CHIEF COMPLAINTS:                 

1.                Fatigue

2.                Depression, especially while on anti-viral medication

3.                Hepatitis C

4.               Obesity  

CHIEF COMPLAINTS:                           The examinee, now a 45 year old female,was initially diagnosed with hepatitis C by Dr. family physician, after being evaluated for complaints of fatigue which the patient attributed to being overweight and middle age.  The examinee, who had symptoms of fatigue for approximately 25 years, was progressively feeling more tired.

Subsequent to being diagnosed by Dr. family physician with hepatitis C, the examinee was referred to Dr. Koslov, gastroenterologist, whom she saw during February and April, 1998.  Various diagnostic studies were performed including blood tests and biopsy of the liver, which was consistent with chronic active hepatitis.  Dr. gastroenterologist apparently advised the examinee of her being in a higher risk category, thereby, being an appropriate candidate for interferon.

On 4/29/98, because of a disdain for Dr. gastroenterologist, the examinee sought a second opinion from another Dr. gastroenterologist, who had been suggested by a friend and who also discussed the examinee’s condition and recommended Infergen 9 micrograms three times per week which the patient did for the first three months, subsequently increasing the dose to 15 micrograms. By 9/22/98 her viral count apparently responded by becoming lower. The examinee, however, became more sick after 6/98 with symptoms of loss of appetite, loss of hair and an inability to cook; the examinee also would remain in bed for several days, and the examinee’s husband physically separated from her. 

During 10/98 through 11/98 the examinee felt increasingly worse and, in addition to taking Xanax periodically, was prescribed Paxil 10 mg. and was continued by Dr. gastroenterologist with the previously prescribed 15 micrograms three times weekly, a dose anticipated to be used for approximtely one year.

By 12/9/98, after a best friend of the examinee had died and the examinee’s husband advised the examinee of divorce proceedings, the examinee was evaluated by Dr. gastroenterologist who noted her being distraught and depressed with suicidal ideations and considered that Interferon could clearly aggravate the examinee’s depression and subsequently had the examinee taken directly by his nurse to Hospital Emergency Department where she was then transferred to Hospital Psychiatric Unit.  While in the psychiatric unit the examinee was evaluated by psychiatrists, and Paxil was increased to 30 mg, daily; the patient remained in the hospital for three days and had not had any psychiatric or psychological follow-up.  Upon leaving the hospital the examinee stayed with her brother for approximately one week before returning to her home where she has lived by herself doing household activities such as cleaning and caring for the pool.  Infergen  was discontinued at that time.

By 2/17/99 hepatitis C virus load had increased without medication.  During 4/99 the examinee attempted mediation with her husband, and they attended marriage counseling together.  During this time the married couple met frequently, oftentimes with the examinee traveling to Naples where her husband was residing with a consort; the examinee was feeling much improved and more energetic while off the medication for approximately the first 3-4 months after discontinuing the medication during 12/98.

On 6/21/99 the examinee was advised that preliminary reports indicated her HCV genotype was sub-type 1B associated with more severe liver disease and a poor prognosis to interferon, and since the examinee has been feeling progressive diminution in her energy level. 

After the examinee’s final visit with Dr. gastroenterologist, 10/4/99 when she continued to take Paxil 30 mg. daily, Xanax 10 mg. 3-4 times per month, an occasional Ambien 10 mg. to sleep, she was advised Dr. gastroenterologist would be moving to S Hospital, and she was referred to a list of gastroenterologists from which she chose Dr. D.O.    

On 4/6/00 the examinee had her first visit with Dr. D.O. gastroenterologist, at which time various diagnostic studies were performed and a hepatitis A vaccine apparently administered.  The examinee has continued to attend the office of Dr. D.O. gastroenterologist though sees P. A., who, in concert with Dr. D.O. gastroenterologist, has recommended beginning combination therapy with ribavirin and interferon for one year.  The examinee is also to have a psychiatric evaluation with Dr. psychiatrist on 9/10/00 prior to beginning a new treatment course.

The examinee notes having also been evaluated, during 1996 prior to returning from Georgia to Florida, with Dr. B who prescribed Phen-Fen, which the examinee took for an unexpressed period of time.  Moreover, the examinee has been evaluated by Dr. obstetrician/gynecologist, several months ago with mammogram, Pap smear and overall female evaluation, which was apparently normal.  The examinee also has had two visits to E W Hospital Emergency Department for chlorine exposure to the eye and a bladder infection.

On 12/5/98 the examinee had periodontal surgery with Dr. K, dentist, and the examinee has also had oral hygiene with Dr. S, dentist. 

PAST MEDICAL HISTORY:        Status post barracuda bite right thigh during childhood with post traumatic scarification. 1970, tattoo to the back while in Canada, presumably a possible etiology of exposure to hepatitis C. History of psychotherapy for two years while in her 20’s, attended Alanon.  Gravida 0, para 0, has used IUD birth control(husband had vasectomy, examinee and husband have not wanted children). Denies history of sexually transmitted diseases though had multiple sexual encounters prior to present marriage without condom.  Status post resection skin tags. Otherwise denies additional serious illnesses, injuries, operations, medications or allergies. 

