A fixed-dose, once-daily HIV drug regimen has significantly out-performed an older treatment in a South African trial limited to women. The open-label ARIA study, which is a combination of abacavir, dolutegravir and lamivudine (Trimeq), showed superior results when compared to the older combination of ritonavir-boosted atazanavir (Reyataz) and tenofovir/emtricitabine (Truvada). The new single-pill, fixed-dose combination also had better tolerability, according to Kimberly Smith, MD, of ViiV Healthcare, which is developing the new regimen.
Smith said that the findings are important because women are “often under-represented in clinical trials of HIV drugs, despite the fact that they bear much of the burden of the HIV/AIDS pandemic.”
The study enrolled 495 “treatment-naive” women from 12 countries. The largest group of participants came from South Africa and the U.S. All were randomly assigned to one of the two treatment regimens. The goal was to determine the number of patients in each group who had a plasma viral load of less than 50 copies per milliliter of HIV RNA after receiving treatment for 48 weeks.
According to Smith, the fixed-dose regimen was statistically superior to those in the atazanavir group, with 82 percent versus 71 percent reaching the primary endpoint. She said two things were responsible for the 10.5 percent difference in the two groups. One reason is that more people in the atazanavir group stopped therapy because of adverse affects. Also, those in the dolutegravir group had fewer virologic failures.
Only 33 percent of patients in the fixed-dose group reported drug-related adverse events, compared with 49 percent in the atazanavir group. Drug-related reactions included diarrhea, nausea, dyspepsia, headache, ocular icterus and jaundice.