PHOTO COURTESY OF ORASURE TECHNOLOGIES

The Food and Drug Administration (FDA) approved a new home HIV test on July 3 that makes it possible for people to test themselves in the privacy of their homes. The availability of an HIV test that’s as easy to use as a home pregnancy test could be another step in the direction of reducing stigma associated with the disease and increasing the number of people who know their HIV status.

Dr. Anthony S. Fauci, longtime AIDS researcher and director of the National Institute of Allergy and Infectious Diseases (NIAID), called the new test a “positive step forward” and one that could help bring the 30-year-old epidemic under control.

Studies have shown that getting HIV-positive people onto antiretroviral drug therapy lowers the chance that they will transmit the virus to someone else by as much as 96%. Testing and treatment have therefore become crucial to prevention and are part of the National HIV/AIDS strategy, though questions remain as to how to guarantee access to care and treatment for those who test positive.

The OraQuick test, by OraSure Technologies, uses a mouth swab and gives results in 20 to 40 minutes. A previous test sold over the counter required the user to prick a finger and mail a drop of dried blood to a lab, thus making it days before results were known.

The new test has some drawbacks. While it is extremely accurate when administered by medical professionals, it is less so when used by consumers. Researchers found the home test to be accurate 99.98% of the time for people who do not have the virus. By comparison, they found it to be accurate 92% percent of the time in detecting people who do. So, while only about one person in 5,000 would get a false positive test, about one person in 12 could get a false negative.

One concern is the “window period” between the time someone gets the virus and begins to develop the HIV antibodies that the test detects. That can take up to three months.

Any positive test needs confirmation in a doctor’s office, the FDA said, and people engaged in high-risk sex should test themselves regularly.

The agency does not intend for the home test to replace medical testing, but instead to provide another way for people to find out their HIV status, said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.

Of concern to those who work as testers in AIDS service organizations is the issue of pre- and post-test counseling, especially for those who test positive. “My main concern is that anyone who got a positive result might harm themselves,” says Derek Worley, a tester and member of the Prevention Department at Test Positive Aware Network. “Finding out you’re positive can be a traumatic event, even if a trained counselor is there with you. I can’t imagine it would be any easier if you’re alone,” he added.

OraSure intends to set up a toll-free, 24-hour phone line to provide answers to questions and guidance to those who test positive about how to connect with care and service providers.

The home test should be available in 30,000 pharmacies, grocery stores, and online retailers by October, said Douglas Michels, OraSure’s chief executive. The price has not yet been set, but he said it would be higher than the $17.50 now charged to medical professionals because the company will do more complicated packaging for the home kit, open the 24-hour hotline, and advertise to high-risk groups, including gay men, blacks and Hispanics, and sexually active adults. Still, he said, it will be kept inexpensive enough to appeal to people who might want to buy several a year. In addition, because the FDA approved the home test only for people 17 and older, retail stores may ask customers to show ID.

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Zinc Finger Nuclease Technology Has Potential For Safer, Simpler HIV Treatment

First reported by Positively Aware in January 2010, research on the use of zinc finger nuclease technology to battle HIV has been one of the promising gene therapies in development. Pablo Tebas, MD, presented additional data from the first zinc finger nuclease (SB-728) cohorts at CROI and ICAAC last year and scientists at The Scripps Research Institute have now shown that a new technique may be a safer alternative to current experimental gene therapy against HIV infection.

“We showed that we can modify the genomes of cells without the troubles that have long been linked to traditional gene therapy techniques,” said the study's senior author Carlos F. Barbas , the Janet and Keith Kellogg Professor of Molecular Biology and Chemistry at The Scripps Research Institute.

The new technique, reported in Nature Methods, employs zinc finger nuclease (ZFN) proteins, which can bind and cut DNA at precisely defined locations in the genome. ZFNs are coming into widespread use in scientific experiments and potential disease treatments, but typically are delivered into cells using potentially risky gene therapy methods.

The Scripps Research scientists simply added ZFN proteins directly to cells in a lab dish and found that the proteins crossed into the cells and performed their gene-cutting functions with high efficiency and minimal collateral damage.

“This work removes a major bottleneck in the efficient use of ZFN proteins as a gene therapy tool in humans,” said Michael K. Reddy, who oversees transcription mechanism grants at the National Institutes of Health's (NIH) National Institute of General Medical Sciences, which helped fund the work, along with an NIH Director's Pioneer Award. “The directness of Dr. Barbas's approach of 'simply' testing the notion that ZFNs could possess an intrinsic cell-penetrating ability is a testament to his highly creative nature and further validates his selection as a 2010 recipient of an NIH Director's Pioneer Award.”

Scientists had assumed that ZFN proteins cannot cross cell membranes, so the standard ZFN delivery method has been a gene-therapy technique employing a relatively harmless virus to carry a designer ZFN gene into cells. Once inside, the ZFN gene starts producing ZFN proteins, which seek and destroy their target gene within the cellular DNA.

