Hepatitis C: Treatment: Special Situations News Announcement

On December 19, 1999, B.C. Pharmacare approved the funding of Rebetron, the name for the combination of Intron (interferon alpha) and Ribavirin. Rebetron is manufactured by Schering Canada Inc., B.C. Pharmacare have set guidelines for Rebetron approval:

1. Eligibility:

patients must have had hep C for over 3 months,
– the ALT must be over 1 and 1/2 times the upper limit of normal on 2 occasions 3 months apart,
– Hep C must be documented by a positive HCV RNA by PCR,
– the dose of Ribavirin is weight determined, patients over 75 kg receive 1200 mg/day in divided dose, patients under 75 kg receive 1000 mg/day in divided dose, taken with food,
– patients will all be tested at 6 months for a response with an HCV RNA by PCR,
– if the HCV RNA is positive, no further treatment will be funded,
– if the HCV RNA is negative:
– patients with genotype 1 will receive funding for 6 more months,
– patients with genotypes 2,3 or 4 will require no further treatment.
(the genotype will have to be done prior to the therapy since the genotype can only be done if there is detectable virus in the blood) – genotype will only be done on patients approved to undergo treatment.

2. Funding formula:

– the same as for all other Pharmacare funded medications,
– the patient (or his/her third party coverage) must pay the first $800.00 in a calendar year,
– after the first $800.00, Pharmacare pays 70%, the patient (or his/her third party coverage) pays 30%,
– after a cost of $2,000.00, Pharmacare pays 100%,
– patients on welfare and seniors will be covered 100% of total cost.

3. Financial calculation:

– the cost of Rebetron is about $1,800.00 a month,
– for the first month the patient (or their third party coverage) will pay:
– $800.00 plus 30% of $1,000.00 ($300.00) = $1,100.00
– for the second month, the patient (or their third party coverage) will pay:
– 30% of $1,800.00 = $540.00
– for the third month the patient (or their third party coverage) will pay:
– $360.00 ($2,000.00 less $1,100.00 less $540.00)
– for all subsequent months, Pharmacare pays the full cost.

4. Assistance:

– for patients who may have financial difficulty, assistance towards the amount not covered by Pharmacare may be provided through the CARE line,
– CARE (Canadian Advisory Reimbursement Exchange) is an independant agency that
determines a patient’s financial status and recommends to the pharmaceutical company
compensation for the costs not covered by Pharmacare.

Iron Overload:

o some patients with hep C may have an abnormal serum ferritin,
o ferritin is an acute phase reactant protein and may be moderately elevated simply because of inflammation, (i.e. the hepatitis),
o very high ferritin levels may indicate iron overload,
o iron overload may be due to hemochromatosis,
o the inherited disease is autosomal recessive,
o increased hepatic iron may also be due to alcohol, or hemolysis,
o the serum iron and iron binding capacity are usually elevated in hemochromatosis and the % saturation is usually 100%,
o the iron binding (transferrin) may be low in patients with advanced liver disease due to inadequate synthesis,
o patients with iron overload should be treated with phlebotomies to reduce iron to normal levels before treatment for hep C,
o patients with normal iron levels should not be phlebotomized prior to treatment for hep C.

Porphyria Cutanea Tarda (PCT):

o porphyria cutanea tarda occurs in a small number of patients with hep C,
o symptoms of PCT may antedate the diagnosis of hep C,
o characteristic symptoms are blistering, then sores, then pigmented scars on exposed skin such as hands, arms and shins,
o PCT is not related to enzyme levels, viral levels, or hepatic pathology,
o diagnosis is confirmed with 24 hour urine porphyrins,
o treatment required:
– phlebotomy is often effective,
– treating the hep C usually causes improvement,
– a few patients require drug therapy,
o PCT can occur in other advanced liver diseases.

Lichen planus:

o may occur as first symptom of hep C,
o often seems to effect the oral cavity,
o a biopsy may be necessary to confirm the diagnosis,
o is not related to level of serum enzymes,
o is not related to viral load,
o is not related to hepatic pathology,
o can become much more severe during interferon treatment,
o can be very painful and interfere with eating and nutrition,
o aggressive therapy may be required,
o sometimes systemic steroids may be required as treatment,
o there is no evidence that steroids make hep C more active.

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