Fight against HIV
Every year at this time, we take a look at where we stand in the fight against HIV. Let's start by taking a look back at where we came from.
In the beginning…
The first mention of AIDS was in a report dated June 5, 1981, when five cases of Pneumocystis carinii pneumonia (PCP) were noted among five previously healthy young men in Los Angeles. The report attracted attention because PCP is only found among those with severely suppressed immune systems, and these young men had no previous health problems. Soon, similar reports emerged from cities such as San Francisco and New York, and the syndrome we know as AIDS was identified.
The first years of the worldwide pandemic were absolutely devastating.
"People in the prime of their lives were brought down by this totally new disease that ruined their immune systems," said Robin Isaacs, Executive Director of Clinical Research at Merck. "They had previously been well and had no expectation they would get sick. By the late 1980s there were wards full of people with AIDS, and the future outlook for them was very poor."
"I always tell young people to watch the movie Philadelphia (1993)," said Marty St. Clair of GlaxoSmithKline. "It is the best way to understand that very emotional time when the fear was beyond comprehension, people were dying, and we didn't know what to do."
The first breakthrough
The first drug that suppresses HIV was discovered in the virology lab at Burroughs Wellcome (a forerunner of GlaxoSmithKline) on November 16, 1984. Marty St. Clair was the one who conducted the tests in petri dishes that first gave evidence that AZT was effective against HIV.
"Technology was primitive then, compared to today. Back then, there were no clinical markers (viral load and T-cell count)," St. Clair recalls. "The only way we had to test whether AZT worked in humans was to try it out and see who died. In one test comparing AZT to placebo, 16 people on the placebo died, and only one on AZT. So the study was stopped, and all the participants got AZT."
But AZT, by itself, was not enough to completely suppress HIV over the long term. (No HIV drug is fully effective on its own.)
"I remember back in the '80s when AZT first came out," says George Hanna, Executive Director of Virology Medical Strategy at Bristol-Myers Squibb. "It had to be taken every four hours, and it was unclear how much impact it would have. People were debating whether going on therapy was a good thing or a bad thing. Eventually we had trials that showed taking AZT alone did not have a durable benefit over the long run. There was a lot of discouragement."
Turning the corner
As the years went by, additional drugs were discovered to be effective against AIDS. Toward the end of 1995, clinical trials showed that using three or more drugs in combination was highly effective. The multiple-drug approach, called "Highly Active Anti-retroviral Therapy" (HAART) changed everything.
"It was like night and day," says George Hanna. "We went from an era that had dedicated wards in hospitals for AIDS and hospices dedicated to AIDS. Now we can manage HIV on an outpatient basis."
Where we stand today
"If you look back at the therapeutic progress that's been made-it's impressive," says Glenn Mattes, president of Tibotec Therapeutics. "You can reasonably say that no patient should die of AIDS today if they're compliant with their drug regimen. That's remarkable. But it is important that we don't get too cocky or complacent. The durability of current therapies is wonderful, but this is a very intelligent virus. It could still throw us a curve ball. And only half the battle has been won in terms of diagnosing and treating our disenfranchised populations and segments of the population that are still seeing an increasing infection rate."
What is still needed
According to George Hanna, further advances need to come in two areas.
"First, we'll always have to deal with drug resistance. With the drugs we have now, the incidence of resistance is much lower, but it is not zero. So we need to develop new agents to fight HIV."
"Next, we need to adapt to the idea that HIV has become a life-long chronic illness. For most patients, treatment will go on for decades-for a lifetime. So we need to make sure that we have regimens that are not only effective over the long term, but as simple, safe and tolerable as possible. There have been a lot of new drugs in the past few years, and a lot of new combination drugs that make compliance easier. Based on our experience from the begining of the epidemic and with Atripla, BMS clearly recognizes the benefits of these combination drugs for patients. And we can remain optimistic that similar solutions that bring value to the patient will be highly sought after by the pharmaceutical companies."
All the researchers we talked with confirmed that their companies are actively developing new HIV drugs, new classes of drugs, and new possibilities for combination drugs.
"I think there will be additional combinations of both existing and new anti-retrovirals," said James Rooney, VP of Medical Affairs for Gilead Sciences. "There are plans in the works for several different combinations in the next five years, including additional three-in-one combinations like Atripla. Not every patient can tolerate all drugs, so it's good to have various combinations to choose from."
A new approach to prevention
Efforts to create an HIV vaccine have been very disappointing, but another way to keep people from getting HIV is being studied.
"There are half-a-dozen studies either underway or planned to test the ability of Viread and Truvada to prevent HIV," says James Rooney. "These trials will compare Viread or Truvada to a placebo in men at high risk, women at high risk, discordant couples, and IV drug users. Total planned enrollment will be close to 20,000, which should provide us with important information on using Viread or Truvada to prevent HIV."
Every year when we write this status review on where we stand in the fight against HIV, we ask the researchers about the chance of an actual cure-a treatment that would eradicate the virus from a patient's body. Unfortunately, as in years past, no one was very encouraging.
"HIV is a very difficult virus to treat because it becomes incorporated in the cells of the patient-and it can live in those cells for a long time. There's a great deal of interest in understanding this long-term latent infection so ultimately we can think in terms of a cure. But, in the near term, I can't speculate," said Robin Isaacs.
"There may be a cure in the far future," said Marty St. Clair. "I don't think it's close. But, if we have non-toxic drugs that can keep the virus completely suppressed for a lifetime, a cure is not necessarily the only goal."
"People should not get complacent," St. Clair says. "The best way to deal with HIV is not to get it in the first place. Everybody should be aware, and everybody should get tested. Everybody should practice safe sex. It's an easy thing to do-we should all take responsibility."
Copyright 2015, Positive Health Publications, Inc.
This magazine is intended to enhance your relationship with your doctor - not replace it! Medical treatments and products should always be discussed with a licensed physician who has experience treating HIV and AIDS!