Abacavir Sulfate (Page 4 of 9)

Abacavir Once Daily Versus Abacavir Twice Daily (CNA30021)

Treatment-emergent clinical adverse reactions (rated by the investigator as at least moderate) with a greater than or equal to 5% frequency during therapy with abacavir 600 mg once daily or abacavir 300 mg twice daily both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily from CNA30021 were similar. For hypersensitivity reactions, subjects receiving abacavir once daily showed a rate of 9% in comparison with a rate of 7% for subjects receiving abacavir twice daily. However, subjects receiving abacavir 600 mg once daily, experienced a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea compared with subjects who received abacavir 300 mg twice daily. Five percent (5%) of subjects receiving abacavir 600 mg once daily had severe drug hypersensitivity reactions compared with 2% of subjects receiving abacavir 300 mg twice daily. Two percent (2%) of subjects receiving abacavir 600 mg once daily had severe diarrhea while none of the subjects receiving abacavir 300 mg twice daily had this event.

Laboratory Abnormalities

Laboratory abnormalities (Grades 3 to 4) in therapy-naive adults during therapy with abacavir 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily compared with zidovudine 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily from CNA30024 are listed in Table 4.

Table 4. Laboratory Abnormalities (Grades 3 to 4) in Therapy-naive Adults (CNA30024) Through 48 Weeks of Treatment
Grade 3/4 Laboratory Abnormalities Abacavir plusLamivudine plus Efavirenz(n = 324) Zidovudine plus Lamivudineplus Efavirenz(n = 325)
Elevated CPK (> 4 x ULN) 8% 8%
Elevated ALT (> 5 x ULN) 6% 6%
Elevated AST (> 5 x ULN) 6% 5%
Hypertriglyceridemia (> 750 mg/dL) 6% 5%
Hyperamylasemia (> 2 x ULN) 4% 5%
Neutropenia (ANC < 750/mm3) 2% 4%
Anemia (Hgb ≤ 6.9 gm/dL) < 1% 2%
Thrombocytopenia (Platelets < 50,000/mm3) 1% < 1%
Leukopenia (WBC ≤ 1,500/mm3) < 1% 2%
ULN = Upper limit of normal.n = Number of subjects assessed.

Laboratory abnormalities in CNA3005 are listed in Table 5.

Table 5. Treatment-emergent Laboratory Abnormalities (Grades 3 to 4) in CNA3005
Grade 3/4 Laboratory Abnormalities Number of Subjects by Treatment Group
Abacavir plusLamivudine/Zidovudine(n = 262) Indinavir plusLamivudine/Zidovudine(n = 264)
Elevated CPK (> 4 x ULN) 18 (7%) 18 (7%)
ALT (> 5 x ULN) 16 (6%) 16 (6%)
Neutropenia (< 750/mm3) 13 (5%) 13 (5%)
Hypertriglyceridemia (> 750 mg/dL) 5 (2%) 3 (1%)
Hyperamylasemia (> 2 x ULN) 5 (2%) 1 (< 1%)
Hyperglycemia (> 13.9 mmol/L) 2 (< 1%) 2 (< 1%)
Anemia (Hgb ≤ 6.9 g/dL) 0 (0%) 3 (1%)
ULN = Upper limit of normal.n = Number of subjects assessed.

The frequencies of treatment-emergent laboratory abnormalities were comparable between treatment groups in CNA30021.

Pediatric Trials

Therapy-experienced Pediatric Subjects

Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a greater than or equal to 5% frequency during therapy with abacavir 8 mg/kg twice daily, lamivudine 4 mg/kg twice daily and zidovudine 180 mg/m2 twice daily compared with lamivudine 4 mg/kg twice daily and zidovudine 180 mg/m2 twice daily from CNA3006 are listed in Table 6.

Table 6. Treatment-emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4, ≥ 5% Frequency) in Therapy-experienced Pediatric Subjects (CNA3006) Through 16 Weeks of Treatment
Adverse Reaction Abacavir plus Lamivudine plus Zidovudine(n = 102) Lamivudine plus Zidovudine(n = 103)
Fever and/or chills 9% 7%
Nausea and vomiting 9% 2%
Skin rashes 7% 1%
Ear/nose/throat infections 5% 1%
Pneumonia 4% 5%
Headache 1% 5%

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