New HIV Vaccine Approach Shows Promise – Researchers from several U.S. medical centers have collaborated to create an HIV vaccine that strongly binds to and activates immune cells to destroy HIV. The vaccine was tested in monkeys and better stimulated their immune systems to create antibodies against HIV as compared to previous vaccine methods. Antibodies recognize bacteria and viruses and signal for the immune system to destroy the infectious agents. For more information, see the study in PLoS Pathogens or the Duke University Medical Center press release.

Texas HIV/AIDS Programs Face Significant Cuts In Federal Funding – As in many other states, federal funds for HIV care through the Ryan White Care Act have been cut and delayed in Texas. As a result, AIDS Resources of Rural Texas has closed, sending its clients to other North Texas HIV/AIDS organizations, which are also facing the same funding issues. Also due to funding problems, the AIDS Outreach Center in Fort Worth has had to reduce its number of case workers and scale back its food pantry. So far, there is no indication that the U.S. government will increase funding for agencies that help clients displaced by the closure. For more information, please see the related article in the Fort Worth Star-Telegram.

Theratechnologies Applies For Approval Of Egrifta In Argentina And Brazil – Theratechnologies, via an affiliate of its partner Sanofi, has applied for marketing approval of Egrifta (tesamorelin) in Argentina and Brazil. If approved, Egrifta will be the first drug in these countries to treat lipodystrophy, a condition of abnormal fat distribution that is a side effect of certain anti-HIV medications. Based on average approval times, a decision would be expected in early 2012 in Argentina and late 2012 in Brazil. Egrifta was approved in the U.S. in November of last year, and Theratechnologies’ partners have since applied for approval in Europe, Israel, and Canada. For more information, please see the Theratechnologies press releases for Argentina and Brazil.

“The goal of the program is to increase the number of people who know their HIV status while in jail so that they can take advantage of treatment, medications, and discharge planning, including connection to care upon release,” said Alison Jordan, Executive Director of Transitional Health Care Coordination in New York City’s Department of Health and Mental Hygiene (DOHMH), in correspondence with The AIDS Beacon.

“The Rikers Island initiative is important because people incarcerated in New York City jails have a significantly higher HIV prevalence rate than the general population, though many people do not know their HIV status,” added Nancy Mahon, Global Executive Director of the MAC AIDS Fund, which will help sponsor the project.

The hope is that HIV testing will allow inmates who test positive to start treatment at an earlier stage of the disease, which research has shown leads to better health outcomes (see related AIDS Beacon news).

HIV-positive inmates at Rikers Island have access to medical treatment and antiretroviral medications. After release, DOHMH, which oversees the jail’s medical clinics, also provides discharge planning services that allow access to health care, housing, substance abuse treatment, mental health treatment, and social services.

However, to take advantage of these services, DOHMH must know an inmate’s status. Although HIV testing is routinely offered to inmates when they enter a New York City jail, about two thirds of inmates reject this initial offer of HIV testing.

The new POS program will provide a second offer of HIV testing to inmates who reject their first offer during their initial admission to Rikers Island.

“While intake is the recommended time to test, people who come into jail are tired and this is a difficult time to address knowing your HIV status,” said Jordan.

“Offering the test coupled with a health education session – after a couple of days have passed and the incarcerated person had a chance to get adjusted to the setting and circumstances – is leading to promising improvements in the acceptance rate,” she added.

The tests are performed in interview rooms and private areas outside of the jail’s regular health clinic to increase privacy. DOHMH states that it is required by law not to share the information with anyone, including the Department of Corrections, unless a person gives consent.

Those who test positive will be offered educational opportunities concerning treatment options, risk reduction, and strategies for maintaining medication adherence.

Rikers Island was chosen for the project because of the large percentage of its 14,000 inmates that are HIV positive. About 5 percent of the inmates entering Rikers know they are HIV positive, but hundreds remain undiagnosed under the current system. With the pilot project, Jordan reports that about two thirds of inmates who initially refuse HIV testing are accepting a second test offer.

“People who know their HIV status can take measures to stay healthier and are more likely to protect themselves and others. We know that people who test positive can get into care earlier, and live longer and healthier lives,” said Jordan.

