End­ing the epi­demic:

Will PrEP prove to be a game changer in the fight against HIV?

GA Voice - - Front Page - By PA­TRICK SAUN­DERS psaun­ders@the­gavoice.com

The sci­en­tific com­mu­nity and HIV/AIDS ac­tivists are abuzz about the pre­lim­i­nary find­ings of a new PrEP study show­ing not only the ef­fec­tive­ness of the treat­ment over­all, but the suc­cess of an in­no­va­tive reg­i­men wherein par­tic­i­pants took PrEP only when they an­tic­i­pated hav­ing sex in­stead of tak­ing it daily as it is cur­rently pre­scribed.

Par­tic­i­pants in the IPERGAY trial, which oc­curred in France and Canada and closed early due to high ef­fec­tive­ness, took two pills of Tru­vada in the 24-hour pe­riod be­fore an­tic­i­pated sex and, if sex oc­curred, then took two sep­a­rate one-pill doses of the drug in the two days fol­low­ing sex. IPERGAY in­ves­ti­ga­tors did not re­lease any ef­fec­tive­ness fig­ures or other data, but will do so once a com­plete anal­y­sis of the re­sults has been com­pleted, which they say should be some­time in early 2015. HIV/AIDS ac­tivists in At­lanta are cau­tiously op­ti­mistic. “I think it’s sig­nif­i­cant. It adds a way of pro­tect­ing those who are at high risk, es­pe­cially MSMs who are sex­u­ally ac­tive,” said Ron­nie Bass, ex­ec­u­tive di­rec­tor of HIV/AIDS out­reach or­ga­ni­za­tion Some­one Cares, who also warns, “It’s not a Band-Aid to­ward hav­ing un­pro­tected sex, it’s not a quick fix.” Other ac­tivists echo Bass’s sen­ti­ments. “We think it looks real promis­ing, but we will need to look at the de­tails once more in­for­ma­tion comes out. There are a lot of if’s,” said Michael Baker, di­rec­tor of ad­vance­ment at Pos­i­tive Im­pact. “As far as our clinic goes, we will have to ad­here to what­ever the CDC is ad­vis­ing. I will tell you the CDC is mov­ing very strongly in the di­rec­tion of PrEP.”

The U.S. Pub­lic Health Ser­vice re­leased new fed­eral PrEP guide­lines in May, de­vel­oped by a work­ing group led by the CDC, which rec­om­mended PrEP for peo­ple who are at a sub­stan­tial risk for HIV, in­clud­ing gay and bi­sex­ual men.

The an­nounce­ment led to crit­i­cism from Michael We­in­stein, pres­i­dent of the AIDS Health­care Foun­da­tion, who has called PrEP “a pub­lic health dis­as­ter in the mak­ing” and Tru­vada a “party drug.” This week, We­in­stein’s or­ga­ni­za­tion launched a na­tional ad­ver­tis­ing cam­paign in LGBT me­dia us­ing the head­line “What if you’re wrong about PrEP?” The group has also sent press re­leases about the cam­paign to LGBT me­dia or­ga­ni­za­tions across the coun­try, in­clud­ing the GA Voice.

How­ever, We­in­stein doesn’t ap­pear to have many al­lies on this is­sue. HIV/AIDS groups across the world, in­clud­ing here in At­lanta, have blasted him for his com­ments.

“I think it’s re­ally un­for­tu­nate to have some­one in his po­si­tion to make the com­ments he’s mak­ing,” Baker said. “I’ve read the same stud­ies and they say the ex­act op­po­site of what he’s say­ing. I think he’s do­ing the com­mu­nity a ma­jor dis­ser­vice by not back­ing up his claims. From Pos­i­tive Im­pact’s po­si­tion, we don’t be­lieve in sex sham­ing.”

In the mean­time, in the wake of this lat­est study, the CDC is tak­ing a wait-and-see ap­proach.

“It is im­por­tant to point out that while th­ese an­nounce­ments are en­cour­ag­ing, at this point we do not have any data or other crit­i­cal de­tails from th­ese tri­als,” said Dr. Eu­gene McCray, di­rec­tor of the CDC’s Di­vi­sion of HIV/AIDS Preven­tion, in a state­ment re­leased shortly after the find­ings were an­nounced.

“More specif­i­cally, we have no data on fac­tors that may have in­formed th­ese an­nounce­ments in­clud­ing rates of HIV in­fec­tions, PrEP ad­her­ence or risk be­hav­iors among trial par­tic­i­pants. We also do not yet know what IPERGAY will tell us re­gard­ing the fre­quency, tim­ing, or ex­act dose of PrEP re­quired for pro­tec­tion.”

The IPERGAY trial will con­tinue in non-ran­dom­ized form for at least another year to gather safety data and show that “on de­mand” PrEP can have long-term ben­e­fits.

The CDC urges gay and bi­sex­ual men and other groups at higher risk of HIV in­fec­tion to con­tinue to follow cur­rent CDC guide­lines, which rec­om­mend the FDA-ap­proved reg­i­men of daily oral Tru­vada for HIV preven­tion.

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