Abacavir Sulfate (Page 3 of 10)

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 3-4) 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 3-4) in Therapy-Naive Adults (CNA30024) through 48 Weeks of Treatment
ULN = Upper limit of normal. n = Number of subjects assessed.

Grade 3/4 Laboratory Abnormalities

Abacavir plus Lamivudine plus Efavirenz

(n = 324)

Zidovudine plus Lamivudine plus 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/mm 3)

2%

4%

Anemia (Hgb ≤ 6.9 gm/dL)

< 1%

2%

Thrombocytopenia (Platelets

< 50,000/mm 3)

1%

< 1%

Leukopenia (WBC ≤ 1,500/mm 3)

< 1%

2%

Laboratory abnormalities in CNA3005 are listed in Table 5.

Table 5. Treatment-Emergent Laboratory Abnormalities (Grades 3-4) in CNA3005
ULN = Upper limit of normal.
n = Number of subjects assessed.

Grade 3/4 Laboratory Abnormalities

Abacavir plus Lamivudine/Zidovudine

(n = 262)

Indinavir plus Lamivudine/Zidovudine

(n = 264)

Elevated CPK (> 4 x ULN)

18 (7%)

18 (7%)

ALT (> 5.0 x ULN)

16 (6%)

16 (6%)

Neutropenia (< 750/mm 3)

13 (5%)

13 (5%)

Hypertriglyceridemia (> 750 mg/dL)

5 (2%)

3 (1%)

Hyperamylasemia (> 2.0 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%)

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

6.2 Clinical Trials Experience in Pediatric Subjects

Therapy-Experienced Pediatric Subjects (Twice-Daily Dosing)

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 per kg twice daily, lamivudine 4 mg per kg twice daily, and zidovudine 180 mg per m 2 twice daily compared with lamivudine 4 mg per kg twice daily and zidovudine 180 mg per m 2 twice daily from CNA3006 are listed in Table 6.

Table 6. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2-4, Greater than or Equal to 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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