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California Establishes Statewide Hepatitis-C Management Program
by John E. Dannenberg
The California Department of Corrections (CDC) Health Care Services Division instituted a statewide Hepatitis-C Clinical Management Program (Program) in March, 2004. The Program draws from the prototype HCV protocol developed under federal court order at Pelican Bay State Prison and a similar program recently begun at San Quentin State Prison. The Program is in response to the settlement in Plata v. Davis, (U.S.D.C., N.D. Cal., Case No. C 01-1351-1EH), a statewide prison medical care suit brought on behalf of all CDC prisoners by the non-profit Prison Law Office, San Quentin, California. The Program's stated purpose is to ensure a consistent, appropriate, effective and efficient approach to the clinical management of persons infected with HCV." As such, it should bring to an end the mixed bag" of treatment protocols that has characterized CDC's treatment of its estimated 64,000 infected prisoners (40% HCV infection rate). (See: PLN, May, 2004, p.1, Prisons Nationwide Fail to Treat HCV Epidemic.)
The Program's three phases are Screening and Diagnosis," Initial Management After Diagnosis Of HCV," and Staging By Liver Biopsy And Combination Therapy.
Phase I offers HCV screening to all prisoner-patients who request it. The screening consists of a hepatitis [blood] panel and liver function tests. Those testing positive for the HCV antibody shall have their viral load measured and undergo repeated ALT enzyme tests. The estimated time to complete Phase I is three months. Those testing positive shall proceed to Phase II.
Phase II begins with vaccination for hepatitis-A and/or B (if required), to be completed within six months after the start of Phase II. Possible contraindications to effective therapy will be evaluated using a list of sixteen exclusion criteria for combination therapy," which sharply limits the number of patients who qualify for anti-viral treatment. The criteria include mental health concerns, other serious medical conditions, and age. Those over age 60, or having compromised immune systems (e.g., AIDS), cancer, diabetes or kidney disease may be excluded, as may those presenting decompensated cirrhosis (irreversible liver damage).
Next, HCV genotype is considered because it impacts eligibility for receiving combination therapy related to remaining length of incarceration time.
In other words, if a prisoner is too short to the house" to complete the treatment for the diagnosed disease, they will not receive anti-viral treatment. To qualify for a liver biopsy followed by combination therapy, the parole date must be at least 10 or 16 months (depending on genotype) from the time they are referred for the biopsy. Absent a time bar, they may then qualify for a liver biopsy to establish the baseline stage of your disease, if after three ALT tests one month apart, the ALT values are at least twice the normal value (waived if they over age 45). Moreover, if they already had appropriate combination therapy, but relapsed or did not respond, they will not be re-treated. The estimated time to complete Phase II is two months.
Phase III begins with counseling for and implementation of the liver biopsy. A hold will be placed to prevent the prisoner's transfer until the biopsy is done and the decision to begin combination therapy has been made. It is estimated that the biopsy will be completed within three months.
When the biopsy results are reviewed, the prisoner will be given combination therapy if they fit a list of inclusion criteria." Generally, they are included" if they have stage 3 liver fibrosis or greater (except stage 2, if co-infected with HIV). The estimated total time from Stage I screening to initiation of combination therapy is nine months.
The treatment will last until completed as appropriate for the genotype, unless terminated sooner due to non-responsiveness to the pegylated interferon ribavirin combination therapy or to clinical complications from intolerance to it. Non-responders will be kept in the program and will be advised of new treatment options as they may come available.
Throughout one's participation in the program, there is extensive counseling given as to both the risks attending biopsy and combination therapy drugs, as well as expectations of the patient. Instructions include the obvious stop smoking, drinking alcohol and using dope as well as avoid getting tattoos, or sharing toothbrushes or razors; reduce weight if overweight; restrict aspirin and ibuprofen use to that approved by doctors; avoid taking supplemental iron and pain medication.
In sum, if a prisoner is far enough along (chronic HCV" liver deterioration) and not too close to parole, and doesn't have other serious medical conditions that counsel against the stressful and sometimes debilitating combination therapy regimen, they will be treated. Given that no one will be treated who does not request to be tested, but 40% are estimated to be infected, it behooves all California prisoners who have a history of susceptible behavior to request Phase I testing. They might learn that they have qualifying chronic HCV disease without any symptoms but gain treatment before irreversible cirrhosis of their liver sets in.
Among the twelve attachments to the Program plan are lists of potential side effects, exclusion criteria, samples of all Program evaluation forms and charts, the treatment contract they must sign, and recommended anti-viral drug dosage adjustment criteria. See: Hepatitis C Clinical Management Program, March 2004, California Department of Corrections, Health Care Services Division.
While the Program is a step forward in CDC healthcare, it will have little effect on stemming the growing HCV epidemic in California because 40% of CDC prisoners are parole violators, whose short terms preclude them from treatment. With 90,000 parole violators recycling through CDC's revolving doors each year, an estimated 36,000 of whom are HCV infected, the vector of infection from prisons back into the community will be unabated.
Moreover, for the remaining 100,000 term-serving CDC prisoners, 40,000 of whom are presumptively infected, only that tiny fraction whose health has deteriorated to the life-threatening level of Stage 3 liver fibrosis will be considered for the combination therapy.
To effectively stem the epidemic now a national emergency the federal government should take charge with a testing/treatment program targeted at the country's jails and prisons (where the disease is concentrated), that requires 100% testing and follows through by funding 100% treatment inside the walls and back in the community.
