POSITIVELY AWARE MAY/JUNE 2011
The American Heart Association and the American Academy of HIV Medicine (AAHIVM) have created hivandyourheart.org to help people living with HIV make changes to improve their heart health and overall wellness.
The website features informative videos from healthcare providers, a wellness checklist, an HIV quiz, and personal stories from patients and behavioral change coach Michael Patterson. HIV and Your Heart also has an application for the iPhone, iPad, and iPod Touch.
The interactive tracking tool helps patients define their goals and begin the steps necessary to make changes. It's also confidential. The desktop icon is labeled "Your Heart" and the information you enter may be password-protected.
Cardiovascular disease is a major cause of death in HIV patients. Whether due to long-term exposure to HIV, antiretroviral agents, or other factors, people living with HIV often share common factors that affect cardiovascular health, including:
- Higher triglyceride levels
- Problematic cholesterol
- Chronic inflammation
- Kidney Failure
"Several large cohort studies have found increased rates of coronary heart disease and myocardial infarctions [heart attacks] among HIV-infected patients," said Jeffrey Kirchner, DO, Communications Committee Chair at AAHIVM.
"The good news, however, is that much of this risk for coronary heart disease is remedial," said American Heart Association spokesperson and past president, Robert Eckel, MD, of the University of Colorado Denver School of Medicine and University Hospital, Denver, Colorado. "We have concluded that the development of optimized screening, prediction, and treatment algorithms for cardiovascular disease in HIV-infected patients is crucial and timely."In a recent online survey of Positively Aware readers, website visitors, and e-newsletter subscribers, 68% of HIV patients said they're very interested in learning about HIV and CVD.
A January 2011 federal report provided on the condition of anonymity to The Florida Independent alleges that federal audits and site visits show that Florida’s Bureau of HIV/AIDS “failed to use available resources in the best interest of people living with HIV and AIDS” while administering its AIDS Drug Assistance Program (ADAP), which provides HIV/AIDS medications to low-income citizens.
Florida’s ADAP crisis has resulted in a patient waiting list that is the longest in the nation—as of May 2, 3,752 people are on the waiting list. Money for AIDS Drug Assistance Programs is distributed to all states and territories through the Ryan White CARE Act.
The January report was written by the U.S. Department of Health and Human Services’ (DHHS) Health Resources and Services Administration (HRSA) and alleges that administrative, service, and fiscal concerns raised in prior audits and visits are still unaddressed. According to the report, in April 2010, ADAP management identified and announced a budget deficit of federal and state funds adding up to between $25 and $32 million.
The federal report indicates that “an analysis of financial data provided by the Florida Department of Health, Bureau of HIV/AIDS, and the Bureau of Statewide Pharmacy Services indicates that as early as the first quarter of 2009-2010, the deficit was apparent through the analysis of quarterly spending patterns, new enrollments, re-certifications, and total quarterly enrollment.” However, the report continued, “management failed to analyze the emerging trends and used misleading assumptions in developing cost estimates and deficit projections.” In addition, the report noted that management failed to adhere to principles of sound fiscal stewardship by neglecting to initiate and implement cost containment strategies and revenue enhancements before a crisis ensued.
The report provides data on the estimated savings or loss of revenue that the program management “missed out [on] by not recognizing the deficit and quickly implementing cost containment measures that had been recommended to the program since early 2010 by the Formulary committee, HIV-AIDS Bureau consultants, and other technical assistance provided by ADAP organizations.”
Other concerns and recommendations highlighted by this report include:
- The Bureau of HIV/AIDS has used ADAP money to pay the salaries of officials with little or no role in administering the program.
- The Bureau of HIV/AIDS was awarded $3.05 million to take 357 clients off the waiting list, but these funds do not show up in financial reports provided by the bureau.
- The program developed an ineffective cost-containment strategy. The report lists at least five cost-containment strategies that need to be implemented to continue to reduce the number of patients on the waiting list.
- The Florida Department of Health’s inability to manage the Ryan White grant has resulted in the current deficit, which jeopardizes access to HIV services and medications.
Read the report in full here.
ViiV Healthcare announced on April 4 that it will expand the Positive Action U.S. Southern Initiative to four additional states and issued a new request for letters of interest (LOIs).
The Positive Action U.S. Southern Initiative was created to respond to the current realities of HIV—new infection rates are the highest in African-American, followed by Latino populations, in the South. The initiative focuses on linking people living with HIV to care and/or enhancing their treatment adherence and delaying disease progression. Initially piloted in Alabama, Georgia, Louisiana and Mississippi, the expanded program will now continue the mission in Florida, North Carolina, South Carolina and Tennessee. Selected organizations will be awarded up to $50,000 per year for a provisional commitment of two years.
“We know that local challenges are best met with local solutions. The Southern Initiative supports grassroots organizations and programs that reflect an understanding of the culture and knowledge of what will work best to further prevention and support the care of people living with HIV in their communities,” said Bill Collier, Head of North America, ViiV Healthcare.
