Free Response - District Court of Connecticut - Connecticut

Case 3:03-cv-00382-JCH

Document 29-3

Filed 06/14/2004

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UNITED STATES DISTRICT COURT DISTRICT OF CONNECTICUT ) ) PETITIONER, ) ) v. ) Civil Action No. 03-CV-382 ) KUMA DEBOO, ET. AL. ) RESPONDENTS. ) ) ______________________________________________________________________________ FRANKIE DELISE DECLARATION OF JOHN C. D'AVIRRO, M.D. ______________________________________________________________________________ I, John C. D'Avirro, hereby declare and state as follows: 1. I am employed by the United States Department of Justice, Federal Bureau of Prisons as the Clinical Director at the Federal Correctional Institution (FCI), Danbury, Connecticut. I have served in this position since January 21, 1997. Prior to this date, I served as a physician at correctional facilities in New York State since January 1973. I am a licensed physician in the states of New York and New Jersey. Inmate Frankie Delise, Register Number 40043-037, the Petitioner in the above-captioned action, arrived at FCI Danbury on November 15, 2001. Upon intake screening by medical personnel, inmate Delise indicated that she had a history of Hepatitis C. On November 26, 2001, she received a medical examination and it was noted that she has a history of Hepatitis C. Inmate Delise has been seen and followed for Chronic Hepatitis C since her first visit in the Infectious Disease Clinic on April 8, 2002 and has been followed in regular clinic visits (approximately every 3 months) ever since. During this April 8, 2002 visit, inmate Delise was scheduled for a liver biopsy which was accomplished without incident on May 3, 2002. The results confirmed that she had Chronic Hepatitis, Grade 3, Stage 3. Microscopically, the specimen revealed evidence of periportal fibrosis and focal bridging fibrosis. In order to determine whether inmate Delise qualified for antiviral therapy treatment of Hepatitis C, certain evaluations and tests were performed in accordance with the Federal Bureau of Prisons Clinical Practice Guidelines for the Prevention and Treatment of Viral

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Case 3:03-cv-00382-JCH

Document 29-3

Filed 06/14/2004

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Hepatitis, dated July, 2001 (hereinafter "2001 Clinical Practice Guidelines", attached hereto as Exhibit A.) 5. On June 10, 2002, inmate Delise underwent an initial viral load (count) test (RNA PCR) in the Department of Pathology and Laboratory Medicine at Danbury Hospital. The test results indicated that inmate Delise tested positive for HCV RNA (Hepatitis C Virus Ribo Nucleic Acid). Specifically, the test revealed that she had a viral load (count) test that was greater than 850,000. Inmate Delise also underwent HCV (Hepatitis C Virus) genotype testing in order to determine her genotype and the type of treatment indicated. The results determined that inmate Delise had genotype 1b. On July 18, 2002, in accordance with the 2001 Clinical Practice Guidelines, a consult was written for inmate Delise to be evaluated by Psychology. She underwent an evaluation and it was determined that she did not have a psychiatric diagnosis. Subsequently, she was cleared by Psychology and recommended for treatment. See 2001 Clinical Practice Guidelines at p. 44. In accordance with 2001 Clinical Practice Guidelines, interferon/ribavirin drug therapy was recommended for treatment of Hepatitis C, genotype 1. See 2001 Clinical Practice Guidelines at p. 45. The guidelines also require that a viral load (count) test is drawn prior to treatment. After approximately 24 weeks of treatment, the viral load (count) is suppose to be checked. If it is determined after 24 weeks that the viral load (count) is negative then treatment is to be continued for 48 weeks. If the result is positive (meaning that any virus is identified) then treatment is to be stopped. See 2001 Clinical Practice Guidelines at pp. 21- 45. On July 29, 2002, I submitted a request for inmate Delise to receive interferon/ribavirin to the Bureau of Prisons Central Office. An approval for treatment was returned on August 1, 2002. After Central Office approval, it was determined that inmate Delise would receive pegylated interferon which is a better treatment regimen than the regular interferon that what was recommended by BOP clinician notes dated October, 2002. The patient was subsequently interviewed by the Schering Corporation Peg-Intron representative, assigned an access number, and then waited approximately 7 weeks for approval due to a backlog of orders for the pegylated interferon from the supplier. The combination pegylated interferon/ribavirin was ordered on October 7, 2002, and the patient began treatment on October 25, 2002. Thereafter, she received a weekly injection every Friday. Inmate Delise received a dose of 100 micrograms of pegylated interferon Alpha 2b and 600 milligrams of ribavirin. This dosage persisted through January 17, 2003. On January 24, 2003, inmate Delise was started on a new dosage of 150 micrograms of pegylatd interferon Alpha 2b and 1,000 milligrams of ribavirin. Page 2 of 4

