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.
9.
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
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.
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)
Treatment options vary depending on what form of hepatitis you have and what caused the infection. You can prevent some forms of hepatitis through immunizations or lifestyle precautions.
Classification of the RNA viruses has proven to be a difficult problem. This is in part due to the high mutation rates these genomes undergo. Classification is based principally on the type of genome (double-stranded, negative- or positive-single-strand) and gene number and organisation. Currently there are 5 orders and 47 families of RNA viruses recognised. There are also many unassigned species and genera.
Food and Drug Administration
the genetic constitution of an individual organism.
Nonstructural protein 5A (NS5A) is a zinc-binding and proline-rich hydrophilic phosphoprotein that plays a key role in Hepatitis C virus RNA replication.
Ribavirin is an anti-viral drug used for severe Human respiratory syncytial
infection [2]; hepatitis C infection, including if persistent,
The most common side effects experienced by patients taking Zepatier alone were fatigue, headache, and nausea. The most common side effects experienced by patients taking Zepatier with ribavirin were anemia and headache.
No adequate human data are available to establish whether or not ZEPATIER poses a risk to pregnancy outcomes
It is not known whether ZEPATIER is present in human breast milk, affects human milk production, or has effects on the breastfed infant.