Patients Can Switch to Dovato from Biktarvy | AIDS 2024

Dovato can be a switch option for patients with HIV whose virus levels are undetectable, according to an abstract at the International AIDS Conference in Munich, Germany.

Dovato is a combination of dolutegravir/lamivudine that is used to treat HIV-1 in people 12 years and older who have not received HIV-1 medicines in the past. Developed by Viiv Healthcare, Dovato can also be used to replace some HIV medications. The list price for a 30-day supply of Dovato is $2,976.63.

Charlotte-Paige Rolle, M.D.

Researchers, led by Charlotte-Paige Rolle, M.D., MPH, director of Research Operations at Orlando Immunology Center, conducted an open-label study, DYDAD, that switched patients who had an undetectable viral load to the once-daily Dovato from once-daily Biktarvy.

Gilead’s Biktarvy is a combination of bictegravir/emtricitabine/tenofovir alafenamide that is approved to treat HIV-1 in adults and children. The list price of Biktarvy is $3,981 per month.

The DYAD study enrolled 222 adults with HIV-1 below 50 copies per milliliter (mL), which is a measure of viral load that is considered to be undetectable and not to be transmissible. Patients were randomized to switch to Dovato or remain on Biktarvy.

Researchers found that at week 48, Dovato was noninferior to continuing Biktarvy among virologically suppressed adults.

But drug-related adverse events and-withdrawals were higher in the Dovato arm, which researchers said is likely consistent with the open-label nature of this switch study.

Researchers said these data reinforce findings from TANGO, a previous study that assessed switching from Biktarvy to Dovato. That study, published in October 2020 in Clinical Infectious Disease, found that patients who switched to Dovato had no virologic failure or emergent resistance reported at week 48.

In the DYAD study, the primary endpoint is the proportion with HIV-1 of less than 50 per mL at week 48. Clinical safety and changes in renal and metabolic parameters were also evaluated.

Researchers found that at week 48, 6 (4%) participants on Dovato and 5 (7%) on Biktarvy had HIV-1 50 per mL or more, which they said meets the criteria for noninferiority.

Drug-related adverse events and withdrawals due to adverse events occurred in 31 (21%) and 6 (4%) participants with Dovato and 2 (3%) and 0 participants with Biktarvy, respectively. Between week 24 and week 48, no additional drug-related adverse events and withdrawals due occurred in the Dovator arm.

There were no significant differences in mean change from baseline in creatinine, lipid parameters, weight, body mass index and waist circumference between treatment groups.