SOCIAL HISTORY:             Married in 1982, attended graduate school,                                                Fine Arts, Masters degree in Fine Arts, worked at 3 jobs onlyfor a short period of time, once as a prison guard for one year while in college, the second for three months as a school photographer and the third for six months working for a photographer.  Born in Florida though moved to Georgia where she lived for 25 years before returning to Florida.  was a homemaker and, for 11 years, helped her husband renovate a home. Has continued to act as a homemaker, presently keeping the house clean with the intention to sell, maintaining the lawn and pool, volunteering at church and attending a theology book club and a study program.  The examinee, though not doing any recent photography, had a 25 year retrospective art show last year.  The examinee walks daily and swims periodically. The examinee’s husband is a estimator for Construction, and the examinee considers her marriage to have been a great one though, after moving to Florida in 1996/97, she notes her husband appeared unhappy with his job, and she developed hepatitis C and was becoming more tired and “bitchy” and especially fatigued when her husband came home from work. Parents divorced in 1966.  Examinee questionably abused by her mother and stayed with her father, left home at 15. 

FAMILY HISTORY:             Father died of myocardial infarction at 56 years had been a professional football player, 6’ 6”, and during middle age weighed over 300 pounds. Mother recently had breast cancer removed, has degenerative hip disease, which may need replacement, history of alcoholism and weighs over 280 pounds. Grandmother died of uterine cancer, sister disabled from a work related injury and another sister has a fibrotic tumor of the back. Brother was temporarily addicted to heroine. 

REVIEW OF SYSTEMS:              Unremarkable.  

PHYSICAL EXAMINATION:                  5′ 10", 380+/- pound female, articulate, communicative, personable without gross cognitive deficit, walking and sitting normally.  Blood pressure (left) using a large cuff 170/90, heart rate 104, regular, normal respirations.  HEENT:  Pupils equal and reactive to light and accommodation, extraocular muscles within normal limits, cranial nerves 3-12 grossly within normal limits without jaundice with full range of motion of the jaw without clicking or pain otherwise within normal limits. NECK:  With full range of motion in all spheres without midline tenderness or spasm and without thyromegaly. CHEST: Breath sounds and heart sounds within normal limits with full expansion with ni asymmetric radial and femoral pulses.  Breast examination deferred.  Otherwise normal.  ABDOMEN:  Obese, bowel sounds diminished, without tympany, rebound or palpable tenderness.  UPPER BACK: Rotates 120° to the right and left without midline tenderness or spasm. LOWER BACK: Flexes fingers 8” from the toes, hypertension and lateral bending within normal limits.  Straight leg raising (knee to chest) 80° right and left. EXTREMITIES: Bilateral palmar erythema and marked obesity through the legs to the ankles with superficial varicosities along the distal aspect proximal to the ankles, otherwise with full range of without crepitation. NEUROLOGIC:Oriented X3, sensation and strength within normal limits. Deep tendon reflexes 1-2+ symmetric upper and lower extremities, right and left. Toe/heel walk and squat within normal limits. SKIN: With multiple petechial and/or angiomatous papules, diffuse. Tattoo upper back.  Genitourinary and rectal examination deferred.

 

REVIEW OF MEDICAL RECORDS:

9/6/95, TSH 2.98 normal.  IGE 174 normal.

9/6/95, WBC 11.1 high, lymphocytes 2.6 low, hemoglobin 14.9 normal.

9/6/95, Biochem profile essentially normal.

9/8/95, , M.D., internist: “ … allergic … if no better allergy test …”

3/20/96, , M.D., internist: “ … borderline hypertension … borderline diabetes mellitus …morbid obesity … weight decreased 27 pounds in 3 months … on 1200-1300 calories … 160/90 … Xanax … Fastin 30 … Pondimin 20 …”

8/15/96, , M.D., internist: “ … refill Pondimin 20 two b.i.d.

10/17/96, PhD., M.D. 

1.               Morbid obesity with previous 60 pound loss on strict diet. Down to 312 but never below that during her adult life … on multiple diets and in-patient programs.

2.               Hemorrhoid.

3.               Fibrocystic breasts.

4.               Strong family history of obesity.

5.               Situational stress with recent move handling well.

6.               Recent 60 pound weight loss by limiting food intake and exercising.

“ … previously did photos, won both mainsail and Gasparilla competitions … now an interior designer …buying for a shop in … restoring a house … recommended forming … gastric stapling … limit foods … exercise … increase calcium … mammograms …urinalysis … flu shot … ECG … borderline hemoglobin … A1C …”

10/17/96, EKG, PhD., M.D.: Normal sinus rhythm 75. Incomplete right bundle branch block.

10/17/96, Pap smear: Endocervical atypia, favor reactive, also air drying artifact.

10/17/96, Urinalysis: Normal.

10/17/96, Hemoglobin A1C:  Normal.

10/29/96, Bilateral mammogram, , M.D.:  Normal.

11/22/96, PhD., M.D. 

1.               Status post Pap with atypical endocervical cells though to be reactive but no other sign of infection.

2.               Obesity with 2-pound gain.

3.               Muscularb pain of the left posterior shoulder.

“ … range of motion exercises … neck and back stretching and toning … moist heat … ibuprofen …”

6/3/97, Urinalysis: Moderate leukocytes, positive nitrite, protein 100+, blood large, ketones trace, bilirubin small.

9/15/97, s Dental Specialties:  New patient exam. Doxycycline … diazepam.

9/17/97,K D.D.S.:  Severe adult periodontitis.

“..recommended…osseous surgery…home care…possible orthodontic therapy due to posterior arch collapse…antibiotics…”

9/26/97, Urine culture:  Probable contamination.

9/26/97, Urinalysis: Trace leukocytes, non-hemolyzed moderate blood.

12/5/97, Dental Specialties:  Osseous surgery, periosteal maintenance.  “ …advised … risk and procedures … sutures silk … Anaprox … Peridex …”

1/26/98,Pap:  Benign cellular changes associated with inflammation.

1/26/98, EKG, incomplete right bundle branch block, normal sinus rhythm 75.

1/26/98, Urinalysis: Trace leukocytes, otherwise normal.

