Boehringer Ingelheim Launches Co-Pay Rebate Program for Viramune
Senate Committee Votes to Restore Abstinence Education Money
San Francisco Could Lose Up to $5.3 Million in AIDS Funding
Study Highlights HIV/AIDS Challenges in U.S. Prison System
Engineered T-cell Receptor Trial Opens
Boehringer Ingelheim Launches Co-Pay Rebate Program for Viramune
On October 6, Boehringer Ingelheim Pharmaceuticals, Inc. (BI) announced the launch of the Viramune Co-Pay Savings Program, a special program that will allow patients to save up to $50 on their health insurance co-payment on every monthly refill of a Viramune prescription for up to one year. Anyone with a Viramune prescription whose health insurance coverage requires a patient co-payment is eligible for the program.
According to the BI press release, “A valuable feature of the program is the use of a MasterCard debit card that is solely dedicated to the purchase of a Viramune prescription, which can be used at any pharmacy that accepts MasterCard.” The card will immediately deduct up to $50 from the co-payment for Viramune.
"There is a growing reliance by patients on co-pay and patient assistance programs offered by pharmaceutical companies and this rebate program makes it easier for HIV/AIDS patients to benefit," said Albert Ros, executive vice president of Sales and Marketing for BI. "Initiatives to ease the financial burden of health insurance co-payments for HIV/AIDS patients such as this one underscore our commitment to helping patients obtain the care and treatment they need."
Consumers can obtain the Viramune Co-Pay Savings Card through their health care providers. The card will need to be activated by calling a toll-free hotline at 1-888-99-VIRAMUNE (1-888-998-4726) or logging onto www.viramune.com. Once activated, the Viramune Co-Pay Savings Card can be presented, together with a Viramune prescription, at any pharmacy that accepts MasterCard. The Viramune Co-Pay Savings Card will also be accepted at mail order pharmacies.
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Senate Committee Votes to Restore Abstinence Education Money
On September 29, the Senate Finance Committee voted 12-11 to restore $50 million in annual federal abstinence-only funds. The vote came despite objections from committee chair Sen. Max Baucus (D-Montana) and a push by President Barack Obama to direct abstinence money to broader teen pregnancy-reduction programs. Two Democrats, Kent Conrad (ND) and Blanche Lincoln (AR), joined all 10 committee Republicans in voting in favor of the measure. An alternative measure offered by Baucus that would make money available for education on STDs and contraception, in addition to abstinence, passed 14-9. Lawmakers must reconcile the two measures as the legislation moves forward to the full House and Senate.
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San Francisco Could Lose Up to $5.3 Million in AIDS Funding
San Francisco could lose up to $5.3 million dollars in awards for HIV/AIDS care and treatment under the Ryan White CARE Act financing formula currently moving through Congress. The Senate Health, Education, Labor and Pensions (HELP) committee unanimously voted to extend the funding provided under the Ryan White CARE Act of 1990 for four years, but the extension does not include a provision that would help restore funding for San Francisco, aides to House Speaker Nancy Pelosi (D-CA), said.
Since the 2006 reauthorization of the Act, San Francisco has been losing funding due to an increase in the number of AIDS cases in rural areas and among women, causing a shift in the allocation of funding away from cities such as San Francisco, referred to as EMAs (eligible metropolitan areas). Pelosi has been able to mitigate the losses through a separate appropriations process, and last year squeezed out $7 million in extra funding for San Francisco.
If the provision that she supports becomes part of this year's Ryan White funding legislation, it would provide a permanent fix, her aides said. Opponents of the provision, including Sen. Michael Enzi (R-WY), the ranking Republican on the Senate HELP Committee, argue that the provision is just an earmark for San Francisco, but Pelosi's aides said she is trying to increase funding across the country in addition to her district.
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Study Highlights HIV/AIDS Challenges in U.S. Prison System
HIV/AIDS is up to five times more prevalent in American prisons than in the general population. Though adherence to antiretroviral treatment (ART) can be monitored while inmates are in prison, a new study, published in the journal PLoS ONE, suggests the majority (76%) of inmates take their ART intermittently once they leave prison, increasing the risk to the general population.
