BOSTON — A regimen of raltegravir and darunavir/ritonavir was noninferior to tenofovir/emtricitabine and darunavir/ritonavir as first-line treatment for treatment-naive patients with HIV, researchers reported here at the 2014 Conference on Retroviruses and Opportunistic Infections.
The NEAT 001/ANRS 143 trial was a randomized, open-label study in which 805 patients were randomly assigned to darunavir (Prezista/Janssen)/ritonavir (Norvir, AbbVie) with either raltegravir (Isentress, Merck) or tenofovir/emtricitabine (Truvada, Gilead Sciences). The patients were followed for 96 weeks. The primary outcome was time to first occurrence of failure. Failure was categorized as virologic or clinical. Virologic failure was defined as change of treatment before week 32 because of viral load decrease <1 log10 copies/mL by week 18, viral load ≥400 copies/mL at week 24 or viral load >50 copies/mL at or after week 32. Clinical failure included death, AIDS or serious non-AIDS event.
At 96-week follow-up, 17.4% of patients in the raltegravir arm and 13.7% of patients in the tenofovir/emtricitabine arm met the primary endpoint, a difference of 3.7% (95% CI, –1.1 to 8.6). In the raltegravir arm, 23% met the primary endpoint or stopped the treatment for any reason vs. 19.8% in the tenofovir/emtricitabine arm. The difference was 3.2% (95% CI, –1.8 to 8.2).
There was no difference in serious adverse events between the arms. By 96 weeks, 93% of patients in the raltegravir arm and 89% of patients in the tenofovir/emtricitabine arm had a viral load <50 copies/mL. The median increase in CD4 counts also was similar between arms. There was a significant difference in changes in creatinine clearance, with a decrease in the tenofovir/emtricitabine arm. Among patients with available genotype at failure, five of 28 in the raltegravir arm and zero of 13 had treatment-emergent resistance.
“In a subgroup analysis according to baseline CD4, we could not demonstrate noninferiority of the raltegravir regimen among patients with a low CD4 count at baseline,” François Raffi, MD, of the University Hospital in Nantes, France, said during his presentation. “All of this taken together, we conclude that this nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen presents an alternative for first-line patients with a CD4 above 200 cells/mL.”
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Raffi F. #84LB. Presented at: CROI 2014; March 3-6, 2014; Boston.
Disclosure: Raffi reports financial relationships with Abbott Laboratories, AbbVie, Gilead Sciences, Janssen, Merck, Tobira and ViiV Healthcare.