1/26/98, Chem profile:  SGOT (AST) 47 high, SGPT (ALT) 37 high.

1/26/98, CBC normal, TSH 4.3 normal.

1/26/98, Pap smear: Benign cellular changes associated with inflammation.

1/26/98, , PhD., M.D.

1.               Massive obesity with no desire for sustained weight loss program but history of as much as 100-pound weight loss in the past. 

2.               External hemorrhoids.

3.               History of previously atypical Pap.

4.               Mild PMS symptoms.

5.               Elevated blood pressure readings today possibly secondary to stress.

6.               Fibrocystic breasts.

7.               Strong family history of obesity.

“ … eats high salt diet …walks regularly … QOD … 1 hour … water aerobics in the summer … chlorine in the pool … no more UTI’s … 50 pounds below maximum weight … isn’t interested in surgical treatment …”

2/2/98, Hepatitis A antibody (IGG) negative, hepatitis B core antibody is positive, hepatitis B surface antibody is positive (titer 30), hepatitis b surface antigen negative, hepatitis C antibody (HCV) positive.

2/5/98, Dental Specialties:  “ … called about toothbrushes … plaque remover …”

2/11/98, , PhD., M.D. Results of hepatitis screen positive for B & C … did do IV drugs a few times in high school …”

2/20/98, Dental Specialties:  Pain due to sweets and cold.

2/26/98, K, M.D., PhD.: “ … 43 year old woman …antibodies to hepatitis B & C … no symptoms … to liver … considers herself in excellent general health … no active exposure to hepatotoxins …some exposure to shared needles as teen-ager … Hepatitis B infection has resolved … B surface antigen negative … antibodies to hepatitis C …morbid obesity … transaminase abnormality … quite small …pointed out how much we don’t know about the natural history of (hepatitis C) and the limitations of current treatment options … liver enzymes are in that range where one could either observe untreated or initiate treatment with Intron …patient’s choice … important to be sure patient is viremic … gave informed consent to proceed with liver biopsy …”

2/27/98, BP 150/96

3/3/98,Xanax 1 mg #30.

3/17/98, S, M.D.: “….43 year old nullipara…referred for Pap…10/96…endocervical atypia reactive…month later …normal…regular cycles…recently diagnosed …hepatitis C…normal liver enzymes…morbidly obese…been on variety of dietary regimens…no significant success….”

 

3/23/98,Mammogram,  M.D.: Mild fibroglandular tissue both breasts without specific evidence of malignancy.

3/23/98,Bilateral mammogram, M.D.:  Mild fibroglandular tissue both breasts with no specific mammogramific evidence of malignancy.  Unchanged compared to 10/29/96. 

3/27/98,Liver biopsy, M.D., pathologist:  Consistent with chronic active hepatitis with bridging fibrosis and minimal to mild lobular fatty change consistent with clinical impression of chronic active hepatitis C.

4/9/98, K, M.D., “ … discussed … with husband … liver biopsy … chronic active hepatitis with bridging fibrosis … minimally abnormal liver enzymes …significant histological injury apparent in her liver … appropriate candidate for Interferon therapy … gave … informed consent to proceed with Interferon therapy … recommend Infergen 9 mcg … three times a week … if she has responded within four months … keep … on at least twelve months … may escalate the dose … may modify … if new treatment agents …”

4/29/98,M.D., gastroenterologist:  “ … 43 year old … white … female … second opinion … chronic hepatitis C …accompanied by husband …”

4/30/98, M.D., gastroenterologist: “ … second opinion … accompanied by …husband … exposure … likely … 25 years ago at time of a blood transfusion … did not develop acute hepatitis … in retrospect has probably had fatigue … never been known to have a form symptom for hepatitis C (until this year) … I think the patient has had a significant fatigue from hepatitis C not simply related to her weight … has not had signs or symptoms of chronic liver disease … has had peripheral edema … felt … secondary to venous insufficiency … really in good health other than obesity … lost … 40 pounds over the past five months … lived with her husband for a number of years … he does not have it … indicates they do not need to change any of their practices at the present time … recommended … not share toothbrushes or razor blades … biopsy … bridging fibrosis … significant chance … develop cirrhosis over the next 5-10 years … prognostic ability not been great … discussed … if … went untreated … progressed … when she reached … cirrhosis … could be in 5-10 years … roughly 1/3 chance of developing a complication of that cirrhosis over the ensuing decade …discussed liver transplant … weight loss over the next several years would be an important contributor to her being able to handle that … if … became necessary … liver biopsy … grade 1-2 inflammation … bridging fibrosis … recommendation  … Ribavirin combination … anticipated to yield an approximately 50% initial response … as much as a 50% sustained response … begin Infergen 9 mcg three days a week … in several months of she is doing well from side effect point of view … escalate to 15 mcg three times a week … data strongly suggests … sustained response rate … greater than 50% …side effects … thinning of hair …flu like symptoms … irritability … and depression … takes Xanax in low dose … ALT elevation … HCVRNA of 346,000 baseline … ”

5/12/98, AST 61 high … ALT 49 high … monocytes 16.3 high.

5/26/98, AST 50 high … monocytes 21.1 high.

6/16/98, M.D., gastroenterologist: “ … ALT is 52 after 7 weeks of Interferon … does not appear to have had a response … tolerating … without any significant side effects …”

6/16/98, ALT 32 high.

7/14/98, M.D., gastroenterologist:  “… fatigue, arthralgias … tolerable …”

7/14/98, AST 85 high … ALT 87 high …  Monocytes 11.6 high.

7/15/98, HCV RNA 320,000 copies per ml.

8/18/98, Pap smear … satisfactory endocervical and/or squamous metaplastic cells present … within normal limits.