Jordan noted that for people who already have HIV, DOHMH wants to emphasize that those living in jail have access to medications and HIV care.

“If you are arrested and brought into New York City jails, including Rikers Island, and know you are HIV positive, please tell your doctor or nurse in jail right away. There’s help and we can make sure you get your medication right away,” she said.

Funding for the POS program will be provided in part by the MAC AIDS Fund and the Elton John AIDS Foundation.

For more information on the POS Program, please see the Fund for Public Health New York website. For more information on HIV/AIDS services in New York City, please see the DOHMH website.

October 15 Is National Latino AIDS Awareness Day – October 15 marks the eighth National Latino AIDS Awareness Day. Its purpose is to raise awareness of the impact of HIV and AIDS on the Latino community, with a focus on prevention and HIV testing efforts for Latino men and women. In a statement commemorating the day, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, noted that Latino men and women have the second highest death rate from HIV and AIDS of all ethnic groups. He also recognized the high clinical trial participation rates for Latinos, which help bring new research and treatments to the HIV/AIDS population. For more information, please see the National Latino AIDS Awareness Day website.

NIAID To Hold Public Meeting On Restructuring Its HIV/AIDS Clinical Trial Networks – The National Institute of Allergy and Infectious Diseases (NIAID) is hosting a public meeting on October 26 in Arlington, VA to discuss the future of the organization’s clinical trial networks. NIAID seeks to expand its networks to include clinical research on other major infectious diseases, including tuberculosis and hepatitis, that are common in people with HIV. Discussion will center on expectations for the networks, possible changes in structure, research priorities, collaborative opportunities, and information about the upcoming application process. Presently, NIAID supports six HIV/AIDS networks; their funding expires in 2013 and 2014. For more information or to register to attend the meeting, please see the NIAID website.

United States Pledges $4 Billion For Global Fund To Fight HIV/AIDS – The Obama Administration announced last week that it will support the Global Fund to Fight AIDS, Tuberculosis, and Malaria by contributing $4 billion over the next 3 years. However, the Administration also called for reforms to the Fund in specific areas, such as grant management and accountability, more effective investments, and increased contributions from other donor nations. The Fund provides prevention efforts and treatment for people living in low-income countries. For more information, please see the U.S. Department of State website.

For a more detailed listing of HIV/AIDS related events, please check the AIDS Beacon Events Calendar.

The website, created by the United States Department of Health and Human Services, features a “Find Insurance Options” tool to help patients find the health insurance best suited to their needs, including the PCIP program.

A pre-existing condition is defined as a medical condition that exists before a patient enrolls in a new health insurance plan. Conditions that a person has received treatment for, or should have received treatment for, are included in this definition.

People with HIV/AIDS as a pre-existing condition are often denied coverage or have to pay significantly higher rates for health insurance.

The PCIP program covers a broad range of health services, including primary and specialty care, hospital care, and prescription drugs.

PCIP is available in all states. To be eligible for the program, applicants must:

• Be a citizen or national of the U.S. or be lawfully present in the country
• Be uninsured for at least the last six months
• Have a problem getting insurance due to a pre-existing condition.

Eligibility does not depend on the individual’s income.

Premiums will vary depending on the state. For example, the premium in the state of Pennsylvania is $283.20 per month, while premiums in Washington state range from $177 per month to $1,577 per month.

The PCIP program is in response to the Affordable Care Act, which President Obama signed into law on March 23. The law puts into place health insurance reforms that are intended to hold insurance companies more accountable and lower health care costs. The Act also aims to enhance the quality of health care.

Health insurance reforms enacted by the law will roll out over the next four years and beyond, with most changes taking place by 2014.

Discrimination by insurers against pre-existing conditions will be prohibited under the new law; until then, however, the PCIP program is intended to bridge the gap.

To assist people with HIV/AIDS with low incomes, several government programs will remain in place, including the AIDS Drug Assistance Program (ADAP) and the Ryan White Program.

ADAP provides HIV medications approved by the Food and Drug Administration to those with low incomes and limited or no health insurance. This program runs in all 50 states.

The Ryan White Program provides funding to cities to help provide services for low-income people with HIV. Specifically, this program pays for emergency room visits, dental visits, laboratory costs, transportation, and housing assistance for uninsured or under-insured individuals with HIV.

