Triumeq demonstrates superior efficacy for treating women with HIV
Posted: 19 July 2016 | | No comments yet
Triumeq demonstrated superior efficacy compared with ATV/r plus TDF/FTC in 495 treatment-naïve women living with HIV…
ViiV Healthcare has presented 48-week data from the Phase IIIb ARIA study which showed superior efficacy for Triumeq (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naïve women living with HIV.
Results show statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48: 82% versus 71% respectively. ARIA was a non-inferiority study with a pre-specified analysis for superiority. Both non-inferiority and 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 favourable compared to ATV/r plus TDF/FTC, with 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 plus TDF/FTC arm (4% vs 7%).
There were fewer subjects meeting 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.
Women under-represented in HIV trials
The trial results are particularly important as despite women accounting for over half of all adults living with HIV, women are routinely under-represented in HIV clinical trials, with women accounting for an average of 19% of ARV clinical trial participants. Lack of female representation in clinical trials creates gaps in our knowledge about issues regarding ART and female physiology As such, more research is needed to understand how treatments respond to the female physiology and to investigate new therapies that meet the particular needs of women.
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, explains more: “Women account for over 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.”