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New York State Updates HIV Primary Care Guidelines – The New York State Department of Health AIDS Institute and Johns Hopkins University School of Medicine have updated their guidelines on primary care of patients with HIV. Updates primarily affect the section of the guidelines about “Comprehensive Baseline History.” The most significant change is a revision of a table detailing the essential elements of a patient history, which now includes a column on which assessments should be performed on an ongoing basis. The guidelines also recommend that health care providers use language that patients can understand and provide an interpreter or sign language services when needed. For more information, please see the AIDS Institute website.

AIDS Patients May Have A Higher Risk Of Developing Stomach And Esophageal Cancers – Results of a recent study suggest that AIDS patients have a higher risk of developing stomach and esophageal cancers. Scientists at the National Cancer Institute analyzed data from nearly 600,000 AIDS patients. Of those, 1,666 developed stomach cancers, while 240 developed esophageal cancers. Patients with AIDS had a nearly seven-fold greater chance of developing stomach cancer and an almost three-fold greater chance of developing esophageal cancer when compared to the general population. The results were presented last week at the American Association for Cancer Research (AACR) 102nd Annual Meeting. For more information please see the AACR News website or abstract 3744 from the conference.

Risk Of HIV Transmission Can Be Predicted By Virus Levels In Genital Secretions – A study published last week indicates that the levels of HIV in genital secretions,  independently of those in the blood, indicate the risk of transmitting HIV between heterosexual partners. Participants with higher levels of virus in their genital secretions were more likely to transmit HIV, regardless of their viral load (amount of HIV in the blood). The authors stated that the results help scientists better understand when transmission risk is greatest, which could help with HIV prevention technologies and methods. For more information, please see the news article at U.S. News and World Report or the study in Science Translational Medicine (abstract).

GlaxoSmithKline Is Recruiting Participants For Clinical Trial For New Therapeutic HIV Vaccine – GlaxoSmithKline (GSK) is currently recruiting participants for a new Phase 2 clinical trial to study whether its investigational therapeutic HIV vaccine, GSK Biologicals HIV Vaccine 732462, can lower viral loads and delay the need for treatment in treatment-naïve HIV-positive adults. Therapeutic HIV vaccines are meant to help the immune system fight HIV in people who are already HIV positive. Eligible participants must have a viral load between 2,000 and 80,000 copies per milliliter of blood. The study will compare the safety and efficacy of the vaccine to a placebo. For more information, please see the U.S. Clinical Trials Registry.

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American Civil Liberties Union Sues Alabama Over Treatment Of HIV-Positive Inmates – The American Civil Liberties Union has filed a lawsuit against the state of Alabama for its treatment of HIV-positive inmates. The lawsuit claims that Alabama discriminates against inmates with HIV by separating them from other inmates, forcing them to wear armbands identifying their status, and barring them from participating in certain jobs and programs. The lawsuit also claims that the policies concerning HIV-positive inmates in Alabama violate the Americans with Disabilities Act and the Rehabilitation Act, which forbid discrimination against people with disabilities, including HIV. The lawsuit was filed on behalf of 10 HIV-positive inmates from Alabama and cited the Governor of Alabama, the Alabama Department of Corrections Commissioner, and four wardens as defendants. For more information, please see article in The Birmingham News.

Abbott Laboratories Cleared In Norvir Pricing Lawsuit – A jury has cleared Abbott Laboratories of claims that it deliberately raised the price of Norvir (ritonavir) to discourage competition. However, Abbott was forced to pay GlaxoSmithKline (GSK) $3.5 million over allegations that Abbott breached a contract allowing GSK to promote the use of its HIV drugs with Norvir. GSK claimed in its lawsuit that Abbott’s price increase for Norvir, from $1.71 to $8.57 per 100 mg pill, unfairly favored Abbott’s protease inhibitor Kaletra (lopinavir/ritonavir), which already contains Norvir, over other protease inhibitors. GSK stated that the price increase resulted in losses of over $570 million on sales of its protease inhibitor Lexiva (fosamprenavir). Norvir is commonly used as a boosting agent to enhance the efficacy of other HIV drugs, particularly protease inhibitors. For more information, please see the Bloomberg Businessweek website.

