Could six-times-a-year injection become standard HIV treatment?


ViiV Healthcare and Janssen say injections of two new long-acting HIV drugs could make controlling the disease far easier for people living with the disease.

The combination offers to do away with HIV patients having to take daily antiretroviral therapy (ART) pills, with new data suggesting just six or twelve injections a year of each drug works just as well.

If approved, the combination could prove to be very popular with patients and doctors, and could help ViiV Healthcare and Janssen gain market share from Gilead, the dominant player in HIV treatment.

The companies have just unveiled phase 2b data from their LATTE-2 study, introducing the injections in the place of daily pills in patients who already have the disease under control. But the company is also pursuing trials as a first-line treatment in patients who have never had ART before.

The regimen of two investigational long acting, intramuscular (IM) formulations of Janssen's rilpivirine and ViiV Healthcare's cabotegravir—given together every 4 or 8 weeks—showed comparable antiviral activity to 3-drug oral ART (investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs).

While the decision to compare the long-acting injections to cabotegravir rather than an established ART regimen may be questionable, the data nevertheless suggests the combination will make a big impact once approved.

The companies plan to begin phase 3 studies later this year, which means the long-acting injections could reach patients by 2018. The  research is part of a push from GSK, the majority partner in ViiV, to regain ground in the therapy area it once commanded.

ViiV's sales rose strongly in 2015, up 54% to £2.32 billion, largely thanks to new treatments three-in-one pill Triumeq and integrase inhibitor Tivicay.

Despite this growth, ViiV's sales remain a fraction of Gilead's HIV revenues. The US company announced its own news yesterday, with trial data supporting its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF).

F/TAF is a next-generation version of Gilead's blockbuster HIV treatment Truvada (emtricitabine and tenofovir disoproxil fumarate or F/TDF).

Phase 3 data released yesterday showed patients could be safely moved over to F/TAF from Truvada. TAF is the new backbone treatment for Gilead's HIV regimens, and can be dosed at less than one-tenth of its older drug TDF. The advantage of TAF is that it significantly improves the renal and bone safety of treatment, a significant issue in the increasingly older HIV population.

Genvoya (elvitegravir/cobicstat/emitricitabine/tenofovir alafenamide) a once-daily single pill was the first combination containing TAF to gain approval, receiving EU clearance in November.

Andrew McConaghie

24 February, 2016