The California Department of Corrections (CDC) Health Care Services Division instituted a statewide Hepatitis-C Clinical Management Program (Program) in March, 2004. The Program draws from the prototype HCV protocol developed under federal court order at Pelican Bay State Prison and a similar program recently begun at San Quentin State Prison. The Program is in response to the settlement in Plata v. Davis, (U.S.D.C., N.D. Cal., Case No. C 01-1351-1EH), a statewide prison medical care suit brought on behalf of all CDC prisoners by the non-profit Prison Law Office, San Quentin, California. The Program's stated purpose is to ensure a consistent, appropriate, effective and efficient approach to the clinical management of persons infected with HCV." As such, it should bring to an end the mixed bag" of treatment protocols that has characterized CDC's treatment of its estimated 64,000 infected prisoners (40% HCV infection rate). (See: PLN, May, 2004, p.1, Prisons Nationwide Fail to Treat HCV Epidemic.)
The Program's three phases are Screening and Diagnosis," Initial Management After Diagnosis Of HCV," and Staging By Liver Biopsy And Combination Therapy.
Phase I offers HCV screening to all prisoner-patients who request it. The screening consists of a hepatitis [blood] panel and liver function tests. Those testing positive for the HCV antibody shall have their viral load measured and undergo repeated ALT enzyme tests. The estimated time to complete Phase I is three months. Those testing positive shall proceed to Phase II.
Phase II begins with vaccination for hepatitis-A and/or B (if required), to be completed within six months after the start of Phase II. Possible contraindications to effective therapy will be evaluated using a list of sixteen exclusion criteria for combination therapy," which sharply limits the number of patients who qualify for anti-viral treatment. The criteria include mental health concerns, other serious medical conditions, and age. Those over age 60, or having compromised immune systems (e.g., AIDS), cancer, diabetes or kidney disease may be excluded, as may those presenting decompensated cirrhosis (irreversible liver damage).
Next, HCV genotype is considered because it impacts eligibility for receiving combination therapy related to remaining length of incarceration time.
In other words, if a prisoner is too short to the house" to complete the treatment for the diagnosed disease, they will not receive anti-viral treatment. To qualify for a liver biopsy followed by combination therapy, the parole date must be at least 10 or 16 months (depending on genotype) from the time they are referred for the biopsy. Absent a time bar, they may then qualify for a liver biopsy to establish the baseline stage of your disease, if after three ALT tests one month apart, the ALT values are at least twice the normal value (waived if they over age 45). Moreover, if they already had appropriate combination therapy, but relapsed or did not respond, they will not be re-treated. The estimated time to complete Phase II is two months.
Phase III begins with counseling for and implementation of the liver biopsy. A hold will be placed to prevent the prisoner's transfer until the biopsy is done and the decision to begin combination therapy has been made. It is estimated that the biopsy will be completed within three months.
When the biopsy results are reviewed, the prisoner will be given combination therapy if they fit a list of inclusion criteria." Generally, they are included" if they have stage 3 liver fibrosis or greater (except stage 2, if co-infected with HIV). The estimated total time from Stage I screening to initiation of combination therapy is nine months.
The treatment will last until completed as appropriate for the genotype, unless terminated sooner due to non-responsiveness to the pegylated interferon ribavirin combination therapy or to clinical complications from intolerance to it. Non-responders will be kept in the program and will be advised of new treatment options as they may come available.
Throughout one's participation in the program, there is extensive counseling given as to both the risks attending biopsy and combination therapy drugs, as well as expectations of the patient. Instructions include the obvious stop smoking, drinking alcohol and using dope as well as avoid getting tattoos, or sharing toothbrushes or razors; reduce weight if overweight; restrict aspirin and ibuprofen use to that approved by doctors; avoid taking supplemental iron and pain medication.
In sum, if a prisoner is far enough along (chronic HCV" liver deterioration) and not too close to parole, and doesn't have other serious medical conditions that counsel against the stressful and sometimes debilitating combination therapy regimen, they will be treated. Given that no one will be treated who does not request to be tested, but 40% are estimated to be infected, it behooves all California prisoners who have a history of susceptible behavior to request Phase I testing. They might learn that they have qualifying chronic HCV disease without any symptoms but gain treatment before irreversible cirrhosis of their liver sets in.
Among the twelve attachments to the Program plan are lists of potential side effects, exclusion criteria, samples of all Program evaluation forms and charts, the treatment contract they must sign, and recommended anti-viral drug dosage adjustment criteria. See: Hepatitis C Clinical Management Program, March 2004, California Department of Corrections, Health Care Services Division.
While the Program is a step forward in CDC healthcare, it will have little effect on stemming the growing HCV epidemic in California because 40% of CDC prisoners are parole violators, whose short terms preclude them from treatment. With 90,000 parole violators recycling through CDC's revolving doors each year, an estimated 36,000 of whom are HCV infected, the vector of infection from prisons back into the community will be unabated.
Moreover, for the remaining 100,000 term-serving CDC prisoners, 40,000 of whom are presumptively infected, only that tiny fraction whose health has deteriorated to the life-threatening level of Stage 3 liver fibrosis will be considered for the combination therapy.
To effectively stem the epidemic now a national emergency the federal government should take charge with a testing/treatment program targeted at the country's jails and prisons (where the disease is concentrated), that requires 100% testing and follows through by funding 100% treatment inside the walls and back in the community.
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