•  HIV TREATMENT

Raltegravir, First-in-Class HIV Integrase Inhibitor, Wins U.S. Approval
On Oct. 12, the U.S. Food and Drug Administration approved raltegravir (MK-0518, Isentress), the first member of a new class of antiretrovirals known as integrase inhibitors. In clinical trials, raltegravir has shown impressive efficacy in heavily treatment-experienced patients and an encouraging adverse-effect profile.


The Impact of Raltegravir: The Body PRO Interviews David Wohl, M.D.
To learn more about raltegravir (MK-0518, Isentress) and its potential impact on the treatment of HIV-infected patients, The Body PRO spoke by phone with David Wohl, M.D., an associate professor of medicine at the University of North Carolina-Chapel Hill. In this written or audio interview, Dr. Wohl discusses raltegravir's mechanism of action, efficacy, adverse effects, resistance profile and its potential for use in treatment-naive patients as well as treatment-experienced patients.


Mixed Reaction to Raltegravir Pricing: Project Inform
The U.S. price tag for raltegravir (MK-0518, Isentress) has been set at $27 per day, or about $10,000 per year -- approximately the same as the cost of maraviroc (Selzentry, Celsentri). Project Inform, a San Francisco-based HIV organization, expressed a mixed reaction to the announced price for raltegravir. Though Project Inform's founding director Martin Delaney expressed some disappointment that the price wasn't lower, "[Merck has] avoided the temptation to set ever higher prices for each new HIV drug," he said.


Not Your Everyday Antiretroviral: KP-1461, an HIV DNA Killer
"Who is to say that the next generation of drugs should not have eradication as its goal?" asks Stephen Becker, M.D., chief medical officer of Koronis Pharmaceuticals. His company's phase 2 HIV drug, KP-1461, appeared to eradicate HIV from laboratory cell cultures. In vivo clinical trials for the drug are now enrolling. KP-1461's mechanism of action is so fundamentally different from other antiretrovirals that it can seem like science fiction, but as Dr. Becker explains in this detailed interview, its underpinnings are firmly based on scientific fact.


New Dosing Regimen for Fosamprenavir Approved: Ritonavir Dose Reduced
The U.S. Food and Drug Administration approved on Oct. 12 an oral tablet formulation of fosamprenavir (Lexiva, Telzir), as well as a new indication for once-daily dosing of the drug. The newly approved 1,400-mg, once-daily dose of fosamprenavir, boosted with 100 mg ritonavir (Norvir) instead of 200 mg ritonavir, is indicated for treatment-naive patients.

•  KEY RESEARCH FROM ICCAC AND IDSA: INTERVIEWS, SLIDES & CME/CE RECAPS

Looking for thorough take-home discussions of the most important HIV research presented at this autumn's conferences? Let Cal Cohen, M.D., M.S., and Eric Daar, M.D., walk you through the critical study findings from ICAAC 2007 and IDSA 2007. These free CME/CE recaps are available as written or audio reports with accompanying slide sets. For our ICAAC 2007 summary, click here; for our IDSA 2007 summary, click here.

In addition to these CME/CE summaries, The Body PRO is also proud to present a host of one-on-one interviews with researchers and study presenters from ICAAC and IDSA. These interviews (available as podcasts and full transcripts) cover a wide array of issues, including:

	Joseph Eron, M.D., reviews ICAAC 2007 highlights, including new raltegravir (MK-0518, Isentress) data, research on the new CCR5 inhibitor maraviroc (Selzentry, Celsentri), a study comparing boosted darunavir (TMC114, Prezista) + Norvir (ritonavir) to lopinavir/ritonavir (Kaletra), and the results of a French study on whether the immune-boosting drug interleukin-2 can delay the need to initiate HAART.
	Roy Gulick, M.D., M.P.H., discusses the results of his two-year study on treatment-experienced patients taking vicriviroc (SCH 417690, SCH-D), a CCR5 inhibitor in development.
	Michael Mugavero, M.D., explains findings that nearly half of HIV-infected people were no-shows for more than one quarter of their scheduled visits to a Birmingham, Ala., clinic.
	Turner Overton, M.D., examines the outcomes of HIV-infected women in a St. Louis, Mo., clinic who received antiretroviral therapy during pregnancy and then, for various reasons, discontinued treatment.
	Tristan Ferry, M.D., talks about a study he presented reviewing complication risks among HIV-infected patients not directly caused by antiretrovirals.
	Christos Karatzios, M.D., discusses a fascinating study he presented at IDSA 2007 regarding the medical needs and social characteristics of perinatally infected adolescents and young adults.

For more coverage of ICAAC 2007, click here; for more on IDSA 2007, click here.

•  COMPLICATIONS OF HIV/HAART

Routine Hepatitis C Screening Urged for Patients Diagnosed With HIV: Study
Mortality rates are higher among HIV-infected patients who are not screened for hepatitis C than patients who receive such screening, according to the results of a large French study published in the September issue of the Journal of Viral Hepatitis. The mortality rates among unscreened patients were higher despite the finding that, otherwise, the quality of medical care was similar between screened and unscreened patients. The researchers noted that many of the patients who had not been screened for hepatitis C had advanced HIV disease, making treatment with HAART a high priority. The researchers warned, however, that hepatitis C screening should not be neglected in these patients simply due to their urgent need for HIV treatment.


