ViiV Healthcare reported that phase IIIb of the ARIA study showed superior efficacy for Triumeq (dolutegravir / abacavir / lamivudine) compared with atazanavir boosted with ritonavir (ATV/r), along with tenofovir disoproxil fumarate / emtricitabine (TDF / FTC) in women with HIV.
The open-label, international, multi-centre study enrolled 495 treatment-naïve adult women.
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The data showed statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48% to 82% versus 71% respectively.
Non-inferiority, as well as superiority endpoints were met, with superiority being driven by lower rates of both virological failures and discontinuations due to adverse events (AEs) in the dolutegravir / abacavir / lamivudine group.
The safety profile of dolutegravir / abacavir / lamivudine was found to be favourable compared to ATV/r plus TDF/FTC, as fewer drug-related AEs reported on the dolutegravir / abacavir / lamivudine arm (33% vs 49%). There were also fewer AEs leading to discontinuation compared to those in the ATV/r and TDF/FTC arm (4% vs 7%).
Drug-related AEs reported in the dolutegravir / abacavir / lamivudine arm included, nausea, diarrhoea, headache, and dyspepsia .
In the ATV/r and TDF/FTC group, drug-related AEs included nausea, diarrhoea, ocular icterus, dyspepsia, headache, and jaundice.
Fewer subjects met virologic non-response criteria (VL >50c/mL) in the dolutegravir / abacavir / lamivudine arm (6%) compared to the other group (14%) at week 48.
Of the women that met protocol-defined virologic withdrawal criteria, none on the dolutegravir / abacavir / lamivudine arm had treatment-emergent resistance mutations to the components of dolutegravir / abacavir / lamivudine, compared with one in the comparator group.
ViiV Healthcare chief scientific and medical officer John Pottage said: "Women account for more than half of the almost 35 million adults living with HIV worldwide, yet unfortunately they are consistently under-represented in HIV clinical trials.
"For this reason, we are committed to ensuring that the specific treatment needs of women are investigated.
“This trial not only provides physicians with important additional information about Triumeq, it also builds on the strong body of evidence supporting the efficacy of dolutegravir-based regimens in a broad range of patient populations."
