Wednesday, December 7, 2011

Thirty Years of AIDS: The AIDS Alphabet -- H is for HAART (December 7, 1995)

HAART: Highly Active Anti-Retroviral Therapy (or Treatment) regimens (or HAART, pronounced like “heart” and sometimes referred to as ART—Anti-Retroviral Treatment) consist of a combination of three (or sometimes four) anti-HIV drugs. Also known as “the cocktail,” HAART regimens have radically changed the progression of the disease. HAART regimens have the so-called “Lazarus effect” on AIDS patients, turning AIDS from a death sentence into a manageable, life-long disease. The new medications started being FDA approved in 1996. (Some mention December 7th, 1995, as the discovery of HAART regimens.)

Here's an excerpt from JOURNEYS THROUGH DARKNESS on HAART (pronounced like heart). Hope you enjoy the read. And, as always, thanks for stopping by.

Alina Oswald
Author of JOURNEYS THROUGH DARKNESS (now also available as e-book)

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 “man 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.
    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. [Glossary to this book provides more detailed information regarding definition of terms like T cell count and viral load.]
    The lottery took place in August 1995. In Chicago, Kurt’s doctor put his patient’s name in the program. By December, Kurt’s new doctors in California received a phone call from his former physician: Kurt had won the lottery. He was one of the eleven hundred AIDS patients approved to receive the new drug. Winning the drug lottery literally saved his life. To this day, the photographer seriously doubts his ability to stay alive if it wasn’t for the new medication.
    He started treatment in January, right before he got his doctors to take out the silicone gel inserts from his arm. At the time, there was no way for Kurt, or his doctors for that matter, to imagine the powers of the new HAART regimens, to think that in just a matter of months they would be able to bring his immune system back on track and far from the dangerous zone of CMV activation. All Kurt’s physicians knew for sure was that if their patient didn’t receive the two experimental treatments fast enough, he would lose his vision for good. 
    But Kurt knew that his vision was already gone. It took him several months to get his doctor to accept the truth. It wasn’t until May of 1996 that the physician finally agreed to give Kurt a certificate stating that the photographer was legally blind. He needed it to register to the Braille Institute where he could learn how to survive in his new world of new insecurities, and darkness.