Hemoglobin (gm/dL)
Grade 2 7.5 - 8.4 1% 1%
Grade 3 6.5 - 7.4 <1% 1%
Grade 4 <6.5 <1% 0%
Platelet count (103/μL)
Grade 2 50 - 99.999 2% 0%
Grade 3 25 - 49.999 <1% <1%
Grade 4 <25 0% 0%
Blood chemistry
Fasting (non-random) serum glucose test (mg/dL)
Grade 2 126 - 250 3% 4%
Grade 3 251 - 500 1% 0%
Grade 4 >500 0% 0%
Total serum bilirubin
Grade 2 1.6 - 2.5 x ULN 4% 0%
Grade 3 2.6 - 5.0 x ULN 1% 0%
Grade 4 >5.0 x ULN 0% 0%
Serum aspartate aminotransferase
Grade 2 2.6 - 5.0 x ULN 4% 5%
Grade 3 5.1 - 10.0 x ULN 2% 2%
Grade 4 >10.0 x ULN 1% <1%
Serum alanine aminotransferase
Grade 2 2.6 - 5.0 x ULN 6% 9%
Grade 3 5.1 - 10.0 x ULN 1% 2%
Grade 4 >10.0 x ULN 1% 1%
Serum alkaline phosphatase
Grade 2 2.6 - 5.0 x ULN 1% 3%
Grade 3 5.1 - 10.0 x ULN 0% <1%
Grade 4 >10.0 x ULN 0% <1%
Table 3: Lipid Values, Mean Change from Baseline, Protocol 021 Laboratory Parameter Preferred Term ISENTRESS 400 mg Twice Daily + Emtricitabine (+) Tenofovir N = 281 Efavirenz 600 mg At Bedtime + Emtricitabine (+) Tenofovir N = 282
Change from
Baseline at
Week 96 Change from
Baseline at
Week 96
Baseline Mean(mg/dL) Week 96 Mean(mg/dL) Mean Change
(mg/dL) Baseline Mean(mg/dL) Week 96 Mean(mg/dL) Mean Change
(mg/dL)
Notes:
N = Number of subjects in the treatment group. The analysis is based on all available data.
If subjects initiated or increased serum lipid-reducing agents, the last available lipid values prior to the change in therapy were used in the analysis. If the missing data was due to other reasons, subjects were censored thereafter for the analysis. At baseline, serum lipid-reducing agents were used in 5% of subjects in the group receiving ISENTRESS and 3% in the efavirenz group. Through Week 96, serum lipid-reducing agents were used in 7% of subjects in the group receiving ISENTRESS and 9% in the efavirenz group.
LDL-CholesterolFasting (non-random) laboratory tests. 96 103 7 93 115 21
HDL-Cholesterol 39 42 3 38 48 10
Total Cholesterol 159 169 10 156 194 38
Triglyceride 125 121 -4 137 177 40
Table 4: Adverse Drug ReactionsIncludes adverse reactions at least possibly, probably, or definitely related to the drug. of Moderate to Severe IntensityIntensities are defined as follows: Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating with inability to work or do usual activity). Occurring in ≥2% of Treatment-Experienced Adult Subjects Receiving ISENTRESS and at a Higher Rate Compared to Placebo (96 Week Analysis) System Organ Class,
Adverse Reactions Randomized Studies Protocol 018 and 019
ISENTRESS 400 mg Twice Daily
+ OBT
(n = 462)n=total number of subjects per treatment group. Placebo + OBT
(n = 237)
Nervous System Disorders
Headache 2 <1
Table 5: Selected Grade 2 to 4 Laboratory Abnormalities Reported in Treatment-Experienced Subjects (96 Week Analysis) Randomized Studies Protocol 018
and 019
Laboratory
Parameter
Preferred Term
(Unit) Limit ISENTRESS
400 mg Twice Daily +
OBT
(N = 462) Placebo
+
OBT
(N = 237)
ULN = Upper limit of normal range
Hematology
Absolute neutrophil count (103/μL)
Grade 2 0.75 - 0.999 4% 5%
Grade 3 0.50 - 0.749 3% 3%
Grade 4 <0.50 1% <1%
Hemoglobin (gm/dL)
Grade 2 7.5 - 8.4 1% 3%
Grade 3 6.5 - 7.4 1% 1%
Grade 4 <6.5 <1% 0%
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