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2004 HIV Drug Guide

2004 HIV Services Directory

Positively Aware

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What’s New in HIV?

by Deneen Robinson

 

The science of HIV has continued to marvel us with an ever-changing landscape of new information that keeps us guessing as to what is next. The truth is that this virus will always challenge us. We will never be bored. There will always be something new to learn or teach others. We know that antiretroviral therapy is effective in treating HIV disease. However, as people on HIV treatment age, their options become more limited and the need to bring new drugs to market is increasingly important. In addition, women’s access to appropriate care, with specialists who not only understand HIV, but healthcare for women is still an issue. We need to continue to get women and people of color into treatment and clinical trials, in roles other than victims.

New Treatments

The recently approved Lexiva, T-20, Emtriva and Reyataz have given us a few more choices for people who are treatment experienced. Unfortunately, because of the timing of approval and the problem of HIV resistance, there have not been enough drugs to give us a complete regimen of at least three new drugs for treatment-experienced people. As time goes on and people experience multiple resistance, it is more and more difficult to find compounds that will work. The pipeline offers promise for those people.

Tibotec-Virco, a Belgian pharmaceutical company recently purchased by Johnson and Johnson, has two remarkable drugs in development that are designed to meet this need. TMC-114 is a second-generation protease inhibitor designed to be active against protease resistant mutations. In vitro data shows that TMC-114 has potent activity against both wild type and resistant forms of HIV. The drug has demonstrated greater efficacy if boosted with ritonavir. Although the trials have been small (50 people), the results look promising and have allowed the manufacturer to move to the next stage of clinical development. TMC-125 is a non-nucleoside reverse transcriptase inhibitor (NNRTI) also produced by Tibotec-Virco that has demonstrated in vitro that it can work in the presence of the K103N mutation. K103N is the mutation that causes one to lose the entire class of NNRTIs. The future of treating HIV disease depends on the creation of novel compounds that are successful in the presence of multiple resistance.

Superinfection

At the 2003 International AIDS Society (IAS) conference in Paris, superinfection was discussed with clinical data to prove its existence. According to additional information presented at IAS, we now have people who have tested positive with no treatment options. This news has a number of implications. Those who test positive with no treatment options have to wait for new compounds in the same way people were waiting for options in the early years of AZT. It also means that the hope for a vaccine is even more elusive due to the difficulty of creating a vaccine that encompasses all the known mutations and the possible mutations that may occur in the future. Finally, as the number of people who have superinfection increases, mortality may increase as well.

Women and HIV

There has been a great concern about the number of women who are testing positive for HIV. Interestingly, since the early 1980s, women have been present among the numbers of people both living and dying from HIV disease. The sudden fascination with women has yet to translate to equal participation of women in clinical trials, expanded access programs and access to care. In early 2003, Dr. Kathleen Squires presented a paper on the relationship between HIV, gender and treatment. Women are still the last to be treated and the lowest number of participants in clinical trials. Interestingly, she pointed out that women are as capable as men in handling antiretroviral therapy.

For years women have been saying that there are differences in how women respond to antiretrovirals. In this document, Dr. Squires indicates that women do experience greater side effects or more severe side effects to some of the currently used antiretrovirals. In order to minimize these problems women should be consistently part of clinical trials. Also, the different side effects that women are experiencing should be investigated and physicians and other health care providers should be made aware of this information. These differences should be implemented into the care plans of women living with HIV. We should stop paying lip service to these issues. If we truly want to do something, we should consistently do the “extra” work required to ensure the participation of women in all aspects of HIV care.

It means ensuring that the voices of women are heard even if they are not able to disclose their status. It also means that we address the barriers to health care by providing day care, food vouchers, bus tokens, etc. Finally, it means listening to the issues that women have raised and allowing the voice of women to be more than the accepted few that we have been listening to up to this point. It means ensuring that the voice of women continues to grow until there is equal representation.

