ZEPATIER(ELBASVIR AND GRAZOPREVIR)

DONE BY : HUSSIEN SALAM

HEPATITIS

• Hepatitis refers to an inflammatory condition of the liver. It’s commonly caused by a viral infection.

• Viral infections of the liver that are classified as hepatitis include hepatitis A, B, C, D, and E.

• Hepatitis A is a milder version of the disease, and hepatitis C and D are more severe.

HEPATITIS C

• Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years.

HEPATITIS C

• Some people with chronic HCV infection develop cirrhosis over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer.

HEPATITIS C VIRUSHepatitis C virus

Group IV ((+)ssRNA) Group:

Unassigned Order:

Flaviviridae Family:

Hepacivirus Genus:

Hepatitis C virus Species:

INFORMATION

• Name: Zepatier• Company: Merck Inc.• Approval Status: Approved 28 January 2016• Specific Treatments: for the treatment of chronic hepatitis C virus

(HCV) genotypes 1 or 4 infection in adults.

GENERAL INFORMATION

• Zepatier is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor(virus RNA replication), and grazoprevir, an HCV NS3/4A protease inhibitor(viral replication and the formation of infectious viral particles).

GENERAL INFORMATION

• Zepatier is specifically indicated with or without ribavirin (stop viral RNA synthesis and viral mRNA capping) for the treatment of chronic HCV genotypes 1 or 4 infection in adults.

PHARMACOKINETIC

• Absorption: Following administration of ZEPATIER to HCV-infected subjects, elbasvir peak concentrations occur at a median Tmax of 3 hours (range of 3 to 6 hours); grazoprevir peak concentrations occur at a median Tmax of 2 hours (range of 30 minutes to 3 hours).

• Distribution: Elbasvir and grazoprevir are extensively bound (greater than 99.9% and 98.8%, respectively) to human plasma proteins.

PHARMACOKINETIC

• Elimination: The geometric mean apparent terminal half-life is approximately 24 and 31 hours.

• Metabolism: Elbasvir and grazoprevir are partially eliminated by oxidative metabolism, primarily by CYP3A.

• Excretion: The primary route of elimination of elbasvir and grazoprevir is through feces with almost all (greater than 90%) while 1% in urine.

SIDE EFFECTS

Adverse effects associated with the use of Zepatier may include, but are not limited to, the following:• Fatigue• Nausea• Anemia• Headache

Fatigue

Headache Nausea

Anemia

Zepatier+

Ribavirin

ROUTE OF ADMINISTRATION• Zepatier is supplied as a tablet for oral

administration. Recommended dosage: One tablet taken orally once daily with or without food. (50 mg of elbasvir and 100 mg of grazoprevir)

• The duration of treatment is 12 to 16 weeks.

CONTRAINDICATIONS AND PRECAUTION

• Renal Impairment• Hepatic Impairment (moderate or severe)• Pregnancy• Lactation

SUMMARY OF TREATMENT

• Hepatitis A (vaccine available)• Hepatitis B (vaccine available)• Hepatitis C (Antiviral available)• Hepatitis D (Transmission with B virus)• Hepatitis E (Resolves on its own without treatment)

REFRENSESS

• MSD International GmbH, Ballydine, Clonmel, Ireland

For patent information: www.merck.com/product/patent/home.html

• http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm

• http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100130/zepatier-elbasvir-and-grazoprevir

• http://thasso.com/elbasvirgrazoprevir-zepatier-for-the-treatment-of-chronic-hepatitis-c-virus-hcv-genotypes-1-and-4-infections/

• http://www.healthline.com/health/hepatitis#Types2

Thank For Your Attention