HALT-C Study Labwork
August 2000 ~ August 2004


HALT-C LABS @ USC
Test Name
8/22/00
 9/20/00
11/8/00
 11/20/00 11/27/00 12/4/00 12/15/00 1/02/01 1/30/01 3/7/01
3/28/01
 4/24/01
HCV PCR
3,200,000
**
 2,000,000
 **
 **
 **
 **
 **
 1.08+
**
POSITIVE
**
WBC
9.6
**
7.3
 4.4
 4.1
3.9
 3.3
3.6
 3.4
5.0
4.5
3.4
AB-Neutrophiles
5.9
**
 2.5
700
 1.0
 1.0
 900
 1.1
 1.3
2.1
2.2
1.5
Hematocrit
46.2
**
 44.9
 43.4
 45.9
43.5
 43.4
 43.0
 42.1
41.7
41.8
39.1
Hemoglobin
15.4
**
 15.4
14.8
 15.9
14.5
 14.9
 14.4
 14.3
14.5
14.2
13.4
Platelets
158
**
 163
 102
 93
 84
 76
 66
 66
87
58
51
Total Protein
7.2
7.5
 7.4
 **
 **
 7.2
 **
 7.1
 7.3
7.7
7.1
7.3
Bun
11
**
 13
 **
 **
**
 **
 **
 **
14
8
**
Creatinine
.6
**
 .6
 **
 **
 **
 **
 **
 **
.6
.7
**
Glucose
70
**
 68
 **
 **
 **
 **
 **
 **
75
74
**
Triglycerides
69
**
 109
 **
 **
 **
  **
 **
 **
**
122
**
Uric Acid
3.1
**
 4.1
 **
 **
 **
 **
 **
 **
**
4.2
**
TSH
 **
1.05
 **
 **
 **
 **
 **
 **
 **
**
.72
**
AFP
10.57
**
 12.15
 **
 **
 **
**
 **
 **
**
**
**
Ferritin
239
**
 **
 **
 **
 **
**
 **
 **
**
**
**
Serum Iron/IBC
64/341
**
 **
 **
 **
**
 **
 **
 **
**
**
**
Albumin
3.6
3.9
 3.6
 **
 **
 3.7
 **
 3.7
 3.8
4.1
3.9
3.9
Alk Phos
154
142
142
**
**
141
**
136
128
100
71
90
AST
75
88
95
**
**
57
**
64
59
43
53
59
ALT
96
109
 121
 **
**
 72
 **
 71
 71
**
61
68
Total Bilirubin
.3
**
 .5
 **
**
 .4
 **
 .5
 .4
.4
.4
.4
D-Bilirubin
.1
**
 .1
 **
**
 .1
 **
 **
 **
**
**
.1

** Indicates test not run

Other tests run at the first and second screening visit were:

A1-Antitrypsin - 73.9
Pheno - MM
Ceruloplasmin - 31
HIV/HBsAG -  Neg/Neg

Labs will be run at the beginning of treatment, and at weeks 2, 4, 8, 12, 16, 20, and 24.

November 8, 2000 was the beginning of my treatment. My PCR in August was the highest it has ever been. In November, the baseline PCR went down but was still much higher than when I first began in March 1998. At that time it was 474,000. The PCR will be done again at week 12 and at week 20. The final week of treatment shouldbe April 23, 2001. At that point, depending on my viral load, I will either continue on the Peg/Riba
for another 6 months, or go into the next arm of the study. The Long Term portion of the study will have us randomized into one of 2 groups. We will either be in the Observation Only portion where we do no meds, or we will do a low dosage (90ml) of Pegasys ONLY for the next 3.5 years.

The protocol for this study requires the Neutrophiles to remain above 1.0. When mine dropped below that on Nov. 20, 2000 we were required to hold off on the Peg for a week. When they went back up to 1.0, we resumed the dosage less .25. On Dec. 4, the dosage went back to the retular dosage.

I finally got the Ranges for some of the labs they are running. This will help me in knowing whether I am in the normal range or not. Each lab is different and these labs here are done at USC Medical Center itself.

+ The PCR used is the newest Amplicore test by Roche. They do this test in International Units per mil. instead of copies. I have no clue how to decipher this but I know it has an equivelent of 3.

  NOTE

I went off of treatment in February for 3 weeks due to problems with the side effects. (I IMPLODED!) I had planned to quit the study, but my regular doctor ran a PCR and bloodwork for me and I changed my mind. All my labs looked great and my PCR showed undetected, although this was with a different test, but in my mind UNDETECTED is just that! My March 7 results are an indication of my labs after being off treatment for nearly a month.

March 28 marks the end of the first 6 months on the combo treatment. On April 24, 2001 I was randomized into the OBSERVATION ONLY portion of the study. For the next 3.5 years I will only do labs and they will watch me carefully, to see if I progress to cirrhosis at a faster rate than those who are doing the low dosage of Pegasys. They will now drop their dosage down to 90ml for the rest of the study and will no longer take the Ribavirin. Now we will see if long term, low dose treatment with the Pegasys will slow the progression to cirrhosis, as opposed to doing no treatment whatsoever, or if it has any affect on the progression at all.


HALT-C Labs ~ Observation (Control) Group
Test Name
Month 9
Month 
12
Month 15
Month 18
Month 21
Month 24
Month 27
Month 
30
Month 33
Month 36
Month 39
Month 42
Month 45
Month 48
HCV-RNA-PCR
Pos
4,800,000
 Pos
 Pos
  497,000
 Pos
 Pos
  1,242,000
 Pos
          
WBC
5.8
 10.7
 7.1
 8.8
 7.4
 7.3
 8.4
 7.5
 7.2
          
AB-Neutropiles
2.1
 5.3
 2.9
 4.3
 2.9
 3.1
 3.6
 3.3
 3.1
          
Hemoglobin
14.8
 14.8
 15.4
 15.8
 16.4
 16.5
 16.4
 15.1
 15.9
          
Hematocrit
43.8
 43.2
 45.4
 47.4
 48.0
 47.9
 48.6
 45.5
 47.6
          
Platelets
134
 237
 171
 192
 192
 159
 159
 160
 172
          
AST
50
 59
 64
 66
 70
 71
 75
 71
 64
          
ALT
65
 100
 87
 **
 104
 88
 106
 97
 96
          
Total Protein
7.4
 8.1
 7.5
 7.8
 8.1
 7.4
 7.8
 7.4
 7.6
          
Albumin
4.0
 4.0
 4.0
 4.1
 4.0
 3.7
 4.0
 4.2
 4.1
          
Alk Phos
50
 131
 120
 142
 152
 156
 153
 121
 131
          
T Bili\D Bili
.3/.1
 .5/.2
 .4/.1
 .6/**
 .6/.2
 .3/.1
 .3/.1
 .4/**
 .6/**
          

Below are the ranges for the USC lab. This lab will be doing my bloodwork for the next 4 years.
The ALT and AST are ranged very high at this lab. Normal levels for women are in the mid 20's.


Test Name
Range
WBC
4.2 - 12.7
RBC
3.87 - 4.96
Platelets
176 - 363
Neutrophiles
1.8 - 8.0
Hemoglobin
11.8 - 14.7
Hematocrit
34.5 - 43.9
Total Bilirubin
0.0 - 1.0
Direct Bilirubin
0.0 - 0.3
Albumin
3.5 - 5.0
ALT
20 - 65
AST 
10 - 40
Alk Phos
45-140

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