Kaposi's Sarcoma Outbreak Among HAART Patients in San Francisco
Physicians from San Francisco General Hospital have reported a baffling outbreak of 15 Kaposi's sarcoma (KS) cases since November 2004 among HIV-infected men who have sex with men. The report was initially published in a letter in the Sept. 27 issue of the New England Journal of Medicine. The majority of the KS patients are in their 40s and 50s, have been HIV infected for almost 20 years and have undetectable HIV viral loads. Although the new cases are unsightly and difficult to treat, they are neither aggressive nor fatal, the physicians say.


Stress May Speed HIV Disease Progression, Study Suggests
Stress contributes to disease progression in HIV-infected patients, according to a commentary by U.S. and Canadian researchers published in the Oct. 10 issue of the Journal of the American Medical Association. Sheldon Cohen, Ph.D., of Carnegie Mellon University, and colleagues reviewed research examining the mechanisms linking stressors -- such as depression, divorce or the death of a loved one -- with the progression of several diseases, including HIV. "Effects of stress on regulation of immune and inflammatory processes have the potential to influence depression, infectious, autoimmune, and coronary artery disease, and at least some (e.g., viral) cancers," Cohen et al write.

Click here to read an article excerpt.


HAART May Help Protect HIV-Infected Patients From Neurodegeneration, Study Says
The slowly progressing neurological damage associated with long-term HIV infection may be less likely to occur among patients receiving HAART, according to a small Swedish study published in the Oct. 9 issue of Neurology. The researchers tracked the levels of light-chain neurofilament protein (NFL) in patients' cerebrospinal fluids as a marker of central nervous system damage; they found that, after three months on HAART, 48% of the study participants with high baseline NFL levels had achieved normal NFL levels. After one year of treatment, most had achieved normal levels.

•  HIV TRANSMISSION & EPIDEMIOLOGY

HIV Prevalence Among U.S. Inmates Continues to Fall, but Remains High
HIV rates in U.S. state and federal prisons appear to be dropping, according to a new report from the U.S. Department of Justice. The report said that the number of HIV-infected inmates dropped in 2005, marking the sixth year in a row of declining prevalence. The number of inmates dying from AIDS-related complications has also seen a downward trend. Still, the state and federal prison system was home to more than 22,000 HIV-infected people in 2005, and nearly 200 inmates that year died from AIDS-related complications. HIV prevalence remains much higher in the U.S. prison system than in the general public.


U.S. Congress Passes Prison HIV-Testing Bill Without Requiring Written Consent
Federal inmates in the United States may be more likely to receive HIV testing as the result of a bill passed by the U.S. House of Representatives. The Stop AIDS in Prison Act would make opt-out HIV testing routine for all current and newly admitted U.S. inmates. Despite the praise many HIV advocates have given this legislation, the HIV organization Housing Works counters that the law has one critical flaw: a lack of written informed consent from the inmate. This article reports on both sides of the argument over this bill, which has yet to be considered by the U.S. Senate.


Hispanic Americans' Place of Origin May Impact HIV Risk Behaviors, Study Finds
Although 65% of all HIV-infected, Hispanic-American men born in South America became infected through sexual contact with another man, the same is true for only 46% of HIV-infected, Hispanic-American men born inside the United States. This was among the findings from a massive study by U.S. government researchers that could have implications for HIV prevention efforts among Hispanics living in the United States. "In terms of the prevention messages, if you are looking at Hispanics, you can't look upon them as a monolithic group," said Ken Dominguez, M.D., M.P.H., one of the study authors.

Click here to read a detailed overview of the study results.


Researchers Examine Effect of Failed HIV Vaccine
When news broke in September that one of the most promising HIV vaccines in development was a confirmed flop, it sent a chill through many of those who remain hopeful for a way to immunize individuals against HIV. However, although the 3,000-patient study failed, scientists say the information it provided can still help develop a vaccine. "The trial shows a failure of a specific product but not a failure of a concept," said Gary Nabel, M.D., Ph.D., director of the Vaccine Research Center at the U.S. National Institutes of Health.


Health Officials in San Francisco Discuss Centers for Injection Drug Users
Should U.S. taxpayer money be used to set up safe, supervised areas for injection-drug users? That is the controversial issue that San Francisco health officials debated last week during an all-day symposium. Advocates of safe-injection sites argue that they will prevent overdoses and reduce the use of unsanitary injection equipment, which can help prevent the spread of HIV. However, it appears unlikely that San Francisco will become the first city in the United States to create injection centers. San Francisco's mayor "is not inclined to support this approach," a spokesperson said.

•  HIV IN THE U.S. NEWS

U.S. HIV Organizations Call on Presidential Candidates to Address Domestic HIV
Leaders of HIV organizations across the United States have banded together for the "AIDS in America" effort, urging U.S. presidential candidates to address the U.S. HIV epidemic in their campaigns. According to the group's statement, "One of our overarching concerns is the lack of emphasis on domestic HIV/AIDS in the media, among elected officials, and the general public in recent years. ... We want to work with all presidential campaigns to raise awareness about the domestic epidemic, provide information and data, and discuss how HIV/AIDS will be addressed in healthcare reform proposals."

The "National AIDS Strategy" coalition issued a similar call to presidential candidates last month. Click here to read about it.

•  HIV OUTSIDE THE UNITED STATES

Clinton Foundation Aims to Provide Universal HIV Treatment for Kenyan Children
Currently, fewer than 13% of the 102,000 HIV-infected children in Kenya have access to treatment, but an ambitious three-year program funded by the Clinton Foundation intends to provide HIV meds to the other 87%. Former president Bill Clinton's foundation will spend US$38 million next year to purchase antiretrovirals for HIV-infected children in Kenya. In a country where 50% of HIV-infected children die because they have no treatment access, the "[t]ime to act is now, to let these children live," Kenya's director of medical services said.