Ma­jor HIV study backs early use of an­tiretro­vi­ral drugs

Los Angeles Times - - THE NATION - By Karen Ka­plan karen.ka­plan@la­times.com Twit­ter: @LATkarenka­plan

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.

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