•  MARAVIROC NEWS & RESEARCH

FDA Approves Maraviroc, First-in-Class CCR5 Inhibitor
On Aug. 6, the U.S. Food and Drug Administration (FDA) granted approval for maraviroc (Selzentry), the first in a new class of antiretrovirals known as CCR5 inhibitors. Maraviroc has been approved for use specifically in treatment-experienced patients. Patients must take a tropism assay prior to receiving maraviroc to ensure they have CCR5-tropic virus; the drug appears largely ineffective in patients with dual/mixed or CXCR4-tropic virus. Maraviroc is expected to be widely available in the United States by September. Click Here

Meanwhile, the expanded access program for maraviroc is expected to continue through the end of the year to assist HIV-infected patients who have limited treatment options. Click here for more information.


The Body PRO Exclusive: Joel Gallant, M.D., Provides Overview of Maraviroc
Maraviroc (Selzentry) is not your everyday antiretroviral. It is unique among HIV medications not only for its mechanism of action, but also for the manner in which clinicians will have to determine whether the drug is a good fit for their patients. To get the bottom line on this newest addition to the HIV treatment armamentarium, we spoke with Joel Gallant, M.D., M.P.H., a professor of medicine and epidemiology at the Johns Hopkins University School of Medicine and a leading HIV specialist in the United States. This interview is available as a podcast or a full transcript. Click Here

For more information on maraviroc, including full prescribing information and background research, visit The Body PRO's maraviroc index.


Maraviroc Update From IAS 2007: Pooled Subanalyses Confirm Positive Findings
The approval of maraviroc (Selzentry) in the United States was based largely on results from the MOTIVATE trials, a pair of studies running concurrently in the United States, Canada, Europe and Australia. Data from these two studies were a highlight of the 14th Conference on Retroviruses and Opportunistic Infections (CROI 2007) earlier this year. At the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2007), two subanalyses of pooled data from the MOTIVATE trials were presented; the results largely confirm the encouraging findings from CROI 2007. The Body PRO's Edwin DeJesus, M.D., details the new results. Click Here

•  IAS 2007 CONFERENCE SUMMARIES

Top Experts Discuss Conference Highlights: The Body PRO's IAS 2007 Podcasts
Want to hear what some of the world's top HIV specialists feel was the most significant research presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2007)? Don't have time to sift through the nearly 1,000 presentations showcased in Sydney last month? Let The Body PRO be your guide. We spoke with Cal Cohen, Eric Daar, Steven Deeks, Anthony Mills and other prominent physician-researchers to get their take on the highlights of IAS 2007. (A transcript is available for the Cal Cohen interview; transcripts for other interviews will be available soon.) Click Here


Earn CME/CE Credit With Our IAS 2007 Daily Podcast Summaries
Included in our extensive coverage of IAS 2007 are three in-depth, CME/CE-accredited summaries of the major research presented during each day of this conference. Daniel Berger, M.D., and Joel Gallant, M.D., team up to provide these 30-minute activities, which are available as podcasts and transcripts, and are accompanied by study slides. This is one set of IAS 2007 summaries you don't want to miss! Click Here

•  HIV TREATMENT/COMPLICATIONS: FEATURED STUDIES FROM IAS 2007

When to Start Treatment: Experts at IAS 2007 Weigh in on Debate
Starting patients on HIV treatment at a CD4+ cell count of 350 or higher may become the new precedent, explains The Body PRO's Joel Gallant, M.D., in his CME/CE-accredited IAS 2007 roundup. Dr. Gallant reviews newly presented data on when to begin antiretroviral therapy from the CASCADE, SMART and HOPS studies. Results from these three large cohorts found associations between a lower CD4+ cell count and several adverse effects, including a higher risk for cardiovascular disease, more resistance mutations and death. Given this compelling data, Dr. Gallant asks the intriguing question: "When would you not treat a patient?" Click Here

There's a great deal more on the "when to start" question in The Body PRO's podcast coverage of IAS 2007. Benoit Marin spoke with us (download MP3; transcript available soon) about his research on the CASCADE cohort, which examined the association between CD4+ cell count/viral load and death due to non-AIDS-related causes. His results indicate that even non-AIDS-related mortality could be avoided with earlier antiretroviral therapy.

Jonathan Uy, M.D., of the HOPS group, also discussed his research with The Body PRO (download MP3; transcript available soon). The new HOPS data show that patients who initiated antiretroviral therapy at a CD4+ cell count greater than 350 cells/mm³ were half as likely to develop any major resistance mutations as patients who started at below 200 cells/mm³.

In addition, listen to our podcast interviews (transcripts will be available soon) with Eric Daar, M.D. (download MP3), Steven Deeks, M.D. (download MP3), and Pietro Vernazza, M.D. (download MP3), for more take-home analysis on the "when to start" question, as well as other highlights of IAS 2007.


Skin Cancers More Common in HIV-Infected Patients, Research Finds
Skin cancers are among the growing number of malignancies that occur with greater frequency among HIV-infected patients, according to research presented at IAS 2007. The study shows that melanoma is approximately three times as common among HIV-infected patients than HIV-uninfected patients, and basal cell carcinoma is more than twice as common. The researchers recommend regular skin cancer screening for HIV-infected patients. Click Here

Click here to read expert analysis from Daniel Berger, M.D., on this and other important studies from IAS 2007 on the growing rate of non-AIDS-related malignancies in HIV-infected patients. It's all part of The Body PRO's comprehensive podcast coverage of the conference!


