Gastroenterol Res

Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access

Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc

Journal website http://www.gastrores.org

Original Article

Volume 11, Number 2, April 2018, pages 138-144

Efficacy and Safety of Entecavir 0. 5 mg in Treating Naive Chronic Hepatitis B Virus Patients in Egypt: Five Years of Real Life Experience

**Table 1.** Patients and Ultrasound Results
	Frequency	Percent
Sex	8	16.7%
Female	40	83.3%
Male
HBeAg-0
Negative	29	60.4%
Positive	19	39.6%
HCV Ab
Negative	48	100%
Positive	0	0.0%
US-0
Bright liver	10	20.8%
Cirrhosis	8	16.7%
Coarse liver	7	14.6%
Hepatomegaly	14	29.2%
Normal	9	18.8%

Table 1. Patients and Ultrasound Results

Frequency

Percent

Sex

16.7%

Female

83.3%

Male

HBeAg-0

Negative

60.4%

Positive

39.6%

HCV Ab

Negative

100%

Positive

0.0%

US-0

Bright liver

20.8%

Cirrhosis

16.7%

Coarse liver

14.6%

Hepatomegaly

29.2%

Normal

18.8%

**Table 2.** Percent Change in Levels of ALT, AST and Serum Creatinine Over Study Period as Compared to Baselines Among Study Subjects
	Mean	Standard deviation	Minimum	Maximum
ALT showed 43.2% reduction on average comparing its level from baseline to 6 months and 48.14% reduction after 1 year of treatment from baseline and reached 53.37 % after 5 years. AST showed 36.15% reduction on average comparing its level from baseline to 6 months and 44.57% reduction after 1 year of treatment from baseline and reached 54.37 % after 5 years. Serum creatinine levels showed an increase by 41.85% on average after 1 year of treatment versus 34.07% after 5 years of treatment.
ALT AT 6 months (n = 48)	-43.2	± 36.7	-90.7	109.76
ALT at 12 months (n = 48)	-48.1	± 28.7	-93.87	12.2
ALT at 24 months (n = 40)	-51.9	± 35.7	-94.71	62.96
ALT at 36 months (n = 31)	-52.0	± 26.5	-92.47	27.69
ALT at 4 years (n = 24)	-56.2	± 23.8	-90.91	21.95
ALT at 5 years (n = 16)	-53.4	± 28.4	-94.29	18
AST at 6 months (n = 48)	-36.2	± 29.4	-89.7	27.9
AST at 12 months (n = 48)	-44.6	± 27.8	-89.4	27.59
AST at 24 months (n = 40)	-49.1	± 30.4	-88.74	37.04
AST at 5 years (n = 16)	-54.4	± 19.2	-84.96	-13.95
Serum creatinine at 12 months (N = 48)	41.86	± 49.9	-27.27	175
Serum creatinine at 5 years (N = 16)	34.08	± 41.2	-20	116.67

Table 2. Percent Change in Levels of ALT, AST and Serum Creatinine Over Study Period as Compared to Baselines Among Study Subjects

Mean

Standard deviation

Minimum

Maximum

ALT showed 43.2% reduction on average comparing its level from baseline to 6 months and 48.14% reduction after 1 year of treatment from baseline and reached 53.37 % after 5 years. AST showed 36.15% reduction on average comparing its level from baseline to 6 months and 44.57% reduction after 1 year of treatment from baseline and reached 54.37 % after 5 years. Serum creatinine levels showed an increase by 41.85% on average after 1 year of treatment versus 34.07% after 5 years of treatment.

ALT AT 6 months (n = 48)

-43.2

± 36.7

-90.7

109.76

ALT at 12 months (n = 48)

-48.1

± 28.7

-93.87

12.2

ALT at 24 months (n = 40)

-51.9

± 35.7

-94.71

62.96

ALT at 36 months (n = 31)

-52.0

± 26.5

-92.47

27.69

ALT at 4 years (n = 24)

-56.2

± 23.8

-90.91

21.95

ALT at 5 years (n = 16)

-53.4

± 28.4

-94.29

AST at 6 months (n = 48)

-36.2

± 29.4

-89.7

27.9

AST at 12 months (n = 48)

-44.6

± 27.8

-89.4

27.59

AST at 24 months (n = 40)

-49.1

± 30.4

-88.74

37.04

AST at 5 years (n = 16)

-54.4

± 19.2

-84.96

-13.95

Serum creatinine at 12 months (N = 48)

41.86

± 49.9

-27.27

175

Serum creatinine at 5 years (N = 16)

