Anti-Hepatitis Agents
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adefovir
(Hepsera ®):
TOP
| Nucleoside Reverse Transcriptase
Inhibitor. Activity against human
hepatitis B virus. Hepatitis
B (chronic): Initial dosing - 10 mg orally once daily.
Dose adjustments are indicated in renal impairment. It is no
longer being considered for treatment of HIV.
Renal dosing:
(CrCl 20-49 ml/min): 10 mg every 48 hours
(CrCl 10-19 ml/min): 10 mg every 72 hours.
(CrCl < 10 ml/min):
no recommendation available.
(Hemodialysis): 10 mg every 7
days following dialysis.
Supplied: 10 mg tablet.
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entecavir
(Baraclude ®)
TOP
| Nucleoside Reverse Transcriptase
Inhibitor.
Dosing (Adults): Treatment
of chronic hepatitis B infection:
1) Nucleoside treatment naive: 0.5 mg
orally once daily.
2) Lamivudine-resistant viremia (or known
lamivudine-resistant mutations): 1 mg orally once daily
Renal dosing:
CrCl 30-49 ml/min: Administer 50% of
usual dose.
CrCl 10-29 ml/min: Administer 30% of
usual dose.
CrCl <10 ml/min (including dialysis):
Administer 10% of usual dose. Administer after hemodialysis.
Supplied: 0.5 mg, 1 mg
tablet. 0.05 mg/mL (210 mL) oral solution.
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lamivudine
Epivir-HBV®
TOP
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Nucleoside Reverse Transcriptase
Inhibitor.
Dosing (Adults): hepatitis B:
100 mg daily. HIV: 150 mg twice daily or 300 mg once daily.
<50 kg: 4 mg/kg twice
daily (maximum: 150 mg twice daily).
Renal dosing:
See package insert.
Supplied:
Epivir ®: 150 mg, 300 mg
tablet. Epivir-HBV ®: 100 mg tab.
Oral solution: Epivir®: 10 mg/mL (240 mL). Epivir-HBV®: 5 mg/mL (240
mL).
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peginterferon
alfa-2a
(Pegasys ®)
TOP
| Dosing
(Adults):
Chronic hepatitis C: Monotherapy: 180 mcg SQ once weekly
for 48 weeks. Combination therapy with ribavirin:
Recommended dosage: 180 mcg SQ once/week with ribavirin.
Chronic hepatitis B:
180 mcg SQ once
weekly for 48 weeks.
Modification
of dosing based on ADR:
Moderate to severe adverse
reactions: Initial: 135 mcg/week - may need decreased to 90 mcg/week in some
cases.
Based on hematologic parameters:
ANC <750/mm3: 135
mcg/week
ANC <500/mm3:
Suspend therapy until >1000/mm3, then restart at 90 mcg/week and monitor.
Platelet count
<50,000/mm3: 90 mcg/week.
Platelet count
<25,000/mm3: Discontinue therapy.
Depression (severity based on
DSM-IV criteria):
- Mild depression: No
dosage adjustment required; evaluate once weekly by visit/phone call. If
depression remains stable, continue weekly visits. If depression improves,
resume normal visit schedule.
- Moderate depression:
Decrease interferon dose to 90-135 mcg once/week; evaluate once weekly with
an office visit at least every other week. If depression remains stable,
consider psychiatric evaluation and continue with reduced dosing. If
symptoms improve and remain stable for 4 weeks, resume normal visit
schedule; continue reduced dosing or return to normal dose.
- Severe depression:
Discontinue interferon permanently. Obtain immediate psychiatric
consultation. Discontinue ribavirin if using concurrently. |
Renal dosing:
CrCl <50 ml/min: Use caution - monitor
for toxicity. End-stage renal disease
- hemodialysis: 135 mcg/week - monitor for toxicity.
Supplied:
Injection: 180 mcg/0.5 ml (0.5 ml) prefilled syringe.
180 mcg/mL (1 ml). |
peginterferon
alfa-2b
(PEG-Intron ®):
TOP
| Dosing
(Adults): Chronic hepatitis C: Administer SQ dose
once weekly. Note: Usual duration is for 1 year. After 24 weeks of
treatment, if serum HCV RNA is not below the limit of detection of the
assay, consider discontinuation:
Monotherapy: Initial:
<= 45
kg: 40 mcg
46-56 kg: 50 mcg
57-72 kg: 64 mcg
73-88 kg: 80 mcg
89-106 kg: 96 mcg
107-136 kg: 120 mcg
137-160 kg: 150 mcg |
Combination therapy with ribavirin (400 mg
twice daily): Initial: 1.5 mcg/kg/week
<40 kg: 50 mcg
40-50 kg: 64 mcg
51-60 kg: 80 mcg
61-75 kg: 96 mcg
76-85 kg: 120 mcg
>85 kg: 150 mcg |
Renal dosing:
Monitor
for signs and symptoms of toxicity and if toxicity occurs then adjust dose.
Do not use in patients with CrCl <50 mL/minute. Patients were excluded
from the clinical trials if serum creatinine >1.5 times the upper limits
of normal.
Supplied:
Injection (powder for reconstitution) - syringe or vial: 50 mcg, 80 mcg,
120 mcg, 150 mcg.
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Rebetron ®
(interferon alfa-2b + Ribavirin ):
TOP
| Rebetron Combination
Therapy. Indications: treatment of chronic hepatitis C in patients
with compensated liver disease previously untreated with alpha
interferon or who have relapsed following alpha interferon therapy.
Adult
(usual):
(75 kg or less): ribavirin (1000 mg/day) 400 mg orally qam and 600
mg orally qpm (two 200 mg capsules in the morning and three
200 mg capsules in the evening) - plus interferon- 3 million IU SC 3 times a week.
(>75 kg): ribavirin (1200 mg/day) - 600 mg orally bid (three 200 mg capsules in the morning and three 200 mg capsules in the
evening) plus interferon- 3 million IU
SC 3 times a week.
Renal dosing: Patients
with CrCl <50 ml/min should not receive ribavirin.
Supplied: [Rebetol Capsules - 200mg
+ Intron A Injection combination package]. Refrigerate.
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ribavirin
(Rebetol ®):
TOP
| Indications: Use in combination with
Intron A (interferon alfa-2b,
recombinant) injection for the treatment of chronic hepatitis C in
patients with compensated liver disease previously untreated with alpha
interferon or who have relapsed following alpha interferon therapy.
Adult
(usual):
( 75 kg or less): ribavirin, 400 mg orally qam and
600 mg orally qpm.
(>75 kg): ribavirin, 600 mg orally bid
(given in the morning and evening).
Renal dosing:
Patients
with CrCl <50 ml/min should not receive ribavirin. |
