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Atazanavir/ritonavir accelerated time to virologic failure in women
Women who received atazanavir/ritonavir had a significantly shorter time to virologic failure compared with those treated with efavirenz-based treatments, recent data suggest.
“These findings may have important clinical implications given that ritonavir-boosted protease inhibitors are often favored over efavirenz for women of childbearing potential,” the researchers wrote in Clinical Infectious Diseases. “The findings of the current study should warrant additional investigation of antiretroviral regimens in randomized clinical trials and cohorts with large enrollment of women.”
Researchers with the ACTG 5202 study team conducted a randomized, open-label trial that included 1,857 patients with HIV who were treatment-naive. They were enrolled between September 2005 and November 2007 and randomly assigned atazanavir (Reyataz, Bristol-Myers Squibb) boosted with ritonavir (Norvir, AbbVie) or efavirenz (Sustiva, Bristol-Myers Squibb) with either abacavir/lamivudine (Epzicom, ViiV Healthcare) or tenofovir/emtricitabine (Truvada, Gilead Sciences).
Overall, there was no difference in virologic efficacy between the atazanavir/ritonavir regimen and the efavirenz/abacavir/lamivudine regimen. However, when the researchers evaluated the group by sex, the risk for virologic failure was higher among women who received atazanavir/ritonavir. The incidence rate for virologic failure was 12.42 per 100 person-years vs. 4.86 per 100 person-years (HR=2.55; 95% CI, 1.2-5.41). This difference was not seen in men.
For atazanavir/ritonavir vs. efavirenz/tenofovir/emtricitabine, the results were similar. Overall, there was no difference between the groups. However, the risk for virologic failure was higher among women who received atazanavir/ritonavir. The incidence rate for virologic failure was 10.9 per 100 person-years vs. 5.06 per 100 person-years (HR=2.16; 95% CI, 0.97-4.8). This difference was not observed among men.
The safety and tolerability for the regimens did not differ by sex. Women on efavirenz/abacavir/lamivudine had a 32% higher safety risk compared with men, and those on efavirenz/tenofovir/emtricitabine had a 20% higher safety risk.
Disclosure: Some researchers report financial relationships with Abbott, AbbVie, Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen, Johnson and Johnson, Merck, Pfizer, Schering-Plough, Teva, Tibotec and ViiV.