Cocktail all in one: ten years after the introduction of the AIDS cocktail, many lives have been saved, but some problems still persist. Will a new one-a-day AIDS pill help?

When Nelson Vergel was diagnosed with HIV in 1985, he had few treatment options and faced almost certain death. AZT, the very first drug used to treat HIV infection, hadn't yet been approved by the Food and Drug Administration. And when it was in 1987, it was no panacea.

Vergel, a gay native of Venezuela who has lived in Houston for the past 20 years, had to take AZT several times a day in very high dosages that were later deemed toxic. "The drug was killing [patients] faster than HIV," Vergel recalls.

Vergel, now 46, also had a difficult time fighting off AIDS-related wasting and fatigue. "Many of us at the time were resorting to things like steroid injections, which we could only get illegally," Vergel says. "Frankly, I was supposed to be dead."

But everything changed in the mid 1990s with the advent of two new classes of anti-HIV drugs--first in December 1995 with protease inhibitors, then in June 1996 with nonnucleoside reverse transcriptase inhibitors. Researchers found that combining these new drugs with older ones in a drug cocktail improved people's health, decreased side effects, lessened the likelihood of drug resistance, and brought HIV viral loads down to undetectable levels. Now marking the 10-year anniversary of its introduction, this powerful drug combination, known as highly active antiretroviral therapy, or HAART, has saved countless lives and is still the standard of care for the treatment of HIV infection.

"I've seen these drugs turn my patients around," says Lucky Santana, 46, who works as a registered medical assistant at a private medical practice in Atlanta specializing in HIV. "They gained weight. Some went back to work. These drugs gave them a second chance. For years being HIV-positive was a death sentence. It's not that way anymore."

But severe side effects and the cumbersome number of different pills that patients must take every day have hampered the drugs' overall performance. So researchers have been working hard in recent years to improve the situation. In fact, many patients are now down to taking only two pills a day--far fewer than the 20 or so once required.

Now two leading pharmaceutical companies are working together to come up with a one-a-day pill. Bristol-Myers Squibb and Gilead Sciences announced their joint venture in December 2004 to combine Sustiva and Truvada into one medication. They hope to have the new pill available by the end of 2006. "Taking one pill once a day is as close to the ideal schedule for treatment as you can get," says Norbert Bischofberger, executive vice president of clinical research and development at Gilead.

Santana, diagnosed with HIV in 2002, is currently on a two-pill-a-day regimen with no side effects. Even so, he can't wait for the new one-a-day pill, in part because it will mean just one insurance copayment instead of two. "When you have HIV you have to think about payment," he notes. "I have one patient who spends $540 a month because he's on so many different medications. The stress from the financial strain alone can have an effect on your T-cells."

Still, even with newer and better drugs, there are concerns. "We don't know the long-term effects of HIV in the body," says Howard Grossman, MD, executive director of the Washington, D.C.-based American Academy of HIV Medicine. "No drug has turned out to be perfect. There are still side effects. And people still grow resistant to drugs over time, which leads to people having to switch drugs. And resistance leads to more complicated regimens and more side effects."

Grossman, who has spent 18 years as a leading physician treating HIV patients in New York City, calls HIV/AIDS a "chronic, unmanageable disease. Yes, the drugs work for a while, but then they fail. They don't work for everybody, and they don't work forever."

But Bischofberger is optimistic that the easier treatments become, the more people will get tested, which will lead to a decrease in infection rates. "Often the virus is transmitted by people who don't know that they are infected," he says. "But even if you don't change your behavior, treatment can reduce the amount of virus in your body. And the less virus present, the less likely you are to transmit the virus."

For Vergel, treatment has been a bumpy road, even after he started HAART. Side effects early on included what he calls "diarrhea from hell.... I had to live in the bathroom." Then there was the fear of lipodystrophy, abnormal body-fat changes related to the medications. "Yes, we'd live to be older, but we were all afraid we'd look like monsters," he says.

The all-in-one pill won't help Vergel much either, since he has been HIV-positive for so long and developed resistances to all drugs. "But for the newly diagnosed," he adds, "it will be a wonderful thing. Having HIV still won't be a picnic, but things are obviously getting better."