IDWeek 2016: Dolutegravir Regimen Works Better than Atazanavir in Clinical Trial for Women

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A once-daily regimen containing the potent HIV integrase inhibitor dolutegravir worked better than an older atazanavir-containing regimen -- with higher rates of viral suppression both overall and across race subgroups -- in the ARIA trial, one of the few antiretroviral therapy studies to enroll only women, according to a presentation at IDWeek last week in New Orleans.

Over the course of the HIV/AIDS epidemic white men have been over-represented while women and people of color have been under-represented in clinical trials of new therapies. But worldwide, women make up about half of all people living with HIV and people of African heritage have the highest burden of disease -- also true of African-Americans in the U.S. -- and it is important for new treatments to be tested in all the groups that will ultimately use them.

Debbie Hagins from the Chatham County Health Department in Savannah, Georgia, presented findings from the ARIA trial (NCT01910402), sponsored by ViiV Healthcare, which enrolled 495 previously untreated women in 12 countries.

The study compared a fixed-dose combination of dolutegravir/abacavir/lamivudine (sold as Triumeq) versus ritonavir-boosted atazanavir (Reyataz) plus tenofovir DF/emtricitabine (Truvada). Dolutegravir has been shown to have a high barrier to resistance and it is potent enough to be used without a booster.

Nearly a third of trial participants were enrolled in the U.K. and Europe, a quarter in the U.S., 13% in South Africa, and the rest in Russia, Argentina, Thailand, and Mexico. Just under half (46%) were white, 41% were of African heritage, and 13% were of other races/ethnicities, mostly Asian. The median age was 37 years. The median baseline CD4 T-cell count was approximately 350 cells/mm3 and over a quarter had a viral load above 100,000 copies/mL.

Half the women were randomly assigned to receive dolutegravir/abacavir/lamivudine and half to receive atazanavir/ritonavir plus tenofovir/emtricitabine. The study's primaryendpoint was the proportion in each arm with viral load below 50 copies/mLafter 48 weeks on treatment.

Results

Dolutegravir/abacavir/lamivudine "demonstrated superior efficacy and a favorable safety profile compared to atazanavir plus tenofovir/emtricitabine in treatment-naive women after 48 weeks of treatment," the investigators concluded in their study abstract. "Race subgroup analyses were consistent with overall results."

This study, they added," provides important information to help guide treatment decisions in women."

10/31/16

Source

D Hagins, C Dietz, M Jain, et al. "Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) Fixed Dose Combination (FDC) compared with Ritonavir Boosted Atazanavir (ATV/r) plus Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) in Treatment-Naïve Women with HIV-1 Infection (ARIA Study): Analyses by Race Subgroups." IDWeek. New Orleans, October 26-30, 2016. Abstract 949.