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CURRENT TREATMENT OF HEPATITIS C IN THE
CORRECTIONAL SETTING
ROBERT RUDAS, M.D., AAHIVSHIV / HEP C PROVIDER, MULE CREEK STATE PRISON
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Inmate populations bear a disproportionate share of hepatitis c virus infection
16-41 % of prisoners in the US had evidence of exposure to HCV, compared to 1.6% of the general population.
MULE CREEK STATE PRISON – 29% HCV Ab +
1 in every 3 persons with HCV infection in US has passed through jail or prison over the course of a year.
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TREATMENT IN THE CORRECTIONALSETTING IS COST EFFECTIVE
Traditional therapy with Pegylated
Interferon & Ribavirin has been cost effective with cost per “quality adjusted life-years” gained
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SUDDENLY A NEW DYNAMIC EMERGES
2 New direct-acting antivirals (DAAs), BOCEPREVIR & TELAPREVIR
More effective and can treat some patients for shorter duration of time
BUT! Increases the cost of treatment from $25,000 (for Peg/Riba alone) to $50,000 - $75,000 for these new 3-drug regimens
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TWO-THIRDS OF THOSE LIVING WITH HCV WERE BORN BETWEEN 1945 & 1965
HOW DOES THIS IMPACT CORRECTIONAL TREATMENT COSTS?
THE GOOD NEWS: As the birth cohort ages out of crime-prone years (approximately 20-45 years of age), prisons would be expected to bear a declining share of the epidemic.
THE BAD NEWS: The cost burden correctional institutions will have to carry in the next 10-15 years is going to astronomical!
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ETHICALLY, CORRECTIONAL HCV TREATMENTPROVIDES:
Unquestionable increased live span and improved quality of life for the patient
Huge contribution to the health of the prison inmates
Big contribution to the community for inmates that parole
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OH BY THE WAY………Don’t forget about the millions, if not billions, of dollars that will be saved from the onslaught of Baby Boomers that will require repeated hospitalizations for their end-stage liver disease (ESLD) if they are not treated.
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THE HCV RNA VIRUS
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HCV GENOTYPE BREAKDOWN IN THE US:Genotype 1 - 70%, most difficult to treat
Genotype 2 – 16%, easier to treat
Genotype 3 – 12%, easier to treat
Genotype 4 - 1%, moderately difficult to treat
Genotypes 5 & 6 – Very rare in the US. (mostly in Africa & Asia)
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HOW IS HCV CONTRACTED?
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ONE OF THE MOST PREVALENT VECTORS IN THE PRISON POPULATION
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HOW IS HCV CONTRACTED?
SEXUAL CONTACT:
Men having sex with men (MSM) – 3-4%
Male-Female intercourse - <1%
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HOW IS HCV CONTRACTED?
Blood Transfusions:
Since 1992 all transfused blood is tested for HCV, but before 1992 blood transfusions was one of the leading causes of HCV transmission.
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NORMAL LIVER HISTOLOLGY
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CIRRHOSIS
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CIRRHOSIS / FIBROSIS STAGING
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CIRRHOSIS / HCV / HCC
20 % OF PATIENTS WITH HCV DEVELOP CIRRHOSIS
20% OF PATIENTS WITH CIRRHOSIS DEVELOP HEPATOCELLUAR CA
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BREAKDOWN ON CIRRHOSIS
COMPENSATED CIRRHOSIS
DECOMPENSATED CIRRHOSIS
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DECOMPENSATED CIRRHOSIS
ASCITES
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HEPATIC ENCEPHALOPATHY
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ESOPHOGEAL VARICIES WITH HEMORRAGE
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DECOMPENSATED CIRRHOSISSPONTANEOUS BACTERIAL PERITONITIS
HEPATORENAL SYNDROME
HEPATOPULMONARY DISEASE
CHILD-PUGH SCORE >/= to 7 (>/= TO 6 if HIV+)
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CHILD-PUGH SCORE CALCULATION
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DECOMPENSATED CIRRHOSISHEPATOCELLULAR CARCINOMA
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APPROACH TO HEP C TREATMENT
WHO TO TEST
WHO TO TREAT
WHO NOT TO TREAT
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WHO TO TEST ? High risk behavior eg. MSM, IVDU, Tattoos.
EVERYONE born between 1945 & 1965. This “baby boomer” cohort has a 5 times greater risk of having contracted HCV than the rest of the population.
Any suspicious acute elevation in AST/ALT on a routine chemistry panel.
ALL incarcerated persons?
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WHO TO TREAT?All GENOTYPE 1 patients with:
Stage 3 or > fibrosis liver biopsy in the past 5 years if HIV negative.
Stage 2 or > fibrosis in the past 3 years if HIV+.
This is whether they are treatment naïve or whether they have failed a failed an Interferon/Ribavirin regimen in the past.
Need for an adequate depth biopsy – ideal 2.5 cm.
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WHO TO TREAT?
All treatment naïve patients with GENOTYPE 2 & 3 with NO BIOPSY required.
All treatment naïve patients with GENOTYPE 4, 5, & 6 with a liver biopsy of Stage 2 or greater.
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WHO NOT TO TREAT ? MUST NOT HAVE: Poorly controlled cardiopulmonary disease,
cerebrovascular disease, thyroid disease, blood dyscrasias, seizures, cancer, renal insufficiency (Cr >2, Cr Cl<50), or uncontrolled
Diabetes (Hgb A1C.8.5) HIV infection with CD4<200 Hx kidney, lung, or heart transplant Autoimmune disease Ongoing illicit drug or alcohol use WBC < 1,500 Platelet count < 75,000 (of which many cirrhotics have)
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WHO NOT TO TREAT ?
