As the New Year begins, it's time to take stock of where we've been and where we're going. Around the world, only a fraction of the people who need AIDS treatment get it and the virus continues to spread like wildfire in Asia, Eastern Europe, and Africa.
It's a busy season for the folks at the FDA who approve AIDS drugs. At least five new products have passed or are soon to pass under their scrutiny on the way to your medicine shelf. And while none is expected to cause a treatment revolution, each new drug offers something that will surely improve life for someone living with HIV.
The following is the text of a letter being sent to health care providers in New York State concerning the first wave of cutbacks to New York State's AIDS Drug Assistance Program (ADAP).
Developing new drugs is one thing, but finding ways to get them to the vast majority of people in the world who need them is proving a lot tougher than hoped. Of course price has been and will continue to be a problem, but the logistics of shipping, clearing customs, transporting and storing medicines need attention too. Then come issues of diagnosing, dispensing and monitoring therapy when doctors, diagnostics and skilled staff are in short supply or lacking altogether.
Boehringer Ingelheim has announced that they have finally settled on a dosage for their protease inhibitor, tipranavir. Now, larger Phase III clinical trials of the drug can begin. A recently completed Phase II study had compared three different dose combinations of tipranavir plus ritonavir given twice daily. A dosage of 500mg tipranavir plus 200mg ritonavir was chosen as providing the best balance of adequate viral suppression with the fewest side effects. The ritonavir acts to keep blood levels of tipranavir higher, longer, by slowing its metabolism through the liver.
GMHC Treatment Issues: November - Volume 16, Number 11
What is treatment education, really? Seminars, peer education, workshops, "one-on-ones," adherence counseling, training programs? Pamphlets, articles, interactive exercises, pens with drug company logos, occasional trips and free lunches? Military metaphors, biology lessons, tearful confessions, and cultural clashes?
Julie Davids and Val Sowell,
Project TEACH, Philadelphia FIGHT
Project TEACH stands for Treatment Education Activists Combatting HIV. TEACH was initiated in Philadelphia in 1995 by Julie Davids and Jeff Maskovsky, two members of ACT UP Philadelphia, working in collaboration with two local organizations, Philadelphia FIGHT and We the People Living with HIV/AIDS, Inc.
Around the time I learned my HIV status about 12 years ago, we started Thailand's first group of PLWHAs, Wednesday Friends Club (WFC) at Chulalongkorn University Hospital. At first I just participated in their social activities and group support, recreational stuff and seminars.
The woman who led me into the group room said, "There aren't going to be many people here today" and then left. There were four people, two of whom had chronic HBV, and they had lots of questions. I know I'm needed when people ask which hepatitis virus is airborne. I offered to meet with each of the participants individually after the group and one agreed.
GMHC Treatment Issues: October - Volume 16, Number 10
It is very, very hard to obtain an organ transplant in the United States. First, there are so few organs available. Second, it is hard to locate a transplant center willing to do coinfecteds - that's what they call you when you have a virus like HIV with hep B or C.
More and more people with HIV and/or hepatitis B and/or hepatitis C are going to need organ transplants, particularly liver transplants. This is not an opinion. This is a fact. As more and more of us all over the world discover we are carrying one or more of these viruses, even if we are being treated for them -- or particularly if we are being treated for them -- the more likely it becomes that one of our organs is going to cease working effectively.
GMHC Treatment Issues: September - Volume 16, Number 9
By the Save ADAP Committee AIDS Treatment Activists Coaliton (ATAC)
The AIDS Drug Assistance Program (ADAP) is a federally funded program intended to provide access to HIV/AIDS treatments for low-income people who are uninsured or lack adequate prescription drug coverage. The program is administered by the states and, in some cases, additional state funding augments basic drug coverage. Because the extent of coverage offered is left to the states to determine, various programs may differ considerably in the number of drugs on the formulary, ancillary services covered, and in financial and clinical eligibility criteria.
Coinfection with HIV and the hepatitis C virus (HCV) has increased in the past few years. Until very recently, the major risk factors for acquiring HCV were thought to be injection drug use (IDU), haemophilia and blood transfusion; sexual transmission was considered to be theoretical but insignificant.
The Human Immunodeficiency Virus (HIV) is a virus that has a detrimental effect on the human immune system. That much should be obvious from its name. Virologists study viruses and immunologists study immune systems, but since HIV came along, more and more scientists from the two fields are learning about each other's work.
There is an old science joke about a drunk who is searching for his car keys under a streetlight. A cop happens along, and after appraising the situation, asks the drunk where he had last seen the keys. The drunk points toward a dark alley.
Immune assays are laboratory tests that attempt to measure various aspects of the immune system such as function, quantity and stage of maturation. Researchers are seeking correlations between these markers and health in a desire to test and describe the potential benefits of immune-based HIV therapies such as IL-2 and other immune regulators, as well as vaccines that might have therapeutic potential.
Immune assays have generated several key findings about HIV pathogenesis: The selective depletion of naive CD4 T-cells is a hallmark of progressive HIV disease. Chronic immune activation results in increased proliferation and apoptosis rates, which may play a major role, perhaps overshadowing the contribution of the direct cytopathic effects of HIV and/or cell-mediated destruction of HIV-infected cells.
Early on the beautiful spring morning of May 19, a few hours before 42,000 people gathered in Central Park for New York's annual AIDS Walk, Fred Gormley, a longtime friend of GMHC's Treatment Issues, passed away.
GMHC Treatment Issues: April - Volume 16, Number 4
First Michigan and now Massachusetts have thrown down the gauntlet to the pharmaceutical industry over high drug prices and runaway healthcare costs. Will New York be next? Unable to sustain ballooning Medicaid drug budgets, these states are telling pharmaceutical makers to either bring prices down or face banishment to a list of medications that will require third party approval before they can be prescribed.
