New law al­lows HIV+ donors to help HIV+ re­cip­i­ents

GA Voice - - Georgianews -

In March of this year, Johns Hop­kins Hos­pi­tal be­came the first hos­pi­tal in the United States to trans­plant the or­gans of an HIV-pos­i­tive donor into HIV-pos­i­tive re­cip­i­ents. The liver and kid­ney trans­plants saved the lives of two peo­ple.

“This is an un­be­liev­ably ex­cit­ing day for our hos­pi­tal and our team, but more im­por­tantly for pa­tients liv­ing with both HIV and end-stage or­gan dis­ease. For these in­di­vid­u­als, this could mean a new chance at life,” said Dorry L. Segev, M.D., Ph.D., pro­fes­sor of surgery at the Johns Hop­kins Uni­ver­sity School of Medicine in a state­ment.

The surgery was the re­sult of the strik­ing down of a 25-year-old law pro­hibit­ing HIV-pos­i­tive or­gans from be­ing used for trans­plant. Those two re­cip­i­ents of the or­gans are part of a study with 30 pa­tients ex­pected to be en­rolled at six med­i­cal cen­ters na­tion­wide, with five of those HIV-pos­i­tive pa­tients to come from At­lanta, where they and the doc­tors at Emory Uni­ver­sity will take part in this new step in med­i­cal his­tory.

And the development will not only help HIV-pos­i­tive peo­ple on the wait­ing list for or­gans, but also the HIV-neg­a­tive ones on the list who will then move up in pri­or­ity once the HIV-pos­i­tive ones get the trans­plants they need.

The path to Pres­i­dent Obama’s desk

In 1988, Congress adopted a law that pre­vented pa­tients from re­ceiv­ing or­gans from HIV-pos­i­tive donors. The law made sense at the time con­sid­er­ing the lack of treat­ment op­tions avail­able for HIV-pos­i­tive peo­ple and the dam­age that the virus can do on the kid­ney and liver in par­tic­u­lar. But as new treat­ment op­tions be­came avail­able over the years and HIV-pos­i­tive in­di­vid­u­als be­gan liv­ing longer lives, doc­tors started look­ing at the is­sue again.

It be­gan in 2011 when the au­thors of a study at Johns Hop­kins Uni­ver­sity pub­lished an ar­ti­cle in the Amer­i­can Jour­nal of Trans­plan­ta­tion say­ing that a change in the pol­icy could save up to 1000 lives.

“Around the same time they ap­proached us to see if it was an is­sue we would like to take on and our board re­ally en­thu­si­as­ti­cally took it up,” says Kim­berly Miller, se­nior pol­icy of­fi­cer at the HIV Medicine As­so­ci­a­tion (HIVMA), an or­ga­ni­za­tion that is home to more than 5,000 physi­cians, sci­en­tists and other health care pro­fes­sion­als who prac­tice HIV medicine.

HIVMA de­vel­oped a pol­icy state­ment and, with Johns Hop­kins, started or­ga­niz­ing a coali­tion of groups and de­vel­op­ing ma­te­ri­als to go to Capi­tol Hill and ed­u­cate peo­ple on the is­sue. It took a cou­ple of years of work, but by Fe­bru­ary 2013 a bill with bi­par­ti­san sup- port was in­tro­duced, it passed both houses of Congress in June, and on No­vem­ber 21, 2013, Pres­i­dent Obama signed the HIV Or­gan Pol­icy Equity Act (or HOPE Act) into law.

“Our coun­try has come a long way in our un­der­stand­ing of HIV and in de­vel­op­ing ef­fec­tive treat­ments. And as our knowl­edge has grown, the pos­si­bil­ity of suc­cess­ful or­gan trans­plants be­tween HIV-pos­i­tive peo­ple has be­come more real. The HOPE Act lifts the re­search ban. In time, it could lead to these or­gan do­na­tions for peo­ple liv­ing with HIV. And that, in turn, would help save and im­prove lives and strengthen the na­tional sup­ply of or­gans for all who need them,” said Pres­i­dent Obama in a state­ment at the time. “Im­prov­ing care for peo­ple liv­ing with HIV is crit­i­cal to fight­ing the epi­demic, and it’s a

You can reg­is­ter as an or­gan donor when you get or re­new your li­cense at the Ge­or­gia Depart­ment of Driver Ser­vices. You can also des­ig­nate your de­ci­sion to be an or­gan donor on­line at www.do­natelife­ge­or­gia.org key goal of my Na­tional HIV/AIDS Strat­egy. The HOPE Act marks an im­por­tant step in the right di­rec­tion, and I thank Congress for their ac­tion.”

Safe­guards writ­ten into the law

Im­ple­men­ta­tion of the law took some time due to a num­ber of pre­cau­tions put in place in the lan­guage of the bill.

“It’s re­ally one of the most highly reg­u­lated med­i­cal pro­ce­dures that’s out there,” HIVMA’s Miller says. “With this they ob­vi­ously wanted to be es­pe­cially care­ful set­ting up safe­guards and mak­ing sure that they had pro­to­col to en­sure the safety of the or­gan sup­ply and that the or­gans would be ap­pro­pri­ately matched. Also it was set up so that these trans­plants are ini­tially done un­der re­search pro­to­cols only.”

That meant trans­plant cen­ters that are do­ing these pro­ce­dures have to get the ap­proval of an In­sti­tu­tional Re­view Board, a com­mit­tee used in re­search that ap­proves, mon­i­tors and re­views any re­search in­volv­ing hu­man sub­jects in the United States. Luck­ily there was a bit of a roadmap thanks to doc­tors over­seas.

“There had been some ex­pe­ri­ence to draw on from South Africa where these HIV-toHIV trans­plants were tak­ing place as early as 2010,” Miller says. “Those clin­i­cians and re­searchers have been closely col­lab­o­rat­ing so that when we un­der­take this in the U.S. we can learn from what the South Africans did. But they had tremen­dous suc­cess with it. They saw their pa­tients do very well and we ex­pect that to be the same here.”

The IRBs across the coun­try will re­view the re­search an­nu­ally and, with time and suc­cess, they can be­gin to rec­om­mend that the IRB re­stric­tion be lifted and the pro­ce­dure be a nor­mal op­tion of care.

By PA­TRICK SAUN­DERS

CON­TIN­UES ON PAGE 7

Au­gust 5, 2016

Emory will soon en­roll pa­tients in a study that will al­low HIV-pos­i­tive peo­ple to get a kid­ney from an HIV-pos­i­tive donor. (Stock photo)

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