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POSITIVELY AWARE December 12th 2011

Number of people on the ADAP waiting list, 9,066

NYC Health Officials Recommend AIDS Drugs for Any Person with HIV

Health officials in New York City are recommending that any resident living with HIV be offered AIDS drugs as soon as the virus is diagnosed, an aggressive move that has been shown to prolong life and stem the spread of the disease, according to an Associated Press report on msnbc.com on December 1. San Francisco is the only other city known to have made such a recommendation, in 2010.

New York City Health Commissioner Thomas Farley said recent studies have shown that the benefits of early treatment, combined with education and testing, appear to be a promising strategy for countering the epidemic.

City health officials said the new recommendation could initially help about 3,000 people get on medications. About 66,000 New Yorkers living with HIV that the Health Department tracks are being effectively treated with AIDS drugs, they said. But they said it was difficult to estimate how many people would eventually need the medications.

Some doctors agree with the Department of Health that it is time to update the guidelines for initiating AIDS drug treatment.

Dr. Joel Gallant of Johns Hopkins University School of Medicine and vice chair of the HIV Medicine Association also agrees with the New York recommendation for offering early treatment. He recommends early treatment for his own patients.

"Nobody I know who is an HIV expert feels that it's a bad idea to treat HIV at high CD4 counts from a medical or scientific standpoint," Gallant said. "If there are objections, they'd usually be based on cost or feasibility."

Cost questions are important because brand-name drugs can retail for $1,200 to $1,600 per month. City health officials said they anticipate that the cost for expanding the use of AIDS drugs would be covered by private insurance or by the AIDS Drug Assistance Program (ADAP). The officials said they expect the benefits over the long term would far outweigh the initial costs because there would be fewer hospitalizations and new HIV cases.

Dr. Moupali Das, the director of research at the San Francisco Department of Health HIV Prevention Section, said its surveillance data indicated that physicians were treating their HIV patients early even before the city recommended doing so. She said they are currently analyzing what has happened since the recommendations went into effect. But, anecdotally, she said that there has been a change among patients seeking treatment. "It's changed the dialogue and empowered our patient population," she said.

"What we're doing here is we're making a really clear and unequivocal statement that we think this is good for the health of the patient, good for the health of the entire population, good for the response to the epidemic," Farley said.

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Majority of Americans with HIV Are Not Getting Optimal Care

In a November 29 article in the Washington Post, it was reported that only slightly more than a quarter of HIV-positive Americans are getting the kind of medical care that maximizes their life expectancy, according to a new estimate from the Centers for Disease Control and Prevention (CDC).

The goal of HIV treatment is to suppress the virus until it is no longer detectable in the bloodstream. Only 28% of the 1.2 million people living with HIV in the United States have their viral load controlled to that optimal degree, according to epidemiologists at the CDC.

 “It is time to act even more aggressively,” said Jonathan Mermin, MD, director of the CDC’s Department of HIV/AIDS Prevention. Having such a small fraction of people adequately treated “is not acceptable from a public health, humanitarian, or economic perspective,” he said.

Several years ago, the CDC endorsed universal HIV testing of Americans. With new research showing that treated people are unlikely to transmit the virus to others, the agency is campaigning for physicians and health departments to make sure that people who are found to be HIV-positive get into treatment. For those who enter and stay in care, approximately 77% achieve undetectable viral loads. However, the CDC reports that as many as 50% of those who enter care, end up dropping out.

While high rates of attrition from treatment can be common due to reluctance to take pills, drug side effects, inconvenience, expense, and denial, studies have shown that 32% of Latinos, 21% of blacks and 16% of whites are uninsured, potentially creating an obstacle to HIV treatment. This is not likely to improve with the current political climate and proposed cuts to Medicare and Medicaid.

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Activists Launch Survey for HIV-Positive People to Help Cure Research

A coalition of HIV advocacy groups is calling on all people with HIV to take 10 minutes to complete a survey they hope will help speed the pace of HIV cure research.

At issue are the kinds of risks that the U.S. Food and Drug Administration (FDA) will allow in early phase clinical studies of promising treatments to either eradicate HIV from the body or to help the immune system better control the virus without the need for antiretroviral drugs.

“There are complex considerations in the FDA’s regulation of early studies that might carry certain health risks, especially if those studies are designed more to move the science forward than to achieve an immediate cure in the individual,” said David Evans, director of research advocacy for Project Inform in San Francisco.

“We believe that soliciting the opinions of people with HIV regarding the potential risks involved will help inform discussions regarding the design of these trials, and shed light on the extent to which individuals are willing to assume some risk even if the study would only help people further down the road,” Evans continued.

