My Hep

Uses

My Hep is used for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. My Hep efficacy has been established in subjects with MCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.

My Hep is also used to associated treatment for these conditions: Chronic Hepatitis C Genotype 1, Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 3, Chronic hepatitis C genotype 4, Chronic hepatitis C genotype 5, Genotype 6 chronic hepatitis C infection

How My Hep works

My Hep is nucleotide analog inhibitor, which specifically inhibits HCV NS5B (non-structural protein 5B) RNA-dependent RNA polymerase. Following intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), sofosbuvir incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator . More specifically, My Hep prevents HCV viral replication by binding to the two Mg2+ ions present in HCV NS5B polymerase's GDD active site motif and preventing further replication of HCV genetic material .

Dosage

My Hep dosage

One 400 mg tablet taken once daily with or without food. Should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC.

Recommended combination therapy: (HCV Mono-infected and HCV/HIV-1 Co-infected)-

• Genotype 1 or 4: My Hep + Peginterferon alfa + Ribavirin for 12 weeks
• Genotype 2: My Hep + Ribavirin for 12 weeks
• Genotype 3: My Hep + Ribavirin for 24 weeks

My Hep in combination with Ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are Interferon ineligible

Should be used in combination with Ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation whichever occurs first

A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease

Side Effects

The most common adverse events observed with My Hep in combination with ribavirin were fatigue and headache.

The most common adverse events for My Hep, peginterferon alfa and Ribavirin combination therapy were fatigue, headache, nausea, insomnia and anemia.

The following ADRs occured in <1% of subjects receiving My Hep in combination regimen.

Hematologic effects: pancytopenia (particularly in subjects receiving concomitant Pegylated Interferon).

Psychiatric disorders: severe depression (particularly in subjects with pre-existing history of psychiatric illness), including suicidal ideation and suicide.

Toxicity

My Hep, as a single agent, has very mild toxicity. The most common adverse reactions are headache and fatigue. The FDA Label currently warns of a risk of symptomatic bradycardia when Epclusa is used in combination with amiodarone .

Precaution

Bradycardia with amiodarone co-administration: Serious symptomatic bradycardia may occur in patients taking amiodarone and My Hep in combination with another direct acting antiviral (DAA), particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Co-administration of amiodarone with My Hep in combination with another DAA is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.

Interaction

Reduced therapeutic effect with drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/ oxcarbazepine, rifabutin/ rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered with amiodarone in combination with another direct acting antiviral.

Food Interaction

• Take with or without food.

My Hep Drug Interaction

Moderate: insulin glargineUnknown: aspirin, fexofenadine, aspirin, calcium / vitamin d, Allergy , heparin, esomeprazole, multivitamin with minerals, acetaminophen, peginterferon alfa-2a, peginterferon alfa-2b, tacrolimus, vitamin a topical, bioflavonoids, sotalol, valproic acid, thiamine, cyanocobalamin, cholecalciferol

My Hep Disease Interaction

Major: immunosuppressionModerate: hepatic impairment, renal impairment

Volume of Distribution

The volume of distribution for sofosbuvir has yet to be determined .

Elimination Route

When given orally, sofosbuvir reaches its maximum plasma concentration in about 0.5 to 2 hours with a maximal concentration (Cmax) of 567 ng/mL .

Half Life

My Hep has a terminal half life of 0.4 hours .

Clearance

The clearance of sofosbuvir has yet to be determined .

Elimination Route

My Hep is eliminated by three routes: urine ( 80%), feces (14%), and respiration (2.5%); however, elimination through the kidneys is the major route .

Pregnancy & Breastfeeding use

Pregnancy Category- B. Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least 2 effective methods of contraception and have monthly pregnancy tests.

Lactation: Unknown if distributed in human breast milk; take into account the importance of therapy to the mother when administered combination with ribavirin and/or peg-interferon alfa; because of the potential for adverse reaction, breastfeeding is not recommended

Contraindication

When Sofosbivur is used in combination with Ribavirin or Peginterferon alfa/ Ribavirin, the contraindications applicable to those agents are applicable to combination therapies. My Hep combination treatment with Ribavirin or Peginterferon alfa/Ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant, because of the risks for birth defects and fetal death associated with Ribavirin.

Special Warning

Geriatric Use: No dose adjustment of My Hep is warranted in geriatric patients.

Acute Overdose

The highest dose of My Hep is a single dose of My Hep 1200 mg. No specific antidote is available for overdose treatment. Treatment of overdose with My Hep consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

Storage Condition

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.

Innovators Monograph

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