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Case 3:03-cv-00382-JCH

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New BOP Clinical Practice Guidelines on Viral Hepatitis dated February 28, 2003 (hereinafter "2003 Clinical Practice Guidelines", attached hereto as Exhibit B), recommend treatment for genotype 1 Hepatitis C for the Bureau of Prisons with a combination of pegylated interferon 1.5 micrograms per kilogram of body weight, given subcutaneously once weekly, plus 1000 milligrams of ribavirin given by mouth daily in divided dose for a period of 12 weeks. See 2003 Clinical Practice Guidelines at p. 74. Prior to treatment, a viral load test is drawn, with a 12-week follow-up when another viral load is compared to the pre-treatment level result. A positive response consists of a 2 log decrease in number after the 12-week period. If this 2 log decrease exists, treatment is extended for 36 weeks (total of 48 weeks course of treatment). See 2003 Clinical Practice Guidelines at p. 50. The Hepatitis C PCR (viral count) quantitative test available to the FCI is done at Danbury Hospital and has a linear range from 600 to 850,000. Inmate Delise underwent this initial viral load (count) test on June 10, 2002. The test revealed that her viral load (count) was positive and greater than 850,000. A 2 log decrease would be in an area below 8,500. Since inmate Delise was given a new dosage of pegylated interferon and ribavirin on January 24, 2003, it was felt that the 12 week time frame to conduct a sample viral load (count) test as recommended by BOP Clinical Practice Guidelines dated February, 2003 would be waived. It was determined that the viral load (count) test would take place after the 24 week time frame to better assess the problem at this dosage. As a result of the interferon/ribavirin treatment, inmate Delise has experienced a few common side effects. On March 3, 2003, inmate Delise complained of a one week history of weight loss and tremor. She was diagnosed with a hyperactive thyroid condition secondary to the interferon/ribavirin treatment. She was placed on propylthiuracil (PTU), and propranolol to control her symptoms. Inmate Delise initially responded well to this medication, but on March 17, 2003 she required an increase in PTU to 150 milligrams, 3 times a day, in order to get her thyroid in balance. As a result of this change in medication, her thyroid had improved. On March 25, 2003, I evaluated inmate Delise and her condition had improved. On or about April 16, 2003, she began to develop hypothyroidism as a result of the interferon/ribavirin treatment. This was managed by discontinuation of proplythiuracil, and repeated lab testing of the hypothyroid state. Subsequently, thyroid replacement hormone was prescribed. I consulted with an endocrinologist concerning this treatment regimen protocol and he agreed with this treatment regimen and asked that inmate Delise be seen in the Endocrinology Clinic at FCI Danbury which was accomplished on May 14, 2003. The endocrinology consultant reaffirmed the therapy and advised continuation as predicated by future test results. Inmate Delise is currently being maintained on this treatment regimen. Page 3 of 4

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Case 3:03-cv-00382-JCH

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Filed 06/14/2004

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After receiving 27 weeks of pegylated interferon/ribavirin treatment inmate Delise received a viral load (count) test on May 2, 2003. On June 2, 2003, I received the results of the viral load test. The results revealed that inmate Delise had a viral load count less than 600. In accordance with the 2003 Clinical Practice Guidelines, these results warranted that inmate Delise continue with pegylated interferon/ribavirin course of treatment for a total of 48 weeks. See 2003 Clinical Practice Guidelines at p. 50. Inmate Delise was continued on the pegylated Inerferon/Ribaviron therapy until completion of the regimen on October 25, 2003, tolerating the therapy quite well despite weight loss, hair loss, anemia, and the above mentioned thyroid problems. Her liver enzymes normalized during the treatment period ut began to rise notably on February 26, 2004. Concurrent with the liver enzyme elevation she developed upper abdominal pain that heralded the probable recurrence of the Hepatitis C activity. On March 19, 2004, inmate Delise underwent Hepatitis C PCR testing (viral load testing) which was found to be above 850,000. This confirmed to me that inmate Delise was a relapser. See 2003 Clinical Practice Guidelines at p. 51. Thereafter, I referred inmate Delise to an Infectious Disease specialist at Danbury Hospital, in Danbury, Connecticut for a consultation concerning her treatment for Hepatitis C. Inmate Delise was seen by this Infectious Disease Specialist on May 14, 2004. To date, however, a written report has not yet been received. Upon receipt of the report I will forward it to the appropriate personnel in Central Office of the Bureau of Prisons for review and direction.

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I declare under penalty of perjury that the foregoing is true and accurate to the best of my knowledge. Executed this ____ day of June, 2004.

_______________________________ John C. D'Avirro, M.D. Clinical Director Federal Correctional Institution Danbury, Connecticut

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