For those of us who have always been the stakeholders, it means sharing your “territory” with someone who has as much right to be at the table as you. Most importantly, it means that stakeholders take the responsibility of bringing someone else along, so that there is always a voice at the table that reflects the unique needs of all populations impacted by HIV.

African Americans and HIV

In addition to the constant hype about women, we are touting that African Americans are the new “face” of HIV. It boggles the mind. African Americans have always been disproportionately impacted by HIV. Always. For those of us who have been around since the epidemic began, we know what the myth has been. “HIV is a gay, white male disease.” Instead of dispelling that rumor, that myth has actually been the catalyst for much of the denial that occurs in the African-American community about their HIV risk. Unfortunately, it is very difficult to fix something this huge. Now what has happened since we have begun to talk about African Americans has been a decrease in funding, waiting lists for AIDS Drug Assistance Programs, flat funding of Ryan White and limited pharmaceutical dollars for community organizations. On observation that does not make sense. What are we doing to deal with the societal issues that have caused this new incidence? What are we going to do for the large number of people who are going to be accessing care? More importantly, how are we going to pay for it?

The one thing that women and African Americans have in common is limited resources to pay for costly medical care and AIDS drugs. In light of the large number of underpriveleged people accessing services and society’s expressed concern for these groups, why are we limiting money for services instead of increasing it? It brings to mind the idea that now that the epidemic has become more associated with poverty and other societal ills, we are treating it just like we have consistently treated the poor in this country. We treat them with disrespect. We show our disrespect for this “new” group of infected individuals by not ensuring that they are a part of the “cure.” Going forward, why don’t we try to ensure that these groups are included in trials and ensure that they have equal access to medical care and treatment?

The saying goes, “The more things change, the more they stay the same.” As the arsenal of medications to treat HIV has grown, we are still perplexed about finding new ways to treat HIV disease. As the advancements in understanding this virus have grown, we still have yet to discover an effective way to create a vaccine. We have learned that HIV has a way of changing its outer core to elude antibodies. We have learned that HIV replicates at such a rapid rate that the body is always behind in trying to kill the newly created virions.

We have a number of novel ways of treating HIV in the pipeline. The success of creating T-20 has opened the door for other entry inhibitors. There are a number of different types of entry inhibitors that, if successful, will give us more ways of suppressing this virus. The reality of a cure is still far off. The more we learn about HIV, the more the difficulty of finding a cure seems. There are a number of companies manufacturing vaccine options. Our greatest hope for a vaccine is a number of years in the future. In the meantime, we are going to have to work on ways to keep people healthy until the cure or better treatment options are available.

The host

The host for HIV is very complicated. Each of us is unique with our own problems and clinical deficiencies. These differences make it difficult for us to develop a simple formula of treating HIV disease. Clinicians are learning that understanding the host is the key to successfully treating HIV disease. As we pay attention to host factors such as family disease histories, risk for cardiovascular disease, cultural differences and gender differences, we are better able to find the most appropriate treatment for the person living with HIV. We have a number of trials that are exploring host issues such as TDM—therapeutic drug monitoring. The TDM trials are trying to see the impact on viral suppression if we dose medications based on the unique issues of the host. We’ll see what the results show. Also as we learn more about HIV disease, we are including host factors as ways to measure someone’s risk for hyperlipidemia and high glucose in people living with HIV.

Perhaps the newest reality is that the more we learn, the more we realize we need to learn. The most important idea is that we need to be vigilant in this fight. The future of treating HIV disease is for all of us to continue to advocate for new treatments and better care for those living with HIV.

Deneen Robinson is an African American woman who has been working in the field of HIV education for seven years. She has been living with HIV for 11 years. She says that, “During this time, my ability to access and understand information has been the most powerful tool in my personal fight against HIV.” She is a resident of Dallas, and a graduate of the African American AIDS Institute in Los Angeles. Shortly after finishing work on the Drug Guide project she accepted a position as Advocacy Relations Manager with Abbott Laboratories.

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