AIDS Drug Programs Tighten Belts Even as Medications Are Shown to Curb Contagion

The troubled economy is creating funding shortfalls for AIDS Drug Assistance Programs (ADAPs), even as financial difficulties increase the need for help among some of the low-income HIV/AIDS patients who rely on these programs to supply their medication.

Meanwhile, the need for such programs continues to intensify in the wake of a recent large-scale international study that demonstrated the effectiveness of oral antiretroviral drugs in safeguarding the uninfected sexual partners of individuals with HIV infection. The trial showed protective benefits when these drugs were taken by HIV-positive persons with an immune system that was still relatively uncompromised (the immediate-treatment group). Data from this randomized controlled trial from the HIV Prevention Trials Network (HPTN) were released in May, earlier than the scheduled 2015 completion date for the study, because of the markedly positive results. The ongoing trial (HPTN 052) is now being modified to offer antiretroviral therapy to all HIV-infected study participants in the deferred-treatment group, according to Myron S. Cohen, MD, chair of the study and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill.

With ADAPs as a lifeline for HIV-positive patients and now perhaps indirectly for their sexual partners as well, the AIDS community is voicing alarm about the fate of the program's funding. “This is absolutely a crisis, and the crisis is growing,” said Brandon M. Macsata, CEO of the ADAP Advocacy Association. “It's a perfect storm where the weakened economy has caused many HIV-positive patients to lose their jobs and their health insurance, and in some cases, their COBRA [Consolidated Omnibus Budget Reconciliation Act] coverage as well. So they're turning to ADAPs for care, where the funding is becoming less certain. This should be a public health concern for anyone in the health care arena, from physicians to hospitals to health departments.”

ADAPs began providing patients with drugs for HIV infection in 1987, when only 1 antiretroviral drug had been approved. The federal government currently is the source of much of the ADAP funding but states also contribute to the programs' financial resources, as well as determine eligibility requirements and formulary composition. The federal dollars are distributed under Part B of the Ryan White Program (formerly known as the Ryan White Comprehensive AIDS Resources Emergency [CARE] Act).

Drugs in ADAPs cost on average about $11 000 per patient annually. Despite worries about present and future funding, the fiscal year (FY) 2011 federal budget allotted more than $880 million for ADAPs, which is more than in FY 2010. But it still may not be enough to meet current needs.

“There is an expanding pool of people on treatment, which is great—HIV-infected people are living longer,” said Murray C. Penner, deputy executive director of the National Alliance of State and Territorial AIDS Directors (NASTAD). “But at the same time, the need for services puts more demands on the system.”

Current funding is not expected to eliminate ADAP waiting lists, which are growing. While some governors and state legislatures have made ADAPs a funding priority, ADAPs in a number of states had waiting lists as of June 30, 2011, representing a record total of approximately 8600 individuals living with HIV/AIDS and awaiting access to treatment, according to the NASTAD.

Macsata said that approximately 100 to 200 patients are being added each week to these waiting lists, and as some states cut programs, even the increase in federal dollars is not enough to keep pace with demand. “With the way ADAP funding is evolving, people who are HIV-positive feel angry and fearful,” he said. “They don't blame one party or the other; there's plenty of blame to go around.”

Penner pointed out that in those states that are overstretched and have lengthy ADAP waiting lists, some people hear the words “waiting list” and do not even bother trying to enroll, placing their health at risk. “The waiting lists are the tip of the iceberg, and the most visible sign that states are having trouble meeting the needs of patients,” he said.

At the same time, the Centers for Disease Control and Prevention and AIDS advocacy groups have encouraged people to be tested to learn their own HIV status. But while more widespread testing is a goal, Macsata believes that both federal and state governments are sending a mixed message about their commitment. Not only are waiting lists a continuing concern, but so is the narrowing of ADAP eligibility criteria in some regions. Restricting ADAP eligibility, particularly by adjusting the threshold income for inclusion (based on the federal poverty level income requirements), has led to a number of cases of disenrollment—although in some states, patients already in the program have been “grandfathered in,” even if they no longer meet the revised income guidelines.