New Data Provide Added Support for Abacavir Hypersensitivity Testing
Support for HLA testing has steadily gathered steam since research began to indicate it could effectively predict a patient's risk of developing a hypersensitivity reaction to abacavir (Ziagen). New research presented at IAS 2007 further drives home the utility of HLA testing, by showing just how dramatically it can reduce the incidence of hypersensitivity reaction. Daniel Berger, M.D., examines this important research as part of our CME/CE-accredited coverage of IAS 2007. Click Here

For further analysis of this study by Graeme Moyle, M.D., click here.


The "Other" CCR5 Inhibitor: Latest Research on Vicriviroc
Maraviroc (Selzentry) may be the first CCR5 inhibitor to win U.S. approval, but it's not the only one in development. Vicriviroc, which suffered a setback last year due to adverse-effect fears, is still working its way through clinical trials. The Body PRO's Edwin DeJesus, M.D., provides an update on the latest vicriviroc research that was presented at IAS 2007. Click Here


Pediatric HIV Treatment: Where Are the Antiretrovirals?
Pediatricians and HIV specialists alike acknowledge that HIV-infected children require a specialized approach to treatment that is entirely distinct from that of HIV-infected adults. Nonetheless, access to pediatric formulations of antiretrovirals remains a challenge throughout much of the world, said Annette Sohn, M.D., who is conducting pediatric HIV research in the developing world. At an IAS 2007 plenary session, she cited research detailing this need, and provided context for its urgency: The results of the CHER study in South Africa, presented in a late-breaker session at IAS 2007, found that starting HIV treatment within 12 weeks of birth reduced mortality by 75% compared to withholding treatment until a child's CD4+ cell percentage fell below the World Health Organization threshold for treatment initiation. Click Here

In this MP3 podcast (transcript available soon), Dr. Sohn speaks about her IAS 2007 presentation and answers questions about pediatric HIV treatment. To learn more about the CHER study, you can read the abstract online or download the slide presentation.

•  HIV/STD TRANSMISSION: FEATURED STUDIES FROM IAS 2007

Serodiscordant Couples Use PrEP and Timed Intercourse to Safely Conceive Children
Timed, unprotected intercourse could be a safe and effective alternative to expensive fertility treatments for heterosexual, serodiscordant, monogamous couples wanting to conceive a child, according to research presented at IAS 2007. In this interview (available as a podcast and a transcript), Pietro Vernazza, M.D., discusses his study, in which 22 couples attempted to get pregnant without using sperm washing or in vitro fertilization. The male partner in each couple was HIV infected, but had an undetectable viral load. The couples timed their intercourse to ovulation, and in 21 cases the women also took pre-exposure prophylaxis (PrEP) as a precaution. More than 50% of the couples achieved pregnancies after three ovulation cycles, and a total of 15 of the women became pregnant after up to 10 attempts. All women tested negative for HIV three months after their last exposure. Click Here

For an impartial analysis of Dr. Vernazza’s study, read this discussion by Daniel Berger, M.D., which is part of our CME/CE-accredited coverage of IAS 2007.


Exploring New HIV Prevention Methods for Women (MP3 Podcast)
A plenary session at IAS 2007 featured a wide-ranging discussion on HIV prevention for women. Nancy Padian, Ph.D., provided an update on technologies such as microbicides, dental dams and the female condom. She also summarized disappointing results from a study finding that diaphragm use did not appear to reduce the risk of HIV infection among women. In this podcast (transcript available soon), Dr. Padian summarizes these issues and answers questions on her presentation. Click Here

Dr. Padian's presentation is also available online as a webcast and as a series of PowerPoint slides.


HCV Transmission Occurs Sexually Among MSM, Research Shows
Data presented at IAS 2007 support the contention that hepatitis C (HCV) is sexually transmissible, particularly among men who have sex with men (MSM). Long thought to be a rare occurrence at best, sexual HCV transmission is on the rise among HIV-infected MSM, driving home the need for more aggressive HCV prevention education and screening, even among those who do not use injection drugs and thus have not traditionally been considered at high risk for HCV. Daniel Berger, M.D., reviews the latest research on this issue as part of our CME/CE-accredited coverage of IAS 2007. Click Here

•  OTHER HIV TREATMENT NEWS

European Union Suspends Roche's Nelfinavir Marketing License
The European Commission has announced the suspension of Roche's license to market nelfinavir (Viracept) in the European Union. The drug was withdrawn from the market in June after Roche said some batches were contaminated with unusually high levels of the cancer-causing agent ethyl mesylate. Roche later admitted that the contamination had been present in some batches of nelfinavir since production of the drug began in 1998. Most of the world has been impacted by the contamination scandal; only the United States, Canada and Japan have been unaffected. Click Here

For more background on this story, read this news article from aidsmap.com. The New York Times also recently reported on the impact of the nelfinavir recall on HIV-infected patients in developing countries; click here for a summary.