Gilead’s Complera® Non-Inferior To Atripla® Among Treatment-Naïve HIV Patients

Baseline mean CD4 cell counts were 396 cells/mm ³ for Complera patients and 385 cells/mm ³ for Atripla patients, and baseline HIV RNA levels were 4.8 log ₁₀ copies/mL in both treatment arms. In the Complera and Atripla arms, respectively, at baseline, 66 and 64 percent of patients had HIV RNA levels of ≤ 100,000 copies/mL, 25 percent and 30 percent had HIV-1 RNA levels between 300,000 and 500,000 copies/mL, and 9 percent and 6 percent had HIV-1 RNA levels > than 500,000 copies/mL.

At week 48, changes in CD4 cell counts were +200 cells/mm ³ for patients taking Complera and +191 cells/mm ³ for patients taking Atripla (p=0.34). The overall virologic failure rate per snapshot algorithm was similar in both treatment arms (8 percent for Complera and 6 percent for Atripla).

Seven percent (n=29) and 14 percent (n=54) of patients in the Complera and Atripla arms, respectively, experienced a Grade 3 or 4 adverse event. The most common treatment-related adverse events occurring in more than 5 percent of Complera patients were headache, insomnia, dizziness, depression, abnormal dreams, anxiety and somnolence.

Laboratory abnormalities (Grade 3-4) occurring in at least one percent of patients in either treatment arm included neutrophils, ALT, AST, GGT, amylase, creatine kinase, hyperglycemia, total cholesterol, glycosuria and hematuria. Only creatine kinase occurred in more than 5 percent of patients (5.1 percent in both arms).

Complera patients experienced lower mean increases compared to Atripla patients in fasting total cholesterol (1 vs. 22 mg/dL) and LDL (1 vs. 14 mg/dL) (p<0.001 for both tests). HDL increased by an average of 2 mg/dL in the Complera arm vs. 8 mg/dL in the Atripla arm (p<0.001). Triglycerides decreased by an average of 8 mg/dL among Complera patients and increased by 8 mg/dL among Atripla patients at 48 weeks (p<0.001). The ratio of total cholesterol to HDL declined by an average of 0.2 in both treatment arms.

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