Evans, in partnership with Nelson Vergel, director of the Program for Wellness in Houston, and Richard Jefferys from the Treatment Action Group in New York City, devised the survey to help measure the willingness of people with HIV to participate in research for more altruistic reasons and to gauge the factors that are most strongly associated with a person’s willingness.

The activists are hoping that the results of the survey may lead to more openness toward community input on the part of the FDA’s Center for Biologics and Evaluation Research (CBER) which will be responsible for reviewing many cure-oriented treatments.

“Several researchers are designing studies right now that will soon ask people to take some risks to learn more about new approaches to cure HIV. It is important for the HIV community to let them and the FDA know what it is willing to do to advance a cure of an illness that kills more than 2 million people per year,” said Vergel.

Vergel and his colleagues are hoping that people with HIV and their service providers will spread word widely about the survey. The larger the number of people who take it, and the greater the diversity of the survey-takers, the more legitimacy the survey results will have. The group intends to make the results of the survey public before the launch of the 2012 International AIDS Conference that will take place in July in Washington, D.C.

To take the survey here.

To read more about it, go to Evans’ blog here, or Vergel’s web site—powerusa.org.

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December 15 Webinar on Sequestration Effects on HIV Programs

The Congressional Super Committee didn’t reach a budget deficit reduction agreement before Thanksgiving, meaning automatic federal budget cuts will go into effect in 2013.  The media says the Super Committee failed, but the lack of agreement might result in critical protections for programs that are vital for people with HIV.  

-Are the automatic budget cuts a win or loss for people with HIV?  

-What do automatic budget cuts mean for health reform, Medicaid and Medicare, and under-funded HIV prevention, care, housing and research programs?

-What can our community do to continue to protect these programs

-What happens next, and how can you explain what’s happening to your community without making everyone’s eyes glaze over?

If you have a hard time spelling “s-e-q-u-e-s-t-r-a-t-i-o-n”, this webinar’s for you!  Please join AIDS Foundation of Chicago, AIDS United, and Treatment Access Expansion Project/Harvard Law School for a live webinar entitiled “Is no deal a good deal? Deficit Reduction, HIV Services & What Comes Next” on Thursday, December 15 at 1 p.m. ET/12 p.m. CT/11 a.m. MT/10 a.m. PT.

Space is limited. Reserve your Webinar seat now.

After registering you will receive a confirmation email containing information about joining the Webinar.

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Mayo Clinic Makes Kidney and Pancreas Transplants Available to HIV-Positive Patients

Mayo Clinic in Florida is now offering kidney and pancreas transplants to HIV-positive patients with advanced kidney disease and diabetes, according to a report from December 6 at ScienceDaily. Evidence is now solid that HIV-positive patients have the same favorable outcome in terms of patient and allograft survival as HIV-negative positive organ transplant recipients, says Mary Prendergast, MD, a kidney specialist whose focus is the care of patients who receive kidney and pancreas transplants.

"With the utilization of HAART therapy to control HIV disease, it is very clear that solid organ transplant is both feasible and successful," she says. "We are very excited to be able to offer this service, which will provide end-stage kidney disease patients an alternative to years of difficult dialysis treatment."

Past concerns relating to the necessity of using anti-rejection medications for already-immunosuppressed HIV-positive patients have been overcome with clear evidence that there is no increase in either the incidence of opportunistic infection or an acceleration of HIV disease, as demonstrated in a recent large multi-center U.S.-based study, published in November in The New England Journal of Medicine.

Mayo Clinic in Florida has offered liver transplant for HIV-positive patients for a number of years now, according to Dr. Prendergast, and currently performs approximately 110 kidney transplants each year, and 10 pancreatic transplants, either alone or in combination, for non-HIV patients. Criteria for transplantation in HIV-positive patients include an undetectable viral load and CD4 count greater than 200 cells per cubic millimeter, she says. Patients will be eligible to receive both deceased and living donor transplant organs.

The need for organ transplants is widespread, Dr. Prendergast adds. Currently there are 96,000 patients on the kidney transplant and 1,300 on pancreas transplant wait lists, according to the United Network for Organ Sharing (UNOS).

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Gilead’s Cobicistat Meets Phase 3 Primary Objective

Gilead Sciences, Inc. announced on December 5 that a Phase 3 clinical trial (Study 114) of its pharmaco-enhancing, or boosting agent, cobicistat, met its 48-week primary objective of non-inferiority to Norvir (ritonavir). Cobicistat increases blood levels of certain HIV medicines to allow for one pill once-daily dosing.

The Study 114 primary endpoint analysis indicated that after 48 weeks of treatment, 85% of patients taking a regimen of cobicistat-boosted Reyataz (atazanavir, a protease inhibitor) plus Truvada (emtricitabine and tenofovir disoproxil fumarate) achieved an undetectable HIV RNA (viral load) of less than 50 copies/mL, compared to 87% of patients taking Norvir-boosted Reyataz plus Truvada. Discontinuation rates due to adverse events were 7.3% and 7.2% in the cobicistat and ritonavir arms of the study, respectively. Gilead plans to submit these data for presentation to a scientific conference in 2012.

