Success for Tivicay (dolutegravir) + 2 NRTIs versus lopinavir/ritonavir in DAWNING study for HIV adults. ViiV HealthCare.

ViiV Healthcare, announced positive interim results from DAWNING study. This is a non-inferiority study conducted to compare second-line treatment of the protease inhibitor-sparing regimen of dolutegravir and 2 nucleoside reverse transcriptase inhibitors (NRTIs), with a current WHO-recommended regimen of dolutegravir and 2 nucleoside reverse transcriptase inhibitors (NRTIs), with a current WHO-recommended regimen of lopinavir/ritonavir in HIV-1-infected adults. Results are being presented at the International AIDS Society congress in Paris.

The study’s Independent Data Monitoring Committee (IDMC) noted significant and clinically-relevant differences between treatment arms in favour of dolutegravir and recommended that the boosted lopinavir treatment arm be discontinued. Participants receiving lopinavir/ritonavir were offered the opportunity to switch to a regimen with dolutegravir as the core agent, if considered appropriate by the investigator.

The primary endpoint was the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at week 48. The 24-week interim data showed an 82% response rate in the dolutegravir arm versus 69% for lopinavir/ritonavir (p<0.001). Key secondary endpoints include evaluation of the development of viral resistance and measurements of safety and tolerability. No subjects in the dolutegravir arm of the study failed treatment with either integrase or nucleoside resistance. The safety data for dolutegravir at week 24 was consistent with previous dolutegravir studies. Additional data from DAWNING will be presented at future medical meetings.