MUST NOT HAVE: Hemolytic anemia Hgb < 11 Hct < 33 Allergy to Interferon or Ribavirin Pregnancy Inability to practice contraception History of decompensated cirrhosis Hepatocellular CA Inability to cooperate with treatment
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WHO NOT TO TREAT ?
MUST NOT HAVE: Inability to give informed consentPoorly controlled depressionSuicidal behavior in the past 12 monthsGenotypes 2,3,4,5,or 6 that have not
responded to prior Peg/Riba treatmentParole dates of <16 months if genotype
1, 4, 5, 6 or parole date <8 months if genotype 2 or 3.
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GOAL OF HCV TREATMENT
To have a non-detectable HCVviral load 6 months after the completion of the treatmentregimen = “CURE”
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CURRENT TREATMENT REGIMENS
PEGINTERFERON 2 ALPHA WITH RIBAVIRIN (genotype 2, 3, 4, 5, 6)
BOCEPREVIR PROTOCOL WITH PEG/RIBA (genotype 1 only)
TELAPREVIR PROTOCOL WITH PEG/RIBA (genotype 1 only)
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PEGINTERFERON 2 ALPHAAlpha Interferons used since 1980 to treat Hep C.Still backbone of HCV treatment.Pegylated interferon was introduced in Jan 2001 (covalent bond with Polyethylene glycol, giving it a longer duration of action).Clinically proven antiviral activity against HCV, but exact mechanism is not known.When given with Ribavirin yields 30-55% success with genotype 1, 60-70% success with genotype 2 & 3.Started at a dose of 180mcg/week and lowered to
135mcg/week if drug induced neutropenia or thrombocytopenia.
Causes a plethora of side effects.
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PEGINTERFERON SIDE EFFECTSFever, chills, headache myalgia, fatigue, nausea, anorexia
Psychiatric side effects of depression, irritability, anxiety, insomnia, confusion, difficulty concentration and memory.
While less common also: aggressive behavior, psychosis, hallucinations ,and even suicidal behavior.
Hematologic side effects of neutropenia & thrombocytopenia.
Additional side effects of colitis, pancreatitis, retinopathy (to include blindness), hair loss and injection site reactions.
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RIBAVIRIN A nucleoside inhibitor that will not treat Hepatitis unless
it is given with interferon. Clinically proven to increase the efficacy of interferon For genotypes 2 & 3 is given at a standard dose of 400mg bid For genotypes 1, 4, 5, 6 is given on a weight base dosage Is teratogenic Contraindicated if Creat > 2 or Cr Cl > 50. Primary side effect is hemolytic anemia, and dosage is
decreased if Hgb drops to < 10.
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PEGYLATED INGTERFERON / RIBAVIRIN (Peg Riba) TREATMENT RULES: Genotype 2 or 3 / HIV negative: 24 weeks Peg/Riba 400mg bid.Genotype 2 or 3 / HIV positive: 48 weeks Peg/Riba 400mg bid.Genotype 4,5,6 – 48 weeks Peg and weight based Riba.
FUTILITY RULES:Genotype 2 or 3 – HIV neg: Week 12, any detectable viral load--------------STOP TXGenotype 2 or 3 – HIV pos: Week 12, < 2 log decrease in viral load---------STOP TXGenotype 4,5,6: Week 12, < 2 log decrease in viral load-----------------------STOP TXGenotype 2,3,4,5,6: Week 24, any detectable viral load-----------------------STOP TX
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BOCEPREVIRProtease inhibitor / Direct Acting Antiviral (DAA) agentApproved by the FDA in 2011For treatment of genotype 1 onlyDramatically increase cure rate (75% compared to 30-
45% with Peg/Riba)Duration of treatment is based on viral load response –
“Viral Response Guided Therapy”Need to give 4 pills (total 800mg) exactly every 8 hours
with fatty content meal in the stomachSide effects include: Anemia, neutopenia, dysgeusia
(alteration in taste), dry mouth, nausea, vomiting & diarrhea
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BOCPREVIR TREATMENT PROTOCOL
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TELAPREVIRAlso a protease inhibitor / DAAApproved by FDA in 2011 Included in the CDCR Formulary in 2012Successful cure rate parallels Boceprevir at about 75%Also given with “Viral Response Guided Therapy”Need to give 2 pills (total 750mg) every 8 hours with
fatty meal in stomachSide effects include: Rash, especially a burning anorectal
pruritis in 11% of patients; serrious skin reactions like DRESS and Steven-Johnson, and anemia.
Less drug interactions with HIV meds c/w Boceprevir
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TELAPREVIR TREATMENT PROTOCOL
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RESISTANCE MUTATIONS WITH BOEPREVIR & TELAPREVIR 100% cross-resistance with
Boceprevir and Telaprevir
No logic to switch between the 2 agents for management of treatment failure
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NEW DAA AGENTS IN THE PIPELINE
Next-generation protease inhibitorsNonstructural protein (NS5A) inhibitorsNonnucleoside polymerase inhibitorsNucelos(t)ide polymerase inhibitorsInterferon alpha “free” regimensRecent trials yielding 90% cure rates!
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AGENTS YOU WILL SEE IN THE NEXT YEAR
SOFOSBUVIR Nuceloside polymerase inhibitor To be approved for NON-interferon tx of
genotypes 2 & 3 Very low side effect profile May be approved by FDA in December 2013
DACLATASVIR Completely different mechanism (NS5A
Inhibitor) No cross resistance with protease or
polymerase inhibitors
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PARALLELS IN THE DEVELOPMENT OF HEPATITIS C TREATMENT WITH THE HISTORY OF HIV TREATMENT