Early Use of AIDS Drugs Cuts Patients’ Risk of Death

By Rob Waters

April 1 (Bloomberg) -- Patients who start antiviral drugs before their immune systems are damaged by the AIDS virus substantially cut their risk of death, according to a study published today in the New England Journal of Medicine.

Researchers reviewed the medical records of more than 17,000 patients infected with HIV, the virus that causes AIDS. Patients who started treatment before their infection-fighting cells had fallen below a certain level cut their risk of dying by as much as 94 percent compared with those who waited longer.

The study lends support to revising current treatment guidelines, by adding weight to a growing body of research that suggests treating HIV at earlier stages can help save lives. Doctors and patients have been wrestling for years with the question of when best to start AIDS medications, which can cause substantial side effects including stomach upset, nausea, altered mental processes and disturbances in blood fat levels.

“The pendulum has shifted,” said Richard Moore, an author of the study and professor of medicine at the Johns Hopkins Bloomberg School of Public Health in Baltimore. “The drugs are now safer and the evidence mounting from our data and other data suggests it makes sense to start therapy earlier.”

While the findings were already known to many doctors who treat patients with HIV, the publication is likely to spur greater use of antiviral drugs, said Jason Kantor, an analyst with RBC Capital Markets in San Francisco. This will benefit Gilead Sciences Inc., the Foster City, California-based company that is the leading seller of AIDS drugs, Kantor said in a telephone interview today.

AIDS Drugs

In the fourth quarter of 2208, sales of Gilead’s top- selling AIDS drug Truvada, a two-drug combination pill, rose 25 percent to $562.1 million from a year earlier. Its three-drug AIDS pill Atripla had sales of $465.5 million, a 79 percent increase from a year earlier.

More people are being tested and diagnosed early for HIV infection, Kantor said. “So now you have earlier diagnosis and earlier treatment and that leads to market expansion,” he said.

Today’s study, known as NA-ACCORD, was sponsored by two U.S. agencies including the National Institutes of Health.

The project analyzed two large groups of patients by looking at the number of white blood cells known as CD4+ in their blood stream. Patients with higher CD4+ counts have greater infection-fighting ability because their immune systems haven’t yet been depressed by the virus.

Starting Treatment

Current federal guidelines call for patients whose CD4+ counts fall below 350 to be started on medications and leave it to doctors to decide whether to treat patients with higher levels.

One group started taking drugs when their CD4+ counts were from 351 to 500 per cubic millimeter of blood. They cut their risk of death by 69 percent compared with those who waited longer to start therapy.

The second analysis looked at people who started taking medications even earlier, when their CD4+ counts were 500 or higher. That group lowered their risk of death by 94 percent compared with those who started medication later.

“I think this article really does provide a scientific foundation for a practice that a lot of patients and doctors have already been doing, namely starting medications earlier,” said Brad Hare, medical director of the University of California, San Francisco’s Positive Health Program at San Francisco General Hospital, in a telephone interview today.

Not Conclusive

The results of the study can’t be considered conclusive because the study looked at patient records rather than randomly assigning new patients to take drugs at different stages, said two Harvard Medical School researchers who weren’t involved in the study. Still, the study shows the importance of investigating benefits of earlier treatment, they said.

“The supportive evidence for the benefits of earlier therapy continues to increase,” said Paul Sax and Lindsey Baden, writing in an editorial that accompanied the study. Still, the Harvard researchers wrote, data from the study “do not provide definitive proof that we should start antiretroviral therapy in all patients with HIV infection.”

The study will help guide a debate over whether to change the current federal guidelines and whether the U.S. government should now fund a randomized clinical trial, Hare said.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.

Last Updated: April 1, 2009 20:50 EDT

Copyright Issues?