ViiV Healthcare has reported positive results from the Phase IIIb STAT clinical trial of Dovato (dolutegravir/lamivudine) for the rapid initiation of treatment in adults living with HIV-1.
Dovato is a once-daily, single-pill, two-drug regimen combining integrase strand transfer inhibitor (INI) dolutegravir (Tivicay, 50mg) with NRTI lamivudine (Epivir, 300mg).
The drug was effective and well tolerated in the multi-centre, open label, single arm, 48-week trial, which is being performed in the US. The data is said to indicate the drug’s feasibility as a treatment in this indication.
The STAT study involved a rapid ‘Test and Treat’ model, where treatment was initiated within 14 days of diagnosis prior to obtaining baseline HBV co-infection status, renal function, and resistance test results.
All study participants were tested for HBV co-infection before treatment with Dovato and results were available following treatment initiation.
In the Phase IIIb trial, 92% of subjects with available data at 24 weeks reached a viral load of <50c/mL. The findings was on patients who continued on Dovato, as well as those who switched to alternative antiretroviral (ART).
Eight patients switched from ViiV’s drug to an alternative ART regimen, including five due to HBV co-infection.
Data revealed that all five of these participants achieved a viral load of <50c/mL at 24 weeks, without any HBV or HIV resistance-associated mutations. This is said to indicated that rapid Dovato initiation did not impact outcomes in this subset.
The trial demonstrated that Dovato was well tolerated, with low rates of grade 2-5 drug-related AEs and serious AEs.
ViiV Healthcare Research & Development head Kimberly Smith said: “The results from the STAT study reinforce the proven efficacy of Dovato and provide further evidence supporting its use in settings where rapid treatment initiation is the standard.
“These findings represent an important step forward in our understanding of current treatment options that can be rapidly initiated after an HIV diagnosis and confirm the validity of this approach with Dovato.”
Last month, ViiV reported that its long-acting, injectable cabotegravir, given every two months, showed superior efficacy over Gilead Sciences’ daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets to prevent HIV.