34.08

± 41.2

-20

116.67

**Table 3.** Relation of Age Group to Different Parameters at Different Intervals of Study Period
Parameter	Age	Mean	Standard deviation	Significance
*DNA levels were found significantly higher among age group below 40 at baseline and at 24 months of treatment (P = 0.009 and 0.047, respectively). On the contrary, age group above 40 years showed statistically significant higher serum creatinine at baseline and at 12 months of treatment (P = 0.016 and 0.02, respectively).
ALT baseline	< 40 years	82.4	± 44.8	0.187
	40+	113.2	± 101.6
DNA baseline	< 40 years	80,063,074	± 122,898,706	0.009*
	40+	11,774,394	± 25,576,875
Serum creatinine baseline	< 40 years	0.7	± 0.2	0.016*
	40+	0.9	± 0.2
DNA at 12 months	< 40 years	15,926	± 53,180	0.149
	40+	317	± 1,475
Serum creatinine at 12 months	< 40 years	0.9	± 0.2	0.02*
	40+	1.1	± 0.3
ALT at 12 months	< 40 years	33.1	± 11.1	0.159
	40+	39.2	± 17.2
ALT at 24 months	< 40 years	38.3	± 17.7	0.139
	40+	30.5	± 15.1
Serum creatinine at 24 months	< 40 years	0.9	± 0.2	0.463
	40+	1.0	± 0.2
DNA at 24 months	< 40 years	2,410	± 5,534	0.047*
	40+	1.2	± 5.8
DNA at 5 years	< 40 years	0.0	-	-
	40+	0.0	-
ALT at 5 years	< 40 years	37.3	± 15.4	0.064
	40+	27.3	± 5.5
Serum creatinine at 5 years	< 40 years	0.8	± 0.4	0.05*
	40+	1.1	± 0.2

Table 3. Relation of Age Group to Different Parameters at Different Intervals of Study Period

Parameter

Age

Mean

Standard deviation

Significance

*DNA levels were found significantly higher among age group below 40 at baseline and at 24 months of treatment (P = 0.009 and 0.047, respectively). On the contrary, age group above 40 years showed statistically significant higher serum creatinine at baseline and at 12 months of treatment (P = 0.016 and 0.02, respectively).

ALT baseline

< 40 years

82.4

± 44.8

0.187

40+

113.2

± 101.6

DNA baseline

< 40 years

80,063,074

± 122,898,706

0.009*

40+

11,774,394

± 25,576,875

Serum creatinine baseline

< 40 years

0.7

± 0.2

0.016*

40+

0.9

± 0.2

DNA at 12 months

< 40 years

15,926

± 53,180

0.149

40+

317

± 1,475

Serum creatinine at 12 months

< 40 years

0.9

± 0.2

0.02*

40+

1.1

± 0.3

ALT at 12 months

< 40 years

33.1

± 11.1

0.159

40+

39.2

± 17.2

ALT at 24 months

< 40 years

38.3

± 17.7

0.139

40+

30.5

± 15.1

Serum creatinine at 24 months

< 40 years

0.9

± 0.2

0.463

40+

1.0

± 0.2

DNA at 24 months

< 40 years

2,410

± 5,534

0.047*

40+

1.2

± 5.8

DNA at 5 years

< 40 years

0.0

40+

0.0

ALT at 5 years

< 40 years

37.3

± 15.4

0.064

40+

27.3

± 5.5

Serum creatinine at 5 years

< 40 years

0.8

± 0.4

0.05*

40+

1.1

± 0.2

**Table 4.** ALT and AST Change Reduction Over Study Period
	N	Mean	Standard deviation	Minimum	Maximum
ALT showed 43.2% reduction on average comparing its level from baseline to 6 months and 48.14% reduction after 1 year of treatment from baseline and reached 53.37 % after 5 years. AST showed 36.15% reduction on average comparing its level from baseline to 6 months and 44.57% reduction after 1 year of treatment from baseline and reached 54.37% after 5 years.
Per_changeALT0_6	48	-43.2	36.7	-90.7	109.76
Per_changeALT0_12	48	-48.1	28.7	-93.87	12.2
Per_changeALT0_24	40	-51.9	35.7	-94.71	62.96
Per_changeALT0_36	31	-52.0	26.5	-92.47	27.69
Per_changeALT0_4 years	24	-56.2	23.8	-90.91	21.95
Per_changeALT0_5 years	16	-53.4	28.4	-94.29	18
Per_changeAST0_6	48	-36.2	29.4	-89.7	27.9
Per_changeAST0_12	48	-44.6	27.8	-89.4	27.59
Per_changeAST0_24	40	-49.1	30.4	-88.74	37.04
Per_changeAST0_5 years	16	-54.4	19.2	-84.96	-13.95

Table 4. ALT and AST Change Reduction Over Study Period

Mean

Standard deviation

Minimum

Maximum

Per_changeALT0_6

-43.2

36.7

-90.7

109.76

Per_changeALT0_12

-48.1

28.7

-93.87

12.2

Per_changeALT0_24

-51.9

35.7

-94.71

62.96

Per_changeALT0_36

-52.0

26.5

-92.47

27.69

Per_changeALT0_4 years

-56.2

23.8

-90.91

21.95

Per_changeALT0_5 years

-53.4

28.4

-94.29

Per_changeAST0_6

-36.2

29.4

-89.7

27.9

Per_changeAST0_12

-44.6

27.8

-89.4

27.59

Per_changeAST0_24

-49.1

30.4

-88.74

37.04

Per_changeAST0_5 years

-54.4

19.2

-84.96

-13.95

**Table 5.** Serum Creatinine Levels Showed an Increase by 41.85% on Average After 1 Year of Treatment Versus 34.07% After 5 Years of Treatment
	N	Mean	Standard deviation	Minimum	Maximum
Per_changeSCreat0_12 months	48	41.86	49.87	-27.27	175
Per_changeSCreat0_5 years	16	34.08	41.37	-20	116.67

Table 5. Serum Creatinine Levels Showed an Increase by 41.85% on Average After 1 Year of Treatment Versus 34.07% After 5 Years of Treatment

Mean

Standard deviation

Minimum

Maximum

Per_changeSCreat0_12 months

41.86

49.87

-27.27

175

Per_changeSCreat0_5 years

34.08

41.37

-20

116.67