8/18/98, M.D. ., gastroenterologist:  “… fatigue occasionally tolerable …”

8/18/98, AST 94 high … ALT 98 high.

9/22/98, M.D. ., gastroenterologist: “ … fatigue, hair loss, sleeps poorly, depression … PCR … Ativan …”

9/23/98, HCV RNA less than 2,000 copies per ml.

10/29/98,  M.D.,gastroenterologist: “ … because of depression … Paxil … continue 15 mcg TIW … November obtain qualitative PCR, ALT and CVC … plan to continue this dose for one year …”

10/29/98, M.D., gastroenterologist: “ … hair loss, fatigue, depressed … Paxil …”

11/17/98, ALT normal.

11/18/98, Hepatitis C virus RNA by PCR not detected.

11/19/98, Flu shot.

12/8/98, M.D., psychiatrist: 

1.               Major depressive disorder, severe, single without psychosis. 

2.               Hepatitis C by history.

3.               Obesity

“ … eliminate suicidal thoughts and plans … admit to a therapeutic…”

12/9/98, D, M.D.

1.               Morbid obesity.

2.               History of Hepatitis C.

3.               Bilateral leg swelling due to venous insufficiency.

“ … complete lab … thyroid… advised to continue treatment with Interferon and follow-up with hepatologist as out patient…”

12/9/98, M.D., gastroenterologist:“ … very distraught with suicidal ideation … divorce papers … clearly Interferon could aggravate the depression … discontinued … taken by my nurse directly to emergency room … admitted psychiatric hospital last night …”

12/10/98,Hospital Emergency Department, Behavioral Medicine intake: Depression, suicidal ideation, Hepatitis C. “ Dr. gastroenterologist had called earlier … admit to Dr. S…transfer to Hospital … states has been feeling suicidal off and on for two months … planned to shoot self jumping off …”

12/11/98,Discharge summary, Hospital, S, M.D., psychiatrist:

4.               Major depressive disorder, severe, single without psychosis. 

5.               Hepatitis C. 

6.               Obesity. 

“… recent separation from husband.  “ … 44 year old white female … chief complaint ‘my husband left me’ … diagnosis hepatitis C … 2/98 … on Interferon … suicidal ideations and plans … depressed syndrome … seen by psychiatrist on daily basis … rule out physical and medical problems … consultation … Dr. Desai … advised to continue treatment with Interferon … Paxil … Ativan … p.r.n. … on discharge … no longer suicidal … discharged to the care of her brother, follow-up … therapist … prognosis should be good … no restrictions … needs to definitely lose weight …”

2/17/99, M.D., gastroenterologist: 

1.               Depression under good treatment with Paxil and improving.

2.               Hepatitis C status post 8 months of treatment.

“ … ended up in hospital for three days (serious depression) … not actually going to a therapist at this time … bright and articulate today … sad .. HCV, PCR, LFT, CBC … if patient needs to restart … probably do it in 2-3 months at the earliest …real low dose …”

2/17/99, HCV RNA 383.000 copies per ml

2/17/99, AST 203 high … ALT 83 high …

4/28/99, S, M.D.: “….no…complaints….Dr. gastroenterologist ….for hepatitis C…was on interferon….discontinued…will be changing from Dr, B to new primary care physician…Paxil, Xanax prn…multivitamin…374 pounds 192/96, 5’10”…mammogram…bimanual…rectovaginal…impossible to evaluate …obesity…”

5/11/99, Pap:  Normal.

6/21/99, M.D., gastroenterologist: “ … Infergen 9 mcg April through June …increased to 15 mcg June through December … good response … negative qualitative PCR in November prior to discontinuing … do believe … can tolerate medicine … if home life is stable … then … likely to restart …Infergen … final dose 15 mcg for one year … does have stage III fibrosis …combination … increased percentage of depression …”

6/21/99, AST 47 high… ALT 45 high

6/21/99, HCV genotype 1B  (preliminary reports indicate that particularly subtype 1B associated with more severe liver disease and a poor response to Interferon).

10/4/99,  M.D., gastroenterologist: “ … chronic hepatitis C … biopsy … stage III fibrosis …Interferon for little over 7 months … negative qualitative PCR with a good response … depressed … 12/98 … medicine discontinued … 12/8/98 …relapsed with positive viral load 2/99 … unclear how much of that depression was related tingling Interferon since her husband had left at that time … mild liver elevation … recheck PCR … liver function … CVC … carries viral load approximately 300,000 type I … not had any decompensating events of chronic liver … recommend treatment over the next 6 months depending …depression … relationship … husband … medications Paxil 30 mg … Xanax 1 mg … does not abuse medicines …”

10/4/99, HCV RNA PCR 773.77, ALT 21.

10/4/99, AST 33 high

11/11/99, S, M.D.: “….history of occasional irregular Pap smear…apparently hepatitis C is in full remission….on no meds…”

 4/6/00, , D.O.,gastroenterologist:

1.               Chronic hepatitis C.

2.               Obesity.

“ … CBC … CMP … liver panel … TSH … ferritin … A1  antitrypsin … urinalysis … serum globulin … hepatitis A & B profile … HCVRNA QPCR … ultrasound of the abdomen … hepatitis A vaccine after lab results …educational materials …”

4/5/00, Emergency Department: Chemical conjunctivitis.

4/6/00, HCVRNA PCR quantitative, 557.64 X 1000 per ml, ALT 24 normal, CMP normal, CVC normal, urinalysis normal, ferritin, TSH, Alpha 1 antitrypsin normal, hepatitis B E AG and hepatitis B E AB negative, total protein serum electrophoresis 7.2 normal, HAV AB total negative, HBS AG negative, HBC AB, total negative, HBC AB (IGM) negative, anti HBS positive, AFP tumor marker 5.9 normal.   

