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Table 1

From: Efficacy and safety of TMC278 in treatment-naïve, HIV-infected patients: week 96 data from TMC278-C204

  

TMC278

TMC278

TMC278

TMC278

 

Parameter

Wk

25 mg qd (n = 93)

75 mg qd (n = 95)

150 mg qd (n = 91)

All (n = 279)

EFV 600 mg gd (n = 89)1

 

48

80(71–88)

80(72–88)

77(68–86)

79(74–84)

81(73–89)

VL <50 cps/mL (ITT-TLOVR algorithm), % (95% CI)

96

76(68–85)

72(62–81)

71(62–81)

73(68–78)

71(61–80)

Mean (SE) increase from baseline in CD4 cell count, cells/mm3

48

122(12)

145(15)

143(15)

137(8)

127(11)

 

96

146(12)

172(16)

159(16)

159(9)

160(13)

AE incidence at Wk 96 (%)

      

Any AE

 

90

97

92

93

93

AEs leading to discontinuation

 

9

12

14

12

9

Any grade 3 or 4 AEs

 

30

25

26

27

21

Any serious AEs

 

13

14

10

12

15

Grade 3 or 4 lab abnormalities

 

33

22

24

27

24

AEs of interest*

      

Any Rash

 

5

10

13

9‡

21

Nervous system AEs

 

32

32

30

31‡

48

   Headache

 

17

23

19

20

16

   Dizziness

 

13

10

10

11‡

30

   Somnolence

 

3

3

4

11

Psychiatric AEs

 

17

17

14

16

21

   Insomnia

 

8

6

7

7

6

   Depression

 

7

6

3

5

7

   Abnormal dreams/nightmares

 

1

6

0

3

11

Mean (SD) changes from baseline in lipids (mg/dL)

      

   Total cholesterol (TC)

 

10(28)

8(35)

9(29)

9(31)‡

34(31

   LDL-C

 

5(25)

5(30)

3(25)

5(27)‡

18(28)

   HDL-C

 

6(10)

7(11)

6(12)

6(11)‡

11(12)

   Ratio TC/HDL-C

 

-0.4(1.3)

-0.5(1.1)

-0.3(1.0)

-0.4(1.1)

0.1(0.9)

   Triglycerides

 

-8(75)

-15(79)

-7(90)

-10(81)‡

29(87)

  1. 1N = 88 for CD4; *Regardless of causality, occurring in ≥ 5% in any group; †well-described AEs for current NNRTIs; §p < 0.05, ‡p < 0.01 vs EFV; Fisher Exact test (AEs); non-parametric Wilcoxon rank-sum test (lipids)