So, what’s in the HIV pipe­line?

GA Voice - - News -

Did you know that peo­ple with HIV can live a nor­mal—or even longer—life­span if they get on treat­ment early and take it con­sis­tently? This awesome news is made pos­si­ble by po­tent drugs that sup­press HIV to low lev­els and stop pro­gres­sion to AIDS in its tracks. Yes, we can End AIDS! But drugs have side ef­fects, and some are more com­pli­cated to take, pos­ing chal­lenges for the high lev­els of ad­her­ence re­quired for suc­cess­ful treat­ment. It’s no sur­prise that safety, tol­er­a­bil­ity, and sim­plic­ity are a ma­jor fo­cus for new drug de­vel­op­ment. For­tu­nately, we also are still see­ing ex­cit­ing new drugs di­rected at new tar­gets.

The new­est HIV drug at your lo­cal phar­macy is Gen­voya®, a sin­gle-tablet for­mu­la­tion of elvite­gravir/co­bici­s­tat/FTC/TAF (teno­fovir alafe­namide) ap­proved by the FDA on Novem­ber 5. TAF is the kinder, gen­tler off­spring of the version of teno­fovir found in Viread®, Tru­vada®, Com­plera®, Atripla®, and Stri­bild®. Think of Gen­voya® as the “TAF sis­ter” of Stri­bild®. TAF was de­vel­oped specif­i­cally to de­crease teno­fovir side ef­fects on kid­neys and bone, and stud­ies show less bone den­sity loss and fewer kid­ney side ef­fects with TAF. But if you switch from TDF to TAF, ex­pect a small in­crease in “bad” LDL choles­terol, but also in “good” HDL choles­terol. You must watch closely to de­cide whether the bal­ance is good or bad for you. In 2016, we are likely to see a TAF sis­ter of Tru­vada® and then Com­plera®. There will be no TAF-Atripla®, and no stand-alone TAF. The first pro­tease in­hibitor sin­gle-tablet reg­i­men con­tain­ing darunavir, co­bici­s­tat, FTC, and TAF is in clin­i­cal tri­als.

Novem­ber 27, 2015

Do­ravirine, a mem­ber of the NNRTI fam­ily that in­cludes efavirenz (Sus­tiva®), rilpivirine (Edu­rant), and etravirine (Isen­tress), is in its fi­nal tri­als be­fore FDA sub­mis­sion. So far, do­ravirine has caused fewer prob­lems with sleep, vivid dreams, de­pres­sion, dizzi­ness, and sui­ci­dal­ity than efavirenz. A larger study is un­der­way, and an­other is look­ing at a sin­gle tablet combo of do­ravirine, 3TC and teno­fovir DF.

GS 9883, a once-daily in­te­grase in­hibitor, is mov­ing like a bul­let through the de­vel­op­ment path­way. Un­like elvite­gravir, it does not re­quire co­bici­s­tat or ri­ton­avir boost­ing, and its long half-life places it squarely in com­pe­ti­tion with do­lute­gravir (Tivicay®). Few clin­i­cal data are pub­lic about this drug, but it has sailed through early tri­als with no safety is­sues and is be­ing tested as a combo pill with FTC and TAF. Four new stud­ies start this month in peo­ple who have never been on treat­ment and those with “un­de­tectable” virus.

Two drugs aimed at new tar­gets also are in the pipe­line. Fos­tem­savir is an at­tach­ment in­hibitor that keeps HIV out of the cell by bind­ing to vi­ral pro­tein gp120. It is be­ing stud­ied in in­di­vid­u­als whose virus has re­bounded and who have lim­ited drug op­tions. An early study showed po­tent de­creases in vi­ral load com­pa­ra­ble to boosted atazanavir, and no un­usual tox­i­c­i­ties. Given twice daily, it is now be­ing stud­ied for ini­tial treat­ment where the stan­dard of care is once-daily dos­ing.

The mat­u­ra­tion in­hibitor BMS-955176 is once daily and is be­ing stud­ied for per­sons never on treat­ment, as well as those on fail-

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