The Golden Era

Despite their complex workings and complicated names, AIDS drugs are based on a relatively straightforward concept. By stopping or retarding the duplication of HIV inside the body's cells, the virus is prevented from overwhelming the immune system as it does when left unchecked. Researchers creating early HIV medicines followed this concept, and current medication has built on the theory.

The first drug to treat AIDS, the well-known AZT (zidovudine), was approved by the FDA in the United States in 1987. Initially created as a potential treatment for cancer, AZT was heralded as a wonder drug. Given the time and circumstances, it's understandable why. AZT was the first drug to show true promise in keeping the virus in check.

Consequently, AIDS patients and advocates began to demand access to the drug even while it was still in clinical trials. To accommodate patients' needs, the FDA streamlined the approval process to help get the drug to those who needed it while still ensuring its safety.

AZT belongs to a group of AIDS drugs known as nucleoside analogue reverse transcriptase inhibitors (NRTIs), which was the first group of drugs developed to fight the virus. These drugs work by interfering with an enzyme called reverse transcriptase that the virus needs to integrate itself into a human cell. In addition to AZT (Retrovir, zidovudine), NRTI drugs include Epivir (lamivudine, 3TC), Videx (didanosine, ddI), Hivid (zalcitabine, ddC), Zerit (stavudine, d4t), and one of the newest drugs on the market, Ziagen (abacavir).

However, AZT and the other NRTIs were no cure. While they seemed to lower the amount of virus in the blood — called the viral load — for a time or keep it in check, they didn't eradicate the virus from the body completely. Another troubling finding: AZT, which had held so much promise, began to lose its effectiveness as the virus began to change to overcome the drug's effect. Though inroads were being made, researchers knew there was still a long battle ahead.

"It was getting better, but people were still dying," says Jeffrey S. Murray, M.D., M.P.H., a veteran FDA researcher and clinician in the fight against AIDS. More weapons against HIV were needed. Gradually, the medical arsenal expanded.

A major addition has been the protease inhibitors, which became widely available in 1995. Protease inhibitors include Crixivan (indinavir), Norvir (ritonavir), Viracept (nelfinavir), Fortovase (saquinavir), and Agenerase (amprenavir). Like NRTIs, these drugs interfere with the virus's ability to replicate in the body and inhibit the action of another key enzyme (protease). This enzyme is responsible for breaking apart large HIV proteins within the virus into smaller ones.

Another group of drugs to treat AIDS is the non-nucleoside reverse transcriptase inhibitors, or NNRTIs. Like AZT and other NRTIs, these drugs also interfere with the reverse transcriptase enzyme to prevent HIV from replicating in the body. NNRTI drugs include Viramune (nevirapine), Sustiva (efavirenz) and Rescriptor (delavirdine).

Combination 'Cocktails'

None of these drugs proved to be a solution in and of themselves, particularly as the virus would again mutate to overcome the drug's effects. However, scientists began to realize that the drugs together packed a powerful punch against the virus. In 1995, the National Institute of Allergy and Infectious Diseases (NIAID) showed that combining these drugs slows the high rate of mutation, a characteristic of HIV.

The drug combinations became known as cocktails, a breezy name for a major advance in the battle against HIV. A new treatment era was born, accompanied by previously unknown levels of optimism.

Between 1996 and 1997, the number of AIDS-related deaths dropped 42 percent. Another decline, this time of 20 percent, followed between 1997 and 1998. In a report released by the Kaiser Family Foundation, AIDS-related deaths numbered 44,991 in 1993. Just five years later, the toll had dropped to only 17,171.

"That was the golden age," says the FDA's Murray.

It was at this time when Ken Eppich of Minneapolis, then 53, was told he was HIV-positive.

Eppich, who is gay, clearly remembers the sunny fall day in 1994 when he learned his diagnosis. Equally clear in his memory is the almost instant acceptance of his fate. Eppich believed that he would die soon, like so many of the friends and colleagues he had known with the disease.

"I thought I had 18 months to live,'' Eppich says.

Eppich set about making a will and making peace with himself. "I was OK with it. I'd had a good life.''

Eppich's experience, however, epitomizes the changing expectations for AIDS patients brought on by this golden era. Having first learned of AIDS in the 1980s, he and his friends and family viewed AIDS as a death sentence.

"I never asked for a prognosis and my doctor wisely didn't offer one. My friends were sure I was dying and my brother felt that the Thanksgiving of 1994 would be my last,'' Eppich says.

Instead, he was given a bunch of drugs he'd never heard of. He took them, he read up on them — to the point that his doctor joked that the patient was the one really prescribing the medications — and made major changes in his life to stay healthy. And he lived.

Seven years later, in September 2001, Eppich found himself at a cabin in northern Minnesota on another clear, fall day with friends. They hoisted a toast to him and to his life.

"(AIDS) is a part of me, but it doesn't define or control me,'' says Eppich. "I think of it as a manageable, chronic illness rather than a fatal disease."

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Tags: HIV and AIDS

About the Author

FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.