People with HIV who switch their antiretroviral (ARV) treatment to ViiV Healthcare’s long-acting injectable Cabenuva (cabotegravir/rilpivirine) may not have to take a four-week oral lead-in of the two drugs in the regimen. A recent clinical trial found no difference in outcomes based on whether participants went directly from taking Triumeq (dolutegravir/abacavir/lamivudine) to receiving the monthly Cabenuva injections or first took four weeks of a daily pill form of the regimen before starting the injections.

Cabenuva has already been approved in Canada. The U.S. Food and Drug Administration has expressed concerns about the regimen’s manufacturing process, which ViiV is seeking to address in hopes of securing approval in the United States; a decision is expected in late January.

The trial enrolled about 560 people with HIV who had never been treated for the virus and were first started on Triumeq. Those who achieved a fully suppressed viral load at the end of 20 weeks were then evenly randomized to either stay on Triumeq or switch to Cabenuva.

Those in the Cabenuva group first received a lead-in of oral versions of cabotegravir and rilpivirine. After at least four weeks of that treatment, they were switched to monthly injectable Cabenuva. At the two-year mark, those in the Triumeq group could elect to switch to Cabenuva and either start on the injectable regimen directly or first take the oral lead-in.

After another six months, the study authors concluded that switching to Cabenuva was comparably effective between those who did and did not use the oral lead-in. Rates of adverse health events were also similar. Other recent research has shown that taking Cabenuva every other month, rather than monthly, is similarly effective.