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[ by | Sep 12, 2011 11:41 am | Comments Off ]

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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[ by | Jun 27, 2011 2:57 pm | Comments Off ]

Texas AIDS Drug Assistance Program Faces Budget Shortfall – The Texas AIDS Drug Assistance Program has failed to secure additional funding and will face budget shortages starting in September 2012. State officials have said that they will likely implement cost-cutting measures, such as excluding more expensive HIV drugs and asking pharmaceutical companies for discounts, to mitigate the shortages. The Texas legislature had previously decided not to give the program an additional $19 million to prevent cutbacks (see related AIDS Beacon news), instead deciding that the program could receive additional funds from the state’s Medicaid budget if needed. However, Medicaid also faces a $4.8 billion shortfall, making such assistance unlikely. For more information, please see the Associated Press article.

GeoVax Adds Los Angeles Site To Phase 1 Trial Of Therapeutic HIV Vaccine – Biotechnology company GeoVax Labs has announced that it is adding a third location, in Los Angeles, to its Phase 1 trial of a therapeutic vaccine to treat HIV. The first two sites are in Atlanta and Birmingham, AL. The trial 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. GeoVax expects to enroll 10 participants. For more information, please see the GeoVax press release or the U.S. Clinical Trials Registry.

Tibotec Therapeutics Changes Name To Janssen Therapeutics – Tibotec Therapeutics, the maker of the HIV drugs Prezista (darunavir), Intelence (etravirine), and Edurant (rilpivirine), has changed its name to Janssen Therapeutics. The name change is an attempt to create a common link between all of the Janssen companies, which are subsidiaries of Johnson & Johnson and include Janssen Pharmaceuticals and Janssen Biotech. The company’s new website includes links to information on its antiretrovirals and patient assistance programs to help low-income patients pay for the drugs. For more information, please see the Johnson & Johnson press release or the Janssen Therapeutics website.

Reminder: Free HIV Testing Today – As part of National HIV Testing day, many locations nationwide will offer free HIV testing today (see related AIDS Beacon news). To find a testing location, please see the Centers for Disease Control’s National HIV Testing Day website.

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[ by | Mar 28, 2011 4:47 pm | Comments Off ]

Texas Considers Cuts To State HIV Medication Program – Texas is considering cuts to its AIDS Drug Assistance Program (ADAP), called the HIV Medication Program, after the state senate failed to approve an additional $19 million in funds for the next two years. The program currently serves an estimated 14,000 low-income Texans who cannot afford their antiretroviral medications. The Texas Department of State Health Services will consider tightening income requirements, making patients wait longer to start treatment, or restricting the drugs the program covers if additional funding is not provided. For more information, please see the article in the Houston Chronicle.

California ADAP Asks Gilead To Reduce Drug Prices – California’s State Controller John Chiang sent a letter to Gilead Sciences last week asking Gilead to assist California’s ADAP by further reducing its HIV drug prices. According to the letter, California has experienced a 275 percent increase in AIDS drug expenditures since 2000, with Atripla now costing $21,900 per patient per year. In his letter, Chiang asks Gilead to continue providing financial assistance to ADAP programs and to consider additional drug price cuts so that state programs can continue to provide the drugs without cutting services. For more information, please see the article in the Silicon Valley/San Jose Business Journal or the letter from Mr. Chiang.

HIV/AIDS Community Mourns The Passing Of Elizabeth Taylor – Actress Dame Elizabeth Taylor, one of the first prominent HIV/AIDS activists, passed away last week from heart failure. Taylor became an AIDS activist in 1984, soon before her friend and fellow actor Rock Hudson died of the disease in 1985. Her efforts raised millions of dollars for the American Foundation for AIDS Research (amfAR) and the Elizabeth Taylor AIDS Foundation (ETAF). Her children have asked that donations be made to ETAF in her memory. AmfAR has created a page on its website in memory of Taylor that includes a video tribute and a message wall. For more information or to make a donation, please see the amfAR website or the Elizabeth Taylor AIDS Foundation website.

ViiV Healthcare Recruits Participants For Phase 3 Clinical Trial For Integrase Inhibitor GSK1349572 – ViiV Healthcare, a joint venture between Pfizer and GlaxoSmithKline, is currently recruiting treatment-experienced HIV-positive adults to study the safety and efficacy of its proposed integrase inhibitor, GSK1349572, versus Isentress (raltegravir). Participants may not have taken Isentress previously and must have a viral load (amount of HIV in the blood) of 400 copies per milliliter or more. The trial will last 48 weeks and will compare once-daily GSK1349572 to twice-daily Isentress. ViiV expects to recruit a total of 688 participants. For more information, please see the U.S. Clinical Trials registry.

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[ by | Jan 12, 2010 5:49 pm | 4 Comments ]
New Laws For The New Year – Part 2: Mandatory Prenatal HIV Testing In Texas And Affordable Housing For AIDS Patients In New York

Among new laws enacted at the start of 2010, Texas now requires testing pregnant women multiple times for HIV, and New York may provide more affordable housing for people living with HIV/AIDS.

Put into effect January 1, Texas legislation mandates physicians to administer HIV tests, with informed consent, to all pregnant women during their third trimester.

Prior to this law, standard procedures involved testing soon-to-be mothers for HIV, syphilis, and hepatitis B during their first prenatal visit as well as when the women are admitted to the hospital for delivery.…

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