The study of early treatment is strong evidence that putting more people on treatment and doing it earlier would save more lives, federal health officials said.
Everyone with HIV should be put on antiretroviral drugs as soon as they learn they are infected, federal health officials said Wednesday as they said they were halting the largest clinical trial of early treatment because its benefits were already so clear and pronounced.
The trial — known as START, for Strategic Timing of Antiretroviral Treatment — was stopped more than a year early because preliminary data showed that those put on treatment immediately had a 53 percent lower chance of dying prematurely or having an AIDS-related event than those who got drugs later. Typically, patients get medication before they show symptoms but after blood tests indicate their immune systems have begun to deteriorate.
The study is strong evidence that putting more people on treatment and doing it earlier would save more lives, the officials said. An estimated 35 million people are infected with HIV worldwide; about 13 million were being treated as of early 2014.
“This is another incentive to seek out testing and start therapy early, because you will benefit, said Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Disease, which sponsored the trial. “The sooner, the better.”
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Although the Centers for Disease Control and Prevention (CDC) recommends starting treatment immediately, data recently released showed that only about 30 percent of all Americans with HIV were on the drugs and taking them often enough to suppress the virus.
The agency blamed a mix of factors, including HIV-positive people missed by testing, those who had no health insurance and therefore did not see doctors or could not afford the drugs, and those whose doctors were unfamiliar with treatment guidelines or did not follow up with patients to make sure they were taking their drugs.
Among donors to African countries hit hard by AIDS, there has been little enthusiasm for putting people on drugs earlier because there still is not enough money to help everyone who is already sick. Finding and treating everyone with HIV would require at least tripling the amount of money now donated, some experts estimate. The Global Fund to Fight AIDS, Tuberculosis and Malaria is in a constant struggle to raise money, and the Presidents Emergency Plan for AIDS Relief has been essentially flat-funded since 2010.
Many AIDS researchers and advocates have been arguing for years — based on their own observations and smaller studies — that treatment should start immediately. The study announced Wednesday is the first major clinical trial to produce evidence that patients would live longer and be healthier if they did so.
“I had no doubt how it was going to turn out,” said Fauci, who has been treating AIDS patients for about 35 years. James Neaton, a biostatistician at the University of Minnesota and the trial’s principal investigator, said: “Now you have strong evidence of the benefits.” He joined Fauci on a telephone news conference announcing the results.
Immediate treatment greatly benefits patients and prevents them from passing the disease on. Several other studies have shown that people taking their drugs regularly are more than 90 percent less likely to infect others, including spouses with whom they have regular unprotected sex.
Although it may seem self-evident that it is best to treat a patient with a potentially fatal illness promptly, the evidence had been lacking on the benefits to individual patients. Providing antiretrovirals upon diagnosis has not been universal practice either among doctors in wealthy countries, or in poor countries where donors pay the treatment bills.
In the United States, some doctors are swayed by patients’ reluctance to start drugs before they have symptoms because many patients fear side effects. The early antiretroviral drugs prescribed in the 1990s often had harsh side effects, including rashes, accumulation of belly fat and loss of feeling in the fingers and feet. But modern regimens usually do not. Many AIDS experts have expressed frustration that doctors have not pushed their patients harder to start the drugs right away.
The START trial enrolled its first patients in 2009, but the study was publicly announced in 2011. When it was stopped recently, it had followed 4,685 HIV-infected men and women in 35 countries, all of whom had CD4 counts in the healthy range — above 500 — and had never taken anti-HIV medication.
The study had been scheduled to conclude at the end of 2016.