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Norvir Prescribing Information Updated To Include Risk Of Life-Threatening Skin Condition – The U.S. Food and Drug Administration (FDA) has approved updated prescribing information for Norvir (ritonavir) to warn of the possibility of toxic epidermal necrolysis, a rare, life-threatening reaction to medications in which the top layer of skin detaches from the bottom layer and dies. The new prescribing information also notes that when Norvir is taken with the cancer drugs Tasigna (nilotinib) or Sprycel (dasatinib), used to treat certain forms of leukemia, or the painkiller fentanyl (Duragesic, Actiq), dose adjustments of these drugs may be necessary. For more information, please see the FDA press release.

Gilead Sciences And Janssen Therapeutics Agree To Lower AIDS Drug Prices For ADAPs – Gilead Sciences and Janssen Therapeutics (a division of Johnson & Johnson) have reached agreements with the ADAP Crisis Task Force (ACTF) to further reduce the prices for antiretrovirals purchased by state AIDS Drug Assistance Programs (ADAPs), which provide free antiretrovirals to low-income people with HIV. Due to state budget crises and an increase in the number of people requesting assistance, many states have tightened eligibility requirements or implemented waiting lists for ADAPs. According to ACTF, there were 6,595 people on ADAP waiting lists nationwide as of November 17. For more information, please see the press releases from ACTF (pdf) and the AIDS Healthcare Foundation.

GeoVax Begins Phase 1/2 Trial Of Therapeutic AIDS Vaccine; Still Recruiting Participants – Biotechnology company GeoVax Labs announced today that the first patient has received a dose of its investigational therapeutic HIV vaccine as part of a Phase 1/2 trial. The company is testing the safety and efficacy of the vaccine in controlling HIV replication in people already infected with the virus; participants will stop taking antiretrovirals for 12 weeks as part of the trial. The company also noted that it is still recruiting participants for the trial. Eligible participants must be HIV-positive and have started antiretrovirals within 18 months of their last negative HIV test; or have had a negative HIV test within the past 18 months and not yet started antiretrovirals. For more information, please see the GeoVax press release (pdf) or the U.S. Clinical Trials Registry.

Governors Push For Legalization Of Medical Marijuana – The governors of Rhode Island and Washington states have petitioned the federal government to legalize use of marijuana for medicinal purposes. Both states have legalized medical marijuana, and the governors argue that the change in federal law is necessary so that state employees are not prosecuted for distributing the drug. The U.S. Justice Department had previously sent letters to state governments warning of prosecution if they continued to distribute medical marijuana (see related AIDS Beacon news). The federal Drug Enforcement Agency rejected a request to reclassify the drug as acceptable for medicinal use in June; however, the governors argued that the evidence used for that rejection is several years old and that the medical community has since changed its stance on marijuana. For more information, please see the article in the New York Times.

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Congresswoman Lee Introduces Bill To Repeal Certain HIV Criminalization Laws – Representative Barbara Lee from California has introduced legislation that requires state officials nationwide to reevaluate HIV criminalization laws. The proposed legislation also offers incentives for states to repeal or modify laws that criminalize behavior by people with HIV that is legal for HIV-negative individuals or that has been shown scientifically to convey no measurable risk of HIV transmission. Representatives Hansen Clark and John Conyers from Michigan are co-sponsors of the bill. For more information, please see Rep. Lee’s press release or the article in the Michigan Messenger.

Large HIV Prevention Trial For Women Modified Due To Viread Inefficacy – A large trial that is testing the efficacy of Truvada (emtricitabine/tenofovir) pills, Viread (tenofovir) pills, and a Truvada vaginal gel in preventing HIV transmission to women has been modified because of interim results showing that Viread pills are ineffective. Based on the results, women in the Vaginal and Oral Interventions to Control the Epidemic (VOICE) study who were taking Viread will stop taking the drug and will no longer be included in the study. Women taking Truvada pills or the Truvada vaginal gel will continue as planned. For more information, please see the National Institutes of Health press release or the article on the Science Magazine website.

Phase 1 Clinical Trial Shows New HIV Vaccine May Be Highly Effective – Results from a Phase 1 clinical trial of a new preventative HIV vaccine in Spain show that 90 percent of healthy HIV-negative adults who received the vaccine showed an immune response; 85 percent still had an immune response one year after vaccination. This is a much higher percentage than researchers have observed in previous vaccine clinical trials. However, the scientists still have to show that the vaccine actually reduces the risk of contracting HIV. The researchers also plan to test the vaccine as a therapeutic vaccine in people who already have HIV to see if it reduces the severity of infection. For more information, please see the press release from Consejo Superior de Investigaciones Científicas or the articles on the ABC news and Fox news websites.

Clinical Trial To Test Victrelis In People With HIV And Hepatitis C Is Currently Recruiting Participants – A Phase 4 clinical trial that will test the efficacy of Victrelis (boceprevir) in HIV-positive adults with hepatitis C virus compared to HIV-negative adults with hepatitis C is currently recruiting participants. Study participants will receive Victrelis in combination with peginterferon-2b (PegIntron) and ribavirin (Rebetol). Eligible participants must not have taken the antiretrovirals Ziagen (abacavir), zidovudine (Retrovir), didanosine (Videx), stavudine (Zerit), Sustiva (efavirenz), or Intelence (etravirine) within the past six months. Additional medication and health restrictions also apply. For more information, please see the U.S. Clinical Trials Registry.

