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Simeprevir Dosage

Applies to the following strength(s): 150 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis C

150 mg orally once a day with food

Recommended Regimen and Duration of Therapy:
Therapy-naive and therapy-experienced patients with HCV genotype 1 infection:
-Without cirrhosis, without HIV coinfection: Simeprevir and sofosbuvir for 12 weeks
-With cirrhosis, without HIV coinfection: Simeprevir and sofosbuvir for 24 weeks

Therapy-naive patients and prior relapsers with HCV genotype 1 or 4 infection, with or without cirrhosis, without HIV coinfection:
-First 12 weeks: Simeprevir, peginterferon alfa, and ribavirin
-Additional 12 weeks: Peginterferon alfa and ribavirin
-Total duration of therapy: 24 weeks (unless patient meets stopping rules)

Therapy-naive patients and prior relapsers with HCV genotype 1 or 4 infection, without cirrhosis, with HIV coinfection:
-First 12 weeks: Simeprevir, peginterferon alfa, and ribavirin
-Additional 12 weeks: Peginterferon alfa and ribavirin
-Total duration of therapy: 24 weeks (unless patient meets stopping rules)

Therapy-naive patients and prior relapsers with HCV genotype 1 or 4 infection, with cirrhosis, with HIV coinfection:
-First 12 weeks: Simeprevir, peginterferon alfa, and ribavirin
-Additional 36 weeks: Peginterferon alfa and ribavirin
-Total duration of therapy: 48 weeks (unless patient meets stopping rules)

Prior non-responders (including partial and null responders) with HCV genotype 1 or 4 infection, with or without cirrhosis, with or without HIV coinfection:
-First 12 weeks: Simeprevir, peginterferon alfa, and ribavirin
-Additional 36 weeks: Peginterferon alfa and ribavirin
-Total duration of therapy: 48 weeks (unless patient meets stopping rules)

Treatment Stopping Rules for Patients with Inadequate On-Treatment Virologic Response during Treatment with Simeprevir, Peginterferon alfa, and Ribavirin:
-HCV-RNA level at least 25 international units/mL at treatment week 4: Discontinue simeprevir, peginterferon alfa, and ribavirin.
-HCV-RNA level at least 25 international units/mL at treatment week 12 or 24: Discontinue peginterferon alfa and ribavirin (simeprevir finished at week 12).

Comments:
-Liver chemistry tests should be monitored before and during simeprevir combination therapy.
-Before starting this drug with sofosbuvir, may consider screening patients with HCV genotype 1a infection for virus with the NS3 Q80K polymorphism
-Before starting this drug with peginterferon alfa and ribavirin, screening patients with HCV genotype 1a infection for virus with the NS3 Q80K polymorphism is strongly recommended; alternative therapy should be considered if the Q80K polymorphism is present.
-Therapy-experienced patients include prior relapsers, prior partial responders, and prior null responders who failed prior interferon-based therapy.
-Prior relapsers: HCV-RNA not detected at the end of prior interferon-based therapy and HCV-RNA detected during follow-up.
-Prior partial responder: Prior on-treatment reduction in HCV-RNA at least 2 log10 international units/mL from baseline at week 12 and HCV-RNA detected at end of prior interferon-based therapy.
-Prior null responder: Prior on-treatment reduction in HCV-RNA less than 2 log10 international units/mL from baseline at week 12 during prior interferon-based therapy.
-Virologic treatment stopping rules not available for combination therapy with sofosbuvir.
-HCV-RNA should be monitored during combination therapy with peginterferon alfa and ribavirin as clinically indicated. It is not likely that patients with inadequate on-treatment virologic response (i.e., HCV-RNA at least 25 international units/mL) will achieve a sustained virologic response; therapy discontinuation recommended in such patients.

Use: In combination with other antivirals, for the treatment of chronic HCV genotype 1 or 4 infection

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended.

Comments:
-The manufacturer product information for coadministered HCV drugs should be consulted regarding use in patients with renal dysfunction.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate or severe liver dysfunction (Child-Pugh B or C): Not recommended.

Comments:
-The manufacturer product information for coadministered HCV drugs should be consulted regarding use in patients with liver dysfunction or hepatic decompensation.

Dose Adjustments

To prevent treatment failure, reducing the dose of this drug or interrupting treatment should be avoided. If this drug is stopped due to side effects or inadequate on-treatment virologic response, it must not be restarted.

The manufacturer product information for coadministered HCV antiviral drugs should be consulted for appropriate dose adjustment or interruption due to side effects. If any of the coadministered HCV antiviral drugs are permanently stopped for any reason, this drug should also be discontinued.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:
-Significant removal via dialysis is not likely (highly protein bound).

Other Comments

Administration advice:
-Use in combination with other antiviral drugs for the treatment of chronic HCV; do not use as monotherapy.
-Administer with food.
-Swallow capsules whole.
-If any of the coadministered HCV antiviral drugs are permanently stopped for any reason, discontinue this drug.
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store capsules in the original bottle to protect from light; store at room temperature below 30C (86F)

General:
-The assay used to monitor HCV-RNA levels should be sensitive, with a lower limit of quantification of at least 25 international units/mL.
-Efficacy of this drug with peginterferon alfa and ribavirin is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism at baseline compared to those without the Q80K polymorphism.
-This drug is not recommended for patients who previously failed therapy with a regimen that included this or other HCV protease inhibitors.
-The manufacturer product information for coadministered HCV antiviral drugs should be consulted for additional information.

Monitoring:
-General: HCV-RNA levels (at weeks 4 and 12 and as clinically indicated during combination therapy with peginterferon alfa and ribavirin)
-Hepatic: Liver chemistry tests (before and as clinically indicated during therapy)

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information).
-Contact healthcare provider at once if fatigue, weakness, lack of appetite, nausea and vomiting, jaundice, or discolored feces develop.
-Use sun protection (e.g., hat, sunglasses, protective clothing, sunscreen), limit exposure to natural sunlight, and avoid artificial sunlight (e.g., tanning beds, phototherapy) during use of this drug.
-Contact healthcare provider at once if photosensitivity reaction or rash occurs; do not stop this drug due to either event unless directed by healthcare provider.

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