4/11/00, Hemoglobin 16.7, pro-time 14.6 high, PPT 29.8 within normal limits.

4/23/00 Emergency Department: Urinary tract infection.

“…Bactrim…fluids…”

4/27/00, Upper abdominal and retroperitoneal ultrasound, radiologist:

1.               Multiple gall stones in the gall bladder.

2.               Spleen slightly prominent.

3.               Otherwise normal.

5/25/00, S, M.D.: “….no gynecological complaints…stress ….divorce…on Paxil… Ambien as needed for sleep…”

 5/26/00,Pap:  Normal with moderate/marked inflammation.

6/14/00,Mammogram, M.L. Struthers, M.D.: Normalwithout interval change.

6/14/00, ,D.O. (PAC):

1.               Hepatitis C with increasing viral load, 1B.

2.               fatigue.

3.               Depression.

4.               Obesity.

“…psychiatric management of depression…Walter Griffith,M.D….Ambien…”

10/30/00, M.D. psychiatrist: 

1.               Axis I, major depression, chronic, moderate, partial remission, family marital conflict.

2.               Axis II deferred.

3.               Axis III Hepatitis C, stage III, bridging fibrosis.

4.               Axis IV, primary support group, occupational, economic, health, chronicity. Strengths:  insight ego strength, intelligence, verbal skills, motivation, treatment access.

5.               Axis V, current 60, past year 70.

“… alert, oriented, neat. Obese, casual attired, pleasant, cooperative, help seeking, friendly, appropriate relaxed behavior, depressed mood, restricted affect, normal speech and thoughts, intact cognition, insight and judgment and above intelligence … initiate Wellbutrin 50-150 SR/AM … continue Paxil 20 mg. hs and Ambien … psychotherapy … substance abuse abstinence … follow-up visit 2-3 weeks … ” 

8/23/00, Dr. D.O. gastroenterologist,gastroenterologist, (P. A.):  “….discussion about treatment options…Infergen vs. Rebetron (Ribivirin and Interferon alpha 2-B)….Xanax…paxil…”

9/20/00, Dr. D.O. gastroenterologist, gastroenterologist,  (P. A.): “…wants to start Rebetron…Rx written…will start when approved.”

10/22/00, Office of Dr. D.O. gastroenterologist, gastroenterologist,: “…problems with meds and authorization….”

10/27/00, Office of Dr. D.O. gastroenterologist,gastroenterologist: “….patient ..not come for teaching…lab protocol…do not refill Rebetron.”

11/3/00, Office of Dr. D.O. gastroenterologist, gastroenterologist: “…Rebetron… sent to wrong Albertsons….patient to be late for teaching…will be here…”

11/3/00, Office of Dr. D.O. gastroenterologist, gastroenterologist:  “….patient upset…..wouldn’t allow me to schedule teaching….”

11/21/00, Dr. D.O. gastroenterologist,gastroenterologist,  (P. A.):

1.               Hepatitis C in treatment

2.               Obesity.

3.               Depression.

“….Hepatitis A and B vaccine, CBC, liver profile, BUN, Cr….mild fatigue…”

11/21/00, Hepatic function profile, BUN, Cr, CBC, all normal.

11/28/00, Dr. D.O. gastroenterologist,gastroenterologist, (P. A.):

4.               Chronic hepatitis C.

5.               Obesity.

6.               Depression.

“…stated 385#…arthralgia, mild insomnia…mild depression…Interferon IM 30 q 3 x week,Ribivirin 1200mg….second week on Rebetron….renew Rx… Ambien, Rebetron…3 month…”

ASSESSMENT:

1.               History chronic fatigue, rule out effect of hepatitis B and C, effect of medications, obesity, depression.   

2.               Signs of palmar erythema and diffuse angiomata, petechiae, rule out effect of chronic liver disease.

3.               Exogenous obesity, 380+ pounds.

4.               History hepatitis B and C with positive hepatitis B core antibody, positive hepatitis B surface antibody (titer 30), hepatitis C antibody (HCV) positive (2/2/98).

5.               Bridging fibrosis 2+ in a scale of 4 and minimal to mild lobular fatty change consistent with clinical impression of chronic active hepatitis C (3/27/98, Liver biopsy, M.D., pathologist).

6.               Hepatitis C virus genotype subtype 1B associated with more severe liver disease, poor prognosis to interferon ( 6/21/99 ).

7.               History of major depressive disorder, severe, single without psychosis (12/8/98, M.D., psychiatrist). 

8.               History chronic depression on Paxil 30 mg. daily, Xanax .1 mg. 3-5 times per month and occasional Ambien 10 mg. for sleep.

9.               Multiple gallstones and prominent spleen (b>4/27/00, Upper abdominal and retroperitoneal ultrasound, radiologist). 

10.          Mild fibroglandular tissue both breasts without specific evidence of malignancy (3/23/98, Mammogram, M.D.).

11.          Borderline hypertension.

12.          Bilateral leg swelling due to venous insufficiency (12/9/98,  M.D.).

13.          History of chemical conjunctivitis (4/5/00, Emergency Department).

14.          History of urinary tract infection. (4/23/00, Emergency Department).

15.          History of severe adult periodontitis (9/17/97, K.,D.D.S.) with osseous surgery, periosteal maintenance (12/5/97 Dental Specialties).

16.          Benign cellular changes associated with inflammation (1/26/98, Pap smear).

17.          Post traumatic scarification right thigh, status post barracuda bite.

18.          Incomplete right bundle branch block (10/17/96, EKG).

NATURAL HISTORY HEPATITIS C:

References:

1.     Consultant Magazine, August, 2000, Dr. Dieterich, Assistant Professor of Clinical Medicine, New York University School of Medicine, Chief of gastroenterology and hepatology, Cabrini Medical Center in New York. 

