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Table 5 Grade 2–4 Treatment-Related Adverse Events & Laboratory Abnormalities Occurring in ≥ 2% of Subjects

From: A randomized, controlled trial of initial anti-retroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study)

 

ABC/3TC/ZDV (N = 138)

ATV+3TC/ZDV (N = 140)

Any Grade 2–4 event (Grade 3–4)

30% (7%)

47% (25%)

Hyperbilirubinemia

0

21% (15%)

Nausea

11% (<1%)

4% (0)

Headache

4% (<1%)

4% (0)

Neutropenia

4% (4%)

5% (4%)

Fatigue

5% (<1%)

2% (0)

Suspected Abacavir Hypersensitivity1

5% (0)

0

Vomiting

2% (0)

2% (0)

Anemia

<1% (<1%)

3% (3%)

Ocular Icterus

0

4% (2%)

Abdominal pain

2% (0)

<1% (0)

Increased Creatinine Phosphokinase

0

2% (1%)

Rash

0

2% (0)

  1. 1 Includes 1 report of a Grade-1 suspected abacavir hypersensitivity reaction