For more information and to enroll in PCIP, please see the HealthCare.gov website.

The result has been budget shortfalls and a series of cutbacks in state ADAP programs around the country.

ADAPs are programs that provide antiretroviral drugs to low-income Americans living with HIV.

Although run by states, the majority of ADAP funding usually comes from the federal government through the Ryan White Program. State contributions typically account for 15 percent to 20 percent of ADAP budgets.

This year, many states are struggling to keep up with increased need for financial assistance from people living with HIV.

“The nation’s current economic situation, increased HIV testing efforts, and more individuals living longer have resulted in a ‘perfect storm’ that has rapidly resulted in swelling ADAP rolls,” wrote NASTAD in a press release.

In a report released May 4, NASTAD noted that ADAP budgets for 2009 increased 4 percent over the 2008 financial year with 63 percent of ADAPs experiencing a growth in budget. However, in many cases this was offset by increases in the number of people relying on ADAPs for their medications.

Furthermore, federal and state contributions to ADAP budgets are at or near all-time lows as a percent of the total budget. Rebate payments from pharmaceutical companies made up 31 percent of ADAP budgets in 2009.

“Increased funds from federal and state governments in addition to price freezes and increased discounts and rebates from companies are all necessary to sustain ADAPs until health reform is fully implemented in 2014,” wrote NASTAD.

During 2009, ADAPs added an average of nearly 1,300 people to its programs per month, an 80 percent increase over 2008. Seventy-five percent of individuals using ADAPs make less than 200 percent of the federal poverty level, or $22,000 per year.

ADAPs with reduced budgets are seeking to control costs by limiting the list of prescription drugs covered, instituting enrollment caps on particular medications, and restricting the number of prescriptions provided per month.

In addition, NASTAD reported last week that ten states had waiting lists, with over 1,000 people nationwide waiting for ADAP assistance.

ADAPs have been working with drug company patient assistance programs to help make medications as accessible as possible for those on the waiting lists.

In response to the crisis and lobbying efforts by NASTAD, the AIDS Healthcare Foundation (AHF), and other AIDS groups, several pharmaceutical companies have agreed to implement price freezes and other measures on drugs purchased through ADAPs.

Merck announced that it would extend price freezes on Isentress (raltegravir) and Crixivan (indinavir) through 2013 for ADAPs, increase discounts, and process rebate payments more quickly.

NASTAD also announced agreements with Abbott Laboratories and Tibotec Therapeutics to extend existing financial agreements. Abbott is the maker of Kaletra (lopinavir/ritonavir) and Norvir (ritonavir); Tibotec makes Prezista (darunavir) and Intelence (etravirine).

Nonetheless, state ADAP programs are pressing for additional federal funding to cover budget gaps.

“Many [ADAPs] are currently advocating for an emergency supplemental appropriation of $126 million to help sustain current services and eliminate waiting lists and other cost containment measures,” wrote NASTAD in a March “Crisis Strategy” briefing.

“Abbott, Merck, and Tibotec’s willingness to help with this crisis demonstrates that they are fully carrying their share of the burden, strengthening the case for further assistance from the federal and state governments at this critical time of unprecedented need for ADAPS,” added Jennifer Brown, spokesperson for the ADAP Crisis Task Force in a press release.

For more information, including the 2010 National ADAP Monitoring Project Annual Report (pdf), please see the NASTAD website.

The program, entitled Massive Good, allows people to donate two dollars each time they purchase travel services, such as a plane ticket. This mechanism is called Voluntary Solidarity Contribution (VSC). During the VSC, an individual checks off a box during a commercial transaction, which simply adds two dollars to the final cost of the purchase.

Initial data suggest that Massive Good will raise approximately $1 billion during its first four years in operation. In addition, the project also aims to eliminate the disparity in medical coverage between the rich and the poor.

These monetary contributions support HIV/AIDS, malaria, and tuberculosis medical efforts in developing countries. All funds are collected by the Millennium Foundation, and distributed by UNITAID, a World Health Organization supported institute dedicated to fighting these three diseases.