3.               Journal American Board of Family Practice, September/October, 2000.

4.               Lancet, 10/28/00.

5.               Harrison’s Internal Medicine.

Hepatitis C (HCV) is the most common blood borne infection in the United States.  About 1.8% of the population is currently infected and, during the 1980’s, as many as 230,000 new hepatitis C infections occurred each year. The two most important modes of HCV and transmission have been transfusion of infected blood and blood products and sharing of contaminated needles for injection drug use. 

Clinical Features:      Only a minority of patients with acute HCV infection experience significant illness or symptoms. Most patients in whom chronic hepatitis C is later diagnosed do not recall any significant symptoms indicative of initial infection though some may have nonspecific symptoms such as general malaise, anorexia and abdominal pain.

Chronic hepatitis C develops in approximately 75-85% of patients with acute HCV infection with a percentage considerably higher among persons who are exposed to hepatitis B virus.  Spontaneous resolution of HCV infection is demonstrated by continued absence of HCV RNA and sustained normalization of serum ALT levels occurs in only 15-25% and only during the acute phase.  Most patients with chronic hepatitis C are unaware of their status and may remain asymptomatic for years or decades usually being diagnosed after routine laboratory studies showing an elevated ALT level or tests performed for blood donor screening.

HCV does not cause death by itself though leads to cirrhosis, liver failure and hepatoma which are potentially fatal through a process involving hepatic fibrosis triggered by inflammation caused by hepatitis C virus.  Alcohol abuse contributes substantially to the development of cirrhosis and, within 20 years after initial infection.  Cirrhosis of the liver develops in approximately 20% of patients with chronic hepatitis C; hepatocyte carcinoma occurs in 1-4% of patients with cirrhosis each year, and patients with chronic hepatitis C virus infection and liver disease are at increased risk for hepatitis A diagnosis. 

Two antibody tests are currently used to diagnose HCV infection, EIA enzymoimmunoassay for routine screening and RIBA recombinant immunoblot assay for confirmatory testing; many clinicians now use techniques that directly measure RNA such as quantitative HCV RNA tests.  ALT readings vary markedly in patients with hepatitis C and cannot be relied on either for diagnosis or for assessing the severity of liver damage though 60-70% of patients with HCV infection have persistently elevated ALT levels.  Liver biopsy remains the gold standard for staging liver disease treatment. Patients with chronic hepatitis C have persistently elevated ALT, detectable HCV RNA levels and liver biopsy results that show portal or bridging fibrosis or at least moderate inflammation or necrosis have generally been considered prime candidates for Interferon alpha therapy though clinical experience has shown only about 10-20% of patients with chronic hepatitis C demonstrate a sustained response to Interferon monotherapy when response is defined as the absence of detectable virus. Particularly poor sustained response rates have been reported in patients with high levels of HCV RNA who are infected with HCV genotype 1 which includes the majority of patients in the United States.  Since 1998 combination therapy with Interferon Alpha-2B and Ribavirin for the treatment of chronic hepatitis C, 40% of those treated with combination therapy for 48 weeks had undetectable HCV RNA levels six months after treatment ended in contrast to only 15% of those receiving 48 weeks of Interferon monotherapy and combination therapy was associated with significant improvement in liver histology and normalization of ALT though infection with HCV genotype 1 has been associated with lower response rates; increasing the duration of combination therapy, however, has improved the sustained response rate in patients with genotype 1.

With regard to side effects, both Interferon and Ribavirin have serious side effects and are contraindicated for several groups of patients.  The most common adverse effects associated with combination therapy are flu like symptoms such as headache, fatigue, myalgia and fever.  Severe psychiatric adverse effects have also been reported, and patients should be monitored for depression though mild depression and irritability may be treated successfully with various commonly prescribed antidepressants. Interferon also causes generalized bone marrow suppression, especially neutropenia (decreased white blood cells).  Combination therapy must not be used by women who may become pregnant during therapy or during the six months after therapy as significant teratogenic and embryocidal effects have been noted in animal studies. Hemolytic anemia, nausea, dry cough, chest pain, rash, dry skin and puritus are also additional adverse effects. 

 Additional Facts  (some may conflict with aforementioned, dependent on source)

1.   1-3% mortality and up to 20% develop cirrhosis within 5 years, and liver disease will

     progress to cirrhosis in approximately 77% of patients with chronic hepatitis C virus.

2.   After 10 years cirrhosis developed in 100% of patients with severe inflammation plus bridging fibrosis though after 20 years cirrhosis developed in only 60% of the patients with little or no partial fibrosis on initial biopsy. 

3.   The mean duration between exposure and development of cirrhosis is 21 years and for hepatocellular carcinoma 29 years. 

4.   A lack of response to Interferon is associated with an increased risk of hepatocellular carcinoma. 

5.   Approach to treatment is controversial and pharmacologic therapy is not proven to prevent cancer or mortality but is often recommended based on the ability to suppress biochemical and histologic markers of disease, which may contribute to cirrhosis, liver failure or cancer.

6.   Predictors of sustained response to combination antiviral therapy include genotype 2-6, viral load less than 2,000,000 copies per ml., short duration of infection female sex low body weight, mild inflammation and fibrosis on liver biopsy versus severe. 

7.   Contraindications to combination antiviral therapyinclude decompensated liver disease, preexisting psychiatric condition or history of severe psychiatric disorder, active alcohol or injection drug abuse, autoimmune hepatitis or history of autoimmune disease, immunosuppression due to organ transplantation, preexisting thyroid abnormalities not controlled by medication, breast feeding; relative contraindications include debilitating medical conditions, pregnancy at young age.

