Dolutegravir-Based Regimen Demonstrates Superior Efficacy to Current WHO-recommended HIV Regimen

Dolutegravir (Tivicay) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) achieved positive interim results from a phase 3b non-inferiority trial, according to a press release.

The DAWNING clinical trial compared a protease inhibitor-sparing regimen of dolutegravir and 2 NRTIs with lopinavir/ritonavir and 2 NRTIs as a second-line treatment in HIV-1 infected patients, according to a press release.

Included in the 52-week open-label study were adult patients with HIV who failed first-line therapy. The participants were randomized 1:1 to receive either dolutegravir or lopinavir/ritonavir combined with an investigator-selected dual NRTI background, including at least 1 fully active NRTI.

The primary endpoint was the proportion of patients with plasma HIV-1 RNA<50 c/mL at week 48. Key secondary endpoints were the evaluation of the development of viral resistance and measurements of safety and tolerability.

The 24-week interim data showed an 82% response rate in the dolutegravir arm versus 69% for lopinavir/ritonavir, indicating that the dolutegravir-based regimen demonstrated superior efficacy.

None of the patients in the dolutegravir arm failed treatment with either integrase or nucleoside resistance, according to the release. At week 24, the safety data for dolutegravir were consistent with prior dolutegravir studies.

The Independent Data Monitor Committee observed significant and clinically-relevant differences between treatment arms in favor of dolutegravir. The committee recommended that the boosted lopinavir treatment arm be discontinued, and patients receiving lopinavir/ritonavir were given the opportunity to switch to a dolutegravir-based regimen.

“The initial results from DAWNING are important because they not only provide information that may help guide second-line treatment decisions in resource-limited settings, but also reaffirm the position of dolutegravir at the core of HIV care,” John C. Pottage Jr, MD, chief scientific and medical officer of ViiV Healthcare, said in the release. “We are working with investigators to ensure that dolutegravir can be provided to patients in the control arm and are looking forward to sharing the 48-week results, as soon as they will be available.”

The findings were presented at the International AIDS Society Congress in Paris.