Arizona Releases Final Rules On Medical Marijuana Dispensaries – The Arizona State Health Department has released its rules regarding the formation of medical marijuana dispensaries in the state. According to the rules, the number of dispensaries will be proportionate to the number of pharmacies, likely between 120 and 126 throughout the state. The rules specify that dispensary agents must create a business plan and apply for a registration certificate as well as an operating license. The dispensaries are a result of a November vote legalizing marijuana for treatment of certain medical conditions, including HIV. The medical marijuana program will start on April 14, when the state will begin accepting patient applications. For more information, please see the article in The Arizona Republic.

Former Surgeon General Koop Recounts Early Days Of The AIDS Epidemic –The Annals of the Forum for Collaborative HIV Research has published an article, “The Early Days of AIDS, As I Remember Them,” by former Surgeon General Dr. C. Everett Koop. Dr. Koop was the Surgeon General responsible for managing the nation’s response to AIDS when the disease first began appearing in the United States. His paper recounts the details of what occurred in the early days of the AIDS epidemic and the public health challenges the country faced. For more information, please see the press release from The Annals of the Forum for Collaborative HIV Research.

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FDA Concludes Ziagen Does Not Increase Risk Of Heart Attack – The U.S. Food and Drug Administration (FDA) announced last week its conclusion that Ziagen (abacavir) does not increase the risk of heart attack in people with HIV. Ziagen is also an ingredient in Trizivir (zidovudine/lamivudine/abacavir) and Epzicom (abacavir/lamivudine). The announcement came after an FDA safety review of 26 clinical trials found, contrary to some previous reports, that Ziagen was not associated with an increased risk of heart attack. Based on its findings, the FDA recommended that patients continue to take Ziagen as prescribed and report any side effects to the FDA’s MedWatch program. For more information, please see the FDA website.

GlaxoSmithKline Sues Abbott Laboratories Over Price Of Norvir – Arguments began last week in a lawsuit between pharmaceutical companies GlaxoSmithKline (GSK) and Abbott Laboratories over the price of Abbott’s HIV drug Norvir (ritonavir). Norvir is often prescribed in combination with protease inhibitors to increase the effectiveness of a protease inhibitor-based antiretroviral regimen. GSK claims that Abbott’s 2003 price increase for Norvir, from $1.71 to $8.57 per 100 mg tablet, prevented GSK and other protease inhibitor manufacturers from competing effectively with Abbott’s protease inhibitor Kaletra (lopinavir/ritonavir), which already includes Norvir. Abbott argues that the price increase was reasonable and that Kaletra makes up less of the protease inhibitor market today than it did in 2003. GSK, Rite Aid, and other drug retailers and distributors are seeking damages of up to $4.5 billion. A decision on the case is expected within a few weeks. For more information, please see the Bloomberg news article.

National Women And Girls HIV/AIDS Awareness Day – Thursday, March 10 will mark the annual National Women and Girls HIV/AIDS Awareness Day. Coordinated by the Office on Women’s Health, the day is meant to encourage nationwide discussion about HIV and AIDS among women and girls, including educating women and girls about prevention, testing, and how to live a healthy life after becoming infected with HIV. For more information or to find local events, please see the National Women and Girls HIV/AIDS Awareness Day website.

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ViiV Healthcare Opens Its Patient Assistance Program For People With HIV – On January 1, ViiV Healthcare, a joint venture by pharmaceutical companies Pfizer and GlaxoSmithKline, opened its patient assistance program to help low-income people with HIV obtain their medications. The program will cover the medications Combivir (zidovudine/lamivudine), Epivir (lamivudine), Epzicom (abacavir/lamivudine), Lexiva (fosamprenavir), Rescriptor (delavirdine), Retrovir (zidovudine), Selzentry (maraviroc), Trizivir (zidovudine/lamivudine/abacavir), Viracept (nelfinavir), and Ziagen (abacavir). Eligible participants must have an annual household income of no more than 500 percent of the federal poverty level ($72,850 for a family of two) and no prescription drug coverage for brand-name drugs. Patients on Medicaid are eligible if they meet income requirements and have spent $600 or more out of pocket for their HIV medications. For more information or to apply for the program, please see the ViiV Healthcare website.

AIDS Healthcare Foundation Offers Free HIV Drugs To People On Florida ADAP Waiting Lists – The AIDS Healthcare Foundation (AHF), a California-based treatment and advocacy group for people with HIV and AIDS, announced today that it will provide up to $1 million in free HIV drugs to people who have been placed on an AIDS Drug Assistance Program (ADAP) waiting list in Florida or have been removed from the program due to new, stricter eligibility requirements. ADAPs are programs that provide anti-HIV medications to low-income people with HIV. The offer from AHF is expected to benefit about 2,850 people and is intended to allow time for them to transition to private patient assistance programs without interrupting treatment. The HIV drugs will be distributed by AHF’s pharmacies throughout the state. For more information, please see the AHF press release.

