FDA slaps a hold on Gilead’s injectable HIV treatment over concerns about potential glass contaminants

Merdad Parsey, Gilead CMO

The FDA is com­ing down on yet an­oth­er ther­a­py over con­cerns about glass par­tic­u­lates wind­ing up in drug so­lu­tion.

Reg­u­la­tors have slapped a clin­i­cal hold on 10 tri­als study­ing in­jectable ver­sions of Gilead’s ex­per­i­men­tal HIV treat­ment lenaca­pavir, due to con­cerns that vials made of borosil­i­cate glass could lead to the for­ma­tion of sub-vis­i­ble glass par­ti­cles in the so­lu­tion.

‘We are com­mit­ted to work­ing dili­gent­ly with FDA to re­solve this glass vial com­pat­i­bil­i­ty qual­i­ty is­sue and re­sume in­jectable lenaca­pavir dos­ing in the af­fect­ed stud­ies in a time­ly fash­ion,’ CMO Mer­dad Parsey said in a state­ment.

The dos­ing of oral for­mu­la­tions will con­tin­ue, ac­cord­ing to Gilead, and in­ves­ti­ga­tors will con­tin­ue mon­i­tor­ing the pa­tients who have al­ready been dosed with in­jectable for­mu­la­tions, as well as dose par­tic­i­pants in com­para­tor arms.

Gilead’s been work­ing on lenaca­pavir, an HIV-1 cap­sid in­hibitor, for both the treat­ment and pre­ven­tion of HIV-1 in­fec­tion. While most an­tivi­rals act on just one stage of vi­ral repli­ca­tion, the com­pa­ny says lenaca­pavir is de­signed to in­hib­it HIV-1 at mul­ti­ple stages of its life­cy­cle.

The drug is Gilead’s big next-gen an­tivi­ral. Back in March, the com­pa­ny signed a co-de­vel­op­ment pact to study the can­di­date in com­bi­na­tion with Mer­ck’s is­la­travir.

How­ev­er, Mer­ck slammed the brakes on its pro­gram in No­vem­ber af­ter in­ves­ti­ga­tors flagged a drop in im­mune cell counts that an ex­ter­nal com­mit­tee de­ter­mined was re­lat­ed to is­la­travir. The FDA placed an of­fi­cial clin­i­cal hold on the ex­per­i­men­tal treat­ment ear­li­er this month.

The clin­i­cal hold af­fects sev­er­al mid- and late-stage tri­als, in­clud­ing one Phase III as­sess­ing pre-ex­po­sure pro­phy­lax­is in cis­gen­der men, trans­gen­der women, trans­gen­der men, and gen­der non-bi­na­ry peo­ple 16 years or old­er; and an­oth­er Phase III look­ing at pre-ex­po­sure pro­phy­lax­is in ado­les­cent girls and young women in com­bi­na­tion with stan­dards of care emtric­itabine/teno­fovir alafe­namide.

This isn’t the first time Gilead has run in­to trou­ble with glass par­tic­u­lates. Ear­li­er this month, the phar­ma com­pa­ny re­called two lots of its Covid-19 treat­ment Vek­lury af­ter the ap­pear­ance of par­tic­u­lates. A cus­tomer com­plaint had been con­firmed by a Gilead in­ves­ti­ga­tion.

Over the last year, glass par­tic­u­lates have emerged as an in­dus­try-wide prob­lem. Back in Oc­to­ber, one lot of Mer­ck’s an­tibi­ot­ic Cu­bicin was re­called af­ter a piece of glass was found in a vial, rais­ing safe­ty con­cerns. And in June, the FDA is­sued a warn­ing let­ter to the Japan­ese man­u­fac­tur­er Toy­obo Co af­ter 12 batch­es of in­jecta­bles were found to have cel­lu­lose and glass fibers, stains, and par­ti­cles on vials, the FDA said.

This month, the FDA re­leased draft guid­ance aim­ing to help drug­mak­ers pre­vent the risk of par­tic­u­late con­t­a­m­i­na­tion.

While side ef­fects caused by the glass pieces de­pend on the route of ad­min­is­tra­tion, the pa­tient pop­u­la­tion, and the na­ture of the par­tic­u­lates them­selves (such as size or shape), the agency not­ed that some pa­tients could ex­pe­ri­ence in­fec­tion, ve­nous or ar­te­r­i­al blood clots, in­flam­ma­tion, or even em­boli, ab­scess­es, and gran­u­lo­mas in vis­cer­al or­gans.

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