GSK sets the stage for a toe-to-toe market showdown with Gilead's HIV champion Truvada
ViiV Healthcare and majority owner GlaxoSmithKline have cleared another important hurdle on a long-running quest to challenge Gilead’s dominance in preventative HIV treatments.
The final analysis of a new study shows the GSK subsidiary’s long-lasting injection, cabotegravir, proved 66% more effective in HIV prevention than Gilead’s breakthrough Truvada pill. And they now intend to carve away some of the blockbuster revenue that Gilead has enjoyed for years.
The study, released Tuesday, compared the effects of patients taking cabotegravir versus those taking daily oral pills. Within the injection arm of the test, researchers documented only 13 cases of HIV, or an incidence rate of 0.41%. In the pill arm, 39 cases were found, amounting to a rate of 1.22%. The study also noted high levels of adherence to daily oral therapy.
Due to the Covid-19 pandemic, the blinded phase of the study was halted in May. After a final analysis and review, ViiV was able to confirm the injections proved more effective than daily pills at the highlighted 66 percent rate.
“This advancement has the potential to be a game-changer for HIV prevention, offering … the convenience of reduced dosing from daily to just six times per year,” Kimberly Smith, R&D chief at ViiV, told Reuters.
The results of the study come as generic versions of Truvada, a once-daily pill that reduces the risk of contracting HIV through sex by about 99 percent, are about to hit the market. Truvada and Descovy, another Gilead HIV treatment, have allowed the company to essentially own the entire drug sector ever since Truvada was green-lit by the FDA in 2012 as the first preventative measure for HIV.
However, Gilead is facing a lawsuit from activists claiming the company extended its monopoly by illegally altering development times, and a lawsuit from the US government alleging improper patent practices. Gilead has also faced heavy criticism of price gouging, as Truvada treatment can cost around $20,000 per year.
Truvada netted Gilead $2.8 billion in sales last year in both HIV prevention and treatment.
Though Truvada and Descovy are already highly effective treatments, GSK hopes it can sell the idea of increased compliance with its new drug. Because cabotegravir only requires one injection every two months, patients are less likely to forget to take it, as opposed to the risk of missing a daily Truvada pill.
Cabotegravir has had its own share of road bumps as well. Back in December, the FDA issued a complete response letter to ViiV and rejected its application for monthly cabotegravir injections, citing manufacturing and control concerns. As a result, the NDA for the bimonthly regimen was pushed back from the first quarter of 2020.