The Millennium Foundation for Innovative Finance for Health is a Swiss non-profit foundation dedicated to developing financial schemes to help fight HIV/AIDS, malaria, and tuberculosis. The organization works with UNITAID, which is a global health partnership dedicated to purchasing drugs and treatments for patients affected by these three diseases worldwide.

Nearly 85 percent of the UNITAID’s funds are used to provide health care to 93 developing nations. So far, UNITAID has been able to reduce the cost of HIV/AIDS antiretroviral drugs by 50 percent.

The Massive Good program utilizes an original fundraising mechanism that ultimately seeks to fulfill the humanitarian goals of UNITAID by providing a consistent source of funding.

For more information please see the Millennium Foundation for Innovative Finance for Health Web site.

Although it is the second largest amount ever approved by the Global Fund, the number of accepted grants fell by 35 percent from the year before.

The Global Fund is an organization that attracts aid from wealthy governments and the private sector for distribution among poor countries to prevent and treat people with HIV/AIDS, tuberculosis, and malaria.

These diseases account for 12.5 percent of deaths in low-income nations, according to 2004 World Health Organization estimates.

Since its inception in 2002, the Global Fund has provided $18.4 billion in aid to 144 countries. It is responsible for disbursing almost a quarter (23 percent) of HIV/AIDS international donor aid.

Earlier this year, there were fears the Global Fund could halt the 2010 funding round altogether, due to the economic crisis. Instead, the Global Fund rearranged its plans for this year by cutting funding by 10 percent and delaying the grant review by six months.

In the end, the current figure of $2.4 billion was decided upon. The amount is smaller than last year’s disbursement, and leaders of the Global Fund expressed concern over its future funding abilities.

“We are seeing a tremendous demand for funding,” said Michel Kazatchkine, the Executive Director of the Global Fund. “We may not be able to continue approving such amounts of financing and see continued progress in health in the coming years unless donor countries scale up their funding even further than what they have done so far.”

If the United States follows its contribution trend, it will donate between $840 and $900 million for 2009. Critics such as the Health Global Access Project, an AIDS advocacy group, argue that this is about $1 billion less than necessary.

The next round of grant funding will be in May 2010.

For more information, please see the press release on the Global Fund Web site, the Campaign for Access to Essential Medicines booklet (pdf), and related Beacon news.

This includes more than one million people infected every year in the best case scenario, and a cost of $722 billion over 22 years, or nearly $8,000 for every infection prevented.

However, the report also suggests these costs could be cut nearly in half by focusing on high-impact measures in at-risk groups, such as sex workers and injecting drug users.

The AIDS 2031 project was designed to figure out what can be done to alter the course of the AIDS pandemic. The goals of the AIDS 2031 project are to reduce the number of new infections, to provide infected individuals with necessary treatment, and to assist AIDS orphans in regaining normal lives.

Currently, there are 33 million infected people worldwide, and 2.3 million adults were newly infected in 2007. If the current trend continues, by 2031, the AIDS pandemic will enter its fiftieth year.

The report estimated AIDS costs based on 48 interventions, including prevention, care and treatment, mitigation, program support, and international support.

The economic models assumed that condom usage, drug usage, and circumcision would be widespread, while microbicides and vaccines would not be widely used due to their high costs.

Different economic strategies were proposed in order to control the financial problems. One strategy is for policy changes focusing on high-impact prevention and efficient treatment, which could cut costs in half. Another strategy is for nurses to provide treatment instead of doctors.

Additionally, male circumcision has been shown to be very effective in reducing female-to-male HIV transmission, and antiretroviral drugs are effective in reducing mother-to-child HIV transmission risk.

The researchers state that rapidly developing countries like Brazil, China, India, Mexico and Russia should be able to pay for fighting their own epidemics. Attention will be focused on southern African countries, Kenya, Mozambique, Uganda, and Zambia. Currently, these countries have been facing the greatest problem with controlling infection with limited financial resources (see related AIDS Beacon news).

For more information, please see the full report in Health Affairs.

The ATAC report card assessed Abbott Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Hoffman La Roche, Merck & Co., Pfizer, and Tibotec in five areas: drug development and plans, access to treatment, U.S. pricing, community relations, and marketing practices.