8.   Recommended duration of therapy is one year if genotype 1 and 6 months for other genotypes at a cost of $8,000 for 6 months.  

9.   Combination Interferon Alpha-2B and Ribavirin is recommended for patients with persistently abnormal ALT for greater than 6 months, positive hepatitis C virus RNA plus liver biopsy showing portal or bridging fibrosis plus at least moderate degrees of inflammation or necrosis.Response may be sustained long term in 10-20% of patients who achieve sustained response.

10.                      Hepatitis A vaccine is indicated in patients with chronic liver disease.

11.                      Routine monitoring of patients with chronic HCV infection has been recommended to include testing every 6 months for ALT, bilirubin, albumen, prothrombin time and routine question for alcohol use.  For patients with HCV but normal ALT repeat ALT at 3-4 months with elevation, otherwise every 6-12 months.

12.                      Failure to clear HCV RNA after 12 weeks of Interferon monotherapy or 24 weeks of combination therapy predicts virological non-responsiveness on longer treatment and has been used as a stopping rule although continuing therapy may be beneficial in that histological improvement, that is slowing the progression of fibrosis, may occur in the absence of complete HCV eradication. 

13.                      Individuals positive for HCV virus should refrain from donating blood, organs, tissue and have safe sexual practice, cover open wounds, avoid sharing razors and toothbrushes.

14.                       Spouses of patients with chronic hepatitis C have an increased risk of acquiring HCV, which increases with longer duration of contact.

EFFECTS OF MEDICATIONS (PHYSICIANS’S DESK REFERENCE, 2000):

1.   PAXIL (paroxetine hydrochloride, page 3027):anti-depressant for social anxiety, obsessive compulsive disorder and panic disorder.

2.    XANAX (alproazolam, contolled IV, page 2492): tranquilizer indicated for anxiety and panic disorder.

3.   AMBIEN, (zolpidem tartrate, contolled IV, page 2884):  sedative/hypnotic with central nervous system depressant effects indicated for the short term treatment of insomnia.

These medications do have adverse
side effects though are not contraindicated when taken appropriately in a person with chronic hepatitis C.

PERMANENT FUNCTIONAL IMPAIRMENT RATING BASED ON THE AMA GUIDES TO THE EVALUATION OF PERMANENT IMPAIRMENT, 5^TH EDITION:

When combined and rounded to the nearest value ending with 0 or 5 this examinee has a permanent functional impairment rating of 20% to the body as a whole secondary to chronic hepatitis C and chronic depression.

MEDICAL OPINION BASED ON MEDICAL EVALUATION, REVIEW OF AVAILABLE MEDICAL RECORDS (9/6/95-6/14/00) AND RESEARCH ON THE NATURAL HISTORY OF HEPATITIS C

In my opinion, by medical history, physical examination and review of available medical records, this examinee, who has a history of morbid obesity, venous insufficiency of the lower extremities and borderline diabetes mellitus and hypertension, has also been diagnosed with chronic active hepatitis B and C; during 12/98, subsequent to treatment with interferon and concurrently with situational stresses, the examinee developed an acute depression with suicidal ideation which led to hospitalization and the discontinuation of antiviral therapy.  After noted absence of virus detection (11/18/98) while on medication, the examinee has since developed an exacerbation of symptoms of progressive fatigue with viral replication.

The examinee has a history of having a mother who was alcoholic and possibly abusive, divorce of parents at 12 years of age, history of chronic obesity, a brother who was a heroin addict and several years of psychotherapy and attendance at Alanon.  Moreover, the examinee had a history of multiple unprotected sexual encounters prior to marriage as well as a tattoo at 16 years of age, either of which may have contributed to the hepatitis C infection diagnosed 2/98.  Moreover, during 1996/97, the examinee was also treated by Dr., internist, in Georgia with Phen-Fen for weight loss though she denies any specific symptoms attributable to the medication at that time. 

Progressive fatigue has been noticeable for approximately 25 years although the examinee indicates having participated in the renovation of a home as well as an ongoing ability to maintain a home, lawn and pool in addition to daily walks, periodic swimming, volunteering with church activities and spiritual study. 

The examinee, though diagnosed with depression and treated with Paxil by M.D., gastroenterologist, in addition to periodic Xanax and Ambien, despite having the acute depression leading to hospitalization (12/08/98), has not had additional psychological or psychiatric follow-up or consultation other than a single encounter with, M.D.,psychiatrist, (10/30/00) when she was diagnosed with major depression, chronic, moderate, partial remission, family marital conflict and prescribed Wellbutrin, Paxil, Ambien and psychotherapy and substance abuse abstinence; she was also noted to have intact cognition, insight and judgment and above average intelligence.

The opinion of  M.D., gastroenterologist, (4/30/98) was that the examinee’s symptom of significant fatigue was from hepatitis C and not simply related to her weight, that though unclear how much of the examinee’s depression was related to the Interferon as the examinee’s husband had left at that time (12/8/98), clearly Interferon could aggravate the examinee’s depression which, associated with suicidal ideation, subsequently led to discontinuation of anti-viral medication and psychiatric hospitalization and that the examinee could eventually tolerate resuming anti-viral medication over a six month period if her home life were stabilized though the chance of depression would certainly be increased (10/4/99) (confirmed telephonically, 1/15/01, Hospital, … “fulltime job only if tailored to her skills…”)

As noted in the aforementioned natural history of hepatitis C and particularly relevant with regard to the examinee:

Chronic hepatitis C develops in approximately 75-85% of patients with acute HCV infection with a percentage considerably higher among persons who are exposed to hepatitis B virus with spontaneous resolution of HCV infection demonstrated by continued absence of HCV RNA and sustained normalization of serum ALT levels occuring in only 15-25% and only during the acute phase.  

