Complete Information @ Medscape
Hepatitis C Medication
Author: Sandeep Mukherjee, MB, BCh, MPH, FRCPC; Chief Editor: Julian Katz, MD
Overview
Presentation
DDx
Workup
Treatment
Medication
Follow-up
Telaprevir (Incivek)
Inhibits HCV NS3/4A protease needed for proteolytic cleavage of the HCV encoded polyprotein into mature forms. Indicated for treatment of chronic hepatitis C (CHC) genotype 1 infection in combination with peginterferon alfa and ribavirin. Indication is specifically for adults with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Adult Dosing & Uses
Dosing Forms & Strengths
tablet 375mg
Chronic Hepatitis C
Indicated for treatment of chronic hepatitis C (CHC) genotype 1 infection in combination with peginterferon alfa and ribavirin
Indication is specifically for adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers
750 mg PO TID (ie, q7-9hr) with food (not low fat)
Administer for 12 weeks in combination with peginterferon alfa and ribavirin (telaprevir must not be used as monotherapy)
Treatment Duration
Duration of treatment depends on HCV-RNA levels
Triple therapy: telaprevir, peginterferon alfa, and ribavirin
Dual therapy: peginterferon alfa and ribavirin
Treatment-naïve and prior relapse patients
HCV-RNA levels undetectable at weeks 4 and 12: Administer triple therapy first 12 weeks, then dual therapy an additional 12 weeks
HCV-RNA levels detectable at weeks 4 and 12 (ie, <1000 IU/mL): Administer triple therapy first 12 weeks, then dual therapy an additional 36 weeks
Prior partial and null responder patients
All patients: Administer triple therapy first 12 weeks, then dual therapy an additional 36 weeks
Treatment futility
Patients with inadequate viral response are unlikely to achieve sustained virologic response, and may develop treatment-emergent resistance substitutions
Discontinuation of therapy is recommended in all patients with either of the following circumstances:
HCV-RNA levels >1000 IU/mL at treatment weeks 4 or 12, OR
HCV-RNA levels detectable at treatment week 24
Renal or Hepatic Impairment
See peginterferon alfa and ribavirin monographs for recommended dose adjustments
Renal impairment
Mild, moderate, or severe: No dosage adjustment required
Has not been studied in patients with end-stage renal disease (ESRD) or on hemodialysis
Hepatic impairment
Moderate-to-severe (Child-Pugh B or C, score 7 or greater): Not recommended
Decompensated liver disease: Not recommended
Administration
Must be administered in combination with peginterferon alfa and ribavirin
If peginterferon alfa or ribavirin is discontinued for any reason, telaprevir must also be discontinued
To prevent treatment failure, dose must not be reduced or interrupted
Administer with a meal or snack (not low fat)
Also View;
Drug Interactions
Adverse Effects
Contraindications & Cautions
Pregnancy & Lactation
Pharmacology
Boceprevir (Victrelis)
Inhibits HCV NS3/4A protease needed for proteolytic cleavage of the HCV encoded polyprotein into mature forms. Indicated for treatment of chronic hepatitis C (CHC) genotype 1 infection in combination with peginterferon alfa and ribavirin. Indication is specifically for adults with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Adult Dosing & Uses
Dosing Forms & Strengths
capsule 200mg
Chronic Hepatitis C
Indicated for treatment of chronic hepatitis C (CHC) genotype 1 infection in combination with peginterferon alfa and ribavirin
Indication is specifically for adults with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy
Initiate therapy with peginterferon alfa and ribavirin for 4 weeks, THEN
Add boceprevir 800 mg PO TID (ie, q7-9hr) with food
Treatment duration
Duration of treatment depends on HCV-RNA levels at treatment weeks 8, 12, and 24
HCV-RNA levels at 8 weeks
Previously untreated and HCV-RNA levels undetectable: Complete 3-medication regimen at week 28
Previously untreated and HCV-RNA levels detectable: Continue 3 medication regimen through week 36, then continue peginterferon alfa and ribavirin through week 48
Partial responders or relapsed and HCV-RNA levels undetectable: Complete 3-medication regimen at week 36
Partial responders or relapsed and HCV-RNA levels detectable: Continue 3 medication regimen through week 36, then continue peginterferon alfa and ribavirin through week 48
HCV-RNA levels at 12 weeks
Response-guided therapy was not studied in individuals who had less than a 2-log10 HCV-RNA decline by treatment week 12 during prior therapy with peginterferon alfa and ribavirin
If considered for treatment, these patients should receive peginterferon alfa and ribavirin x4 weeks followed by boceprevir x44 weeks in combination with peginterferon alfa and ribavirin
In addition, consideration should be given to treating previously untreated patients who are poorly interferon responsive (as determined at TW 4) with 4 weeks peginterferon alfa and ribavirin followed by boceprevir x44 weeks in combination with peginterferon alfa and ribavirin in order to maximize rates of a sustained virologic response
HCV-RNA levels at 24 weeks
If HCV-RNA levels are undetectable at treatment week 24, continue with treatment regiment identified at week 8
Treatment futility
Discontinuation of therapy is recommended in all patients with either of the following circumstances:
If HCV-RNA levels 100 IU/mL or greater at week 12, discontinue 3-medication regimen, OR
If confirmed, detectable HCV-RNA levels at week 24, discontinue 3-medication regimen
Compensated cirrhosis
Peginterferon alfa and ribavirin x 4 weeks followed by boceprevir x44 weeks in combination with peginterferon alfa and ribavirin
Renal or Hepatic Impairment
No dose adjustment for boceprevir is required
See peginterferon alfa and ribavirin monographs for recommended dose adjustments
Administration
Must be administered in combination with peginterferon alfa and ribavirin
Administer with a meal or light snack
AlsoView;
Drug Interactions
Adverse Effects
Contraindications & Cautions
Pregnancy & Lactation
Pharmacology
View full drug information Interferon alfa-2b (Intron-A)
Protein product manufactured by recombinant DNA technology. Modulation of host immune response may play important roles in the treatment of viral diseases.
View full drug information Interferon alfacon 1 (Infergen)
Protein product manufactured by recombinant DNA technology. Modulation of host immune response may play important roles in the treatment of viral diseases.
Synthesized by combining most common amino acid sequences from all 12 naturally occurring IFNs.
View full drug information Peginterferon alfa 2b (PEG-Intron)
Consists of IFN alfa-2b attached to a single 12-kd PEG chain. Excreted by kidneys. Has sustained absorption, slower rate of clearance, and longer half-life than unmodified IFN. Permits more convenient once-weekly dosing. Significantly improves quality of life for patients.
View full drug information Pegylated interferon alfa-2a (Pegasys)
Consists of IFN alfa-2a attached to a 40-kd branched PEG molecule. Predominantly metabolized by liver.
View full drug information Ribavirin (Rebetol)
Antiviral nucleoside analog. Chemical name is D -ribofuranosyl-1H-1,2,4-triazole-3-carboxamide. Given alone, has little effect on course of hepatitis C. Given with IFN, significantly augments SVR rate.
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