One risk of the gene-therapy approach is that viral DNA—even if the virus is not a retrovirus—may end up being incorporated randomly into cellular DNA, disrupting a valuable gene such as a tumor-suppressor gene. Another risk with this delivery method is that ZFN genes will end up producing too many ZFN proteins, resulting in a high number of “off-target” DNA cuts. The viral delivery approach involves a lot of off-target damage, according to Barbas, and it is hoped that the new methodology will enable scientists to avoid such damage.

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Interactive AIDS Map Updated

AIDSVu allows users to view HIV rates in the U.S. by state and county, alongside key social determinants of health, such as poverty, lack of health insurance, and educational attainment. It also provides local information about HIV testing and treatment site locations, state AIDS Drug Assistance Programs (ADAPs), and the estimated percentage of HIV diagnoses that are made late in the course of the disease. 

With the new update, AIDSVu now shows the latest HIV prevalence data for 13 U.S. cities by ZIP code or census tract. Cities include: Atlanta, New York City, New Orleans, San Francisco and Detroit. 

“The new city maps on AIDSVu help us understand which communities are most impacted by HIV and where we need to focus resources,” says principal researcher Patrick Sullivan, PhD, DVM, associate professor of epidemiology, Emory University’s Rollins School of Public Health. “The information on AIDSVu can help educate all Americans about what HIV looks like in the U.S., and support efforts to prevent new HIV infections, expand HIV testing and improve care for people living with HIV.”

To visit the AIDSVu site, please click here.

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Studies Find Once-daily “Quad” Pill for HIV is Safe and Effective

The findings of two large international randomized trials published last week in The Lancet indicate that the new once-daily pill combining three antiretrovirals and a booster molecule is a safe and effective alternative to two widely used drug regimens for newly diagnosed HIV-positive adults who have had no previous treatment. The study results also indicate that the new "Quad" pill is faster acting, doesn't have the neuropsychiatric side effects associated with other combinations, and could improve compliance with treatment.

“Patient adherence to medication is vital, especially for patients with HIV, where missed doses can quickly lead to the virus becoming resistant to medication. Older HIV treatment regimens involve taking several pills multiple times a day,” explains Paul Sax from Brigham and Women's Hospital, Harvard Medical School, lead author of the first study. “Our results provide an additional highly potent, well-tolerated treatment option, and highlight the simplicity of treatment resulting from combining several antiretrovirals in a single pill. Studies have shown that single pill treatments improve both adherence and patient satisfaction, and help prevent prescription errors, thereby reducing the likelihood of treatment failure and drug resistance.”

The first trial randomly assigned 700 patients from centers across North America to start treatment with two different single tablet regimens—either Quad, combining the new integrase inhibitor elvitegravir (EVG) boosted with cobicistat (a new pharmacoenhancer; COBI) plus emtricitabine/enofovir (Emtriva/Viread), or Atripla, the current gold standard regimen approved by the FDA in 2006.

After 48 weeks of treatment, 88% of patients given Quad suppressed viral loads to undetectable levels (less than 50 copies per mL of blood), compared with 84% in the Atripla group.

Adverse events that led to patients discontinuing treatment were infrequent and similar in both groups. Mild nausea was more common with Quad, but patients were less likely to have dizziness, abnormal dreams, insomnia, and rash compared with the Atripla regimen.

The second trial included 708 treatment-naïve adults from 146 medical centers across Australia, Europe, North America, and Thailand. Patients were randomly assigned to receive once-daily Quad or a popular and recommended twice-daily combination of Norvir-boosted atazanavir (atazanavir/ritonavir or Reyataz/Norvir) plus emtricitabine/tenofovir.

The primary endpoint, to achieve viral levels below 50 copies per mL of blood by week 48, was reached by 90% of people in the Quad group compared with 87% in the atazanavir/ritonavir/emtricitabine/tenofovir group.

The safety of the two regimens was also similar with only 3.7% of patients stopping treatment in the Quad group and 5.1% of patients in the ATV/RTV/FTC/TDF group. However, a higher number of kidney complications were reported in patients taking Quad compared with the other HIV treatments.

“If approved by regulatory agencies, the Quad would be the first once-daily single-tablet regimen containing an HIV integrase inhibitor. Based on the safety and efficacy results from the two large-scale clinical studies, Gilead believes the Quad represents a potentially important new treatment option for a wide range of HIV patients initiating therapy,” concludes Brian Kearney, one of the authors from Gilead Sciences who developed the Quad pill.

In a linked Comment, Rik Schrijvers and Zeger Debyser from the Katholieke Universiteit Leuven in Belgium say, “[The studies] show that Quad has high efficacy and a good tolerability profile, with the limitations of potential drug interactions and a need to be taken with food. The underrepresentation of women in these studies, and absence of long-term safety data (especially for renal toxic effects) and resistance data, warrant further research.”

