HEPATITIS C VIRUS (HCV) RT-PCR QUANT VIRAL LOAD HCV RNA QUANTITATION

THE ALL IMPORTANT TEST.

WELL, THIS WAS THE CLINCHER FOR MARY.. THIS REPORT WAS RECIEVED ON JUNE 4, 1998. COPIES/ML REPRESENTS THE NUMBER OF HCV RNA HCV RNA SEQUENCES/ML AMPLIFIED IN THIS TEST. THE HCV RNA SEQUENCES MAY REPRESENT EITHER INTACT VIRUS, DEGRADED HCV RNA OR BOTH. THE 2000 COPIED/ML VALUE IS THE LIMIT OF HCV RNA DETECTIONS FOR THIS TEST.

FOR YOUR INTEREST I WILL LIST BELOW THE LAB REPORTS OF PERTINENT TESTING SO YOU CAN SEE HOW THINGS ARE PROGRESSING

BUT FIRST OF ALL I WILL GIVE YOU THE ABNORMAL RESULTS FROM MARY'S PRIMARY CARE PHYSICIAN, PRIOR TO TAKING INFERGEN.

JANUARY 15, 1998

CHOLESTEROL-TOTAL 341-h (REFERENCE RANGE 200)

LDL-CHOLESTEROL 200-H ( REFERENCE RANGE 0-130)

CHEMISTRY

AST (SGOT) 74-H ( REFERENCE RANGE 0-42)

ALT(SGPT) 57-H (REFERENCE RANGE 0-48)

CBC INCLUDES DIFF/PLT)

WBC 2.7-L (REFERENCE RANGE 3.8-10.8)

ABSOLUTE NEUTROPHILS 1223 L ( REFERENCE RANGE 1500-7800)

ABSOLUTE EOSINOPHILS 3-L ( REFERENCE RANGE50-550)

URINALYSIS, REFLEX LEUKOCYTE ESTERASE +1 ( REFERENCE RANGE NEG)

DATE MAY 7 , 1998

HEPATITIS C ANTIBODY REACTIVE (REF.RANGE NON REACTIVE)

A REPEATEDLY REACTIVE RESULT INDICATES PST OR PRESENT HEPATITIS C VIRUS (HCV) INFECTION OR POSSIBLY A CARRIER STATE, BUT DOES NOT SUBSTANTIATE INFECTIVITY OR IMMUNITY. HOWEER, A PATIENT WITH A REPEATEDLY REACTIVE RESULT SHOULD BE CONSIDERED INFECTIOUS.

WITH THE HCV ANTIBODY TEST, FALSE POSITIVE RESULTS CAN OCCUR . THE ABSCENCE OF ANTIBODIES TO HEPATITIS C VIRUS DOES NOT RULE OUT INFECTION WITH HCV. THEREFORE, WHEN THE DIAGNOSIS OF NANBH IS STRONLY SUSPECTED, SEQUENTIAL REPEAT TESTING FOR ANTI-HCV IS RECOMMENDED.

DATE MAY 22, 1998

CHEM 9-A

AST(SGOT) 48-H (REFERENCE RANGE 0-42)

CHOLESTEROL 301-H (REF. RANGE 200)

HEPATITIS C VIRUS AB BY IMMUNOBLOT ASSAY

C-22-3 +4 (REF.RANGE NEGATIVE) INTERPRETATION

INDETERMINATE ANTIBOCY REACTIVITY

ANY SINGLE HCV BAND HAVING 1+ OR GREATER REACTIVITY OR

REACTIVITY OF 1+ OR GREATER TO HCV 5-1-1 AND C100-3 BANDS ONLY

LIPID PANEL

CHOLESTEROL, TOTAL 274 H (REF.RANGE 200) LDL CHOLESTEROL 153 H (REF.RANGE 0-130)

NOW WE GO TO THE MORE DEFINITIVE TEST LAB RESULTS WHILE TAKING INFERGEN.

