In another win for dolutegravir, the phase 3 ADVANCE trial found strong evidence that dolutegravir-based regimens work just as well as regimens that contain efavirenz (Sustiva, Stocrin), an NNRTI that is currently one of the most commonly used HIV medications in low- and middle-income countries.
According to the ADVANCE trial abstract, NNRTI drug resistance is a growing problem, affecting more than 10% of patients in South Africa.
The ADVANCE trial was a 96-week, open-label study of 1,053 HIV-positive patients in South Africa. It compared three different treatment combinations: TAF/emtricitabine (FTC, Emtriva)/dolutegravir, TDF/emtricitabine/dolutegravir, and TDF/emtricitabine/efavirenz. Investigators did not screen for baseline drug resistance, per South African treatment guidance.
"Both DTG and TAF have been licensed to generic manufacturers and are very cheap to make, so we would theoretically have a cheaper and safer regimen," said Willem Francois Venter, M.D., F.C.P., of Ezintsha, a research group of Wits Reproductive Health and HIV Institute in Johannesburg, South Africa, speaking at an IAS press conference.
Data presented at IAS were simultaneously published in the New England Journal of Medicine. At 48 weeks, the percent of patients with suppressed viral load was 84% in the TAF/emtricitabine/dolutegravir arm, 85% in the TDF/emtricitabine/dolutegravir arm, and 79% in the TDF/emtricitabine/efavirenz arm. Surprisingly, although there's been reported resistance to NNRTIs in South Africa, there were very low rates of virologic failure across all the treatment arms.