"Over a period of 9 years, we studied 512 HIV-positive repeat offender inmates from the San Francisco County jail system," says Dr. Pant Pai, co-author of the study. "Our results show that only 15% continuously took their ART between incarcerations or after their release. Taking ART intermittently is a problem because it depletes the CD4 count—the immunizing cells that fight infection—and increases the probability of developing resistance to the virus." He added, "The risk for rapid disease progression becomes higher and presents a risk for public health transmission of HIV to their partners." According to the study, those on intermittent therapy were 1.5 times more likely to have higher viral loads than those on continuous therapy and those who had never received therapy were three times more likely to have a higher viral load.
"The optimal solution for treating patients and controlling the HIV/AIDS epidemic in the U.S. is to ensure continuous therapy," explains Dr. Milton Estes, medical director of the Forensic AIDS Project, San Francisco. "To achieve this, we must work on various aspects of the prisoners’ lives, such as marginalization, psychiatric problems, and drug use, both before and after their departure from prison."
According to Dr. Jacqueline Tulsky, senior author of the study, "This research highlights the need to examine ART policies inside and outside correctional settings with a view to establishing effective life-long management of HIV in prisoners."
Funding was provided by a grant from the National Institutes of Health.
To read more about the many challenges of HIV care in correctional facilities, be sure to pick up a copy of the November/December issue of Positively Aware entitled “HIV Behind Bars: A Life Sentence,” available in print and online in early November.
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Engineered T-cell Receptor Trial Opens
On October 7, researchers at the University of Pennsylvania School of Medicine and Adaptimmune, Limited announced the approval of an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) and opening for enrollment of the first-ever study using patients’ cells carrying an engineered T-cell receptor to treat HIV. The trial (SL9 HA-GAG-TCR) may provide important information towards the development of new treatments for HIV that potentially slow—or even prevent—the onset of AIDS.
According to a press release, the trial makes use of the body’s natural ability to recognize infected cells by enhancing the power of the T-cell receptor (TCR) on killer T-cells. When a virus infects cells, it hijacks the host cell machinery in order to replicate and spread infection. These infected cells then expose or “present” small parts of the virus proteins on their surface, offering a "molecular fingerprint" called an epitope for killer T-cells from the immune system to identify. This triggers an immune response, eliminating the virus and any cells involved in its production. However, HIV not only replicates itself quickly, but also has the ability to mutate rapidly, thus disguising its fingerprints to enable it to hide from killer T-cells.
Last year, with colleagues at the University of Pennsylvania, researchers from Adaptimmune, Ltd. engineered and tested a killer T-cell receptor that can recognize all the different disguises HIV is known to have used to evade detection. The researchers transferred this receptor to the killer T-cells to create genetically engineered "bionic assassins" able to destroy HIV-infected cells in culture. Now, less than a year later, they are taking their unique technology into the clinic.
Dr. Betn Jakobsen, Chief Scientific Officer at Adaptimmune Ltd., says, “Together with our colleagues at the University of Pennsylvania, we have previously shown that it is possible to engineer a T-cell receptor that detects the known spectrum of HIV escape mutants for this particular fingerprint and triggers a more potent immune response when transferred into a patient’s cells. Today sees that important research result move into the clinic—for the first time allowing us to test the power of super potent immune cells against HIV in reality.”
The trial will be led by Carl June, M.D. of the Abramson Family Cancer Research Institute and the Department of Pathology and Laboratory Medicine with Pablo Tebas, M.D., Director of the adult AIDS Clinical Trials Unit (ACTU), Department of Infectious Diseases Division at the University of Pennsylvania.
“This is the first time an engineered T-cell receptor will be given to patients with HIV infection,” said June. “We will be treating patients currently well-controlled on HAART therapies in order to establish whether the engineered killer T-cells containing the receptor are safe, and to identify a range of doses of the cells that can be safely administered. It is a truly an important day for T-cell immunotherapy.”
HIV-infected patients interested in learning more about the trial should contact Larisa Zifchak at (215) 349-8091 or larisa.zifchak@uphs.upenn.edu.
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