- ViiV Healthcare, a company majority owned by GlaxoSmithKline, reported its two-drug combination regimen succeeded in maintaining HIV suppression with injections every eight weeks in a Phase 3 study.
- According to a Thursday statement, the combination of ViiV's cabotegravir and Janssen's long-acting rilpivirine proved non-inferior at maintaining antiviral activity when compared to same treatment administered once every four weeks. Patients were evaluated over the course of 48 weeks.
- Safety, virologic response and drug resistance were also similar for the longer acting version of the treatment, the company said. Detailed results from the ATLAS-2M study will be presented at an upcoming medical meeting, GSK said.
The results boost GSK's drive to cut into Gilead's hold on the HIV market. The idea that a two-drug medicine can hold the virus in check when given just six times a year would be an improvement for patients who have had to juggle daily pills for decades.
"Approval of this regimen would mark a significant change in the HIV treatment paradigm," ViiV's R&D head Kimberly Smith said in a statement.
GSK, which won approval for the first AIDS drug Retrovir (zidovudine) in 1987, is focusing its HIV strategy on treatments that use fewer medicines. The British drugmaker is aiming for fewer side effects and better adherence, with the goal of ultimately improving quality of life for patients.
Unlike Gilead, which dominates the market with three-drug regimens like Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), ViiV is studying combinations of just two medications. ViiV already has approval for two such treatments, Juluca (dolutegravir/rilpivirine) and Dovato (dolutegravir/lamivudine).
In a study released last month, Dovato proved comparable to three-drug regimens similar to those offered by Gilead, leading analysts to predict that the ViiV drug would start to cut into sales of Gilead's Biktarvy.
The results released Thursday offer the possibility of an even bigger advancement by using ViiV's cabotegravir along with Janssen's long-acting rilpivirine. The Food and Drug Administration granted Priority Review to the once-monthly version of the dual treatment, and GSK expects an answer on approval by Dec. 29.
The latest study included 1,045 adults who had suppressed viral loads for at least six months and had not shown drug resistance to either cabotegravir or rilpivirine. ViiV is developing the dual treatment with Janssen Sciences Ireland.
Pfizer and Shionogi are also shareholders in ViiV.