Positively Aware Online News Brief. Current HIV News and events
POSITIVELY AWARE 8/6/2012
HEADLINES THIS ISSUE:
HarborPath Creates a Single Portal for Access to HIV Meds for Uninsured
HarborPath, a new non-profit organization, has been established to create a program that offers a single place where uninsured HIV-positive people who otherwise qualify for manufacturer-sponsored patient assistance programs can apply for and receive their medications. The “one stop shop” portal will provide a streamlined, online process to qualify individuals and deliver the donated medications through a mail-order pharmacy. HarborPath will pilot the program in states with high need, including Alabama, Texas and Virginia.
To create the portal, HarborPath worked closely with the National Alliance of State and Territorial AIDS Directors (NASTAD) and the Clinton Health Access Initiative (CHAI), which provided the seed funding for the organization. On World AIDS Day 2011, President Clinton noted the need to fight HIV/AIDS in the United States.
“HarborPath’s new program addresses a critical need, and answers this call for a renewed emphasis on the domestic HIV epidemic,” said President Clinton. “I am proud that my Foundation is partnering with NASTAD and other pharmaceutical manufacturers to make sure Americans living with HIV have access to the life-saving medications they need. This is an important step forward in our fight against the disease.”
ViiV Healthcare is the first pharmaceutical company to agree to support the program by donating HIV/AIDS medications and funding.
“We are pleased to support HarborPath as it has the potential to allow more patients in need access to treatment and help retain them in care by simplifying the process of getting their complete regimen,” said Bill Collier, Senior Vice President and Head of North America for ViiV Healthcare.
“Pharmaceutical company-sponsored prescription assistance programs serve as an invaluable safety net for low-income, uninsured individuals,” said Ken Trogdon, Jr., President of HarborPath. “Our program will simplify the process for the thousands of individuals living with HIV/AIDS who fall out of the system. HarborPath has evolved from discussions and requests from the community and the industry for a collaborative, seamless solution for the uninsured.”
The goal of HarborPath is to get all HIV/AIDS medications into the program and serve uninsured individuals with:
- An easy-to-use website with a single portal to determine eligibility for the program and to fill prescriptions for participating companies’ HIV/AIDS medications.
- Automatic notifications for both the individual and the case manager of qualification for the program.
- A pharmacy that ships a 3-month supply of all participating medications in one package within two business days of final approval and confirms delivery of the medications.
- Renewal reminders to individuals and case managers to improve medication adherence.
- A fully automated portal that case managers can access at any time for up-to-the-minute status of an individual’s application or shipment. If needed, live support is also available through a toll-free call center.
Murray Penner, Deputy Executive Director at NASTAD, said, “Under the current PAP process, an individual or their case manager has to apply separately to each company’s program for these medications, which can be complex and time-consuming. Thankfully, individuals are living longer with HIV/AIDS due to combination antiretroviral treatments. Missing doses or failing to fill prescriptions because of complications sometimes associated with these processes may result in serious health consequences, or even death, in addition to increased transmission of the virus. HarborPath is designed to address this urgent need in the United States.”
ACA Provision Increases Access to HIV Testing for Women
On August 1, another beneficial provision of the Affordable Care Act (AC) went into effect—most private insurance plans are now required to cover annual HIV screening and counseling for sexually active women, one of the eight preventative services that must be covered with no co-pay or out-of-pocket cost.
“Increasing access to testing and linking people to care and treatment is critical in our fight to end the AIDS epidemic. Expanded testing for women brings us one step closer towards that goal,” commented Carl Schmid, Deputy Executive Director of The AIDS Institute. “Having coverage for HIV testing is one essential component. Now, we must educate women and their providers that this coverage exists so that all women with private insurance will take advantage of this opportunity and learn their HIV status.”
The coverage of women's preventive services applies to all non-grandfathered insurance plans and though testing may now be more accessible, it remains to be seen how access to treatment will fare. Like many other provisions of the ACA, budget-slashing legislators are determined not to appropriate the funds necessary for implementation.
FDA Updates Victrelis Label for Interactions with Other Drugs
IMAGE © MERCK
The Food & Drug Administration (FDA) updated the Victrelis (boceprevir) label on July 31 to include drug-drug interactions between Victrelis and cyclosporine, tacrolimus, escitalopram, atorvastatin and pravastatin. The main changes to the label are highlighted below.
Changes were also made to the Medication Guide to reflect the new interaction data.
