ViiV Healthcare olnTuesday – June 19 – presented 48-week data from the phase IIIb, open-label, international, multi-centre 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% (adjusted difference 10.5%, 95% CI: 3.1%-17.8%, p=0.005) 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, it was announced in London, England and Durban, South Africa.
“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,” said John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare. “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.”
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%).
Drug-related AEs reported in the dolutegravir/abacavir/lamivudine arm included, nausea (31 individuals / 13%), diarrhoea (12 / 5%), headache (5 / 2%) and dyspepsia (4 / 2%). In the ATV/r plus TDF/FTC group, drug-related AEs included nausea (35 / 14%), diarrhoea (18 / 7%), ocular icterus (18 / 7%), dyspepsia (15 / 6%), headache (14 / 6%) and jaundice (13 / 5%).
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.
HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.
About HIV in women
Globally, HIV/AIDS is the leading cause of death for women of reproductive age (15-44 years old) and infection rates in young women (aged 15-24) are twice as high as those seen in young men. Despite the scale of the challenge, women are routinely under-represented in HIV clinical trials. This may be in part due to lack of child-care services, exclusions from study protocols due to the potential for pregnancy and lack of support in the home. As a result there are gaps in our knowledge about issues regarding antiretroviral treatments that are particular to women. – PRNewswire