Gilead Sciences has filed a new drug application with the U.S. Food and Drug Administration (FDA) for elvitegravir, an experimental integrase inhibitor.  Elvitegravir is also up for approval in a combination tablet with boosting agent cobicistat and tenofovir and emtricitabine.  The new application is for approval of elvitegravir as a separate drug in combination with other HIV medications.  Click here for more on this new treatment and here for more on integrase inhibitors.  (sb)  

Potential good news for HIV-positive men who have sex with men: antiviral therapy may reduce the prevalence of precancerous anal lesions induced by cancer-causing human papilloma virus (HPV), according to a new study published in the Journal of Sexually Transmitted Diseases.  Men who are sexually active with other men have high rates of HPV infection, and untreated HIV is known to increase the risk of developing anal cancer.  HIV-negative men coinfected with HPV have notably fewer instances of anal cancer.  However, it's important to note there have been conflicting studies on whether antiviral therapy has any effect once full-blown anal cancer is diagnosed.  Still, researchers seem optimistic.  "In this cross-sectional study in 250 HIV-positive men who have sex with men," writes researcher Eric van der Snoek, MD, PhD, of the University Medical Center in Rotterdam, "the use of [antiviral therapy] was associated with a significantly reduced prevalence of [pre-cancerous anal lesions] and a significantly lower prevalence of HPV."  Click here to read more.  (sb)

A few weeks ago in an article on organ donation, we reported that it has long been illegal for organs from an HIV-positive person to be donated for transplant--even to another positive individual.  Last week, HIV/AIDS medical experts (including transplant surgeons) and activists presented testimony at a Congressional briefing, advocating that the ban be lifted.  Testifying were the HIV Medicine Association (HIVMA), amfAR, the Human Rights Campaign, AIDS United, and the Treatment Action Group, along with Senators Barbara Boxer and Tom Coburn, MD, and Rep. Lois Capps, RN.  HIVMA estimates that lifting the "outdated" ban (imposed by the 1984 National Organ Transplant Act) on positive-to-positive transplants could save the lives of more than 1,000 individuals with HIV per year.  Additional transplants could also potentially save $500,000 per patient compared with letting them get sicker.  Click here for full information.  (sb)

In the largest settlement ever involving a pharmaceutical company, British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses, and failing to report safety data about a top diabetes drug, U.S. federal prosecutors announced early this week.  The drugs involved are Paxil, Wellbutrin and Avandia, all brand-name, top-tier drugs on most pharmaceutical insurance formularies.  It is not uncommon for these drugs to be prescribed to HIV/AIDS patients since diabetes and depression often accompany long-term HIV infection.  While none of Glaxo's drugs for direct treatment of HIV are involved in this punitive action, the company does manufacture Combivir, Epivir, Retrovir, Trizivir, Ziagen and several other commonly prescribed antivirals.  At this time, no fraud issues with these antivirals have been alleged, but if you are on or have ever taken Paxil, Wellbutrin and/or Avandia at any time, it would be wise to review the matter and other possible treatment options with your doctor.  Click here for the New York Times story and here for BBC coverage.  (sb)    

As we reported last week, the U.S. Supreme Court by a 5-4 margin upheld the individual mandate provision of the Patient Protection and Affordable Care Act (ACA), but declined to require states to expand their Medicare programs.  During this past week, HIV/AIDS advocates have generally praised the ruling, especially noting that people with HIV will benefit from the ACA's ban on insurance exclusion due to pre-existing conditions.  However, some are cautious since the new law in some cases may make it harder for low-income individuals in some states to obtain care, especially regarding Medicaid issues.  "Expanding affordable, meaningful health care coverage is critical to people living with HIV," said National Association of People with AIDS (NAPWA) president Frank Oldham, Jr.  "Many are poor and when poor people with HIV cannot access to regular health care, they don't just get sick, they die--and their deaths are expensive. The ruling brings us one step closer to ensuring that all PLWHA receive medical treatment and care they urgently need."  Lambda Legal, which joined other LGBT and HIV/AIDS advocacy groups in an amicus brief, stated, "This is a victory for all Americans, but in particular, the Court's decision today will save the lives of many people living with HIV--as long as states do the right thing."  Long-time activist Nelson Vergel of the Program for Wellness was reserved:  "The fight over healthcare is not over.  The decision means that state lawmakers will have to pass legislation to establish insurance exchanges to allow uninsured people and small businesses to access quality healthcare coverage at affordable prices."  As expected, response to the Supreme Court ruling has ranged from relief and delight among progressives to the usual rancor and outrage from conservatives.  The amount of available coverage is overwhelming, but click here and here for some reliable resources and links to related articles specific to HIV/AIDS concerns.  (sb)  

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