“For some people, the rules have been changed in the middle of the game,” said Macsata. “One day, people are able to access treatment, and the next day, without having earned a single dollar more, they can't access care.” Once a patient has been disenrolled, he or she may drop off the radar screen, often failing to return, and contributing to a silent crisis, according to the Community Access National Network.

There are other signs that ADAPs in some parts of the country may be trying to stanch an open wound. States such as Arizona, Arkansas, Florida, North Carolina, and Virginia have removed some drugs from their ADAP formularies. Others have implemented annual or monthly expenditure caps per client or instituted client copays or cost-sharing.

With ADAP waiting lists reaching levels that threaten existing safety nets and last-resort options, alternatives are emerging and are being used more widely. Major pharmaceutical manufacturers of antiretroviral drugs have stepped up to make more drugs available through patient assistance programs, although some HIV-positive persons have found the application (and reapplication) process to be burdensome. In addition, nonprofit organizations such as Welvista are providing access to prescription medications for patients on ADAP waiting lists.

The trial by Cohen and colleagues may be one of the more compelling studies occurring since the first diagnosed case of AIDS 30 years ago. Beginning in the early 1990s, when zidovudine became available, Cohen began researching the biological plausibility of using antiretroviral agents for rendering HIV-positive persons no longer contagious. After 7 years of laboratory experiments, HPTN 052 was planned and launched at 13 sites in 9 countries to evaluate the ability of these drugs to reduce HIV transmission between an HIV-positive person and his or her uninfected partner. In the study, 1763 couples (97% of whom were heterosexual) were enrolled, with the HIV-positive individuals meeting criteria of having CD4 cell counts between 350 and 550 × 10⁶/L.

The couples were randomized to 2 groups. In one group, the HIV-positive partner immediately started receiving a cocktail of 3 antiretroviral drugs. In the other group, the HIV-positive partner's drug treatment was deferred until his or her CD4 cell counts declined to 250 × 10⁶/L or less, or upon the onset of an AIDS-related complication as defined by the World Health Organization (such as Pneumocystis pneumonia).

In April 2011, an independent data and safety monitoring board (DSMB) evaluated the results of the study to date, and based on statistically significant findings—a 96% reduced likelihood of HIV transmission to the uninfected partner of treated patients—it recommended that the results be made public (http://tinyurl.com/3dl5kfp). The National Institutes of Health and study investigators decided to offer antiretrovirals to all HIV-positive individuals in the deferred-treatment group, which is a change that is now being implemented. Of 39 new HIV infections found by the DSMB, 28 were linked to the HIV-positive partner via genetic analysis, and of those 28, only 1 new infection occurred in the partner of a HIV-positive individual in whom antiretroviral treatment had been started at the study's onset. Cohen was scheduled to formally present the investigators' findings in detail in mid-July at the 2011 International AIDS Society scientific conference in Rome.

Cohen expressed optimism that the results of his trial may encourage further funding for HIV research as well as support for ADAPs. “My experience is that amazing things happen when the benefit of a treatment is clearly demonstrated,” he said. “With our study showing that treatment can prevent onward transmission of HIV, I believe that considerable changes are possible in resources and policy that would lend themselves to further prevention of HIV infection. When benefits outweigh costs by orders of magnitude, we will see changes in the United States. Policy changes will result from logical thinking.”

While Cohen noted that he will participate in discussions of policies about who to treat and when, his role as principal investigator of HPTN 052 is “to report the results and let them speak for themselves.”

Meanwhile, advocates for HIV-infected patients continue to stress the importance of making drugs available to patients who need them, and the shortsightedness of not doing so. An individual unable to access an ADAP and whose HIV infection progresses to full-blown AIDS may be categorized as disabled and become eligible for Medicaid, Macsata pointed out. Those Medicaid costs, he said, are 2.5 times greater than accessing drugs through ADAPs. “From a public health standpoint, it just doesn't make sense.”

What needs to be done to put ADAPs on a more solid footing throughout the country? “An additional $360 million is necessary for FY 2012 to meet projected needs,” said Penner, “although given the current federal fiscal environment, the request is for an additional $106 million.”