“The majority of today’s protease-based HIV treatment regimens depend on a boosting agent for optimal efficacy,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “These results demonstrate that cobicistat may provide patients taking protease-based regimens with a much-needed alternative boosting agent. We are now working toward a second quarter 2012 U.S. regulatory filing for cobicistat.”

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OraQuick for Hep C Granted CLIA Waiver

OraSure Technologies, Inc. announced on November 29 that the Food and Drug Administration (FDA) has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its OraQuick HCV Rapid Antibody Test, the first and only FDA approved rapid test for the detection of antibodies to the hepatitis C virus (HCV). The test, which can be used with both fingerstick whole blood and venous whole blood specimens, utilizes the OraQuick technology platform and provides results in 20 minutes.

With this waiver, the OraQuick HCV test can now be used by more than 180,000 sites in the United States to test people who are at risk for hepatitis C or have signs or symptoms of hepatitis. These sites now extend to facilities that can perform CLIA-waived tests, such as outreach clinics, community-based organizations, and physician offices.

“Today, more than four million Americans are infected with hepatitis C and the vast majority does not know it,” said Dr. Willis C. Maddrey, President of the Chronic Liver Disease Foundation. “Hepatitis C is a leading cause of chronic liver disease, cirrhosis, and liver cancer. However, new therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic.”

"A CLIA waiver for our OraQuick HCV test represents a critical milestone in our quest to make the test available to the widest possible range of at risk individuals in the U.S.,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies.

For more information on OraSure Technologies, please visit orasure.com.

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Discrimination Suit Filed in Pennsylvania

The AIDS Law Project of Pennsylvania filed a federal discrimination lawsuit against the Milton Hershey School in Hershey, Pennsylvania, for refusing to enroll a 13-year-old pupil because he has HIV, according to a November 30 press release.

The complaint, filed in U.S. District Court in Philadelphia, alleges that the school “violated multiple anti-discrimination laws” when it refused to enroll the Delaware County middle-school pupil for the 2011-12 school year, based solely on his HIV status.

AIDS Law Project Executive Director Ronda B. Goldfein, Esq. said she was struck by the similarities between her client and the late Ryan White, an HIV-positive student who became a national spokesman for AIDS research and public education. White, who died at age 18 in 1990, had been expelled from middle school when his diagnosis became widely known.

“Like Ryan White, this young man is a motivated, intelligent kid who poses no health risk to other students, but is being denied an educational opportunity because of ignorance and fear about HIV and AIDS,” said Goldfein, who is representing the boy and his mother. The names of the plaintiffs are not being released in order to protect their privacy.

Goldfein pointed out that public health authorities have unequivocally declared that HIV is not transmitted through normal day-to-day contact in schools or social settings. According to the suit, the boy “is an honor roll student and an avid athlete.” He controls his HIV through a regimen of medications that “do not impact his school schedule.”

The federal Americans with Disabilities Act and other federal and state laws prohibit discrimination on the basis of a real or even a perceived disability, including having HIV. According to the National Association of State Boards of Education, “the presence of a person living with HIV infection or diagnosed with AIDS poses no significant risk to others in school, day care, or school athletic settings.”

The suit seeks to have the school admit the boy, develop an anti-discrimination policy, and conduct sensitivity training for all staff regarding HIV disease. It also requests awards for compensatory and punitive damages, costs, and attorney fees.

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Legislation Watch

By Sue Saltmarsh

First, the mystery of S. 1920 and H.R. 3515 has been solved. The SMART Prevention Act provides that “The Attorney General, in consultation with the Secretary of Health and Human Services and the Secretary of Education, is authorized to award grants for the purpose of preventing domestic violence, dating violence, sexual assault, and stalking…” Though it is not specifically HIV-related, it’s a good thing.

Otherwise, Congress continues to be mired in dysfunction. No sign of hope for resolution is visible as far as the tax/revenue issue is concerned and indications are that Congress will break for the holidays without letting the employed among the 99% know whether or not more taxes will be taken from their paychecks starting in January. But that’s OK with me, because come November, it will be up to us to make sure that those responsible don’t even have paychecks anymore. Just a reminder—all 435 seats in the House will be up for re-election, except for those who have decided not to run. Do your homework and vote knowledgeably!

If you live in a state that has imposed restrictions on voters’ rights, get your ducks in a row—get that photo i.d., that copy of your birth certificate, join whatever organization that has a membership card they’ll accept as proof of identity, do whatever you have to do to show them that you will fight for your constitutional right to vote no matter what obstacles they throw in your way!

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