Gilead's new blockbuster HIV combination nears filing

Gilead looks set to file its new single tablet HIV regimen, a combination which could prove to be a blockbuster and help keep it ahead of rivals such as ViiV.

New trial results showed the three-in-one combination met targets against rival regimens including ViiV’s Tivicay.

Geoffrey Porges, analyst at Leerink, says the convenience, safety and tolerability of the combination could help it earn peak revenues of more than $10 billion.

The new regimen adds Gilead’s experimental bictegravir (BIC) to its already approved emtricitabine/tenofovir alafenamide (F/TAF), in a bid to compete against Tivicay (dolutegravir), an integrase inhibitor launched three years ago.

Gilead’s latest combination is intended as a successor to its older Atripla (efavirenz+emtricitabine+tenofovir disoproxil fumarate), whose sales are ebbing away as the market becomes more competitive.

In 2016, sales were down slightly compared with the previous year, to just under $1.9 billion – and Teva in December will be able to market a generic version of Viread (tenofovir disoproxil fumarate).

Gilead is also under pressure to come up with new drugs following the huge success of its hepatitis C cures, based around the drug Sovaldi (sofosbuvir).

Although it has generated billions in sales for Gilead, sales are also declining as the number of severely ill hepatitis C patients is falling.

The latest trials showed that in HIV, the bictegravir and (F/TAF) combination was as effective as ViiV’s Triumeq (abacavir+dolutegravir+lamivudine), or regimens including Janssen’s Prezista (darunavir) and Bristol-Myers Squibb’s Reyataz (atazanavir), plus a nucleoside/nucleotide backbone such as Viread.

Gilead said BIC/F/TAF met the definition of non-inferiority in all four studies, with comparable proportions of patients showing viral suppression.

[caption id="attachment_24711" align="alignnone" width="139"] Norbert Bischofberger[/caption]

Norbert Bischofberger, executive vice president, R&D and chief science officer at Gilead Sciences, said: “Since the approval of Viread 16 years ago, Gilead has continually worked to develop and improve treatments for people living with HIV. This investigational single tablet regimen brings together the potency of an integrase inhibitor, bictegravir, with the demonstrated efficacy and safety profile of the F/TAF backbone.”

Gilead plans to file the drug with regulators in the US and EU later this year. Analysts predict it will use a priority review voucher to accelerate its FDA review, which could reach a conclusion before the end of this year.