The highest overall grades, both B’s, went to Merck and Tibotec. Merck produces Isentress (raltegravir) and Crixivan (indinavir sulfate); Tibotec makes Intelence (etravirine) and Prezista (darunavir). The lowest overall grade, an F, was given to Abbott Laboratories, maker of Kaletra (lopinavir/ritonavir) and Norvir (ritonavir).

In the past week, several major pharmaceutical companies have felt increased pressure from AIDS groups to make their HIV/AIDS drugs more affordable.

On September 3, AIDS Healthcare Foundation (AHF) charged Merck with “criminal” pricing of Isentress. The integrase inhibitor was recently cleared as an option for HIV patients who are starting an antiretroviral regimen for the first time. The move makes Isentress the most expensive first-line anti-HIV drug, at $12,864 per patient per year.

“Cash-strapped [Alcohol and Drug Awareness Programs] and Medicaid programs will go bankrupt if these government programs — and the taxpayers who fund them — are forced to continue subsidizing the cost of new medicines like Isentress that are priced unjustifiably high,” said AHF President Michael Weinstein in a press release.

AHF will send postcards to residents of Whitehouse Station, New Jersey, home to Merck headquarters, to raise awareness of Isentress costs. The postcards feature Merck CEO Richard Clark beneath the words, “WANTED: Criminal AIDS Drug Pricing.”

In the United Kingdom, the Guardian reports that GlaxoSmithKline (GSK) has met pressure to pool its HIV drug patents, which would allow inexpensive copies of its drugs to be manufactured in the developing world. On Sunday, fifteen leading organizations, including Doctors Without Borders and UNICEF, sent a letter to GSK CEO Andrew Witty urging him to lift legal restraints that allow the company exclusive manufacturing rights for 20 years.

In a letter to the Guardian defending its practices, Chris Strutt, a senior vice-president at GlaxoSmithKline, said that “we have not ruled out the possibility of participating in the pool, but have yet to see any real proposal that provides benefits beyond GSK’s existing approach.” GSK has developed its own patent pool and has cut prices in developing nations to 75 percent of price levels in industrialized countries, according to the article in the Guardian. GSK has also promised to reinvest 20 percent of its profits from AIDS drugs in the developing world.

Nevertheless, ATAC, which issued the drug company report card, notes that price increases of antiretrovirals have typically been at least double the rate of inflation. “People with HIV, especially those who have run out of treatment options, need new alternatives for the long run,” said  Bob Huff, a member of ATAC’s Board of Directors in a press release, “and pharmaceutical companies need to work closely with the community to help get there.”

For more information, please see the ATAC report card (pdf), ATAC press release (pdf), or AHF press release.

Fifty seven percent of respondents supported HIV-specific provisions in the new legislation, while 43 percent were against “special treatment” of people who require HIV care. Those who rejected the idea of specializing HIV needs believed that doing so would be a form of discrimination that could backfire and prevent patients from receiving proper HIV care.

In response to questions asking how the new health care reform would impact their practices, clinicians responded with both positive and negative answers.

Positive effects on clinicians’ practices:

• Integrating HIV care into primary care (17%)
• Stabilizing finances for their practices (7%)
• Lower drug and administrative costs (7%)

Negative effects on clinicians’ practices:

• Increase the number of HIV patients per practice (larger caseload) (23%)
• Increase in paperwork (23%)
• Decreased reimbursement (13%)
• Rationing of HIV care (10%)

Clinicians also placed recommendations on what they thought would be important to include in health care reform legislation. Some of the recommendations made were:

• Including prevention as a part of HIV care (21%)
• Providing for proper clinician reimbursement (18%)
• Prohibiting insurance discrimination based on HIV diagnosis (14%)
• Guaranteeing HIV drug access (14%)

Finally, when asked about their support of public health insurance, 73 percent of respondents supported the option, while 25 percent rejected it and two percent remained undecided.

The survey comes at a time when Congress is rapidly trying to pass health care reform legislation. The new plan would extend health insurance coverage to those Americans who are uninsured, while still trying to keep health care affordable. The results of this survey show that while support for health care reform amongst health care providers is strong, there remains some divide as to which issues need the most emphasis.

For more information on the survey, please see the press release from IAPAC.