Friday, March 9, 2012

The AIDS Alphabet: R is for Retro...

The AIDS Alphabet: R is for Retro: Retrovirus, anti-Retroviral

HIV is a retro-virus. Medications patients take to keep their retrovirus in check are called anti-retroviral medications, or ARV. In the mid-nineties, Dr. Ho came up with a new class of medications, called HAART, or Highly Active Anti-Retroviral Treatment. HAART (sometimes called ART) and pronounced like "heart" is a combination therapy of three or more medications (usually three or four). It is also known as "the cocktail."

HAART has had a so-called "Lazarus effect" on the lucky patients who could be put on the treatment. That's because HAART has brought individuals on the brink of death back to life, to an active life.

In the fourth decade of the pandemic, it's difficult to remember what it used to take to get these life-saving, life-extending medications. That's because many people were not alive during a time before the advent of HAART, or many other reasons. As I often mention, three decades (now way into our fourth) is a long time to keep track, pay attention and remember, still, AIDS is not something to be put on the back burner, not now and definitely not then...

Here's a short excerpt from Journeys Through Darkness, retelling how AIDS warrior and award-winning visual artist Kurt Weston recalls the beginning of a time of HAART drugs and what it used to take to win the drug lottery.

Hope you enjoy the read. Hope you'll stop by NYC's Rainbow Book Fair, 3/24.

Alina Oswald
Author of Journeys Through Darkness--A Biography of AIDS

Excerpt from Chapter Five: Losing the Light

   By January 1996 the photographer started to realize that he was already legally blind, but when he shared his concerns with his doctor, the HIV specialist remained sure he could save Kurt’s vision. The available solution was to try two new, experimental medications to treat the CMV.
    About the same time a new life-saving medication was coming on the market. It was one of the first protease inhibitors (or P.I.s) medications called Crixivan, and it was part of a new treatment called HAART (pronounced like “heart”) regimen, otherwise known as “the cocktail,” which was going to radically change patients’ lives, turning AIDS from a definite death sentence into the manageable disease that AIDS is today.  
    The Highly Active Anti-Retroviral Treatment was (and continues to be) a revolutionary triple-drug therapy made possible by Doctor Ho of the Aaron Diamond AIDS Research Center in New York City. HAART put Doctor Ho on the cover of Time magazine and made him Person of the Year in 1996.
    These new kinds of medications first started coming out in December 1995, so during the previous months, drugs like Crixivan were still under last, or phase three, of testing and on the verge of getting FDA approved. Because there were not enough medications for everybody needing them, some drug companies offered to give them to patients on a compassionate use basis only, otherwise known as expanded access programs.
    EAP was (still is) a program through which pharmaceutical companies distributed upcoming medications that were already in the pipeline but yet to be FDA approved to people who needed them most. This process had been very rare and extremely difficult before the AIDS years. Usually, a doctor had to call the manufacturer and then the FDA, fill out hours-worth of paperwork and wait for months to get a drug sample, enough only for one patient. And then start all over again, for the next patient. And so on.
The Awakening. Copyright 2009 by Alina Oswald
    Fortunately AIDS has changed all that. The epidemic has forced people living with the disease and AIDS organizations to learn fast the drug industry regulations, to meet with people from the industry and with government officials and to draw proposals. But nothing really happened until people living with AIDS went out in the streets and demonstrated, literally, for their lives. A familiar example is the 1988 ACT-UP demonstration on Wall Street, New York City. [ACT-UP, or AIDS Coalition to Unleash Power was founded in 1987.]
    Only then, the FDA started allowing drug companies to open trial programs as soon as they had available at least some safety information on the drug. That’s how the “drug lotteries” started in 1989. There were several such lotteries and participants had to meet several criteria.
    For example, in 1995 Glaxo provided a (then) upcoming medication called 3TC to over thirty-two thousand people in the United States. It was the largest expanded access program ever.
    Merck announced its Crixivan lottery in July 1995. The company was giving away drugs to eleven hundred people in the U.S. and an additional seven hundred fifty patients from twenty-nine countries in Europe, South America, Canada, and Australia. Merck was to pay for the drug, including shipping, and also for post-selection central laboratory tests and the urine pregnancy tests when and if needed. To be able to participate in Merck-organized P.I. lottery, AIDS patients had to meet several criteria, including to be clinically stable, to be able to follow directions and have certain T cell counts and viral loads.

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