Section 7: Drug Interactions was updated to include information regarding the following drug-drug interactions:
- Atorvastatin: Exposure to atorvastatin was increased when administered with Victrelis. Use the lowest effective dose of atorvastatin, but do not exceed a daily dose of 40 mg when taken with Victrelis
- Cyclosporine: Dose adjustments of cyclosporine should be anticipated when administered with Victrelis and should be guided by close monitoring of cyclosporine blood concentrations, and frequent assessments of renal function and cyclosporine-related side effects.
- Escitalopram: Exposure of escitalopram was slightly decreased when taken with Victrelis. Selective serotonin reuptake inhibitors such as escitalopram have a wide therapeutic index, but doses may need to be adjusted when combined with Victrelis
- Pravastatin: When taking pravastatin with Victrelis, there is increased exposure to pravastatin. Treatment with pravastatin can be initiated at the recommended dose when taken with Victrelis. Close clinical monitoring is warranted
- Tacrolimus: Victrelis taken with tacrolimus requires significant dose reduction and prolongation of the dosing interval for tacrolimus, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects.
Section 12: Clinical Pharmacology was updated to include the magnitude of interaction between Victrelis and these medications.
The complete, revised label and Medication Guide can be viewed at Drugs@FDA.
In a 3-1 vote on July 24, the Los Angeles County Board of Supervisors approved a ballot initiative that will let voters decide whether adult-film actors must wear condoms during sex scenes. The measure would require porn producers to get county-issued health permits; the fees from the permits would be used to cover enforcement costs. More than 371,000 signatures were gathered to get the initiative on the ballot in November.
Alan K. Cubbage, Northwestern University Vice President for University Relations, announced in a statement on July 30, “Northwestern University cancelled the Multicenter AIDS Cohort Study (MACS) subcontract with the Howard Brown Health Center (HBHC) effective July 2, 2012. The decision was made in conjunction with the National Institutes of Health (NIH) after a breach of patient confidentiality by an employee of HBHC. An independent ethics panel, called an institutional review board, suspended the study at HBHC both to protect the MACS participants and to preserve the integrity of the research.”
According to the statement, NU requested that HBHC return all research records relating to the study and contact information for the active participants, but HBHC has yet to provide the research records to NU “in accordance with established federal guidelines for contract cancellation. As a result, the government-funded AIDS research is being jeopardized.”
For almost 30 years, the MACS has collected behavioral and biological data and physical specimens from both HIV-positive and negative men at six-month intervals. The study has produced a significant number of “groundbreaking discoveries, many of which have guided public health policy and the clinical care of people living with HIV worldwide.”
According to Cubbage, “Northwestern University remains committed to the integrity of the MACS and the confidentiality and privacy of its participants.”
NU plans to continue the study and study visits will take place either at Northwestern University in Chicago or the Ruth M. Rothstein CORE Center. Participants wishing to continue should contact NU MACS staff at (312) 908-MACS (6227).
Well after the AIDS 2012 conference ended, Representative Alcee Hastings, Democrat of Florida, introduced H Res 749 on July 31 “expressing support for the XIX International AIDS Conference and the sense of the House of Representatives that continued commitment by the United States to HIV/AIDS research, prevention, and treatment programs is crucial to protecting global health.” David McKinley of W. Virginia was the only Republican co-sponsor among 10 others. Whether or not it will ever get out of committee remains to be seen.
H.R. 1116, gained another Democratic co-sponsor in Mike Thompson of California, bringing the total of co-sponsors to 154 for the Respect for Marriage Act, which would repeal DOMA.
And continuing the practice of repetition that seems to be a favorite among Republicans, GOP House members once again railed against the provision of the Affordable Care Act (ACA) that mandates coverage of contraception.
Representative Tim Huelskamp from Kansas called the policy an example of “anti-Catholic bigotry” and Pennsylvania Representative Mike Kelly, evidently not thinking of the response such comments would draw, said, “I want you to remember August 1, 2012 — the attack on our religious freedom. That is a date that will live in infamy, along with those other dates.”
The comments brought a swift rebuke from Senator Daniel Inouye of Hawaii, a World War II veteran who witnessed the Pearl Harbor attack. "It is complete nonsense to suggest that a matter discussed, debated, and approved by the Congress and the President is akin to a surprise attack that killed nearly 2,500 people and launched our nation into the second World War, or a terrorist attack that left nearly 3,000 dead and led to fighting and dying in Afghanistan and Iraq," Inouye said in a statement.