DATE 6-12-98

TEST- HEPATITIS C VIRUS (hcv)rt-pcr quant viral load HCV RNA QUANTITATION

RESULTS - 217,000 H COPIES/ML

DATE- 6-26-98

TEST- absolute eosinophils

RESULT- 0 LOW

REFERENCE RANGE -50-500

DATE 12-04-98

TEST- T-4 THYROXINE FREE

RESULT - 0.7 LOW

REFERENCE RANGE 0.8-1.8

DATE12-4-98

TEST-RESULTS-(REFERENCE RANGE)

GGT 118 HIGH ( 0-45)

AST 54 HIGH (0-42)

WBC 3.1 LOW (3.8-10.8 )

ABSOLUTE EOSINOPHILS 0 LOW (50-550)

T-4 (THROXINE), FREE 0.7 LOW (0.8-1.8)

DATE 1-6-99

TEST RESULTS (REFERENCE RANGE)

GGT 119 HIGH (0-45)

WBC 2.4 LOW (3.8-10.8)

ABSOLUTE NEUROPHILES 710 LOW (1500-7800)

ABSOLUTE EOSINOPHILS 22 LOW (50-550)

HEPATITIS C VIRUS (HCV)

DATE 3-13-99

TEST RESULTS (REFERENCE RANGE)

GGT 201 HIGH (0-45)

AST 59 HIGH (0-45)

WBC 2.3 LOW (3.8-10-8)

ABSOLUTE NEUTROPHILS 828 LOW (1500-7800)

ABSOLUTE MONOCYTES 115 LOW (200-1100)

ABSOLUTE EOSINOPHILS 0 low (50-550O)

Normal Adult Range: 0 - 48 U/L

Optimal Adult Reading: 24

ALT ( Glutamic-Pyruvic Transaminase - ALT) Serum Glutamic Pyruvic Transaminase or ALT is an enzyme found primarily in the liver but also to a lesser degree, the heart and other tissues. It is useful in diagnosing liver function more so than SGOT levels. Decreased SGPT in combination with increased cholesterol levels is seen in cases of a congested liver. We also see increased levels in mononucleosis, alcoholism, liver damage, kidney infection, chemical pollutants or myocardial infarction.

Normal Adult Range: 0 - 48 U/L

W.B.C. (White Blood Cell Count) White blood cells main function is to fight infection, defend the body by phagocytosis against invasion by foreign organisms, and to produce, or at least transport and distribute, antibodies in the immune response. There are a number of types of leukocytes (see differential) that are classified as follows

Nongranulocytes

Band

Neutrophiles

Lymphocytes

Neutrophils

Monocytes

Eosinophils

Basophils
Each cell, or leukocyte, has a different job in the body .
Normal Adult Range: 3.8 - 10.8 thous/mcl Optimal Adult Reading: 7.3 Higher ranges are found in children, newborns and infants.

June 13, 1999

TEST RESULTS (REFERENCE RANGE)

HEPATITIS C VIRUS RNA BY PCR

QUANTITATION HCV RNA BY PCR QUANT <2000 <2000 NOT DETECTED

HCV RNA COPIES LOG 10 <3.3 <3.3 NOT DETECTED

While the clinical relevance of a change in HCD RNA level, has not been established, monitoring viral levels over time may be helpful in assessing response to antiviral therapy. Changes of less than two=fold in viral load may not be significant due to inherent biological and assay variability . Any significant change in viral load should be interpreted together with other clinical and laboratory data.

GGT --- 255H --- 0-45

WBC --- 3.1 L --- 3.8-10.8

ABSOLUTE NEWTROPHILS -- 1364 L --- 1500-7800

ABSOLUTE EOSINOPHILS -- 3 L -- 50-550

THYROID PANEL -- 18 L -- 22-35
1-6-00 COLLECTION DATE Well, the time has come to report the 3 month test after the end of Infergen therapy.

Effective 1-7-00 according to HCV RNA c copies Log 10 virus not detected. This is truly good news. Another test for the virus will be taken one year from cessation of treatment. See you then.

Albumin, serum 4.8 ---- normal 3.5-5.5

Bulirubin, Total 0.4 ---- 0.1-1.2

Bilirubin, Direct 0.10 ---- 0.00-0.40

Alkaline Phosphatase, Serum 85 ---- 25-150

AST (sgot) 19 ---- 0-45

ALT (sgpt) 9 ---- 0-50

We have been told that HEP C is cured. The one year of treatment with INFERGEN has been effective. We will take this test every year to keep on top of things.

Hope all this has been helpful to you who read it..