'm Dr. Mary Anderson of Medscape HIV/AIDS, and I'm at HIV Management 2007, the New York Course, with Dr. Martin Hirsch.
Dr. Hirsch, the title of your presentation was "Controversies in Antiretroviral Therapy." One of the most important treatment decisions is when to start therapy; how has the answer to that question changed over time?
Dr. Hirsch: In the early days, when we only had AZT, we were treating patients with far-advanced disease only. Later on, that changed to treating everybody who had CD4 counts less than 500 [cells/microliter] in the mid '90s. And now we're somewhere in between treating individuals who have CD4 counts between 200 and 350. There is a pendulum that swings back and forth, and I think we are swinging towards earlier therapy now.
Medscape: What are some of the reasons or data that argue in favor of starting therapy earlier, and what do you find the most convincing?
Dr. Hirsch: There are a lot of cohort studies that suggest that if one starts earlier, that the long-term complications, including cardiovascular complications and central nervous system complications, may be fewer. And that CD4 cell count recovery is more complete.
For example, there's a recent paper by Richard D. Moore and Jeanne C. Keruly in Clinical Infectious Diseases that suggests that after 6 years of follow-up, only those individuals who started treatment when their CD4 counts were greater than 350 had normal CD4 cell counts, or near-normal CD4 cell counts. I think that's the kind of evidence that suggests that earlier therapy may be useful.
In addition, the regimens we have today are a lot more tolerable than the regimens we had a few years ago, and the main argument against treating early has always been that the toxicity might outweigh the benefit. I think we're now at the point where that is no longer the case.
Medscape: What do you think we'll be seeing in the next few years? Will the consensus shift to earlier therapy?
Dr. Hirsch: I think it will unless some unexpected complication turns up. I think there already is a trend and I would anticipate that guidelines, over the next few years, would switch from between 200 and 350 to probably between 350 and 500. A lot of physicians are already anticipating the guidelines and doing that themselves.
Medscape: And finally, will the definitive answer to this question come from randomized clinical trials?
Dr. Hirsch: We would love to do a randomized clinical trial that definitively shows the answer. However, we've discussed this over and over again over the last 10 years or so and I think there are a lot of reasons why that won't happen. It's a very costly enterprise that would involve between 5000 and 10,000 people followed for 5-10 years. And there are so many things that are changing in this field that the trial will be difficult to enroll. People already have their own opinions on this and their own biases. And the question always arises: Will the answer be meaningful 5-10 years from now when the trial's completed and we have all kinds of different drugs out there?
So my guess is, at least in the United States and probably in Western Europe, that this trial won't be done. There are people talking about similar kinds of trials in Africa, for example, but I don't think it will be done in the United States.
Editor's Note:
Speaking at HIV Management 2007: The New York Course, Martin S. Hirsch, MD, reviewed the data that inform decisions and guidelines in 3 controversial areas of HIV management. First, should primary HIV infection be treated, and if so, for how long? Next, as guidelines on initiating HIV therapy have evolved, where do we stand today on recommending antiretroviral therapy in the course of chronic HIV disease -- and how are these recommendations supported by the literature? Finally, should measurements of plasma HIV RNA guide therapy, and if so, how? Mary Anderson, PhD, Clinical Editor of Medscape HIV/AIDS, spoke with Dr. Hirsch, who is Professor of Medicine, Harvard Medical School, and Physician, Massachusetts General Hospital, Boston, Massachusetts, about decisions to treat HIV based on CD4+ cell counts, and how the thresholds for treatment recommendations have changed over time
Take this interview with you!
Download this Interview as an MP3 and load it onto your iPod or other portable audio player.
MP3 Audio file (Right-click and select "Save Target As…" to download)
Transcript
Medscape: I'm Dr. Mary Anderson of Medscape HIV/AIDS, and I'm at HIV Management 2007, the New York Course, with Dr. Martin Hirsch.
Dr. Hirsch, the title of your presentation was "Controversies in Antiretroviral Therapy." One of the most important treatment decisions is when to start therapy; how has the answer to that question changed over time?
Dr. Hirsch: In the early days, when we only had AZT, we were treating patients with far-advanced disease only. Later on, that changed to treating everybody who had CD4 counts less than 500 [cells/microliter] in the mid '90s. And now we're somewhere in between treating individuals who have CD4 counts between 200 and 350. There is a pendulum that swings back and forth, and I think we are swinging towards earlier therapy now.
Medscape: What are some of the reasons or data that argue in favor of starting therapy earlier, and what do you find the most convincing?
Dr. Hirsch: There are a lot of cohort studies that suggest that if one starts earlier, that the long-term complications, including cardiovascular complications and central nervous system complications, may be fewer. And that CD4 cell count recovery is more complete.
For example, there's a recent paper by Richard D. Moore and Jeanne C. Keruly in Clinical Infectious Diseases that suggests that after 6 years of follow-up, only those individuals who started treatment when their CD4 counts were greater than 350 had normal CD4 cell counts, or near-normal CD4 cell counts. I think that's the kind of evidence that suggests that earlier therapy may be useful.
In addition, the regimens we have today are a lot more tolerable than the regimens we had a few years ago, and the main argument against treating early has always been that the toxicity might outweigh the benefit. I think we're now at the point where that is no longer the case.
Medscape: What do you think we'll be seeing in the next few years? Will the consensus shift to earlier therapy?
Dr. Hirsch: I think it will unless some unexpected complication turns up. I think there already is a trend and I would anticipate that guidelines, over the next few years, would switch from between 200 and 350 to probably between 350 and 500. A lot of physicians are already anticipating the guidelines and doing that themselves.
Medscape: And finally, will the definitive answer to this question come from randomized clinical trials?
Dr. Hirsch: We would love to do a randomized clinical trial that definitively shows the answer. However, we've discussed this over and over again over the last 10 years or so and I think there are a lot of reasons why that won't happen. It's a very costly enterprise that would involve between 5000 and 10,000 people followed for 5-10 years. And there are so many things that are changing in this field that the trial will be difficult to enroll. People already have their own opinions on this and their own biases. And the question always arises: Will the answer be meaningful 5-10 years from now when the trial's completed and we have all kinds of different drugs out there?
So my guess is, at least in the United States and probably in Western Europe, that this trial won't be done. There are people talking about similar kinds of trials in Africa, for example, but I don't think it will be done in the United States.