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Results from a Phase 2b clinical trial show that the investigational therapeutic vaccine Vacc-4x successfully reduces viral loads in people with HIV. In addition, study participants who received the vaccine were twice as likely to successfully stay off antiretroviral therapy a year later compared to participants who received a placebo.

The results were presented Wednesday at the AIDS Vaccine 2011 Conference in Bangkok, Thailand.

“We hope that this may lead to a training of the immune system to better control the virus,” said Dr. Jan van Lunzen, medical director of…

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NeurogesX Applies For Approval Of Qutenza For HIV-Related Neuropathy Pain – Biopharmaceutical company NeurogesX has filed an application with the U.S. Food and Drug Administration (FDA) for approval of Qutenza to be used for treating pain associated with HIV-related neuropathy, a condition that causes pain, numbness, burning, or tingling in the extremities. Qutenza is a capsaicin patch that is placed on the skin for 30 minutes. It is currently approved for treatment of nerve pain due to shingles. NeurogesX has applied for a priority review of its application; if granted, the FDA would review the application within six months instead of the standard 10 months. For more information, please see the NeurogesX press release.

New HIV Vaccine Approach Shows Promise – Researchers from several U.S. medical centers have collaborated to create an HIV vaccine that strongly binds to and activates immune cells to destroy HIV. The vaccine was tested in monkeys and better stimulated their immune systems to create antibodies against HIV as compared to previous vaccine methods. Antibodies recognize bacteria and viruses and signal for the immune system to destroy the infectious agents. For more information, see the study in PLoS Pathogens or the Duke University Medical Center press release.

Texas HIV/AIDS Programs Face Significant Cuts In Federal Funding – As in many other states, federal funds for HIV care through the Ryan White Care Act have been cut and delayed in Texas. As a result, AIDS Resources of Rural Texas has closed, sending its clients to other North Texas HIV/AIDS organizations, which are also facing the same funding issues. Also due to funding problems, the AIDS Outreach Center in Fort Worth has had to reduce its number of case workers and scale back its food pantry. So far, there is no indication that the U.S. government will increase funding for agencies that help clients displaced by the closure. For more information, please see the related article in the Fort Worth Star-Telegram.

Theratechnologies Applies For Approval Of Egrifta In Argentina And Brazil – Theratechnologies, via an affiliate of its partner Sanofi, has applied for marketing approval of Egrifta (tesamorelin) in Argentina and Brazil. If approved, Egrifta will be the first drug in these countries to treat lipodystrophy, a condition of abnormal fat distribution that is a side effect of certain anti-HIV medications. Based on average approval times, a decision would be expected in early 2012 in Argentina and late 2012 in Brazil. Egrifta was approved in the U.S. in November of last year, and Theratechnologies’ partners have since applied for approval in Europe, Israel, and Canada. For more information, please see the Theratechnologies press releases for Argentina and Brazil.

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Certain States Will Lose HIV Prevention Funds Due To CDC Formula Change – Due to a change in the way the U.S. Centers for Disease Control and Prevention (CDC) disburse funds toward HIV prevention, states will receive different levels of federal funding for HIV prevention beginning in 2012. States with lower rates of HIV transmission, such as Massachusetts and Michigan, will receive less funding while states with higher HIV rates, primarily in the Southern U.S., will receive more. Activists in states that stand to lose funding fear that the cuts could cause an increase in HIV cases in their states. For more information, please see the articles in the Boston Globe and the Washington Independent.

AIDS.gov Blog Features Highlights From Atlanta HIV Prevention Conference – The AIDS.gov blog, run by the U.S. Department of Health and Human Services (HHS), featured highlights from each day of the National HIV Prevention Conference in Atlanta last week. The posts included discussion of the National HIV/AIDS Strategy, important studies presented at the conference on preventing HIV transmission, and progress in implementing prevention strategies and campaigns. The posts were written by Dr. Ronald Valdiserri, the HHS Deputy Secretary for Health, Infectious Diseases and Director of the Office of HIV/AIDS Policy. For more information, please see the AIDS.gov blog.

International AIDS Vaccine Initiative Finds Promising HIV Vaccine Antibodies – Last week, researchers reported the discovery of 17 promising new anti-HIV antibodies, proteins manufactured by the body’s immune system to mark and neutralize pathogens in the body for destruction. According to the researchers, the antibodies are 10 to 100 times more effective at blocking HIV than previous anti-HIV antibodies that have been isolated. The researchers also noted that the proteins present a promising avenue for creating a vaccine to prevent HIV infection. The next step will be for researchers to begin trying to design a vaccine based on the new antibodies. For more information, please see the study in Nature (abstract) or the press release from the International AIDS Vaccine Initiative.

CDC Adds Information Page About HIV In Transgendered Individuals – The CDC has added a new information page to its HIV/AIDS website on HIV in transgendered adults. The page has information on rates of HIV infection in this population, challenges with regard to HIV prevention, and steps the CDC is taking to better understand and monitor HIV infections in transgendered individuals. According to the CDC, transgendered individuals are three times more likely than men and nearly nine times more likely than women to become infected with HIV. For more information, please see the CDC website.