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Janssen Improves Patient Savings Program

Janssen Therapeutics, formerly Tibotec, has announced changes to its Patient Savings Program (PSP) that will help patients pay for their HIV drugs. Changes include the following:

• Financial criteria for eligibility has been removed. As of February 2012, commercially insured patients no longer have to meet a threshold of income to be considered eligible for this program, as long as they are commercially insured.
• As of April 1, 2012, commercially insured patients who are eligible and enroll in the PSP will now pay no more than $5 per month for each Janssen Therapeutics Product prescribed.  

Changes to the PSP do not change or impact the Janssen Therapeutics Patient Assistance Program (PAP) for patients without insurance coverage who meet program eligibility criteria.

In addition, Janssen will continue its participation in the Welvista initiative which allows patients on AIDS Drug Assistance Program (ADAP) waiting lists in most states to obtain cost-free HIV medications from multiple companies through a single source.  

To learn more about the program, click here or call 1-866-961-7169.

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AIDS2012 Reunion to Provide One-Stop Resource for Conference Events

AIDS2012 Reunion represents the District of Columbia, regional, national and international HIV, AIDS and Lesbian, Gay, Bisexual and Transgender and Questioning communities, all of which will unite to connect, commemorate, collaborate, and energize efforts around the 2012 International AIDS Conference, being held later this month in Washington, D.C.

AIDS2012 Reunion is a one-stop resource for people living with HIV and AIDS, the general public, and international AIDS conference attendees to learn more about community-based events and programs

Some highlighted events:

• International AIDS Candlelight vigil to be held right after the Opening Ceremony
• International AIDS Film Festival
• AIDS2012 Reunion Dance Party at Town Nightclub
• Breakfast satellite symposiums

For information on these events, and many other events happening in the community before during and after the conference please visit the AIDS2012 Reunion Website, or follow it on Facebook, and Twitter. And watch for more information on the downloadable app coming soon!

For questions or media inquiries please e mail: events@AIDS2012Reunion.org  

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Living with Henry Premieres in New York

Living with Henry, a new Canadian musical, explores present day issues of living with HIV such as stigma, disclosure, and interpersonal relationships. The musical will be premiering in New York City this summer from July 23–29 as part of the New York Musical Theatre Festival.

“It has become apparent that there are few, if any, theatrical productions that discuss HIV in the ‘now’ context,” says writer and director Christopher Wilson, who is himself HIV-positive. “Living With Henry is a contemporary theatrical view of HIV/AIDS, framing it as a chronic illness rather than a death sentence.”

Tickets are $25 and can be purchased online at nymf.org or by calling (212) 352-3101. 

For more information, click here.

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TPAN to Present Forum on Healthcare

Confused about the recent Supreme Court ruling on the Affordable Care Act? Unsure about just what to expect from the new law? Wondering if there’s a better way? Come to TPAN’s Committed to Living Forum to learn about and discuss what’s happening in healthcare in the U.S.

The event will take place on July 19, from 7:00 – 9:00pm, at 5537 N. Broadway, Chicago.

The Healthcare Movie, a documentary which explores the history and differences of Canada’s healthcare system, will be shown from 7:00–8:00. Following the screening will be a discussion of the Supreme Court ruling, the facts about what the ACA does and does not provide, and the importance of the HIV community advocating for single-payer healthcare. Speakers include TPAN’s executive director, Bill Farrand, AIDS activist Keith Green, and Sue Saltmarsh, writer and copy editor of Positively Aware magazine and chief organizer of the Demonstration for Universal Healthcare (DUH).

A light meal will be provided. Space is limited, so RSVP by July 16 to Jessie Mott at 773-989-9400 or j.mott@tpan.com.

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Legislation Watch

As predicted, fallout from the Supreme Court ruling on the Affordable Care Act (ACA) is just beginning. The Hill reports that the House Ways and Means Committee will hold a hearing on the “tax ramifications” of the Supreme Court's ruling on the healthcare law. (See the online extra “Stop! In the Name of Health: The Supremes Rule on the ACA” here.)

The July 10 hearing will mark the first chance for members of Congress to formally hash out the ruling, which allowed the law's individual mandate to buy health insurance by treating the penalty for not doing so as a tax, even though Chief Justice John Roberts said it could not be upheld as a way to regulate commerce under the Commerce Clause.

Committee Chairman Dave Camp (R-Mich.), who disagrees with the ruling, said the hearing would help assess the meaning behind it and inform ways to repeal the bill. Republicans are said to have scheduled a vote on repeal as early as July 11, though this hearing may prolong the agony a bit.

Two of our favorite bills gained co-sponsors in late June. HR 3053, the REPEAL Act, to stop HIV discrimination in the law, gained Democrat Jim McDermott from Washington state and Theodore Deutch, Democrat from Florida, signed on to HR 4470, which would require HIV screenings to be covered by insurance.

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