The $US22 billion HIV drug market is gearing up for a major shake-up over the next year.
Right now, people living with HIV suppress the virus with a regimen of three or four pills. Keeping the amount of HIV in the blood low is key for suppressing symptoms of the virus.
Two companies want to essentially upgrade that system, either with three drugs or two.
The first is ViiV, the specialist HIV company majority owned by GlaxoSmithKline, that has Pfizer and Japanese pharmaceutical company Shionogi as shareholders. ViiV is looking to pair its drug dolutegravir with rilpivirine. In December 2016, a pair of late-stage trials showed that two-drug combo worked as well as thre three- and four-drug regimens. If approved, it would be the first 2-drug treatment for HIV.
On May 30, Gilead said it found in four late-stage studies that its its drug, bictegravir, wasn’t inferior to ViiV’s dolutegravir. Gilead hopes to pair bictegravir with emtricitabine/tenofovir alafenamide, drugs that are considered the “backbone” of HIV treatments.
On June 1, Viiv submitted its dolutegravir with rilpivirine combination to the FDA, along with a priority review voucher. The voucher could help speed up the review process by a few months. Gilead plans to file its drug regimen for approval in 2017.
In a note, Morgan Stanley outlined four scenarios on how the $US22 billion HIV market could play out based on the two rival treatments:
- Gilead proves its bictegravir is superior to dolutegravir. If that happens, Gilead could see its HIV revenues peak at $US18.7 billion in 2023. GSK (as a majority owner of ViiV) on the other hand would make $US4.9 billion on dolutegravir under this scenario.
- Bictegravir and dolutegravir end up pretty much the same, and Gilead comes out on top commercially. Gilead could stand to make $US15.0 billion in peak HIV revenue in 2024, while GSK makes $US6.6 billion on dolutegravir.
- Bictegravir and dolutegravir end up pretty much the same, and GSK comes out on top commercially. Gilead could stand to make $US12.8 billion in peak HIV revenue in 2017, while GSK’s revenue from dolutegravir could hit a peak of 9.7 billion in 2023.
- Generic drugs win out. If that happens, it could be detrimental to both companies’ stock prices.