Hello. This is Dr. Paul Sax from Brigham and Women's Hospital and Harvard Medical School. Today I'm coming to you from my office and not my dining room, which is my usual location. The topic of today's little talk will be the top stories in HIV medicine for 2012. I have 4 of them.
Story # 1 is the fact that both of the major treatment guidelines for HIV infection in the United States are now unified behind recommending HIV treatment for all.[1,2] They state that everyone with HIV infection should be offered HIV treatment, because of both the increasing evidence of the benefits of maintaining a normal CD4 cell count as well as the very powerful evidence that HIV treatment prevents transmission.
I should emphasize that this view is not unanimous. In Europe, treatment for people with high CD4 cell counts is sometimes deferred,[3] and there is no conclusive evidence that it benefits the individual, which is why the ongoing START study is very important. This study randomly assigns people with CD4 counts > 500 mm3 to receive either immediate therapy or to wait until the CD4 count falls below 350 mm3.
Story # 2 is new treatment options, and, most importantly, the coformulated tenofovir/FTC/elvitegravir/cobicistat in a single-pill regimen that is now available for treatment-naive patients. It was FDA approved on the basis of 2 phase 3 clinical trials: One compared it with tenofovir/FTC/efavirenz and the other compared it with tenofovir/FTC and boosted atazanavir. In both of these studies, the coformulated elvitegravir-based regimen was not inferior and showed an overall very good safety profile.[4,5] It's also listed as an alternative treatment in both HIV treatment guidelines in the United States.
Story # 3 is the studies on dolutegravir, an investigational once-daily integrase inhibitor. Two phase 3 studies were presented; one compared dolutegravir with raltegravir and the other looked at abacavir/lamivudine plus dolutegravir vs tenofovir/FTC/efavirenz.[6,7] In the former trial, dolutegravir was noninferior to raltegravir; in the latter trial, the abacavir/lamivudine/dolutegravir regimen was actually superior to tenofovir/FTC/efavirenz, largely due to more discontinuations in the tenofovir/FTC/efavirenz arm. This is a very exciting new drug that is under FDA review, probably slated for approval in 2013. We look forward to hearing more data about those studies soon.
Story # 4, and the final one of the top stories I'm going to cover today, is the ongoing research toward HIV cure. I want to highlight a presentation done by colleagues of mine on 2 individuals who underwent allogeneic bone marrow transplantation for malignancies and then were intensively investigated for the size of the latent reservoir.[8] They were still on HIV treatment, but what was presented was that no virus was detectable by single-copy assay, by enhanced culturing methods, outgrowth assays, or by any methodology in which you normally can detect virus in patients who are on HIV treatment. Of course, we don't know that these individuals are cured, but at least there is evidence that their reservoir is reduced. We very much look forward to hearing more data about these individuals and also about other research that's ongoing in various cure strategies.
Those are some top HIV stories for 2012. I wish all of you very happy holidays, and I look forward to communicating with you more about this field in the coming year. Thank you.
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COMMENTARY
Top Stories in HIV Medicine for 2012: An Expert's View
Paul E. Sax, MD
DisclosuresDecember 17, 2012
Hello. This is Dr. Paul Sax from Brigham and Women's Hospital and Harvard Medical School. Today I'm coming to you from my office and not my dining room, which is my usual location. The topic of today's little talk will be the top stories in HIV medicine for 2012. I have 4 of them.
Story # 1 is the fact that both of the major treatment guidelines for HIV infection in the United States are now unified behind recommending HIV treatment for all.[1,2] They state that everyone with HIV infection should be offered HIV treatment, because of both the increasing evidence of the benefits of maintaining a normal CD4 cell count as well as the very powerful evidence that HIV treatment prevents transmission.
I should emphasize that this view is not unanimous. In Europe, treatment for people with high CD4 cell counts is sometimes deferred,[3] and there is no conclusive evidence that it benefits the individual, which is why the ongoing START study is very important. This study randomly assigns people with CD4 counts > 500 mm3 to receive either immediate therapy or to wait until the CD4 count falls below 350 mm3.
Story # 2 is new treatment options, and, most importantly, the coformulated tenofovir/FTC/elvitegravir/cobicistat in a single-pill regimen that is now available for treatment-naive patients. It was FDA approved on the basis of 2 phase 3 clinical trials: One compared it with tenofovir/FTC/efavirenz and the other compared it with tenofovir/FTC and boosted atazanavir. In both of these studies, the coformulated elvitegravir-based regimen was not inferior and showed an overall very good safety profile.[4,5] It's also listed as an alternative treatment in both HIV treatment guidelines in the United States.
Story # 3 is the studies on dolutegravir, an investigational once-daily integrase inhibitor. Two phase 3 studies were presented; one compared dolutegravir with raltegravir and the other looked at abacavir/lamivudine plus dolutegravir vs tenofovir/FTC/efavirenz.[6,7] In the former trial, dolutegravir was noninferior to raltegravir; in the latter trial, the abacavir/lamivudine/dolutegravir regimen was actually superior to tenofovir/FTC/efavirenz, largely due to more discontinuations in the tenofovir/FTC/efavirenz arm. This is a very exciting new drug that is under FDA review, probably slated for approval in 2013. We look forward to hearing more data about those studies soon.
Story # 4, and the final one of the top stories I'm going to cover today, is the ongoing research toward HIV cure. I want to highlight a presentation done by colleagues of mine on 2 individuals who underwent allogeneic bone marrow transplantation for malignancies and then were intensively investigated for the size of the latent reservoir.[8] They were still on HIV treatment, but what was presented was that no virus was detectable by single-copy assay, by enhanced culturing methods, outgrowth assays, or by any methodology in which you normally can detect virus in patients who are on HIV treatment. Of course, we don't know that these individuals are cured, but at least there is evidence that their reservoir is reduced. We very much look forward to hearing more data about these individuals and also about other research that's ongoing in various cure strategies.
Those are some top HIV stories for 2012. I wish all of you very happy holidays, and I look forward to communicating with you more about this field in the coming year. Thank you.
Medscape HIV/AIDS © 2012 WebMD, LLC
Cite this: Top Stories in HIV Medicine for 2012: An Expert's View - Medscape - Dec 17, 2012.
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Authors and Disclosures
Authors and Disclosures
Author
Paul E. Sax, MD
Professor of Medicine, Harvard Medical School; Clinical Director, Division of Infectious Diseases, Brigham and Women's Hospital; Boston, Massachusetts
Disclosure: Paul E. Sax, MD, has disclosed the following relevant financial relationships:
Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Abbott Laboratories; Aileron; Bristol-Myers Squibb; Gilead Sciences; GlaxoSmithKline; Janssen Pharmaceuticals; Merck
Received research grant from: Bristol-Myers Squibb; Gilead Sciences; Merck; GlaxoSmithKline; Janssen Pharmaceuticals