Though HCV does not cause death by itself, cirrhosis, liver failure and hepatoma are potentially fatal through a process involving hepatic fibrosis triggered by inflammation caused by hepatitis C virus with cirrhosis of the liver developing in approximately 20% of patients with chronic hepatitis C; hepatocyte carcinoma occurs in 1-4% of patients with cirrhosis each year.  In other studies after 10 years cirrhosis developed in 100% of patients with severe inflammation plus bridging fibrosis and after 20 years in only 60% of the patients with little or no partial fibrosis on initial biopsy. The mean duration between exposure and development of cirrhosis is 21 years and for hepatocellular carcinoma 29 years. A lack of response to Interferon is associated with an increased risk of hepatocellular carcinoma.   

Particularly poor sustained response rates have been reported in patients with high levels of HCV RNA who are infected with HCV genotype 1 which includes the majority of patients in the United States.Since 1998 combination therapy with Interferon Alpha-2B and Ribavirin for the treatment of chronic hepatitis C, 40% of those treated with combination therapy for 48 weeks had undetectable HCV RNA levels six months after treatment ended in contrast to only 15% of those receiving 48 weeks of Interferon monotherapy, and combination therapy was associated with significant improvement in liver histology and normalization of ALT though infection with HCV genotype 1 has been associated with lower response rates. Failure to clear HCV RNA after 12 weeks of Interferon monotherapy or 24 weeks of combination therapy predicts virological non-responsiveness on longer treatment and has been used as a stopping rule although continuing therapy may be beneficial in that histological improvement, that is slowing the progression of fibrosis, which may occur in the absence of complete HCV eradication. 

Severe psychiatric adverse effects have also been reported, and patients with HCV on a therapeutic regimen should be monitored for depression; mild depression and irritability may be treated successfully with various commonly prescribed antidepressants. Contraindications to combination antiviral therapy, however, include decompensated liver disease, preexisting psychiatric condition or history of severe psychiatric disorder.

Spouses of patients with chronic hepatitis C have an increased risk of acquiring HCV, which increases with longer duration of contact.

PHYSICAL LIMITATIONS AND RESTRICTIONS:         Progressive and unpredictable episodes of fatigue as a consequence of chronic active hepatitis in conjunction with morbid obesity and marked swelling of the legs would necessitate an avoidance of prolonged standing or more strenuous physical effort though the examinee has no restrictions with regard to sitting, bending, twisting, lifting, household activities, mowing the lawn or any activities in which she has participated prior to this medical evaluation, albeit the examinee must be able to do her activities at her own pace and while being in control of her own environmental setting. 

The examinee would be a candidate for vocational rehabilitation subsequent to psychological evaluation and functional capacity testing as she exhibits keen mental skills and full physical function other than diminution in energy.

As chronic hepatitis C is a long standing disorder which may have episodes of exacerbation and remission influenced by environmental and/or internal stresses causing an unpredictable course of events, the examinee, with regard to a vocational effort, should have as much control as possible over her day to day activities. 

RECOMMENDATIONS:

With regard to eyesight, the examinee is recommended to have an ophthalmologic evaluation.

With regard to treatment for chronic hepatitis C, the examinee should continue to follow-up with the recommendations of D. O., gastroenterologist.

As the psychopharmacologic effects of Xanax, a tranquilizer, and Ambien, a sedative/hypnotic, may have central nervous system depressant effects and other adverse side effects, these medications should be monitored by a psychiatrist and/or internist and coordinated with a therapeutically appropriate dose of Paxil (anti-depressant medication), (all of which when metabolized have little or no toxic effect on the examinee’s liver) especially should the examinee re-institute anti-viral therapy.

Moreover, dealing with the issues of stress may require supportive psychotherapy with a psychiatrist and/or psychologist, and the examinee is encouraged to continue attending a hepatitis C support group.

As the examinee has been on the Phen-Fen diet program and association with heart disease has been related to this treatment, an echocardiogram would be recommended to rule out a possible cardiac component of the examinee’s fatigue.

ANTICIPATED FUTURE MEDICAL SCENARIO:       As reviewed in the natural history of HCV, thisexaminee,especially with her history of morbid obesity, dysfunctional family dynamics, episode of major severedepressive disorder (12/8/98),ongoing chronic depression on medication, chronic hepatitis C with liver biopsy demonstrating bridging fibrosis (3/27/98), a  Hepatitis C virus genotype subtype 1B associated with more severe liver disease and poor prognosis to interferon (6/21/99), will, within a reasonable degree of medical probability, not sustain a therapeutic course of currently prescribed medication for HCV unless comprehensively managed with appropriate coordinated psychiatric and medical support.

Medicaltreatment will need to be ongoing dependent upon viral load, clinical manifestations of liver disease and the development of progressive degenerative changes consistent with a history of morbid obesity, venous insufficiency and borderline diabetes mellitus and hypertension.

Within this framework, however, at this time the examinee is not fully impaired and may pursue those activities, which allow her to function as noted within the aforementioned physical limitations and restrictions. 

After review of any additional pertinent medical records and a psychiatric and/or psychological evaluation of the examinee with regard to her psychological ability to tolerate stress, underlying etiology for morbid obesity and an evaluation of the examinee’s ability to take the anticipated antiviral medication in conjunction with her situation and stresses, a more complete description of the examinee’s impairments, physical limitations and restrictions may be ascertained followed by more reasonable vocational expectations.

This examinee was examined for the sole purpose of this medical evaluation.