Zepatier is a fixed-dose combination of elbasvir and grazoprevir approved to treat chronic hepatitis C virus (HCV) genotypes 1 or 4 in adults. Elbasvir is an HCV NS5A inhibitor that blocks viral RNA replication, while grazoprevir is an HCV NS3/4A protease inhibitor that inhibits viral replication and particle formation. Zepatier is administered as a once-daily oral tablet, with or without ribavirin, for 12 to 16 weeks. Common side effects include fatigue, nausea, anemia, and headache. The drug is contraindicated in those with moderate to severe hepatic or renal impairment, during pregnancy or lactation.

1. ZEPATIER
(ELBASVIR AND GRAZOPREVIR)
DONE BY : HUSSIEN SALAM

2. 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.

3. 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.

4. 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.

5. HEPATITIS C VIRUS
Hepatitis C virus
Group IV ((+)ssRNA)Group:
UnassignedOrder:
FlaviviridaeFamily:
HepacivirusGenus:
Hepatitis C virusSpecies:

6. 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.

7. 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).

8. 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.

10. 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.

11. 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.

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

13. Fatigue
Headache Nausea
Anemia
Zepatier
+
Ribavirin

14. 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.

15. CONTRAINDICATIONS AND PRECAUTION
• Renal Impairment
• Hepatic Impairment (moderate or severe)
• Pregnancy
• Lactation

16. 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)

17. 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

18. Thank For Your Attention