U.S. Health Officials Warn H.I.V. Treatment Should Start at Diagnosis. People with H.I.V. should be put on antiretroviral drugs as soon as they learn they are infected, federal health officials said Wednesday as they announced that they were halting the largest ever clinical trial of early treatment because its benefits were already so clear.
The study was stopped more than a year early because preliminary data already showed that those who got treatment immediately were 53 percent less likely to die during the trial or develop AIDS or a serious illness than those who waited.
The study is strong evidence that early treatment saves more lives, the officials said. Fewer than 14 million of the estimated 35 million people infected with H.I.V. around the world are on treatment now, according to U.N.AIDS, the United Nations AIDS-fighting agency. In the United States, only about 450,000 of the estimated 1.2 million with H.I.V. are on treatment, according to the Centers for Disease Control and Prevention.
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“This is another incentive to seek out testing and start therapy early, because you will benefit,” said Dr. Anthony S. Fauci, director of the National Institute for Allergy and Infectious Disease, which sponsored the trial. “The sooner, the better.”
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, announced the findings on Wednesday. Credit Alex Wong/Getty Images
Although the C.D.C. recommends immediate treatment, it said in November that only 37 percent of infected Americans had prescriptions for the drugs. The agency blamed a mix of factors, including H.I.V.-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.
Internationally, there is not nearly enough money even to put those who are already sick on antiretroviral medicines, much less those not yet showing symptoms. The Global Fund to Fight AIDS, Tuberculosis and Malaria is in a constant struggle to raise money and the President’s Emergency Plan for AIDS Relief has been essentially flat since 2010. Putting all the people with H.I.V. in the world’s poor and middle-income countries on treatment immediately would cost almost $20 billion, about triple the $6.3 billion that is now being spent on that, U.N.AIDS said.
“This is a defining moment for social justice,” said Michel Sidibé, executive director of U.N.AIDS. “People will be scared, saying, ‘Oh, it will be a big number.’ But this puts an end to the false debate about whether to pay for treatment.”
Many AIDS researchers and advocates have long argued — based on their own observations and smaller studies — that treatment should start immediately. The trial stopped Wednesday is the first major clinical trial to produce evidence that patients would live longer and be healthier if they did so.
“This is fantastic,” said Dr. Susan P. Buchbinder, director of H.I.V. prevention research for the San Francisco Department of Public Health. Her department began recommending immediate treatment in 2010, and new infections in that city have dropped substantially since then. “The evidence for this has been building for quite some time, but now it’s clear that people should be offered treatment right away and told why it’s beneficial.”
New York City has recommended immediate treatment since 2011, but has not yet achieved San Francisco’s success, partly because the latter is a smaller city in which many AIDS specialists have done their residencies together and learned the same treatment protocols.
“Most doctors in N.Y.C. are starting H.I.V. medications quickly for newly diagnosed patients,” said Dr. Demetre C. Daskalakis, the city health department’s assistant commissioner for H.I.V./AIDS prevention and control. “With this study, we’ve answered the question definitively: Treat H.I.V. — it’s good for both personal and public health. The release of data from such a powerful source should erase any doubt.”
Dr. Julio S. G. Montaner, a former president of the International AIDS Society who wrote a seminal 2006 paper in the Lancet arguing that universal antiretroviral treatment was the best way to curb the AIDS epidemic, said the study “confirms what we have been saying for years.”
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The United Nations estimates a total of 35 million adults and children were living with H.I.V. in 2013 — about the population of Canada.
Portion not treated
Adults (ages 15+)
living with H.I.V.
(through age 14)
living with H.I.V.
Immediate treatment also prevents patients 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.
In the United States, many patients hesitate to start taking drugs while they feel healthy because they have heard reports of harsh side effects. The early antiretroviral drugs prescribed in the mid-1990s often caused rashes, accumulation of belly fat and loss of feeling in the fingers and feet. But modern regimens — many based on tenofovir, which was approved in 2001 but took some years to be widely used — have far fewer side effects.
The Start trial — short for Strategic Timing of Antiretroviral Treatment — enrolled its first patients in 2009 but was publicly announced in 2011. When it was stopped, it had followed 4,685 H.I.V.-infected men and women in 35 countries. It was created to settle the dispute about when to begin treatment. At that time, C.D.C. guidelines for American doctors called for starting therapy when a patient’s CD4 count fell below 500, while the World Health Organization recommended waiting until it was below 350.
The count is a measure of CD4 cells per cubic millimeter of blood. CD4s are white blood cells that act as the immune system’s sentinels and are the virus’s chief target. At a count below 200, a patient has what is sometimes termed “full-blown AIDS” and is at high risk of dying from other opportunistic infections like tuberculosis or Kaposi’s sarcoma, or various pneumonias. A normal CD4 count in a healthy person is 500 to 1,200.
The W.H.O. guidelines were amended in 2013. They endorsed treating at 500 as an ideal, but acknowledged that treatment at 350 was more practical in many poor countries. They also said that it should be started at any count for people with active tuberculosis, people with hepatitis B and severe liver disease, people whose regular partners were not infected, women who were pregnant or breast-feeding and children under age 5.
The W.H.O. committee that sets treatment guidelines is planning to issue new ones soon and is due to meet next month.
James D. Neaton, a University of Minnesota biostatistician and the principal investigator of the Start trial, who made the announcement with Dr. Fauci on a telephone news conference, said he thought the study would make the W.H.O. and many countries reconsider their guidelines.
H.I.V.-infected participants with counts over 500 were enrolled in the Start trial. Half were put on drugs immediately, and the other half were not until their counts reached 350 or they had an AIDS-related event, such as a disease that normally becomes serious only in the immune-suppressed.
An independent safety monitoring board looked at preliminary data two months ago and found that 86 of those in the deferred-treatment group had died, developed AIDS or suffered a serious non-AIDS event like heart, liver or kidney disease or cancer, while only 41 of those in the immediate treatment group had. That 53 percent difference was large enough to recommend stopping the trial.
Dr. Fauci, who has been treating AIDS patients for nearly 35 years, said Wednesday that he had “no doubt how it was going to turn out,” but that hard scientific evidence was needed to back up changes in policy.