“Southern states are disproportionately impacted by HIV and the challenges facing our communities and the organizations that support them are growing. If we don’t act now, we are going to see more communities in crisis,” said Patrick Packer of the Southern AIDS Coalition. “The Positive Action U.S. Southern Initiative expands desperately needed services that are critical to the support of the health and well being of African-Americans and Latinos living with HIV in the South.”Letters of Interest must be received by Tuesday, May 31, 2011, 5:00 p.m. EST for consideration to the full proposal phase. Interested parties can receive detailed information about the two-phase proposal process and download an application form at here.
On April 27, Housing Works issued a press release announcing that federal judge Cheryl Pollak ruled that she will not allow the Bloomberg administration to make a massive staff cut to the HIV/AIDS Services Administration (HASA).
In April, Housing Works, the HIV Law Project, and attorney Virginia Shubert filed for a temporary restraining order against both New York City and New York State, a move meant to stop the illegal implementation of a proposed Bloomberg budget cut to HASA. That cut would have been devastating, eliminating 254 case managers from the agency’s staff. Bloomberg’s HASA reductions violated both New York City’s Local Law 49 and a federal court order that requires HASA to maintain a case manager-to-client ratio of one to 34.Dozens of HASA clients filled the benches of the courtroom as Judge Pollak told city lawyers that they have 30 days to demonstrate that the HASA cuts are off the table, or she will immediately issue an enforcement order. If the city fails to comply, she will hold it in contempt.
Updates to the "Warnings and Precautions, Pneumonia" subsection of the Fuzeon (enfuvirtide) package insert were approved by the FDA on April 28, 2011 in response to results of a study conducted under a Postmarketing Commitment. Drug sponsor Roche submitted the results from an "Observational Cohort Study on the Incidence of Pneumonia in HIV-1 Patients Treated with Fuzeon." The study was conducted as a result of findings during the initial review of the registrational Phase 3 trials, which showed a relative increase in the incidence of bacterial pneumonia for subjects receiving Fuzeon versus control subjects. The increased pneumonia findings were included in the Warnings and Precautions section of the package insert.
Vertex Pharmaceuticals’ telaprevir and Merck’s boceprevir, both hepatitis C (HCV) drugs, have passed FDA advisory committee reviews, thus moving closer to FDA approval.
In unanimous votes, boceprevir (Victrelis) was endorsed on April 27 and telaprevir on April 28. Both drugs were expected to pass reviews, as clinical trials have shown them to be safe and effective, in combination with the current standard treatment of peginterferon and ribavirin, to treat hepatitis C genotype 1.
Both drugs have demonstrated their ability to result in sustained virologic response (SVR) in patients taking them, with boceprevir yielding SVR rates as high as 67% and telaprevir achieving even higher rates up to 79%.
If the FDA approves the two new drugs as expected, they would be the first HCV protease inhibitors to reach the market and are thought to represent a major advance in HCV therapy.
The FDA is expected to make decisions on both boceprevir and telaprevir by the end of May.For more information, visit www.fda.gov.
Though there was nothing new specifically related to HIV, I found the following to be of interest—my apologies if you don’t.
May 2 in the Senate saw the resignation of Republican John Ensign of Nevada, currently under investigation for his handling of an affair with a former political aide whose husband was also a top legislative aide to the senator.
In his letter of resignation he stated, “my family, my staff and I have gone through an emotional, personal, and professional rollercoaster of inquiries by the Department of Justice, the Federal Election Commission, and the Senate Ethics Committee. These inquiries have been time-consuming and distracting to everyone involved and, not unimportantly to me, have been financially very costly.” His replacement will be Republican Dean Heller, currently serving in the House of Representatives.
In the House, also on May 2, Republican Michael Simpson of Idaho and Democrat Mike Ross of Arkansas introduced H.R. 1666, a bill to improve essential oral health care for lower-income individuals by breaking down barriers to care. It was referred to the Committee on Energy and Commerce.
Also in the House on May 2, and perhaps mixed news for those of you who sneak away at lunch to sizzle in a tanning bed, Democrats Carolyn Maloney of New York and Jesse Jackson Jr. of Illinois were joined by Republican Charles Dent of Pennsylvania to introduce H.R. 1676 to help prevent the occurrence of cancer resulting from the use of ultraviolet tanning lamps by imposing more stringent controls on their use. It was also referred to the Committee on Energy and Commerce.And, finally, was the addition of John Kerry as a co-sponsor of S. 775, introduced on April 8 by Democrat Robert Casey of Pennsylvania, encouraging research and implementation of an educational campaign with respect to hypertension. While this is a noble goal, I theorize that the prevalence of high blood pressure is largely due to the overwhelming stress that most Americans experience—money, health care, jobs, gas prices, pollution, crime, injustice, and on and on. If only there was a way for government to eliminate some of that…