Maine Now Requires Registration Cards For Medical Marijuana Use – A new state law that went into effect January 1 now requires registration for people in Maine who wish to use medical marijuana. Previously, the state only required a doctor’s permission for marijuana use. Applications for a registration card can be found on the Maine Department of Health and Human Services website; cards cost $100 ($75 for patients in the state’s Medicaid program, MaineCare). The new law also restricts the amount of marijuana a person can carry to 2.5 ounces and limits the number of marijuana plants a patient or their caregiver is allowed to grow. In addition, it provides for new medical marijuana dispensaries, which are expected to open in March or April. Medical marijuana has been legal in Maine since 1999 for treatment of symptoms related to specific conditions, including HIV and AIDS. For more information, please see the article at the Portland Press Herald.

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FDA Warns Of Potential Harmful Interactions Between Anti-HIV Drugs Invirase And Norvir – The U.S. Food and Drug Administration (FDA) has announced that, when used together, Invirase (saquinavir) and Norvir (ritonavir) can cause potentially life-threatening heart problems. The drugs can lead to conditions known as torsades de pointes, a type of heart arrhythmia, and heart block, which is a problem with the electrical signals in the heart. Symptoms include lightheadedness, dizziness, and abnormal heartbeat. Patients at high risk for these problems include those with preexisting heart conditions, such as abnormal heart rate or abnormal heart rhythms. The FDA encourages patients who are concerned about their antiretroviral regimen to talk to their doctor. Anyone experiencing symptoms can report them to the FDA’s MedWatch program. The FDA has updated the prescribing information for Invirase to include the new warning. For more information, please see the FDA website.

Shionogi-ViiV Healthcare Announces Phase 3 Clinical Trials For New Once-Daily Integrase Inhibitor – Shionogi-ViiV Healthcare has announced the initiation of Phase 3 clinical trials for its new once-daily integrase inhibitor, S/GSK1349572. Integrase inhibitors are a relatively new class of antiretroviral drugs; currently, the only approved integrase inhibitor is Isentress (raltegravir). The Phase 3 trials will include two studies. One will examine the effectiveness of the drug in patients who are treatment experienced but have never received integrase inhibitor-based antiretroviral therapy. The second trial will study the drug’s effectiveness in people who are treatment naïve. Both trials will compare the tolerability, safety, and efficacy of S/GSK1349572 to that of Isentress. For more information, please see the ViiV Healthcare website.

Cytheris Announces Phase 2 Clinical Trial For New Drug Targeting Latent HIV – Cytheris, a small French pharmaceutical company, has announced the initiation of a Phase 2 clinical trial for its new drug CYT107, which targets the latent viral reservoirs in people with HIV. The study will examine the effectiveness of CYT107 in combination with Isentress (raltegravir) and Selzentry (maraviroc). CYT107 is designed to activate HIV-infected cells that are infected with latent HIV – HIV that lies dormant and can start multiplying again if antiretroviral therapy is stopped. The researchers hypothesize that once these cells are activated, the latent virus reservoirs can be reduced or eliminated by administering Isentress and Selzentry. The clinical trial will be conducted in France, Spain, Italy, and the United Kingdom. For more information, please see the Cytheris press release (pdf).

NeurogesX Plans Expansion Of Pain Drug Qutenza To Include HIV-Associated Neuropathy – NeurogesX, a small San Francisco-based pharmaceutical company, has announced plans to apply for an expansion for the use of its drug Qutenza (capsaicin) to include HIV-associated neuropathy. HIV-associated neuropathy is a neurological condition that can be caused by HIV or antiretroviral drugs that damage nerve cells, causing pain, tingling, and numbness. Qutenza is a skin patch currently approved to help with pain from postherpetic neuralgia, a lingering complication of the viral infection shingles. NeurogesX plans to submit a supplemental New Drug Application to the FDA for Qutenza early next year. The application will include clinical data from two recently completed Phase 3 studies examining the effectiveness of Qutenza in patients with HIV-associated neuropathy. For more information, please see the NeurogesX website.