Major HIV study backs early use of antiretroviral drugs

An international clinical trial involving nearly 5,000 people with HIV confirms that treatment with antiretroviral drugs should begin sooner rather than later, the National Institutes of Health announced.

The benefits of early therapy were so clear that the study was stopped early so that everyone in the trial could receive the drugs.

Participants in the Strategic Timing of AntiRetroviral Treatment, or START, study who initiated treatment when their immune system was still strong were 53% less likely to die or develop a serious illness compared with those who delayed treatment until their immune systems had been weakened by the human immunodeficiency virus.

People diagnosed with HIV in the U.S. already start treatment at an early stage, when their count of CD4+ Tcells is still above 500 per cubic millimeter of blood. (The count for a healthy adult ranges from 500 to 1,200.)

But doctors had no firm evidence that this approach was better than delaying treatment until a patient’s CD4+ count had dropped below 350.

“We now have clear-cut proof that it is of significantly greater health benefit to an HIV-infected person to start antiretroviral therapy sooner rather than later,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a statement.

When the START trial began in 2011, Fauci and other medical experts were unsure whether the benefits of early treatment would outweigh the risks.

Some epidemiological studies suggested that patients had better outcomes when they started therapy sooner. But no one knew whether patients would suf- fer side effects from being on antiretroviral drugs for a lifetime, or whether early treatment would help HIV develop resistance to the medications.

So the International Network for Strategic Initiatives in Global HIV Trials, a group funded by NIAID, launched the randomized clinical trial to get a definitive answer.

For the trial, researchers recruited 4,685 HIV-positive adults from 215 sites in 35 countries. All of these men and women had CD4+ counts above 500 when they joined the study, and none had taken antiretroviral drugs.

About half of these volunteers were randomly assigned to begin treatment right away, and the rest waited until their CD4+ count dropped below 350. Researchers checked in with study participants once every four months.

Between March 2011 and March 2015, 86 members of the deferred treatment group developed serious AIDS-related complications, other serious medical problems (such as major cardiovascular disease and cancer) or died. That compared with 41 such cases among those who began treatment right away.

The study’s independent data and safety monitoring board calculated that early treatment reduced the risk of serious health problems or death by 53%.

Members of the early treatment group were less likely to develop AIDS-related and non-AIDS-related conditions, though the reduction in risk was greater for complications related to AIDS, the board found.

The National Institutes of Health recommends patients take antiretroviral drugs as soon as they are diagnosed with HIV.