- GlaxoSmithKline's injectable two-drug pairing of cabotegravir and rilpivirine succeeded in maintaining HIV suppression at 48 weeks in a head-to-head study against the pharma's own once-daily Triumeq, according to topline results announced Tuesday.
- In the FLAIR study, patients whose virus was suppressed after 20 weeks on daily Triumeq remained in suppression after switching to once-monthly injections of the experimental doublet, positing a similar rate to patients who stayed on Triumeq.
- This is the second Phase 3 trial for the injectable formulation, which was developed by GSK's majority-owned ViiV Healthcare and co-developed with Johnson & Johnson. The ATLAS study of the combo showed similar efficacy to standard-of-care, an oral, daily triple therapy.
The HIV market is dominated by Gilead Sciences and GSK's ViiV Healthcare, which is a joint venture with Pfizer and Shionogi.
Through ViiV, GSK owns a wide portfolio of approved antiretroviral medicines, with its oral doublet Juluca (dolutegravir/rilpivirine) the latest to reach the market. Juluca was approved in the U.S. in November 2017, and Europe, Canada and Australia in the second quarter of 2018. It was the first two-drug regimen to be approved for maintenance treatment of HIV-1.
As well as the long-acting injectable combining cabotegravir and rilpivirine, ViiV is working on another oral, daily two-drug product, combining Tivicay (dolutegravir) and Epivir (lamivudine). Two-drug combinations hold potential to reduce side effects compared with standard triplet therapy, and provide alternatives for patients who are unable to take other drugs.
The FLAIR results, supported by this week's announcement of 160-week Phase 2b data that show high rates of virologic response, are a lift to GSK. The success also moves the long-acting HIV maintenance therapy closer to market.
If the long-acting doublet were to be approved, HIV patients used to taking hundreds of pills could have an option for less frequent dosing, albeit through an injection.
“This innovative dosing regimen could transform HIV therapy by reducing the number of days a person receives treatment from 365 to 12," said John Pottage, chief medical officer at ViiV Healthcare, in a statement.
Gilead Sciences, for its part, is sticking with a triplet approach. The biotech reported results from a head-to-head study of Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) against Triumeq earlier this month, showing non-inferiority.
Biktarvy has the benefit of a broad label, and this recent study builds the argument for Biktarvy in HIV-positive patients who are new to therapy.