ADAP stands for AIDS Drug Assistance Program, although some states have different names for similar programs. ADAP provides life-sustaining and life-prolonging medications to low income individuals with HIV who have no other source of payment for these drugs.
The high price of drugs is destroying what there is of the dismal U.S. public healthcare system. AIDS Drug Assistance Programs (ADAP) have been crippled nationwide and the formularies of state Medicaid programs are under enormous strain.
This is an edited email discussion that took place between participants in the AIDS Treatment Activists Coalition (ATAC). George Carter is an activist interested in patent reform and researching complementary therapies; Eric Goldman is a patent attorney.
The marketing reach of the pharmaceutical industry is deep and pervasive. Among the top four U.S. drug makers, marketing expenses last year were at least double the amount spent for scientific research and development. Pharmaceutical marketing is a wide ranging set of activities that includes direct to consumer advertising (which has proliferated wildly since being deregulated in 1997); informative productions (such as those consumer health segments that fill space on local news broadcasts); or "issue awareness visits" with state and national elected officials (lobbying).
GMHC Treatment Issues: March - Volume 16, Number 3
What will a true second-generation antiretroviral drug be like? It's a common marketing claim and there have been several pretenders, but so far, failing to step cleanly away from the shortfalls of its forerunners has compromised every new bid for the title. Atazanavir is a fledgling protease inhibitor that may be just the ticket for knocking down virus levels in therapeutic newbies without incurring lipid problems — so long as its few toxic quirks remain benign.
A new drug to block HIV at a new point in its lifecycle will be a welcome development. But approving a new drug from a new chemical class will also bring great uncertainties. It's not enough to simply be active against HIV, the new drug will also have to leave host functions alone and meet all of the other criteria for a medicine that is tolerable, easy to take, safe, and affordable.
Today my doctor informed me that my first dose of T-20 is just a week away! How I have yearned for this day! Scalding tears of joy spilled copiously down my face, onto my heaving, bountiful pectorals, drenching my grey Donna Karan cashmere sweater. What cared I: "Let the damage be done!" I exulted, whirling around my physician's office, gleefully tossing several other patients' files in the air.
For the past four years I have been taking antiretroviral therapy. I've seen my CD4 count quadruple and my viral load fall from the high hundred thousands to below 50. It would therefore be easy to conclude that for me treatments have been a success. Not least because it is now well over ten years since I was diagnosed with HIV, and nine years since my first AIDS-defining illness.
A single-dose of the AIDS drug nevirapine when taken at the onset of labor is a proven method for dramatically reducing rates of mother to child transmission (MTCT) of HIV. So why does Dr. Joep Lange, President of the International AIDS Society and vocal advocate for expanding the worldwide access to antiretroviral (ARV) drugs, take every opportunity to warn that resistance to nevirapine (NVP) can arise after single-dose use?
There's been a shakeup in the government's efforts to test a vaccine for HIV. First, the National Institutes of Health (NIH) cancelled plans by its HIV Vaccine Trials Network (HVTN) to launch a large, international study of an HIV vaccine next year. The reason? Disappointing smaller studies with a canarypox-based vaccine combination gave little reason to think it would do any better in an 11,000 person, eighty million dollar trial.
GMHC Treatment Issues: February - Volume 16, Number 2
An article in The Los Angeles Times recently reported that seven babies in the region had acquired HIV at birth. The children had been infected at varying times during the past few years but had not been identified sooner because California does not routinely test newborns for HIV. Not surprisingly, most cases of transmission involved women who had declined to be tested for HIV during their pregnancies or had not received prenatal care.
In the U.S., the gold standard for diagnosing HIV infection has evolved into a formal process that respects an individual's need to know the facts about HIV: how the virus is transmitted, how to limit one's risk, and the meaning of a positive test result. The process also respects an individual's privacy and strives to provide appropriate counseling and support if a test result is positive.
Ideas aren't real estate. But when ideas and technical know-how are protected by a legal creation known as a patent, they become a temporary kind of property. Patented ideas are often referred to as intellectual property, a class that also includes copyrights and trademarks. Like other forms of property, intellectual property can be sold, traded, misused and defended in court.
There are certain minimum protections designed to help assure the integrity of research data that one should look for when evaluating reports of clinical trial results. There should always be several layers of review evident that not only evaluate the final result, but monitor the trial from initial design all the way through publication. In each of these, independent review is perhaps the most important common thread.
For the past several years, I have become increasingly worried about how patents could affect our response to the AIDS epidemic. Many of us are familiar with the international debates about patents on AIDS drugs and the fight to use cheaper, generic, equivalents in the developing world.
GMHC Treatment Issues: January - Volume 16, Number 1
It's well understood that unwavering adherence to one's antiretroviral therapy (ART) regimen gives the best chance of keeping drug levels high enough to sustain suppression of viral replication and allow immune recovery to take root. Yet perfect performance is not a sure bet. Some people who never miss a dose fail to see their T-cells rise — even though their viral load stays within moderate levels.
You've heard it said: Amino acids are the building blocks of life. More literally, amino acids are the building blocks of proteins — and proteins are the walls, doors, monorails and kitchen sinks of life. A protein is made from a strand of amino acids strung together like the various figures on a charm bracelet.
P-glycoproteins belong to a family of plasma membrane proteins encoded by the MDR (multidrug resistance) gene(s) that are well-conserved in nature. P-glycoprotein (P-gp) functions as a membrane-localized drug transport mechanism that has the ability to actively pump out all currently prescribed HIV-protease inhibitors (PIs) from the intracellular cytoplasm.
This information is designed to support, not replace, the relationship that exists between you and your doctor.