The Food and Drug Administration (FDA) has expanded the approval of Dovato (dolutegravir/lamivudine; ViiV Healthcare) for use as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral (ARV) regimen in adults who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato. Previously, Dovato was only approved for treatment-naïve adults.
Dovato is a once-daily, fixed-dose tablet that combines dolutegravir, an HIV-1 integrase strand transfer inhibitor, and lamivudine, a nucleoside reverse transcriptase inhibitor. Each Dovato tablet contains 50mg of dolutegravir and 300mg of lamivudine.
The new indication was based on data from the multicenter, open-label, active-controlled phase 3 TANGO study that assessed the efficacy and safety of switching to Dovato in adults with HIV-1 infection who were virologically suppressed and on a stable ARV regimen with no treatment failure.
Patients (n=741) were randomized receive Dovato once daily or continue on their tenofovir alafenamide fumarate-based regimen (TBR) for up to 200 weeks. The primary end point was the proportion of patients with a plasma HIV-1 RNA ≥50 copies/mL (virological nonresponse) at week 48.
Results showed that Dovato met the primary end point achieving noninferiority to the TBR at week 48; <1% of patients in both arms experienced virologic failure (treatment difference [based on Cochran–Mantel–Haenszel-stratified analysis adjusting for baseline third-agent class]: -0.3% [95% CI, -1.2, 0.7]). At week 48, 93% of patients in both treatment arms had HIV-1 RNA <50 copies/mL (secondary end point; adjusted treatment difference: 0.2% [95% CI, -3.4, 3.9]).
Outcomes between treatment arms were found to be similar across the stratification factor, baseline third-agent class (protease inhibitor, integrase strand transfer inhibitor, or non-nucleoside reverse transcriptase inhibitor), and across subgroups by age, sex, race, baseline CD4+ cell count, CDC HIV disease stage, and countries. The median change from baseline in CD4+ count at week 48 was 22.5 cells/mm3 in patients who switched to Dovato and 11.0 cells/mm3 in patients who stayed on the TBR.
“This expanded approval for Dovato is particularly important for my virologically suppressed patients living with HIV who are seeking a new option that can reduce the number of drugs they are exposed to each day,” said Dr Charlotte-Paige Rolle, Director of Research Operations, Orlando Immunology Center. “The data supporting the approval demonstrates how virologically suppressed adults with no known resistance to dolutegravir or lamivudine were able to switch from a TAF-containing regimen of at least 3 drugs to Dovato while maintaining similar efficacy with zero cases of treatment-emergent resistance through 48 weeks.”
For more information visit dovato.com.
1. ViiV Healthcare announces FDA approval of an expanded indication for Dovato (dolutegravir/lamivudine), a complete two-drug regimen for virologically suppressed adults with HIV-1. https://www.businesswire.com/news/home/20200806006103/en/ViiV-Healthcare-announces-FDA-approval-expanded-indication. Accessed August 7, 2020.
2. Dovato (dolutegravir/lamivudine) Prescribing Information. US Approval 2020. Accessed August 10, 2020.